Recruitment

Recruitment Status
Completed
Estimated Enrollment
35

Inclusion Criterias

Histologically confirmed diagnosis of locally advanced (unresectable Stage III) or metastatic (Stage IV) melanoma not amenable to local therapy
At least one measurable lesion
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
...
Histologically confirmed diagnosis of locally advanced (unresectable Stage III) or metastatic (Stage IV) melanoma not amenable to local therapy
At least one measurable lesion
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ function

Exclusion Criterias

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
Has a known hypersensitivity to the components of the study drug or another monoclonal antibody
Human immunodeficiency virus (HIV)-positive
...
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
Has a known hypersensitivity to the components of the study drug or another monoclonal antibody
Human immunodeficiency virus (HIV)-positive
Expected to require any other form of systemic or localized antineoplastic therapy while in study
History or evidence of active pneumonitis
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
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
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
Documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
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
Received a live vaccine within 4 weeks prior to the first dose of trial treatment
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

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 Criterias

Histologically confirmed diagnosis of locally advanced (unresectable Stage III) or metastatic (Stage IV) melanoma not amenable to local therapy
At least one measurable lesion
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
...
Histologically confirmed diagnosis of locally advanced (unresectable Stage III) or metastatic (Stage IV) melanoma not amenable to local therapy
At least one measurable lesion
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ function

Exclusion Criterias

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
Has a known hypersensitivity to the components of the study drug or another monoclonal antibody
Human immunodeficiency virus (HIV)-positive
...
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
Has a known hypersensitivity to the components of the study drug or another monoclonal antibody
Human immunodeficiency virus (HIV)-positive
Expected to require any other form of systemic or localized antineoplastic therapy while in study
History or evidence of active pneumonitis
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
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
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
Documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
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
Received a live vaccine within 4 weeks prior to the first dose of trial treatment
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

Tracking Information

NCT #
NCT02180061
Collaborators
Not Provided
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.