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

NCT02180061 | Completed Phase 1 Results

• 4 other identifiers: 3475-041142637MK-3475-041KEYNOTE-041
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Melanoma

Keywords

PD1; PD-1; PDL1; PD-L1

Outcome Measures

Primary Outcomes (3)

• Number of Participants Experiencing Adverse Events (AEs)

  An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.

  All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)

• Number of Participants Discontinuing Treatment Due to AEs

  An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.

  Up to last dose of study drug (Up to 24 months)

• Overall Response Rate (ORR) Per Central Radiology Review Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

  The ORR, using RECIST 1.1, was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) at any time during the study, based on central radiology review.

  Up to 24 months

Secondary Outcomes (2)

• ORR Per Investigator Assessment Using RECIST 1.1

  Up to 24 months

• ORR Per Central Radiology Review Using Immune-related Response Criteria (irRC)

  Up to 24 months

Study Arms (2)

Advanced Cutaneous Melanoma

EXPERIMENTAL

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).

Biological: Pembrolizumab

Advanced Mucosal Melanoma

EXPERIMENTAL

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

Biological: Pembrolizumab

Interventions

Pembrolizumab BIOLOGICAL

IV infusion

Also known as: MK-3475

Advanced Cutaneous Melanoma; Advanced Mucosal Melanoma

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Yamazaki N, Takenouchi T, Fujimoto M, Ihn H, Uchi H, Inozume T, Kiyohara Y, Uhara H, Nakagawa K, Furukawa H, Wada H, Noguchi K, Shimamoto T, Yokota K. Phase 1b study of pembrolizumab (MK-3475; anti-PD-1 monoclonal antibody) in Japanese patients with advanced melanoma (KEYNOTE-041). Cancer Chemother Pharmacol. 2017 Apr;79(4):651-660. doi: 10.1007/s00280-016-3237-x. Epub 2017 Mar 11.

  PMID: 28283736 RESULT

Related Links

• Merck Oncology Clinical Trials Information

MeSH Terms

Conditions

Melanoma

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2014
• First Posted: July 2, 2014
• Study Start: July 15, 2014
• Primary Completion: August 31, 2017
• Study Completion: August 31, 2017
• Last Updated: March 31, 2020
• Results First Posted: October 4, 2016

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share