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A Trial of Intratumoral Injections of SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

This is a phase 1b/2, open-label, multicenter trial designed to evaluate the safety, tolerability, biologic activity, and preliminary efficacy of intratumoral SD 101 injections in combination with intravenous pembrolizumab in patients with metastatic melanoma or recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

Phase 1 of this trial is a modified 3+3 dose escalation study evaluating escalating or intermediate dose levels of SD-101 given with a fixed dose of pembrolizumab in patients with metastatic melanoma.

Phase 2 of this study will consist of 7 expansion cohorts to further evaluate the efficacy and safety of SD-101 given in combination with pembrolizumab in specific melanoma and HNSCC populations: For each of the indications in melanoma and HNSCC 2 separate cohorts will be recruited, those who are anti-programmed death receptor-1/ligand 1 (anti-PD-1/L1) therapy naïve and those who have progressive disease (PD) while receiving anti-PD-1/L1 therapy.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Dynavax Technologies Corporation

Collaborator: Merck Sharp & Dohme Corp.

Intervention(s):

  • Drug: SD-101(1)
  • Biological: Pembrolizumab
  • Drug: SD-101(2)
  • Biological: Pembrolizumab

Phase:

Phase 1/Phase 2

Eligibility


Inclusion Criteria (Phase 1 and 2 Melanoma and HNSCC patients)

   - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.

   - Life expectancy of at least 6 months.

   - Have provided tissue biopsy sample enough for PD-L1 expression level testing and RNA
   expression profiling.

Inclusion Criteria: Phase 2 Melanoma patients

   - Histologically or cytologically confirmed unresectable or metastatic (stage IV)
   melanoma.

   - Have at least 2 sites that qualify as measurable target lesions per RECIST 1.1 of
   which 1 must be palpable or visualized by ultrasound and easily accessible to multiple
   intratumoral injections.

   - For patients with progressive disease (PD) while receiving anti-PD-1/L1 therapy, must
   have documented PD per RECIST v1.1 while receiving a prior anti-PD-1/L1 therapy.

Inclusion Criteria: Phase 2 HNSCC patients

   - Histologically or cytologically confirmed recurrent or metastatic HNSCC that could not
   be treated with curative intent.

   - Have at least 1 measurable target lesion per RECIST 1.1, which must be accessible and
   amenable to multiple intratumoral injections.

   - Must have documented PD per RECIST v1.1 while receiving a prior anti-PD-1/L1 therapy.

Exclusion Criteria: (Phase 1 and 2 Melanoma and HNSCC patients)

   - Received systemic chemotherapy or biological cancer therapy (except anti-PD-1/L1
   therapy) within 3 weeks prior to study enrollment.

   - Received prior radiotherapy within 2 weeks of start of study therapy.

   - Received small molecule inhibitor targeted therapy, such as tyrosine kinase
   inhibitors, within 2 weeks prior to study enrollment.

   - Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other
   form of immunosuppressive therapy (including immune modulators or systemic
   corticosteroids) within 7 days prior to study enrollment

   - Is expected to require any other form of anti-cancer therapy while in the trial.

   - Positive for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).

   - History of or current uveal or ocular melanoma.

   - Active infection including cytomegalovirus.

   - Active autoimmune disease requiring systemic treatment in the past 2 years or a
   disease that requires immunosuppressive medication. Replacement therapy is not
   considered a form of systemic treatment.

   - Current pneumonitis or history of (non-infectious) pneumonitis that required steroids.

   - Known active central nervous system metastases or carcinomatous meningitis.

   - Use of any investigational agent within the last 28 days prior to study enrollment.

   - Has received a live-virus vaccination within 30 days of planned treatment start.
   Seasonal flu vaccines that do not contain live virus are permitted.

   - Any known additional malignancy that is progressing or requires active treatment,
   except for melanoma and HNSCC.

Exclusion Criteria (Phase 2, Melanoma Expansion Cohorts 1 and 5 only)

   - Any prior combination therapy targeting immunoregulatory receptors or mechanisms and
   an anti-PD-1/L1 agent or an investigational agent targeting immunoregulatory receptors

   - Prior therapy with an anti PD 1/L1 agent

Exclusion Criteria: (Phase 2, Melanoma Expansion Cohort 2 only)

• Any prior combination therapy involving agents given by intratumoral injection that
target the innate immune pathway or system.

Exclusion Criteria: (Phase 2, HNSCC Expansion Cohorts 3 and 6 only)

   - Prior therapy with an anti PD 1/L1 agent

   - Require treatment on anticoagulation therapy.

Exclusion Criteria (Phase 2, HNSCC Expansion Cohorts 4 and 7 only)

   - Any prior combination therapy involving agents given by intratumoral injection that
   target the innate immune pathway or system.

   - Require treatment on anticoagulation therapy

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Phuong Pham
650-725-9810
Recruiting

A Trial of Intratumoral Injections of SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

This is a phase 1b/2, open-label, multicenter trial designed to evaluate the safety, tolerability, biologic activity, and preliminary efficacy of intratumoral SD 101 injections in combination with intravenous pembrolizumab in patients with metastatic melanoma or recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

Phase 1 of this trial is a modified 3+3 dose escalation study evaluating escalating or intermediate dose levels of SD-101 given with a fixed dose of pembrolizumab in patients with metastatic melanoma.

Phase 2 of this study will consist of 7 expansion cohorts to further evaluate the efficacy and safety of SD-101 given in combination with pembrolizumab in specific melanoma and HNSCC populations: For each of the indications in melanoma and HNSCC 2 separate cohorts will be recruited, those who are anti-programmed death receptor-1/ligand 1 (anti-PD-1/L1) therapy naïve and those who have progressive disease (PD) while receiving anti-PD-1/L1 therapy.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Dynavax Technologies Corporation

Collaborator: Merck Sharp & Dohme Corp.

Intervention(s):

  • Drug: SD-101(1)
  • Biological: Pembrolizumab
  • Drug: SD-101(2)
  • Biological: Pembrolizumab

Phase:

Phase 1/Phase 2

Eligibility


Inclusion Criteria (Phase 1 and 2 Melanoma and HNSCC patients)

   - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.

   - Life expectancy of at least 6 months.

   - Have provided tissue biopsy sample enough for PD-L1 expression level testing and RNA
   expression profiling.

Inclusion Criteria: Phase 2 Melanoma patients

   - Histologically or cytologically confirmed unresectable or metastatic (stage IV)
   melanoma.

   - Have at least 2 sites that qualify as measurable target lesions per RECIST 1.1 of
   which 1 must be palpable or visualized by ultrasound and easily accessible to multiple
   intratumoral injections.

   - For patients with progressive disease (PD) while receiving anti-PD-1/L1 therapy, must
   have documented PD per RECIST v1.1 while receiving a prior anti-PD-1/L1 therapy.

Inclusion Criteria: Phase 2 HNSCC patients

   - Histologically or cytologically confirmed recurrent or metastatic HNSCC that could not
   be treated with curative intent.

   - Have at least 1 measurable target lesion per RECIST 1.1, which must be accessible and
   amenable to multiple intratumoral injections.

   - Must have documented PD per RECIST v1.1 while receiving a prior anti-PD-1/L1 therapy.

