Auto-populated list of related Clinical Trials
(Breast, Cleft Lip and Palate, Hand, Lymphedema, Oral, Skin, Trauma)

Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

The purpose is to assess the effect of a new drug REGN2810 on patients with squamous cell skin cancer that are not treatable with surgery or have metastasized. We will assess ifit has any effect on the skin cancer and what the side effects are. We will also assess how severe the side effects are.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Regeneron Pharmaceuticals

Stanford Investigator(s):

Intervention(s):

  • Drug: REGN2810

Phase:

Phase 2

Eligibility


Key Inclusion Criteria:

   - At least 1 measurable lesion

   - Eastern Cooperative Oncology Group (ECOG) performance status ≤1

   - Adequate bone marrow function

   - Adequate renal function

   - Adequate hepatic function

   - Archived or newly obtained tumor material

   - Patients must consent to undergo biopsies of externally visible CSCC lesions (Group 2
   only)

   - Surgical or radiological treatment of lesions contraindicated

Key Exclusion Criteria:

   - Ongoing or recent (within 5 years) evidence of significant autoimmune disease that
   required treatment with systemic immunosuppressive treatments, which may suggest risk
   for immune-related adverse events

   - Prior treatment with an agent that blocks the PD-1/PD-L1pathway

   - Prior treatment with a BRAF inhibitor

   - Prior treatment with other immune-modulating agents within fewer than 4 weeks prior to
   the first dose of REGN2810, or associated with immune-mediated adverse events that
   were ≥ grade 1 within 90 days prior to the first dose of REGN2810, or associated with
   toxicity that resulted in discontinuation of the immune-modulating agent. Examples of
   immune-modulating agents include therapeutic vaccines, cytokine treatments, or agents
   that target cytotoxic T-lymphocyte antigen 4 (CTLA-4), 4-1BB (CD137), or OX-40.

   - Untreated brain metastasis(es) that may be considered active

   - Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within
   4 weeks prior to the first dose of REGN2810

   - Infection with human immunodeficiency virus (HIV) and/or chronic/active infection with
   hepatitis B virus or hepatitis C virus

   - History of pneumonitis within the last 5 years

   - Allergic reactions or acute hypersensitivity reaction attributed to antibody
   treatments

   - Known allergy to doxycycline or tetracycline

   - Patients with a history of solid organ transplant

   - Any medical co-morbidity, physical examination finding, or metabolic dysfunction, or
   clinical laboratory abnormality that renders the patient unsuitable

   - Prior treatment with idelalisib

Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting

Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

The purpose is to assess the effect of a new drug REGN2810 on patients with squamous cell skin cancer that are not treatable with surgery or have metastasized. We will assess ifit has any effect on the skin cancer and what the side effects are. We will also assess how severe the side effects are.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Regeneron Pharmaceuticals

Stanford Investigator(s):

Intervention(s):

  • Drug: REGN2810

Phase:

Phase 2

Eligibility


Key Inclusion Criteria:

   - At least 1 measurable lesion

   - Eastern Cooperative Oncology Group (ECOG) performance status ≤1

   - Adequate bone marrow function

   - Adequate renal function

   - Adequate hepatic function

   - Archived or newly obtained tumor material

   - Patients must consent to undergo biopsies of externally visible CSCC lesions (Group 2
   only)

   - Surgical or radiological treatment of lesions contraindicated

Key Exclusion Criteria:

   - Ongoing or recent (within 5 years) evidence of significant autoimmune disease that
   required treatment with systemic immunosuppressive treatments, which may suggest risk
   for immune-related adverse events

   - Prior treatment with an agent that blocks the PD-1/PD-L1pathway

   - Prior treatment with a BRAF inhibitor

   - Prior treatment with other immune-modulating agents within fewer than 4 weeks prior to
   the first dose of REGN2810, or associated with immune-mediated adverse events that
   were ≥ grade 1 within 90 days prior to the first dose of REGN2810, or associated with
   toxicity that resulted in discontinuation of the immune-modulating agent. Examples of
   immune-modulating agents include therapeutic vaccines, cytokine treatments, or agents
   that target cytotoxic T-lymphocyte antigen 4 (CTLA-4), 4-1BB (CD137), or OX-40.

