West Cancer Center

MELANOMA: NEOADJUVANT: STAGE III: KEYNOTE U02-C

A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants With Melanoma: Substudy 02C

Title

Merck MK-3475-U02C (Neoadjuvant Stage III)

Study Title

A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants With Melanoma: Substudy 02C

Site Link

NCT04303169

Malignancy

Melanoma, Cutaneous Melanoma

Stage

Stage 3

Disease Setting

Neoadjuvant; prior to definitive resection

Line Of Therapy

Neoadjuvant

Investigational Agent

Pembrolizumab, MK-7684, V937

Drug Class

Anti-PD-1, Anti-TIGIT, Oncolytic virus

David Portnoy, MD

Sponsor

Merck Sharp & Dohme Corp

Phase

Phase 2

Status

Open to Enrollment

Key Eligibility Criteria

Key Eligibility Criteria Details

Histologically or cytologically confirmed melanoma
Clinically detectable and resectable Stage IIIB, IIIC, or IIID melanoma
Has been untreated for the melanoma with the exception that primary lesion may have been resected or irradiated
No known CNS mets
No ocular or mucosal melanoma
No known HIV/HBV/HCV
No active autoimmune disease requiring therapy in past 2 years
Must not have received prior oncolytic viruses

Objective

Primary
- pathCR
- Safety
Secondary
- Near pathCR
- Path PR
- RFS

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Melanoma

Dosing Frequency

Control Agents

Study Protocol

Randomized

Yes