Exclusion Criteria: (Phase 1 and 2 Melanoma and HNSCC patients)

   - Received systemic chemotherapy or biological cancer therapy (except anti-PD-1/L1
   therapy) within 3 weeks prior to study enrollment.

   - Received prior radiotherapy within 2 weeks of start of study therapy.

   - Received small molecule inhibitor targeted therapy, such as tyrosine kinase
   inhibitors, within 2 weeks prior to study enrollment.

   - Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other
   form of immunosuppressive therapy (including immune modulators or systemic
   corticosteroids) within 7 days prior to study enrollment

   - Is expected to require any other form of anti-cancer therapy while in the trial.

   - Positive for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).

   - History of or current uveal or ocular melanoma.

   - Active infection including cytomegalovirus.

   - Active autoimmune disease requiring systemic treatment in the past 2 years or a
   disease that requires immunosuppressive medication. Replacement therapy is not
   considered a form of systemic treatment.

   - Current pneumonitis or history of (non-infectious) pneumonitis that required steroids.

   - Known active central nervous system metastases or carcinomatous meningitis.

   - Use of any investigational agent within the last 28 days prior to study enrollment.

   - Has received a live-virus vaccination within 30 days of planned treatment start.
   Seasonal flu vaccines that do not contain live virus are permitted.

   - Any known additional malignancy that is progressing or requires active treatment,
   except for melanoma and HNSCC.

Exclusion Criteria (Phase 2, Melanoma Expansion Cohorts 1 and 5 only)

   - Any prior combination therapy targeting immunoregulatory receptors or mechanisms and
   an anti-PD-1/L1 agent or an investigational agent targeting immunoregulatory receptors

   - Prior therapy with an anti PD 1/L1 agent

Exclusion Criteria: (Phase 2, Melanoma Expansion Cohort 2 only)

• Any prior combination therapy involving agents given by intratumoral injection that
target the innate immune pathway or system.

Exclusion Criteria: (Phase 2, HNSCC Expansion Cohorts 3 and 6 only)

   - Prior therapy with an anti PD 1/L1 agent

   - Require treatment on anticoagulation therapy.

Exclusion Criteria (Phase 2, HNSCC Expansion Cohorts 4 and 7 only)

   - Any prior combination therapy involving agents given by intratumoral injection that
   target the innate immune pathway or system.

   - Require treatment on anticoagulation therapy

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Phuong Pham
650-725-9810
Recruiting

A Trial of Intratumoral Injections of SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

This is a phase 1b/2, open-label, multicenter trial designed to evaluate the safety, tolerability, biologic activity, and preliminary efficacy of intratumoral SD 101 injections in combination with intravenous pembrolizumab in patients with metastatic melanoma or recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

Phase 1 of this trial is a modified 3+3 dose escalation study evaluating escalating or intermediate dose levels of SD-101 given with a fixed dose of pembrolizumab in patients with metastatic melanoma.

Phase 2 of this study will consist of 7 expansion cohorts to further evaluate the efficacy and safety of SD-101 given in combination with pembrolizumab in specific melanoma and HNSCC populations: For each of the indications in melanoma and HNSCC 2 separate cohorts will be recruited, those who are anti-programmed death receptor-1/ligand 1 (anti-PD-1/L1) therapy naïve and those who have progressive disease (PD) while receiving anti-PD-1/L1 therapy.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Dynavax Technologies Corporation

Collaborator: Merck Sharp & Dohme Corp.

Intervention(s):

  • Drug: SD-101(1)
  • Biological: Pembrolizumab
  • Drug: SD-101(2)
  • Biological: Pembrolizumab

Phase:

Phase 1/Phase 2

Eligibility


Inclusion Criteria (Phase 1 and 2 Melanoma and HNSCC patients)

   - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.

   - Life expectancy of at least 6 months.

   - Have provided tissue biopsy sample enough for PD-L1 expression level testing and RNA
   expression profiling.

Inclusion Criteria: Phase 2 Melanoma patients

   - Histologically or cytologically confirmed unresectable or metastatic (stage IV)
   melanoma.

   - Have at least 2 sites that qualify as measurable target lesions per RECIST 1.1 of
   which 1 must be palpable or visualized by ultrasound and easily accessible to multiple
   intratumoral injections.

   - For patients with progressive disease (PD) while receiving anti-PD-1/L1 therapy, must
   have documented PD per RECIST v1.1 while receiving a prior anti-PD-1/L1 therapy.

Inclusion Criteria: Phase 2 HNSCC patients

   - Histologically or cytologically confirmed recurrent or metastatic HNSCC that could not
   be treated with curative intent.

   - Have at least 1 measurable target lesion per RECIST 1.1, which must be accessible and
   amenable to multiple intratumoral injections.

   - Must have documented PD per RECIST v1.1 while receiving a prior anti-PD-1/L1 therapy.

Exclusion Criteria: (Phase 1 and 2 Melanoma and HNSCC patients)

   - Received systemic chemotherapy or biological cancer therapy (except anti-PD-1/L1
   therapy) within 3 weeks prior to study enrollment.

   - Received prior radiotherapy within 2 weeks of start of study therapy.

   - Received small molecule inhibitor targeted therapy, such as tyrosine kinase
   inhibitors, within 2 weeks prior to study enrollment.

   - Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other
   form of immunosuppressive therapy (including immune modulators or systemic
   corticosteroids) within 7 days prior to study enrollment

   - Is expected to require any other form of anti-cancer therapy while in the trial.

   - Positive for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).

   - History of or current uveal or ocular melanoma.

   - Active infection including cytomegalovirus.

   - Active autoimmune disease requiring systemic treatment in the past 2 years or a
   disease that requires immunosuppressive medication. Replacement therapy is not
   considered a form of systemic treatment.

   - Current pneumonitis or history of (non-infectious) pneumonitis that required steroids.

   - Known active central nervous system metastases or carcinomatous meningitis.

   - Use of any investigational agent within the last 28 days prior to study enrollment.

   - Has received a live-virus vaccination within 30 days of planned treatment start.
   Seasonal flu vaccines that do not contain live virus are permitted.

   - Any known additional malignancy that is progressing or requires active treatment,
   except for melanoma and HNSCC.

Exclusion Criteria (Phase 2, Melanoma Expansion Cohorts 1 and 5 only)

   - Any prior combination therapy targeting immunoregulatory receptors or mechanisms and
   an anti-PD-1/L1 agent or an investigational agent targeting immunoregulatory receptors

   - Prior therapy with an anti PD 1/L1 agent

Exclusion Criteria: (Phase 2, Melanoma Expansion Cohort 2 only)

• Any prior combination therapy involving agents given by intratumoral injection that
target the innate immune pathway or system.

Exclusion Criteria: (Phase 2, HNSCC Expansion Cohorts 3 and 6 only)

   - Prior therapy with an anti PD 1/L1 agent

   - Require treatment on anticoagulation therapy.

Exclusion Criteria (Phase 2, HNSCC Expansion Cohorts 4 and 7 only)

   - Any prior combination therapy involving agents given by intratumoral injection that
   target the innate immune pathway or system.