   - Untreated brain metastasis(es) that may be considered active

   - Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within
   4 weeks prior to the first dose of REGN2810

   - Infection with human immunodeficiency virus (HIV) and/or chronic/active infection with
   hepatitis B virus or hepatitis C virus

   - History of pneumonitis within the last 5 years

   - Allergic reactions or acute hypersensitivity reaction attributed to antibody
   treatments

   - Known allergy to doxycycline or tetracycline

   - Patients with a history of solid organ transplant

   - Any medical co-morbidity, physical examination finding, or metabolic dysfunction, or
   clinical laboratory abnormality that renders the patient unsuitable

   - Prior treatment with idelalisib

Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting

Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

The purpose is to assess the effect of a new drug REGN2810 on patients with squamous cell skin cancer that are not treatable with surgery or have metastasized. We will assess ifit has any effect on the skin cancer and what the side effects are. We will also assess how severe the side effects are.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Regeneron Pharmaceuticals

Stanford Investigator(s):

Intervention(s):

  • Drug: REGN2810

Phase:

Phase 2

Eligibility


Key Inclusion Criteria:

   - At least 1 measurable lesion

   - Eastern Cooperative Oncology Group (ECOG) performance status ≤1

   - Adequate bone marrow function

   - Adequate renal function

   - Adequate hepatic function

   - Archived or newly obtained tumor material

   - Patients must consent to undergo biopsies of externally visible CSCC lesions (Group 2
   only)

   - Surgical or radiological treatment of lesions contraindicated

Key Exclusion Criteria:

   - Ongoing or recent (within 5 years) evidence of significant autoimmune disease that
   required treatment with systemic immunosuppressive treatments, which may suggest risk
   for immune-related adverse events

   - Prior treatment with an agent that blocks the PD-1/PD-L1pathway

   - Prior treatment with a BRAF inhibitor

   - Prior treatment with other immune-modulating agents within fewer than 4 weeks prior to
   the first dose of REGN2810, or associated with immune-mediated adverse events that
   were ≥ grade 1 within 90 days prior to the first dose of REGN2810, or associated with
   toxicity that resulted in discontinuation of the immune-modulating agent. Examples of
   immune-modulating agents include therapeutic vaccines, cytokine treatments, or agents
   that target cytotoxic T-lymphocyte antigen 4 (CTLA-4), 4-1BB (CD137), or OX-40.

   - Untreated brain metastasis(es) that may be considered active

   - Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within
   4 weeks prior to the first dose of REGN2810

   - Infection with human immunodeficiency virus (HIV) and/or chronic/active infection with
   hepatitis B virus or hepatitis C virus

   - History of pneumonitis within the last 5 years

   - Allergic reactions or acute hypersensitivity reaction attributed to antibody
   treatments

   - Known allergy to doxycycline or tetracycline

   - Patients with a history of solid organ transplant

   - Any medical co-morbidity, physical examination finding, or metabolic dysfunction, or
   clinical laboratory abnormality that renders the patient unsuitable

   - Prior treatment with idelalisib

Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting

Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

The purpose is to assess the effect of a new drug REGN2810 on patients with squamous cell skin cancer that are not treatable with surgery or have metastasized. We will assess ifit has any effect on the skin cancer and what the side effects are. We will also assess how severe the side effects are.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Regeneron Pharmaceuticals

Stanford Investigator(s):

Intervention(s):

  • Drug: REGN2810

Phase:

Phase 2

Eligibility


Key Inclusion Criteria:

   - At least 1 measurable lesion

   - Eastern Cooperative Oncology Group (ECOG) performance status ≤1

   - Adequate bone marrow function

   - Adequate renal function

   - Adequate hepatic function

   - Archived or newly obtained tumor material

   - Patients must consent to undergo biopsies of externally visible CSCC lesions (Group 2
   only)

   - Surgical or radiological treatment of lesions contraindicated

Key Exclusion Criteria:

