Study of Pembrolizumab (MK-3475) in Participants With Advanced Melanoma (MK-3475-041/KEYNOTE-041)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Melanoma

Treatments: Biological: Pembrolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02180061

3475-041

MK-3475-041 (Other Identifier)

142637 (Registry Identifier)

KEYNOTE-041 (Other Identifier)

Details and patient eligibility

About

This study will assess the safety, tolerability, and efficacy of every-3-week dosing (Q3W) of pembrolizumab (MK-3475) in participants with advanced melanoma; participants may receive pembrolizumab for up to 2 years if deriving clinical benefit. The primary study hypothesis is that treatment with single agent pembrolizumab will result in a clinically meaningful overall response rate.

Full 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 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.

Enrollment: 42 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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
• At least one measurable lesion
• Adequate organ function

Exclusion criteria

• 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
• 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
• 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
• Expected to require any other form of systemic or localized antineoplastic therapy while in study
• 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
• Receiving systemic steroid therapy or any other form of immunosuppressive therapy within 1 week prior to the first dose of study treatment
• Received a live vaccine within 4 weeks prior to the first dose of trial treatment
• Has a known hypersensitivity to the components of the study drug or another monoclonal antibody
• History or evidence of active pneumonitis
• Human immunodeficiency virus (HIV)-positive
• Has known history of active Hepatitis B or C
• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Advanced Cutaneous Melanoma

Experimental group

Description:

Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, intravenously (IV) over 30 minutes on Day 1 of each 3-week dosing cycle (Q3W).

Treatment:

Biological: Pembrolizumab

Advanced Mucosal Melanoma

Experimental group

Description:

Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.

Treatment:

Biological: Pembrolizumab