   - Require treatment on anticoagulation therapy

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Phuong Pham
650-725-9810
Recruiting

A Trial of Intratumoral Injections of SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

This is a phase 1b/2, open-label, multicenter trial designed to evaluate the safety, tolerability, biologic activity, and preliminary efficacy of intratumoral SD 101 injections in combination with intravenous pembrolizumab in patients with metastatic melanoma or recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

Phase 1 of this trial is a modified 3+3 dose escalation study evaluating escalating or intermediate dose levels of SD-101 given with a fixed dose of pembrolizumab in patients with metastatic melanoma.

Phase 2 of this study will consist of 7 expansion cohorts to further evaluate the efficacy and safety of SD-101 given in combination with pembrolizumab in specific melanoma and HNSCC populations: For each of the indications in melanoma and HNSCC 2 separate cohorts will be recruited, those who are anti-programmed death receptor-1/ligand 1 (anti-PD-1/L1) therapy naïve and those who have progressive disease (PD) while receiving anti-PD-1/L1 therapy.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Dynavax Technologies Corporation

Collaborator: Merck Sharp & Dohme Corp.

Intervention(s):

  • Drug: SD-101(1)
  • Biological: Pembrolizumab
  • Drug: SD-101(2)
  • Biological: Pembrolizumab

Phase:

Phase 1/Phase 2

Eligibility


Inclusion Criteria (Phase 1 and 2 Melanoma and HNSCC patients)

   - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.

   - Life expectancy of at least 6 months.

   - Have provided tissue biopsy sample enough for PD-L1 expression level testing and RNA
   expression profiling.

Inclusion Criteria: Phase 2 Melanoma patients

   - Histologically or cytologically confirmed unresectable or metastatic (stage IV)
   melanoma.

   - Have at least 2 sites that qualify as measurable target lesions per RECIST 1.1 of
   which 1 must be palpable or visualized by ultrasound and easily accessible to multiple
   intratumoral injections.

   - For patients with progressive disease (PD) while receiving anti-PD-1/L1 therapy, must
   have documented PD per RECIST v1.1 while receiving a prior anti-PD-1/L1 therapy.

Inclusion Criteria: Phase 2 HNSCC patients

   - Histologically or cytologically confirmed recurrent or metastatic HNSCC that could not
   be treated with curative intent.

   - Have at least 1 measurable target lesion per RECIST 1.1, which must be accessible and
   amenable to multiple intratumoral injections.

   - Must have documented PD per RECIST v1.1 while receiving a prior anti-PD-1/L1 therapy.

Exclusion Criteria: (Phase 1 and 2 Melanoma and HNSCC patients)

   - Received systemic chemotherapy or biological cancer therapy (except anti-PD-1/L1
   therapy) within 3 weeks prior to study enrollment.

   - Received prior radiotherapy within 2 weeks of start of study therapy.

   - Received small molecule inhibitor targeted therapy, such as tyrosine kinase
   inhibitors, within 2 weeks prior to study enrollment.

   - Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other
   form of immunosuppressive therapy (including immune modulators or systemic
   corticosteroids) within 7 days prior to study enrollment

   - Is expected to require any other form of anti-cancer therapy while in the trial.

   - Positive for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).

   - History of or current uveal or ocular melanoma.

   - Active infection including cytomegalovirus.

   - Active autoimmune disease requiring systemic treatment in the past 2 years or a
   disease that requires immunosuppressive medication. Replacement therapy is not
   considered a form of systemic treatment.

   - Current pneumonitis or history of (non-infectious) pneumonitis that required steroids.

   - Known active central nervous system metastases or carcinomatous meningitis.

   - Use of any investigational agent within the last 28 days prior to study enrollment.

   - Has received a live-virus vaccination within 30 days of planned treatment start.
   Seasonal flu vaccines that do not contain live virus are permitted.

   - Any known additional malignancy that is progressing or requires active treatment,
   except for melanoma and HNSCC.

Exclusion Criteria (Phase 2, Melanoma Expansion Cohorts 1 and 5 only)

   - Any prior combination therapy targeting immunoregulatory receptors or mechanisms and
   an anti-PD-1/L1 agent or an investigational agent targeting immunoregulatory receptors

   - Prior therapy with an anti PD 1/L1 agent

Exclusion Criteria: (Phase 2, Melanoma Expansion Cohort 2 only)

• Any prior combination therapy involving agents given by intratumoral injection that
target the innate immune pathway or system.

Exclusion Criteria: (Phase 2, HNSCC Expansion Cohorts 3 and 6 only)

   - Prior therapy with an anti PD 1/L1 agent

   - Require treatment on anticoagulation therapy.

Exclusion Criteria (Phase 2, HNSCC Expansion Cohorts 4 and 7 only)

   - Any prior combination therapy involving agents given by intratumoral injection that
   target the innate immune pathway or system.

   - Require treatment on anticoagulation therapy

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Phuong Pham
650-725-9810
Recruiting

A Trial of Intratumoral Injections of SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

This is a phase 1b/2, open-label, multicenter trial designed to evaluate the safety, tolerability, biologic activity, and preliminary efficacy of intratumoral SD 101 injections in combination with intravenous pembrolizumab in patients with metastatic melanoma or recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

Phase 1 of this trial is a modified 3+3 dose escalation study evaluating escalating or intermediate dose levels of SD-101 given with a fixed dose of pembrolizumab in patients with metastatic melanoma.

Phase 2 of this study will consist of 7 expansion cohorts to further evaluate the efficacy and safety of SD-101 given in combination with pembrolizumab in specific melanoma and HNSCC populations: For each of the indications in melanoma and HNSCC 2 separate cohorts will be recruited, those who are anti-programmed death receptor-1/ligand 1 (anti-PD-1/L1) therapy naïve and those who have progressive disease (PD) while receiving anti-PD-1/L1 therapy.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Dynavax Technologies Corporation

Collaborator: Merck Sharp & Dohme Corp.

Intervention(s):

  • Drug: SD-101(1)
  • Biological: Pembrolizumab
  • Drug: SD-101(2)
  • Biological: Pembrolizumab

Phase:

Phase 1/Phase 2

Eligibility


Inclusion Criteria (Phase 1 and 2 Melanoma and HNSCC patients)

   - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.

   - Life expectancy of at least 6 months.

   - Have provided tissue biopsy sample enough for PD-L1 expression level testing and RNA
   expression profiling.

Inclusion Criteria: Phase 2 Melanoma patients

   - Histologically or cytologically confirmed unresectable or metastatic (stage IV)
   melanoma.

   - Have at least 2 sites that qualify as measurable target lesions per RECIST 1.1 of
   which 1 must be palpable or visualized by ultrasound and easily accessible to multiple
   intratumoral injections.

   - For patients with progressive disease (PD) while receiving anti-PD-1/L1 therapy, must
   have documented PD per RECIST v1.1 while receiving a prior anti-PD-1/L1 therapy.

Inclusion Criteria: Phase 2 HNSCC patients

   - Histologically or cytologically confirmed recurrent or metastatic HNSCC that could not
   be treated with curative intent.

   - Have at least 1 measurable target lesion per RECIST 1.1, which must be accessible and
   amenable to multiple intratumoral injections.

   - Must have documented PD per RECIST v1.1 while receiving a prior anti-PD-1/L1 therapy.