   - Ongoing or recent (within 5 years) evidence of significant autoimmune disease that
   required treatment with systemic immunosuppressive treatments, which may suggest risk
   for immune-related adverse events

   - Prior treatment with an agent that blocks the PD-1/PD-L1pathway

   - Prior treatment with a BRAF inhibitor

   - Prior treatment with other immune-modulating agents within fewer than 4 weeks prior to
   the first dose of REGN2810, or associated with immune-mediated adverse events that
   were ≥ grade 1 within 90 days prior to the first dose of REGN2810, or associated with
   toxicity that resulted in discontinuation of the immune-modulating agent. Examples of
   immune-modulating agents include therapeutic vaccines, cytokine treatments, or agents
   that target cytotoxic T-lymphocyte antigen 4 (CTLA-4), 4-1BB (CD137), or OX-40.

   - Untreated brain metastasis(es) that may be considered active

   - Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within
   4 weeks prior to the first dose of REGN2810

   - Infection with human immunodeficiency virus (HIV) and/or chronic/active infection with
   hepatitis B virus or hepatitis C virus

   - History of pneumonitis within the last 5 years

   - Allergic reactions or acute hypersensitivity reaction attributed to antibody
   treatments

   - Known allergy to doxycycline or tetracycline

   - Patients with a history of solid organ transplant

   - Any medical co-morbidity, physical examination finding, or metabolic dysfunction, or
   clinical laboratory abnormality that renders the patient unsuitable

   - Prior treatment with idelalisib

Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting

Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

The purpose is to assess the effect of a new drug REGN2810 on patients with squamous cell skin cancer that are not treatable with surgery or have metastasized. We will assess ifit has any effect on the skin cancer and what the side effects are. We will also assess how severe the side effects are.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Regeneron Pharmaceuticals

Stanford Investigator(s):

Intervention(s):

  • Drug: REGN2810

Phase:

Phase 2

Eligibility


Key Inclusion Criteria:

   - At least 1 measurable lesion

   - Eastern Cooperative Oncology Group (ECOG) performance status ≤1

   - Adequate bone marrow function

   - Adequate renal function

   - Adequate hepatic function

   - Archived or newly obtained tumor material

   - Patients must consent to undergo biopsies of externally visible CSCC lesions (Group 2
   only)

   - Surgical or radiological treatment of lesions contraindicated

Key Exclusion Criteria:

   - Ongoing or recent (within 5 years) evidence of significant autoimmune disease that
   required treatment with systemic immunosuppressive treatments, which may suggest risk
   for immune-related adverse events

   - Prior treatment with an agent that blocks the PD-1/PD-L1pathway

   - Prior treatment with a BRAF inhibitor

   - Prior treatment with other immune-modulating agents within fewer than 4 weeks prior to
   the first dose of REGN2810, or associated with immune-mediated adverse events that
   were ≥ grade 1 within 90 days prior to the first dose of REGN2810, or associated with
   toxicity that resulted in discontinuation of the immune-modulating agent. Examples of
   immune-modulating agents include therapeutic vaccines, cytokine treatments, or agents
   that target cytotoxic T-lymphocyte antigen 4 (CTLA-4), 4-1BB (CD137), or OX-40.

   - Untreated brain metastasis(es) that may be considered active

   - Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within
   4 weeks prior to the first dose of REGN2810

   - Infection with human immunodeficiency virus (HIV) and/or chronic/active infection with
   hepatitis B virus or hepatitis C virus

   - History of pneumonitis within the last 5 years

   - Allergic reactions or acute hypersensitivity reaction attributed to antibody
   treatments

   - Known allergy to doxycycline or tetracycline

   - Patients with a history of solid organ transplant

   - Any medical co-morbidity, physical examination finding, or metabolic dysfunction, or
   clinical laboratory abnormality that renders the patient unsuitable

   - Prior treatment with idelalisib

Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting

Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

The purpose is to assess the effect of a new drug REGN2810 on patients with squamous cell skin cancer that are not treatable with surgery or have metastasized. We will assess ifit has any effect on the skin cancer and what the side effects are. We will also assess how severe the side effects are.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Regeneron Pharmaceuticals

