West Cancer Center

MELANOMA:Metastatic: 1st Line: KEYNOTE-U02-B

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 02B.

Title

Merck MK-3475-U02B (PD-1 naive metastatic melanoma)

Study Title

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 02B.

Site Link

NCT04305054

Malignancy

Melanoma, Cutaneous Melanoma

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

1st Line, PD-1 naive

Investigational Agent

Multiple

Drug Class

David Portnoy, MD

Sponsor

Merck Sharp & Dohme Corp

Phase

Phase 2

Status

Open to Enrollment

Key Eligibility Criteria

Key Eligibility Criteria Details

Has unresectable Stage III or Stage IV melanoma, not amenable to local therapy
Has been untreated for advanced disease
No ocular or mucosal melanoma
No known additional malignancy that is progressing or requires active treatment within the past two years
No known CNS metastatses
No active autoimmune disease requiring systemic treatment in the past two years
No known HIV/HBV/HCV
Adequate organ function

Objective

Primary
- ORR
- AE
Secondary
- DoR

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Melanoma

Dosing Frequency

Control Agents

Study Protocol

Randomized