Exclusion Criteria: (Phase 1 and 2 Melanoma and HNSCC patients)

   - Received systemic chemotherapy or biological cancer therapy (except anti-PD-1/L1
   therapy) within 3 weeks prior to study enrollment.

   - Received prior radiotherapy within 2 weeks of start of study therapy.

   - Received small molecule inhibitor targeted therapy, such as tyrosine kinase
   inhibitors, within 2 weeks prior to study enrollment.

   - Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other
   form of immunosuppressive therapy (including immune modulators or systemic
   corticosteroids) within 7 days prior to study enrollment

   - Is expected to require any other form of anti-cancer therapy while in the trial.

   - Positive for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).

   - History of or current uveal or ocular melanoma.

   - Active infection including cytomegalovirus.

   - Active autoimmune disease requiring systemic treatment in the past 2 years or a
   disease that requires immunosuppressive medication. Replacement therapy is not
   considered a form of systemic treatment.

   - Current pneumonitis or history of (non-infectious) pneumonitis that required steroids.

   - Known active central nervous system metastases or carcinomatous meningitis.

   - Use of any investigational agent within the last 28 days prior to study enrollment.

   - Has received a live-virus vaccination within 30 days of planned treatment start.
   Seasonal flu vaccines that do not contain live virus are permitted.

   - Any known additional malignancy that is progressing or requires active treatment,
   except for melanoma and HNSCC.

Exclusion Criteria (Phase 2, Melanoma Expansion Cohorts 1 and 5 only)

   - Any prior combination therapy targeting immunoregulatory receptors or mechanisms and
   an anti-PD-1/L1 agent or an investigational agent targeting immunoregulatory receptors

   - Prior therapy with an anti PD 1/L1 agent

Exclusion Criteria: (Phase 2, Melanoma Expansion Cohort 2 only)

• Any prior combination therapy involving agents given by intratumoral injection that
target the innate immune pathway or system.

Exclusion Criteria: (Phase 2, HNSCC Expansion Cohorts 3 and 6 only)

   - Prior therapy with an anti PD 1/L1 agent

   - Require treatment on anticoagulation therapy.

Exclusion Criteria (Phase 2, HNSCC Expansion Cohorts 4 and 7 only)

   - Any prior combination therapy involving agents given by intratumoral injection that
   target the innate immune pathway or system.

   - Require treatment on anticoagulation therapy

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Phuong Pham
650-725-9810
Recruiting

A Trial of Intratumoral Injections of SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

This is a phase 1b/2, open-label, multicenter trial designed to evaluate the safety, tolerability, biologic activity, and preliminary efficacy of intratumoral SD 101 injections in combination with intravenous pembrolizumab in patients with metastatic melanoma or recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

Phase 1 of this trial is a modified 3+3 dose escalation study evaluating escalating or intermediate dose levels of SD-101 given with a fixed dose of pembrolizumab in patients with metastatic melanoma.

Phase 2 of this study will consist of 7 expansion cohorts to further evaluate the efficacy and safety of SD-101 given in combination with pembrolizumab in specific melanoma and HNSCC populations: For each of the indications in melanoma and HNSCC 2 separate cohorts will be recruited, those who are anti-programmed death receptor-1/ligand 1 (anti-PD-1/L1) therapy naïve and those who have progressive disease (PD) while receiving anti-PD-1/L1 therapy.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Dynavax Technologies Corporation

Collaborator: Merck Sharp & Dohme Corp.

Intervention(s):

  • Drug: SD-101(1)
  • Biological: Pembrolizumab
  • Drug: SD-101(2)
  • Biological: Pembrolizumab

Phase:

Phase 1/Phase 2

Eligibility


Inclusion Criteria (Phase 1 and 2 Melanoma and HNSCC patients)

   - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.

   - Life expectancy of at least 6 months.

   - Have provided tissue biopsy sample enough for PD-L1 expression level testing and RNA
   expression profiling.

Inclusion Criteria: Phase 2 Melanoma patients

   - Histologically or cytologically confirmed unresectable or metastatic (stage IV)
   melanoma.

   - Have at least 2 sites that qualify as measurable target lesions per RECIST 1.1 of
   which 1 must be palpable or visualized by ultrasound and easily accessible to multiple
   intratumoral injections.

   - For patients with progressive disease (PD) while receiving anti-PD-1/L1 therapy, must
   have documented PD per RECIST v1.1 while receiving a prior anti-PD-1/L1 therapy.

Inclusion Criteria: Phase 2 HNSCC patients

   - Histologically or cytologically confirmed recurrent or metastatic HNSCC that could not
   be treated with curative intent.

   - Have at least 1 measurable target lesion per RECIST 1.1, which must be accessible and
   amenable to multiple intratumoral injections.

   - Must have documented PD per RECIST v1.1 while receiving a prior anti-PD-1/L1 therapy.

Exclusion Criteria: (Phase 1 and 2 Melanoma and HNSCC patients)

   - Received systemic chemotherapy or biological cancer therapy (except anti-PD-1/L1
   therapy) within 3 weeks prior to study enrollment.

   - Received prior radiotherapy within 2 weeks of start of study therapy.

   - Received small molecule inhibitor targeted therapy, such as tyrosine kinase
   inhibitors, within 2 weeks prior to study enrollment.

   - Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other
   form of immunosuppressive therapy (including immune modulators or systemic
   corticosteroids) within 7 days prior to study enrollment

   - Is expected to require any other form of anti-cancer therapy while in the trial.

   - Positive for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).

   - History of or current uveal or ocular melanoma.

   - Active infection including cytomegalovirus.

   - Active autoimmune disease requiring systemic treatment in the past 2 years or a
   disease that requires immunosuppressive medication. Replacement therapy is not
   considered a form of systemic treatment.

   - Current pneumonitis or history of (non-infectious) pneumonitis that required steroids.

   - Known active central nervous system metastases or carcinomatous meningitis.

   - Use of any investigational agent within the last 28 days prior to study enrollment.

   - Has received a live-virus vaccination within 30 days of planned treatment start.
   Seasonal flu vaccines that do not contain live virus are permitted.

   - Any known additional malignancy that is progressing or requires active treatment,
   except for melanoma and HNSCC.

Exclusion Criteria (Phase 2, Melanoma Expansion Cohorts 1 and 5 only)

   - Any prior combination therapy targeting immunoregulatory receptors or mechanisms and
   an anti-PD-1/L1 agent or an investigational agent targeting immunoregulatory receptors

   - Prior therapy with an anti PD 1/L1 agent

Exclusion Criteria: (Phase 2, Melanoma Expansion Cohort 2 only)

• Any prior combination therapy involving agents given by intratumoral injection that
target the innate immune pathway or system.

Exclusion Criteria: (Phase 2, HNSCC Expansion Cohorts 3 and 6 only)

   - Prior therapy with an anti PD 1/L1 agent

   - Require treatment on anticoagulation therapy.

Exclusion Criteria (Phase 2, HNSCC Expansion Cohorts 4 and 7 only)

   - Any prior combination therapy involving agents given by intratumoral injection that
   target the innate immune pathway or system.