Stanford Investigator(s):

Intervention(s):

  • Drug: REGN2810

Phase:

Phase 2

Eligibility


Key Inclusion Criteria:

   - At least 1 measurable lesion

   - Eastern Cooperative Oncology Group (ECOG) performance status ≤1

   - Adequate bone marrow function

   - Adequate renal function

   - Adequate hepatic function

   - Archived or newly obtained tumor material

   - Patients must consent to undergo biopsies of externally visible CSCC lesions (Group 2
   only)

   - Surgical or radiological treatment of lesions contraindicated

Key Exclusion Criteria:

   - Ongoing or recent (within 5 years) evidence of significant autoimmune disease that
   required treatment with systemic immunosuppressive treatments, which may suggest risk
   for immune-related adverse events

   - Prior treatment with an agent that blocks the PD-1/PD-L1pathway

   - Prior treatment with a BRAF inhibitor

   - Prior treatment with other immune-modulating agents within fewer than 4 weeks prior to
   the first dose of REGN2810, or associated with immune-mediated adverse events that
   were ≥ grade 1 within 90 days prior to the first dose of REGN2810, or associated with
   toxicity that resulted in discontinuation of the immune-modulating agent. Examples of
   immune-modulating agents include therapeutic vaccines, cytokine treatments, or agents
   that target cytotoxic T-lymphocyte antigen 4 (CTLA-4), 4-1BB (CD137), or OX-40.

   - Untreated brain metastasis(es) that may be considered active

   - Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within
   4 weeks prior to the first dose of REGN2810

   - Infection with human immunodeficiency virus (HIV) and/or chronic/active infection with
   hepatitis B virus or hepatitis C virus

   - History of pneumonitis within the last 5 years

   - Allergic reactions or acute hypersensitivity reaction attributed to antibody
   treatments

   - Known allergy to doxycycline or tetracycline

   - Patients with a history of solid organ transplant

   - Any medical co-morbidity, physical examination finding, or metabolic dysfunction, or
   clinical laboratory abnormality that renders the patient unsuitable

   - Prior treatment with idelalisib

Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting

Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

The purpose is to assess the effect of a new drug REGN2810 on patients with squamous cell skin cancer that are not treatable with surgery or have metastasized. We will assess ifit has any effect on the skin cancer and what the side effects are. We will also assess how severe the side effects are.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Regeneron Pharmaceuticals

Stanford Investigator(s):

Intervention(s):

  • Drug: REGN2810

Phase:

Phase 2

Eligibility


Key Inclusion Criteria:

   - At least 1 measurable lesion

   - Eastern Cooperative Oncology Group (ECOG) performance status ≤1

   - Adequate bone marrow function

   - Adequate renal function

   - Adequate hepatic function

   - Archived or newly obtained tumor material

   - Patients must consent to undergo biopsies of externally visible CSCC lesions (Group 2
   only)

   - Surgical or radiological treatment of lesions contraindicated

Key Exclusion Criteria:

   - Ongoing or recent (within 5 years) evidence of significant autoimmune disease that
   required treatment with systemic immunosuppressive treatments, which may suggest risk
   for immune-related adverse events

   - Prior treatment with an agent that blocks the PD-1/PD-L1pathway

   - Prior treatment with a BRAF inhibitor

   - Prior treatment with other immune-modulating agents within fewer than 4 weeks prior to
   the first dose of REGN2810, or associated with immune-mediated adverse events that
   were ≥ grade 1 within 90 days prior to the first dose of REGN2810, or associated with
   toxicity that resulted in discontinuation of the immune-modulating agent. Examples of
   immune-modulating agents include therapeutic vaccines, cytokine treatments, or agents
   that target cytotoxic T-lymphocyte antigen 4 (CTLA-4), 4-1BB (CD137), or OX-40.

