MelanomaOpen to EnrollmentPhase 2

MELANOMA: Metastatic: PD-1 refractory: KEYNOTE-U02-A

A Phase 1/2 open-lable rolling-arm umbrella platford design of investigational agents with or without pembrolizumab or pembrolizumab alone in participants with melanoma (KEYNOTE-U02): Substudy 02A.

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Study snapshot

Title: Merck MK-3475-U02A (PD-1 Refractory Melanoma)
Malignancy: Melanoma
Stage: Stage 4
Disease setting: Metastatic/Palliative
Line of therapy: 2nd Line (post PD-1)
Investigational agent: Multiple
Principal investigator: David Portnoy, MD
Sponsor: Merck Sharp & Dohme Corp
Path: Melanoma
Randomized: No
ClinicalTrials.gov ID: NCT04305041

Eligibility and objectives

Key eligibility criteria details

Has unresectable Stage III or Stage IV melanoma not amenable to curative therapy
Has progressed on treatment with an anti-PD1/L1 monoclonal antibody administered either as monotherapy or in combination with other therapies
Hsa not received more than 3 lines of therapy
No known additional malignancy with past 2 years
No known CNS metastases
No active autoimmune disease requiring systemic treatment in the last 2 years
No known HIV/HBV/HCV

Objective

Primary
- Safety
- ORR
Secondary
- DOR

Treatment details