   - Require treatment on anticoagulation therapy

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Phuong Pham
650-725-9810
Recruiting

A Trial of Intratumoral Injections of SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

This is a phase 1b/2, open-label, multicenter trial designed to evaluate the safety, tolerability, biologic activity, and preliminary efficacy of intratumoral SD 101 injections in combination with intravenous pembrolizumab in patients with metastatic melanoma or recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

Phase 1 of this trial is a modified 3+3 dose escalation study evaluating escalating or intermediate dose levels of SD-101 given with a fixed dose of pembrolizumab in patients with metastatic melanoma.

Phase 2 of this study will consist of 7 expansion cohorts to further evaluate the efficacy and safety of SD-101 given in combination with pembrolizumab in specific melanoma and HNSCC populations: For each of the indications in melanoma and HNSCC 2 separate cohorts will be recruited, those who are anti-programmed death receptor-1/ligand 1 (anti-PD-1/L1) therapy naïve and those who have progressive disease (PD) while receiving anti-PD-1/L1 therapy.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Dynavax Technologies Corporation

Collaborator: Merck Sharp & Dohme Corp.

Intervention(s):

  • Drug: SD-101(1)
  • Biological: Pembrolizumab
  • Drug: SD-101(2)
  • Biological: Pembrolizumab

Phase:

Phase 1/Phase 2

Eligibility


Inclusion Criteria (Phase 1 and 2 Melanoma and HNSCC patients)

   - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.

   - Life expectancy of at least 6 months.

   - Have provided tissue biopsy sample enough for PD-L1 expression level testing and RNA
   expression profiling.

Inclusion Criteria: Phase 2 Melanoma patients

   - Histologically or cytologically confirmed unresectable or metastatic (stage IV)
   melanoma.

   - Have at least 2 sites that qualify as measurable target lesions per RECIST 1.1 of
   which 1 must be palpable or visualized by ultrasound and easily accessible to multiple
   intratumoral injections.

   - For patients with progressive disease (PD) while receiving anti-PD-1/L1 therapy, must
   have documented PD per RECIST v1.1 while receiving a prior anti-PD-1/L1 therapy.

Inclusion Criteria: Phase 2 HNSCC patients

   - Histologically or cytologically confirmed recurrent or metastatic HNSCC that could not
   be treated with curative intent.

   - Have at least 1 measurable target lesion per RECIST 1.1, which must be accessible and
   amenable to multiple intratumoral injections.

   - Must have documented PD per RECIST v1.1 while receiving a prior anti-PD-1/L1 therapy.

Exclusion Criteria: (Phase 1 and 2 Melanoma and HNSCC patients)

   - Received systemic chemotherapy or biological cancer therapy (except anti-PD-1/L1
   therapy) within 3 weeks prior to study enrollment.

   - Received prior radiotherapy within 2 weeks of start of study therapy.

   - Received small molecule inhibitor targeted therapy, such as tyrosine kinase
   inhibitors, within 2 weeks prior to study enrollment.

   - Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other
   form of immunosuppressive therapy (including immune modulators or systemic
   corticosteroids) within 7 days prior to study enrollment

   - Is expected to require any other form of anti-cancer therapy while in the trial.

   - Positive for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).

   - History of or current uveal or ocular melanoma.

   - Active infection including cytomegalovirus.

   - Active autoimmune disease requiring systemic treatment in the past 2 years or a
   disease that requires immunosuppressive medication. Replacement therapy is not
   considered a form of systemic treatment.

   - Current pneumonitis or history of (non-infectious) pneumonitis that required steroids.

   - Known active central nervous system metastases or carcinomatous meningitis.

   - Use of any investigational agent within the last 28 days prior to study enrollment.

   - Has received a live-virus vaccination within 30 days of planned treatment start.
   Seasonal flu vaccines that do not contain live virus are permitted.

   - Any known additional malignancy that is progressing or requires active treatment,
   except for melanoma and HNSCC.

Exclusion Criteria (Phase 2, Melanoma Expansion Cohorts 1 and 5 only)

   - Any prior combination therapy targeting immunoregulatory receptors or mechanisms and
   an anti-PD-1/L1 agent or an investigational agent targeting immunoregulatory receptors

   - Prior therapy with an anti PD 1/L1 agent

Exclusion Criteria: (Phase 2, Melanoma Expansion Cohort 2 only)

• Any prior combination therapy involving agents given by intratumoral injection that
target the innate immune pathway or system.

Exclusion Criteria: (Phase 2, HNSCC Expansion Cohorts 3 and 6 only)

   - Prior therapy with an anti PD 1/L1 agent

   - Require treatment on anticoagulation therapy.

Exclusion Criteria (Phase 2, HNSCC Expansion Cohorts 4 and 7 only)

   - Any prior combination therapy involving agents given by intratumoral injection that
   target the innate immune pathway or system.

   - Require treatment on anticoagulation therapy

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Phuong Pham
650-725-9810
Recruiting

A Trial of Intratumoral Injections of SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

This is a phase 1b/2, open-label, multicenter trial designed to evaluate the safety, tolerability, biologic activity, and preliminary efficacy of intratumoral SD 101 injections in combination with intravenous pembrolizumab in patients with metastatic melanoma or recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

Phase 1 of this trial is a modified 3+3 dose escalation study evaluating escalating or intermediate dose levels of SD-101 given with a fixed dose of pembrolizumab in patients with metastatic melanoma.

Phase 2 of this study will consist of 7 expansion cohorts to further evaluate the efficacy and safety of SD-101 given in combination with pembrolizumab in specific melanoma and HNSCC populations: For each of the indications in melanoma and HNSCC 2 separate cohorts will be recruited, those who are anti-programmed death receptor-1/ligand 1 (anti-PD-1/L1) therapy naïve and those who have progressive disease (PD) while receiving anti-PD-1/L1 therapy.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Dynavax Technologies Corporation

Collaborator: Merck Sharp & Dohme Corp.

Intervention(s):

  • Drug: SD-101(1)
  • Biological: Pembrolizumab
  • Drug: SD-101(2)
  • Biological: Pembrolizumab

Phase:

Phase 1/Phase 2

Eligibility


Inclusion Criteria (Phase 1 and 2 Melanoma and HNSCC patients)

   - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.

   - Life expectancy of at least 6 months.

   - Have provided tissue biopsy sample enough for PD-L1 expression level testing and RNA
   expression profiling.

Inclusion Criteria: Phase 2 Melanoma patients

   - Histologically or cytologically confirmed unresectable or metastatic (stage IV)
   melanoma.

   - Have at least 2 sites that qualify as measurable target lesions per RECIST 1.1 of
   which 1 must be palpable or visualized by ultrasound and easily accessible to multiple
   intratumoral injections.

   - For patients with progressive disease (PD) while receiving anti-PD-1/L1 therapy, must
   have documented PD per RECIST v1.1 while receiving a prior anti-PD-1/L1 therapy.

Inclusion Criteria: Phase 2 HNSCC patients

   - Histologically or cytologically confirmed recurrent or metastatic HNSCC that could not
   be treated with curative intent.

   - Have at least 1 measurable target lesion per RECIST 1.1, which must be accessible and
   amenable to multiple intratumoral injections.

   - Must have documented PD per RECIST v1.1 while receiving a prior anti-PD-1/L1 therapy.