   - Untreated brain metastasis(es) that may be considered active

   - Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within
   4 weeks prior to the first dose of REGN2810

   - Infection with human immunodeficiency virus (HIV) and/or chronic/active infection with
   hepatitis B virus or hepatitis C virus

   - History of pneumonitis within the last 5 years

   - Allergic reactions or acute hypersensitivity reaction attributed to antibody
   treatments

   - Known allergy to doxycycline or tetracycline

   - Patients with a history of solid organ transplant

   - Any medical co-morbidity, physical examination finding, or metabolic dysfunction, or
   clinical laboratory abnormality that renders the patient unsuitable

   - Prior treatment with idelalisib

Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting

Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

The purpose is to assess the effect of a new drug REGN2810 on patients with squamous cell skin cancer that are not treatable with surgery or have metastasized. We will assess ifit has any effect on the skin cancer and what the side effects are. We will also assess how severe the side effects are.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Regeneron Pharmaceuticals

Stanford Investigator(s):

Intervention(s):

  • Drug: REGN2810

Phase:

Phase 2

Eligibility


Key Inclusion Criteria:

   - At least 1 measurable lesion

   - Eastern Cooperative Oncology Group (ECOG) performance status ≤1

   - Adequate bone marrow function

   - Adequate renal function

   - Adequate hepatic function

   - Archived or newly obtained tumor material

   - Patients must consent to undergo biopsies of externally visible CSCC lesions (Group 2
   only)

   - Surgical or radiological treatment of lesions contraindicated

Key Exclusion Criteria:

   - Ongoing or recent (within 5 years) evidence of significant autoimmune disease that
   required treatment with systemic immunosuppressive treatments, which may suggest risk
   for immune-related adverse events

   - Prior treatment with an agent that blocks the PD-1/PD-L1pathway

   - Prior treatment with a BRAF inhibitor

   - Prior treatment with other immune-modulating agents within fewer than 4 weeks prior to
   the first dose of REGN2810, or associated with immune-mediated adverse events that
   were ≥ grade 1 within 90 days prior to the first dose of REGN2810, or associated with
   toxicity that resulted in discontinuation of the immune-modulating agent. Examples of
   immune-modulating agents include therapeutic vaccines, cytokine treatments, or agents
   that target cytotoxic T-lymphocyte antigen 4 (CTLA-4), 4-1BB (CD137), or OX-40.

   - Untreated brain metastasis(es) that may be considered active

   - Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within
   4 weeks prior to the first dose of REGN2810

   - Infection with human immunodeficiency virus (HIV) and/or chronic/active infection with
   hepatitis B virus or hepatitis C virus

   - History of pneumonitis within the last 5 years

   - Allergic reactions or acute hypersensitivity reaction attributed to antibody
   treatments

   - Known allergy to doxycycline or tetracycline

   - Patients with a history of solid organ transplant

   - Any medical co-morbidity, physical examination finding, or metabolic dysfunction, or
   clinical laboratory abnormality that renders the patient unsuitable

   - Prior treatment with idelalisib

Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting

Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

The purpose is to assess the effect of a new drug REGN2810 on patients with squamous cell skin cancer that are not treatable with surgery or have metastasized. We will assess ifit has any effect on the skin cancer and what the side effects are. We will also assess how severe the side effects are.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Regeneron Pharmaceuticals

Stanford Investigator(s):

Intervention(s):

  • Drug: REGN2810

Phase:

Phase 2

Eligibility


Key Inclusion Criteria:

   - At least 1 measurable lesion

   - Eastern Cooperative Oncology Group (ECOG) performance status ≤1

   - Adequate bone marrow function

   - Adequate renal function

   - Adequate hepatic function

   - Archived or newly obtained tumor material

   - Patients must consent to undergo biopsies of externally visible CSCC lesions (Group 2
   only)

   - Surgical or radiological treatment of lesions contraindicated

Key Exclusion Criteria:

   - Ongoing or recent (within 5 years) evidence of significant autoimmune disease that
   required treatment with systemic immunosuppressive treatments, which may suggest risk
   for immune-related adverse events

   - Prior treatment with an agent that blocks the PD-1/PD-L1pathway

   - Prior treatment with a BRAF inhibitor

   - Prior treatment with other immune-modulating agents within fewer than 4 weeks prior to
   the first dose of REGN2810, or associated with immune-mediated adverse events that
   were ≥ grade 1 within 90 days prior to the first dose of REGN2810, or associated with
   toxicity that resulted in discontinuation of the immune-modulating agent. Examples of
   immune-modulating agents include therapeutic vaccines, cytokine treatments, or agents
   that target cytotoxic T-lymphocyte antigen 4 (CTLA-4), 4-1BB (CD137), or OX-40.

