Study of Pembrolizumab (MK-3475) in Participants With Advanced Melanoma (MK-3475-041/KEYNOTE-041)
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 35
Inclusion Criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function
- Histologically confirmed diagnosis of locally advanced (unresectable Stage III) or metastatic (Stage IV) melanoma not amenable to local therapy
- ...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function
- Histologically confirmed diagnosis of locally advanced (unresectable Stage III) or metastatic (Stage IV) melanoma not amenable to local therapy
- At least one measurable lesion
Exclusion Criteria
- Human immunodeficiency virus (HIV)-positive
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
- ...
- Human immunodeficiency virus (HIV)-positive
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
- Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial treatment through 120 days after the last dose of study medication
- Prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-PD ligand-1 (PD-L1), anti-PD-L2, anti-CD137 antibody, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) agent
- Chemotherapy, targeted small molecule therapy, radiotherapy, or biological cancer therapy (including monoclonal antibodies) within 4 weeks prior to the first dose of trial treatment, or not recovered (<= Grade 1 or baseline) from adverse events due to a previously administered agent
- Is currently participating or has participated in a study with an investigational compound or device within 30 days, or 5X half-life of the investigational compound, whichever is longer, of initial dosing on this study
- Has a known hypersensitivity to the components of the study drug or another monoclonal antibody
- Expected to require any other form of systemic or localized antineoplastic therapy while in study
- Receiving systemic steroid therapy or any other form of immunosuppressive therapy within 1 week prior to the first dose of study treatment
- Has known history of active Hepatitis B or C
- Received a live vaccine within 4 weeks prior to the first dose of trial treatment
- History or evidence of active pneumonitis
Summary
- Conditions
- Melanoma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 20 years and 125 years
- Gender
- Both males and females
Description
Participants who discontinue pembrolizumab after achieving a complete response (CR) and subsequently develop progressive disease (PD) may be eligible to enter a Second Course Phase and receive pembrolizumab again. The end of the study for each participant will occur with: 1) the marketing approval o...
Participants who discontinue pembrolizumab after achieving a complete response (CR) and subsequently develop progressive disease (PD) may be eligible to enter a Second Course Phase and receive pembrolizumab again. The end of the study for each participant will occur with: 1) the marketing approval of pembrolizumab for melanoma, 2) the completion of safety follow up or 3) the time when a possibility of entry to second course of treatment is lost, whichever occurs last.
Inclusion Criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function
- Histologically confirmed diagnosis of locally advanced (unresectable Stage III) or metastatic (Stage IV) melanoma not amenable to local therapy
- ...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function
- Histologically confirmed diagnosis of locally advanced (unresectable Stage III) or metastatic (Stage IV) melanoma not amenable to local therapy
- At least one measurable lesion
Exclusion Criteria
- Human immunodeficiency virus (HIV)-positive
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
- ...
- Human immunodeficiency virus (HIV)-positive
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
- Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial treatment through 120 days after the last dose of study medication
- Prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-PD ligand-1 (PD-L1), anti-PD-L2, anti-CD137 antibody, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) agent
- Chemotherapy, targeted small molecule therapy, radiotherapy, or biological cancer therapy (including monoclonal antibodies) within 4 weeks prior to the first dose of trial treatment, or not recovered (<= Grade 1 or baseline) from adverse events due to a previously administered agent
- Is currently participating or has participated in a study with an investigational compound or device within 30 days, or 5X half-life of the investigational compound, whichever is longer, of initial dosing on this study
- Has a known hypersensitivity to the components of the study drug or another monoclonal antibody
- Expected to require any other form of systemic or localized antineoplastic therapy while in study
- Receiving systemic steroid therapy or any other form of immunosuppressive therapy within 1 week prior to the first dose of study treatment
- Has known history of active Hepatitis B or C
- Received a live vaccine within 4 weeks prior to the first dose of trial treatment
- History or evidence of active pneumonitis
Tracking Information
- NCT #
- NCT02180061
- Collaborators
- Not Provided
- Investigators
- Study Director: Medical Director Merck Sharp & Dohme Corp.