Exclusion Criteria: (Phase 1 and 2 Melanoma and HNSCC patients)

   - Received systemic chemotherapy or biological cancer therapy (except anti-PD-1/L1
   therapy) within 3 weeks prior to study enrollment.

   - Received prior radiotherapy within 2 weeks of start of study therapy.

   - Received small molecule inhibitor targeted therapy, such as tyrosine kinase
   inhibitors, within 2 weeks prior to study enrollment.

   - Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other
   form of immunosuppressive therapy (including immune modulators or systemic
   corticosteroids) within 7 days prior to study enrollment

   - Is expected to require any other form of anti-cancer therapy while in the trial.

   - Positive for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).

   - History of or current uveal or ocular melanoma.

   - Active infection including cytomegalovirus.

   - Active autoimmune disease requiring systemic treatment in the past 2 years or a
   disease that requires immunosuppressive medication. Replacement therapy is not
   considered a form of systemic treatment.

   - Current pneumonitis or history of (non-infectious) pneumonitis that required steroids.

   - Known active central nervous system metastases or carcinomatous meningitis.

   - Use of any investigational agent within the last 28 days prior to study enrollment.

   - Has received a live-virus vaccination within 30 days of planned treatment start.
   Seasonal flu vaccines that do not contain live virus are permitted.

   - Any known additional malignancy that is progressing or requires active treatment,
   except for melanoma and HNSCC.

Exclusion Criteria (Phase 2, Melanoma Expansion Cohorts 1 and 5 only)

   - Any prior combination therapy targeting immunoregulatory receptors or mechanisms and
   an anti-PD-1/L1 agent or an investigational agent targeting immunoregulatory receptors

   - Prior therapy with an anti PD 1/L1 agent

Exclusion Criteria: (Phase 2, Melanoma Expansion Cohort 2 only)

• Any prior combination therapy involving agents given by intratumoral injection that
target the innate immune pathway or system.

Exclusion Criteria: (Phase 2, HNSCC Expansion Cohorts 3 and 6 only)

   - Prior therapy with an anti PD 1/L1 agent

   - Require treatment on anticoagulation therapy.

Exclusion Criteria (Phase 2, HNSCC Expansion Cohorts 4 and 7 only)

   - Any prior combination therapy involving agents given by intratumoral injection that
   target the innate immune pathway or system.

   - Require treatment on anticoagulation therapy

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Phuong Pham
650-725-9810
Recruiting

A Trial of Intratumoral Injections of SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

This is a phase 1b/2, open-label, multicenter trial designed to evaluate the safety, tolerability, biologic activity, and preliminary efficacy of intratumoral SD 101 injections in combination with intravenous pembrolizumab in patients with metastatic melanoma or recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

Phase 1 of this trial is a modified 3+3 dose escalation study evaluating escalating or intermediate dose levels of SD-101 given with a fixed dose of pembrolizumab in patients with metastatic melanoma.

Phase 2 of this study will consist of 7 expansion cohorts to further evaluate the efficacy and safety of SD-101 given in combination with pembrolizumab in specific melanoma and HNSCC populations: For each of the indications in melanoma and HNSCC 2 separate cohorts will be recruited, those who are anti-programmed death receptor-1/ligand 1 (anti-PD-1/L1) therapy naïve and those who have progressive disease (PD) while receiving anti-PD-1/L1 therapy.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Dynavax Technologies Corporation

Collaborator: Merck Sharp & Dohme Corp.

Intervention(s):

  • Drug: SD-101(1)
  • Biological: Pembrolizumab
  • Drug: SD-101(2)
  • Biological: Pembrolizumab

Phase:

Phase 1/Phase 2

Eligibility


Inclusion Criteria (Phase 1 and 2 Melanoma and HNSCC patients)

   - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.

   - Life expectancy of at least 6 months.

   - Have provided tissue biopsy sample enough for PD-L1 expression level testing and RNA
   expression profiling.

Inclusion Criteria: Phase 2 Melanoma patients

   - Histologically or cytologically confirmed unresectable or metastatic (stage IV)
   melanoma.

   - Have at least 2 sites that qualify as measurable target lesions per RECIST 1.1 of
   which 1 must be palpable or visualized by ultrasound and easily accessible to multiple
   intratumoral injections.

   - For patients with progressive disease (PD) while receiving anti-PD-1/L1 therapy, must
   have documented PD per RECIST v1.1 while receiving a prior anti-PD-1/L1 therapy.

Inclusion Criteria: Phase 2 HNSCC patients

   - Histologically or cytologically confirmed recurrent or metastatic HNSCC that could not
   be treated with curative intent.

   - Have at least 1 measurable target lesion per RECIST 1.1, which must be accessible and
   amenable to multiple intratumoral injections.

   - Must have documented PD per RECIST v1.1 while receiving a prior anti-PD-1/L1 therapy.

Exclusion Criteria: (Phase 1 and 2 Melanoma and HNSCC patients)

   - Received systemic chemotherapy or biological cancer therapy (except anti-PD-1/L1
   therapy) within 3 weeks prior to study enrollment.

   - Received prior radiotherapy within 2 weeks of start of study therapy.

   - Received small molecule inhibitor targeted therapy, such as tyrosine kinase
   inhibitors, within 2 weeks prior to study enrollment.

   - Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other
   form of immunosuppressive therapy (including immune modulators or systemic
   corticosteroids) within 7 days prior to study enrollment

   - Is expected to require any other form of anti-cancer therapy while in the trial.

   - Positive for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).

   - History of or current uveal or ocular melanoma.

   - Active infection including cytomegalovirus.

   - Active autoimmune disease requiring systemic treatment in the past 2 years or a
   disease that requires immunosuppressive medication. Replacement therapy is not
   considered a form of systemic treatment.

   - Current pneumonitis or history of (non-infectious) pneumonitis that required steroids.

   - Known active central nervous system metastases or carcinomatous meningitis.

   - Use of any investigational agent within the last 28 days prior to study enrollment.

   - Has received a live-virus vaccination within 30 days of planned treatment start.
   Seasonal flu vaccines that do not contain live virus are permitted.

   - Any known additional malignancy that is progressing or requires active treatment,
   except for melanoma and HNSCC.

Exclusion Criteria (Phase 2, Melanoma Expansion Cohorts 1 and 5 only)

   - Any prior combination therapy targeting immunoregulatory receptors or mechanisms and
   an anti-PD-1/L1 agent or an investigational agent targeting immunoregulatory receptors

   - Prior therapy with an anti PD 1/L1 agent

Exclusion Criteria: (Phase 2, Melanoma Expansion Cohort 2 only)

• Any prior combination therapy involving agents given by intratumoral injection that
target the innate immune pathway or system.

Exclusion Criteria: (Phase 2, HNSCC Expansion Cohorts 3 and 6 only)

   - Prior therapy with an anti PD 1/L1 agent

   - Require treatment on anticoagulation therapy.

Exclusion Criteria (Phase 2, HNSCC Expansion Cohorts 4 and 7 only)

   - Any prior combination therapy involving agents given by intratumoral injection that
   target the innate immune pathway or system.