   - Untreated brain metastasis(es) that may be considered active

   - Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within
   4 weeks prior to the first dose of REGN2810

   - Infection with human immunodeficiency virus (HIV) and/or chronic/active infection with
   hepatitis B virus or hepatitis C virus

   - History of pneumonitis within the last 5 years

   - Allergic reactions or acute hypersensitivity reaction attributed to antibody
   treatments

   - Known allergy to doxycycline or tetracycline

   - Patients with a history of solid organ transplant

   - Any medical co-morbidity, physical examination finding, or metabolic dysfunction, or
   clinical laboratory abnormality that renders the patient unsuitable

   - Prior treatment with idelalisib

Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting

Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

The purpose is to assess the effect of a new drug REGN2810 on patients with squamous cell skin cancer that are not treatable with surgery or have metastasized. We will assess ifit has any effect on the skin cancer and what the side effects are. We will also assess how severe the side effects are.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Regeneron Pharmaceuticals

Stanford Investigator(s):

Intervention(s):

  • Drug: REGN2810

Phase:

Phase 2

Eligibility


Key Inclusion Criteria:

   - At least 1 measurable lesion

   - Eastern Cooperative Oncology Group (ECOG) performance status ≤1

   - Adequate bone marrow function

   - Adequate renal function

   - Adequate hepatic function

   - Archived or newly obtained tumor material

   - Patients must consent to undergo biopsies of externally visible CSCC lesions (Group 2
   only)

   - Surgical or radiological treatment of lesions contraindicated

Key Exclusion Criteria:

   - Ongoing or recent (within 5 years) evidence of significant autoimmune disease that
   required treatment with systemic immunosuppressive treatments, which may suggest risk
   for immune-related adverse events

   - Prior treatment with an agent that blocks the PD-1/PD-L1pathway

   - Prior treatment with a BRAF inhibitor

   - Prior treatment with other immune-modulating agents within fewer than 4 weeks prior to
   the first dose of REGN2810, or associated with immune-mediated adverse events that
   were ≥ grade 1 within 90 days prior to the first dose of REGN2810, or associated with
   toxicity that resulted in discontinuation of the immune-modulating agent. Examples of
   immune-modulating agents include therapeutic vaccines, cytokine treatments, or agents
   that target cytotoxic T-lymphocyte antigen 4 (CTLA-4), 4-1BB (CD137), or OX-40.

   - Untreated brain metastasis(es) that may be considered active

   - Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within
   4 weeks prior to the first dose of REGN2810

   - Infection with human immunodeficiency virus (HIV) and/or chronic/active infection with
   hepatitis B virus or hepatitis C virus

   - History of pneumonitis within the last 5 years

   - Allergic reactions or acute hypersensitivity reaction attributed to antibody
   treatments

   - Known allergy to doxycycline or tetracycline

   - Patients with a history of solid organ transplant

   - Any medical co-morbidity, physical examination finding, or metabolic dysfunction, or
   clinical laboratory abnormality that renders the patient unsuitable

   - Prior treatment with idelalisib

Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting

Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

The purpose is to assess the effect of a new drug REGN2810 on patients with squamous cell skin cancer that are not treatable with surgery or have metastasized. We will assess ifit has any effect on the skin cancer and what the side effects are. We will also assess how severe the side effects are.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Regeneron Pharmaceuticals

Stanford Investigator(s):

Intervention(s):

  • Drug: REGN2810

Phase:

Phase 2

Eligibility


Key Inclusion Criteria:

   - At least 1 measurable lesion

   - Eastern Cooperative Oncology Group (ECOG) performance status ≤1

   - Adequate bone marrow function

   - Adequate renal function

   - Adequate hepatic function

   - Archived or newly obtained tumor material

   - Patients must consent to undergo biopsies of externally visible CSCC lesions (Group 2
   only)

