A Study to Evaluate The Efficacy And Safety Of RO7198457 In Combination With Pembrolizumab Versus Pembrolizumab Alone In Participants With Previously Untreated Advanced Melanoma.
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.
- Advanced Melanoma
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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.
- 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.
- Phase 2
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- None (Open Label)
Safety Run-in Period: RO7198457 + Pembrolizumab
|Participants will receive at least one cycle of 200 mg pembrolizumab monotherapy by intravenous (IV) infusion followed by 200 mg pembrolizumab IV infusion every 3 weeks (Q3W) plus a recommended dose of RO7198457.||
Randomized Period: Arm A: Pembrolizumab
|Participants will receive 200 mg pembrolizumab administered by IV infusion Q3W. Participants in Arm A have the option to cross over to combination treatment with RO7198457 plus pembrolizumab (Arm B) after confirmed disease progression.||
Randomized Period: Arm B: RO7198457 + Pembrolizumab
|Participants will receive at least one cycle of 200 mg pembrolizumab monotherapy by IV infusion followed by 200 mg pembrolizumab IV infusion Q3W plus a recommended dose of RO7198457.||
- Genentech, Inc.
Study ContactReference Study ID Number: IMCODE001(GO40558) www.roche.com/about_roche/roche_worldwide.htm
888-662-6728 (U.S. and Canada)