Phase 1
Completed N=42
Study of Pembrolizumab (MK-3475) in Participants With Advanced Melanoma (MK-3475-041/KEYNOTE-041)
Source: ClinicalTrials.gov NCT02180061 ↗Enrolled (actual)
42
Serious AEs
40.5%
Results posted
Oct 2016
Primary outcomePrimary: Number of Participants Experiencing Adverse Events (AEs) — 34; 8 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing Adverse Events (AEs) |
34; 8 | — |
| PRIMARY Number of Participants Discontinuing Treatment Due to AEs |
5; 2 | — |
| PRIMARY Overall Response Rate (ORR) Per Central Radiology Review Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 |
24.1; 25.0 | 0.0216 sig |
| SECONDARY ORR Per Investigator Assessment Using RECIST 1.1 |
29.4; 37.5 | — |
| SECONDARY ORR Per Central Radiology Review Using Immune-related Response Criteria (irRC) |
30.4; 25.0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02180061). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.