   - Surgical or radiological treatment of lesions contraindicated

Key Exclusion Criteria:

   - Ongoing or recent (within 5 years) evidence of significant autoimmune disease that
   required treatment with systemic immunosuppressive treatments, which may suggest risk
   for immune-related adverse events

   - Prior treatment with an agent that blocks the PD-1/PD-L1pathway

   - Prior treatment with a BRAF inhibitor

   - Prior treatment with other immune-modulating agents within fewer than 4 weeks prior to
   the first dose of REGN2810, or associated with immune-mediated adverse events that
   were ≥ grade 1 within 90 days prior to the first dose of REGN2810, or associated with
   toxicity that resulted in discontinuation of the immune-modulating agent. Examples of
   immune-modulating agents include therapeutic vaccines, cytokine treatments, or agents
   that target cytotoxic T-lymphocyte antigen 4 (CTLA-4), 4-1BB (CD137), or OX-40.

   - Untreated brain metastasis(es) that may be considered active

   - Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within
   4 weeks prior to the first dose of REGN2810

   - Infection with human immunodeficiency virus (HIV) and/or chronic/active infection with
   hepatitis B virus or hepatitis C virus

   - History of pneumonitis within the last 5 years

   - Allergic reactions or acute hypersensitivity reaction attributed to antibody
   treatments

   - Known allergy to doxycycline or tetracycline

   - Patients with a history of solid organ transplant

   - Any medical co-morbidity, physical examination finding, or metabolic dysfunction, or
   clinical laboratory abnormality that renders the patient unsuitable

   - Prior treatment with idelalisib

Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting

Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

The purpose is to assess the effect of a new drug REGN2810 on patients with squamous cell skin cancer that are not treatable with surgery or have metastasized. We will assess ifit has any effect on the skin cancer and what the side effects are. We will also assess how severe the side effects are.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Regeneron Pharmaceuticals

Stanford Investigator(s):

Intervention(s):

  • Drug: REGN2810

Phase:

Phase 2

Eligibility


Key Inclusion Criteria:

   - At least 1 measurable lesion

   - Eastern Cooperative Oncology Group (ECOG) performance status ≤1

   - Adequate bone marrow function

   - Adequate renal function

   - Adequate hepatic function

   - Archived or newly obtained tumor material

   - Patients must consent to undergo biopsies of externally visible CSCC lesions (Group 2
   only)

   - Surgical or radiological treatment of lesions contraindicated

Key Exclusion Criteria:

   - Ongoing or recent (within 5 years) evidence of significant autoimmune disease that
   required treatment with systemic immunosuppressive treatments, which may suggest risk
   for immune-related adverse events

   - Prior treatment with an agent that blocks the PD-1/PD-L1pathway

   - Prior treatment with a BRAF inhibitor

   - Prior treatment with other immune-modulating agents within fewer than 4 weeks prior to
   the first dose of REGN2810, or associated with immune-mediated adverse events that
   were ≥ grade 1 within 90 days prior to the first dose of REGN2810, or associated with
   toxicity that resulted in discontinuation of the immune-modulating agent. Examples of
   immune-modulating agents include therapeutic vaccines, cytokine treatments, or agents
   that target cytotoxic T-lymphocyte antigen 4 (CTLA-4), 4-1BB (CD137), or OX-40.

   - Untreated brain metastasis(es) that may be considered active

   - Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within
   4 weeks prior to the first dose of REGN2810

   - Infection with human immunodeficiency virus (HIV) and/or chronic/active infection with
   hepatitis B virus or hepatitis C virus

   - History of pneumonitis within the last 5 years

   - Allergic reactions or acute hypersensitivity reaction attributed to antibody
   treatments

   - Known allergy to doxycycline or tetracycline

   - Patients with a history of solid organ transplant

   - Any medical co-morbidity, physical examination finding, or metabolic dysfunction, or
   clinical laboratory abnormality that renders the patient unsuitable

   - Prior treatment with idelalisib

Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting