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Program for Pembrolizumab (MK-3475) in Participants With Metastatic Melanoma Who Have Failed Standard of Care Therapy Including Ipilimumab (MK-3475-030)

NCT02083484 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2018-01-26

No results posted yet for this study

Summary

This is an expanded access program (EAP) for participants who have progressed after prior systemic therapy including ipilimumab, and V-raf murine sarcoma viral oncogene homolog B1 (BRAF) inhibitor or mitogen-activated protein kinase (MEK) enzyme inhibitor when indicated. Participants cannot be eligible for or have participated in any pembrolizumab (MK-3475) clinical trial with the exception of a participant enrolled in the pembrolizumab protocol MK-3475-006 who received treatment on the ipilimumab treatment arm and progressed; such participants will be eligible to participate in the EAP, regardless of prior treatment with a BRAF/MEK inhibitor, as long as all other eligibility criteria for MK-3475-030 are met.

Conditions

Interventions

BIOLOGICAL

Pembrolizumab

Each participant will receive pembrolizumab every 3 weeks for up to 2 years or until confirmed radiographic disease progression, unacceptable toxicity, confirmed positive pregnancy test, withdrawal of consent, or pembrolizumab approval in the participant's country.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02083484 on ClinicalTrials.gov