A Study to Evaluate The Efficacy And Safety Of RO7198457 In Combination With Pembrolizumab Versus Pembrolizumab Alone In Participants With Previously Untreated Advanced Melanoma.

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy, safety, pharmacokinetics, and patient-reported outcomes (PROs) of RO7198457 plus pembrolizumab compared with pembrolizumab alone in patients with previously untreated advanced melanoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Collaborators: Biontech AG; BioNTech SE
• Treatments: Pembrolizumab

Criteria

Inclusion Criteria:

• Histologically confirmed metastatic (recurrent or de novo Stage IV) or unresectable locally advanced (Stage IIIC or IIID) cutaneous, acral, or mucosal melanoma;

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;

• Life expectancy >/= 12 weeks;

• Adequate hematologic and end-organ function;

• Naive to prior systemic anti-cancer therapy for advanced melanoma with some exceptions;

• Tumor specimen availability;

• Measurable disease per RECIST v1.1.

Exclusion criteria:

• Ocular/uveal melanoma;

• Any anti-cancer therapy with the exceptions as specified in the protocol;

• Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases;

• Previous splenectomy;

• History of autoimmune disease;

• Prior allogeneic bone marrow transplantation or prior solid organ transplantation;

• Positive test for Human Immunodeficiency Virus (HIV) infection;

• Active hepatitis B or C or tuberculosis;

• Significant cardiovascular disease;

• Known clinically significant liver disease.