   - Require treatment on anticoagulation therapy

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Phuong Pham
650-725-9810
Recruiting

A Trial of Intratumoral Injections of SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

This is a phase 1b/2, open-label, multicenter trial designed to evaluate the safety, tolerability, biologic activity, and preliminary efficacy of intratumoral SD 101 injections in combination with intravenous pembrolizumab in patients with metastatic melanoma or recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

Phase 1 of this trial is a modified 3+3 dose escalation study evaluating escalating or intermediate dose levels of SD-101 given with a fixed dose of pembrolizumab in patients with metastatic melanoma.

Phase 2 of this study will consist of 7 expansion cohorts to further evaluate the efficacy and safety of SD-101 given in combination with pembrolizumab in specific melanoma and HNSCC populations: For each of the indications in melanoma and HNSCC 2 separate cohorts will be recruited, those who are anti-programmed death receptor-1/ligand 1 (anti-PD-1/L1) therapy naïve and those who have progressive disease (PD) while receiving anti-PD-1/L1 therapy.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Dynavax Technologies Corporation

Collaborator: Merck Sharp & Dohme Corp.

Intervention(s):

  • Drug: SD-101(1)
  • Biological: Pembrolizumab
  • Drug: SD-101(2)
  • Biological: Pembrolizumab

Phase:

Phase 1/Phase 2

Eligibility


Inclusion Criteria (Phase 1 and 2 Melanoma and HNSCC patients)

   - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.

   - Life expectancy of at least 6 months.

   - Have provided tissue biopsy sample enough for PD-L1 expression level testing and RNA
   expression profiling.

Inclusion Criteria: Phase 2 Melanoma patients

   - Histologically or cytologically confirmed unresectable or metastatic (stage IV)
   melanoma.

   - Have at least 2 sites that qualify as measurable target lesions per RECIST 1.1 of
   which 1 must be palpable or visualized by ultrasound and easily accessible to multiple
   intratumoral injections.

   - For patients with progressive disease (PD) while receiving anti-PD-1/L1 therapy, must
   have documented PD per RECIST v1.1 while receiving a prior anti-PD-1/L1 therapy.

Inclusion Criteria: Phase 2 HNSCC patients

   - Histologically or cytologically confirmed recurrent or metastatic HNSCC that could not
   be treated with curative intent.

   - Have at least 1 measurable target lesion per RECIST 1.1, which must be accessible and
   amenable to multiple intratumoral injections.

   - Must have documented PD per RECIST v1.1 while receiving a prior anti-PD-1/L1 therapy.

Exclusion Criteria: (Phase 1 and 2 Melanoma and HNSCC patients)

   - Received systemic chemotherapy or biological cancer therapy (except anti-PD-1/L1
   therapy) within 3 weeks prior to study enrollment.

   - Received prior radiotherapy within 2 weeks of start of study therapy.

   - Received small molecule inhibitor targeted therapy, such as tyrosine kinase
   inhibitors, within 2 weeks prior to study enrollment.

   - Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other
   form of immunosuppressive therapy (including immune modulators or systemic
   corticosteroids) within 7 days prior to study enrollment

   - Is expected to require any other form of anti-cancer therapy while in the trial.

   - Positive for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).

   - History of or current uveal or ocular melanoma.

   - Active infection including cytomegalovirus.

   - Active autoimmune disease requiring systemic treatment in the past 2 years or a
   disease that requires immunosuppressive medication. Replacement therapy is not
   considered a form of systemic treatment.

   - Current pneumonitis or history of (non-infectious) pneumonitis that required steroids.

   - Known active central nervous system metastases or carcinomatous meningitis.

   - Use of any investigational agent within the last 28 days prior to study enrollment.

   - Has received a live-virus vaccination within 30 days of planned treatment start.
   Seasonal flu vaccines that do not contain live virus are permitted.

   - Any known additional malignancy that is progressing or requires active treatment,
   except for melanoma and HNSCC.

Exclusion Criteria (Phase 2, Melanoma Expansion Cohorts 1 and 5 only)

   - Any prior combination therapy targeting immunoregulatory receptors or mechanisms and
   an anti-PD-1/L1 agent or an investigational agent targeting immunoregulatory receptors

   - Prior therapy with an anti PD 1/L1 agent

Exclusion Criteria: (Phase 2, Melanoma Expansion Cohort 2 only)

• Any prior combination therapy involving agents given by intratumoral injection that
target the innate immune pathway or system.

Exclusion Criteria: (Phase 2, HNSCC Expansion Cohorts 3 and 6 only)

   - Prior therapy with an anti PD 1/L1 agent

   - Require treatment on anticoagulation therapy.

Exclusion Criteria (Phase 2, HNSCC Expansion Cohorts 4 and 7 only)

   - Any prior combination therapy involving agents given by intratumoral injection that
   target the innate immune pathway or system.

   - Require treatment on anticoagulation therapy

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Phuong Pham
650-725-9810
Recruiting

A Trial of Intratumoral Injections of SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

This is a phase 1b/2, open-label, multicenter trial designed to evaluate the safety, tolerability, biologic activity, and preliminary efficacy of intratumoral SD 101 injections in combination with intravenous pembrolizumab in patients with metastatic melanoma or recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

Phase 1 of this trial is a modified 3+3 dose escalation study evaluating escalating or intermediate dose levels of SD-101 given with a fixed dose of pembrolizumab in patients with metastatic melanoma.

Phase 2 of this study will consist of 7 expansion cohorts to further evaluate the efficacy and safety of SD-101 given in combination with pembrolizumab in specific melanoma and HNSCC populations: For each of the indications in melanoma and HNSCC 2 separate cohorts will be recruited, those who are anti-programmed death receptor-1/ligand 1 (anti-PD-1/L1) therapy naïve and those who have progressive disease (PD) while receiving anti-PD-1/L1 therapy.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Dynavax Technologies Corporation

Collaborator: Merck Sharp & Dohme Corp.

Intervention(s):

  • Drug: SD-101(1)
  • Biological: Pembrolizumab
  • Drug: SD-101(2)
  • Biological: Pembrolizumab

Phase:

Phase 1/Phase 2

Eligibility


Inclusion Criteria (Phase 1 and 2 Melanoma and HNSCC patients)

   - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.

   - Life expectancy of at least 6 months.

   - Have provided tissue biopsy sample enough for PD-L1 expression level testing and RNA
   expression profiling.

Inclusion Criteria: Phase 2 Melanoma patients

   - Histologically or cytologically confirmed unresectable or metastatic (stage IV)
   melanoma.

   - Have at least 2 sites that qualify as measurable target lesions per RECIST 1.1 of
   which 1 must be palpable or visualized by ultrasound and easily accessible to multiple
   intratumoral injections.

   - For patients with progressive disease (PD) while receiving anti-PD-1/L1 therapy, must
   have documented PD per RECIST v1.1 while receiving a prior anti-PD-1/L1 therapy.

Inclusion Criteria: Phase 2 HNSCC patients

   - Histologically or cytologically confirmed recurrent or metastatic HNSCC that could not
   be treated with curative intent.

   - Have at least 1 measurable target lesion per RECIST 1.1, which must be accessible and
   amenable to multiple intratumoral injections.

   - Must have documented PD per RECIST v1.1 while receiving a prior anti-PD-1/L1 therapy.

Exclusion Criteria: (Phase 1 and 2 Melanoma and HNSCC patients)

   - Received systemic chemotherapy or biological cancer therapy (except anti-PD-1/L1
   therapy) within 3 weeks prior to study enrollment.

   - Received prior radiotherapy within 2 weeks of start of study therapy.

   - Received small molecule inhibitor targeted therapy, such as tyrosine kinase
   inhibitors, within 2 weeks prior to study enrollment.

   - Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other
   form of immunosuppressive therapy (including immune modulators or systemic
   corticosteroids) within 7 days prior to study enrollment

   - Is expected to require any other form of anti-cancer therapy while in the trial.

   - Positive for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).

   - History of or current uveal or ocular melanoma.

   - Active infection including cytomegalovirus.

   - Active autoimmune disease requiring systemic treatment in the past 2 years or a
   disease that requires immunosuppressive medication. Replacement therapy is not
   considered a form of systemic treatment.

   - Current pneumonitis or history of (non-infectious) pneumonitis that required steroids.

   - Known active central nervous system metastases or carcinomatous meningitis.

   - Use of any investigational agent within the last 28 days prior to study enrollment.

   - Has received a live-virus vaccination within 30 days of planned treatment start.
   Seasonal flu vaccines that do not contain live virus are permitted.

   - Any known additional malignancy that is progressing or requires active treatment,
   except for melanoma and HNSCC.

Exclusion Criteria (Phase 2, Melanoma Expansion Cohorts 1 and 5 only)

   - Any prior combination therapy targeting immunoregulatory receptors or mechanisms and
   an anti-PD-1/L1 agent or an investigational agent targeting immunoregulatory receptors

   - Prior therapy with an anti PD 1/L1 agent

Exclusion Criteria: (Phase 2, Melanoma Expansion Cohort 2 only)

• Any prior combination therapy involving agents given by intratumoral injection that
target the innate immune pathway or system.

Exclusion Criteria: (Phase 2, HNSCC Expansion Cohorts 3 and 6 only)

   - Prior therapy with an anti PD 1/L1 agent

   - Require treatment on anticoagulation therapy.

Exclusion Criteria (Phase 2, HNSCC Expansion Cohorts 4 and 7 only)

   - Any prior combination therapy involving agents given by intratumoral injection that
   target the innate immune pathway or system.

   - Require treatment on anticoagulation therapy

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Phuong Pham
650-725-9810
Recruiting

A Trial of Intratumoral Injections of SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

This is a phase 1b/2, open-label, multicenter trial designed to evaluate the safety, tolerability, biologic activity, and preliminary efficacy of intratumoral SD 101 injections in combination with intravenous pembrolizumab in patients with metastatic melanoma or recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

Phase 1 of this trial is a modified 3+3 dose escalation study evaluating escalating or intermediate dose levels of SD-101 given with a fixed dose of pembrolizumab in patients with metastatic melanoma.

Phase 2 of this study will consist of 7 expansion cohorts to further evaluate the efficacy and safety of SD-101 given in combination with pembrolizumab in specific melanoma and HNSCC populations: For each of the indications in melanoma and HNSCC 2 separate cohorts will be recruited, those who are anti-programmed death receptor-1/ligand 1 (anti-PD-1/L1) therapy naïve and those who have progressive disease (PD) while receiving anti-PD-1/L1 therapy.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Dynavax Technologies Corporation

Collaborator: Merck Sharp & Dohme Corp.

Intervention(s):

  • Drug: SD-101(1)
  • Biological: Pembrolizumab
  • Drug: SD-101(2)
  • Biological: Pembrolizumab

Phase:

Phase 1/Phase 2

Eligibility


Inclusion Criteria (Phase 1 and 2 Melanoma and HNSCC patients)

   - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.

   - Life expectancy of at least 6 months.

   - Have provided tissue biopsy sample enough for PD-L1 expression level testing and RNA
   expression profiling.

Inclusion Criteria: Phase 2 Melanoma patients

   - Histologically or cytologically confirmed unresectable or metastatic (stage IV)
   melanoma.

   - Have at least 2 sites that qualify as measurable target lesions per RECIST 1.1 of
   which 1 must be palpable or visualized by ultrasound and easily accessible to multiple
   intratumoral injections.

   - For patients with progressive disease (PD) while receiving anti-PD-1/L1 therapy, must
   have documented PD per RECIST v1.1 while receiving a prior anti-PD-1/L1 therapy.

Inclusion Criteria: Phase 2 HNSCC patients

   - Histologically or cytologically confirmed recurrent or metastatic HNSCC that could not
   be treated with curative intent.

   - Have at least 1 measurable target lesion per RECIST 1.1, which must be accessible and
   amenable to multiple intratumoral injections.

   - Must have documented PD per RECIST v1.1 while receiving a prior anti-PD-1/L1 therapy.

Exclusion Criteria: (Phase 1 and 2 Melanoma and HNSCC patients)

   - Received systemic chemotherapy or biological cancer therapy (except anti-PD-1/L1
   therapy) within 3 weeks prior to study enrollment.

   - Received prior radiotherapy within 2 weeks of start of study therapy.

   - Received small molecule inhibitor targeted therapy, such as tyrosine kinase
   inhibitors, within 2 weeks prior to study enrollment.

   - Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other
   form of immunosuppressive therapy (including immune modulators or systemic
   corticosteroids) within 7 days prior to study enrollment

   - Is expected to require any other form of anti-cancer therapy while in the trial.

   - Positive for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).

   - History of or current uveal or ocular melanoma.

   - Active infection including cytomegalovirus.

   - Active autoimmune disease requiring systemic treatment in the past 2 years or a
   disease that requires immunosuppressive medication. Replacement therapy is not
   considered a form of systemic treatment.

   - Current pneumonitis or history of (non-infectious) pneumonitis that required steroids.

   - Known active central nervous system metastases or carcinomatous meningitis.

   - Use of any investigational agent within the last 28 days prior to study enrollment.

   - Has received a live-virus vaccination within 30 days of planned treatment start.
   Seasonal flu vaccines that do not contain live virus are permitted.

   - Any known additional malignancy that is progressing or requires active treatment,
   except for melanoma and HNSCC.

Exclusion Criteria (Phase 2, Melanoma Expansion Cohorts 1 and 5 only)

   - Any prior combination therapy targeting immunoregulatory receptors or mechanisms and
   an anti-PD-1/L1 agent or an investigational agent targeting immunoregulatory receptors

   - Prior therapy with an anti PD 1/L1 agent

Exclusion Criteria: (Phase 2, Melanoma Expansion Cohort 2 only)

• Any prior combination therapy involving agents given by intratumoral injection that
target the innate immune pathway or system.

Exclusion Criteria: (Phase 2, HNSCC Expansion Cohorts 3 and 6 only)

   - Prior therapy with an anti PD 1/L1 agent

   - Require treatment on anticoagulation therapy.

Exclusion Criteria (Phase 2, HNSCC Expansion Cohorts 4 and 7 only)

   - Any prior combination therapy involving agents given by intratumoral injection that
   target the innate immune pathway or system.

   - Require treatment on anticoagulation therapy

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Phuong Pham
650-725-9810
Recruiting