West Cancer Center

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.

Title

Merck MK-3475-U02A (PD-1 Refractory 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 02A.

Site Link

NCT04305041

Malignancy

Melanoma

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

2nd Line (post PD-1)

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 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

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Melanoma

Dosing Frequency

Control Agents

Study Protocol

Randomized