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A Study to Evaluate The Efficacy And Safety Of RO7198457 In Combination With Pembrolizumab Versus Pembrolizumab Alone In Participants With Previously Untreated Advanced Melanoma.
A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran (RO7198457) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Participants With Previously Untreated Advanced Melanoma.
- Cancer
- Skin Cancer
- Melanoma
- Advanced Melanoma
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Active, not recruiting
This trial runs in
Cities
- alpharetta
- Antwerpen
- Barcelona
- Boston
- Bruxelles
- Buxtehude
- Charlottesville
- Chicago
- Cleveland
- Denver
- Duarte
- Edegem
- Erlangen
- Farmington
- Hamburg
- Hannover
- Heidelberg
- Jacksonville
- Kortrijk
- Köln
- Liverpool
- London
- Los Angeles
- luik
- Lübeck
- Madrid
- Mainz
- Mannheim
- Melbourne
- Murray
- Münster
- Nashville
- Pamplona
- Portland
- Salt Lake City
- San Diego
- San Francisco
- Scottsdale
- Seattle
- Sevilla
- St. George
- St. Louis
- Subiaco
- Tampa
- Tübingen
- València
- Washington
- Woodville South
Trial Identifier:
NCT03815058 IMCODE001 2018-001773-24 GO40558
Trial Summary
This study will evaluate the efficacy, safety, pharmacokinetics, and patient-reported outcomes (PROs) of autogene cevumeran (RO7198457) plus pembrolizumab compared with pembrolizumab alone in patients with previously untreated advanced melanoma.
Genentech, Inc.
Sponsor
Phase 2
Phase
NCT03815058, GO40558, IMCODE001, 2018-001773-24
Trial Identifier
RO7198457, Pembrolizumab
Treatments
Advanced Melanoma
Condition
Official Title
A Phase II, Open-Label, Multicenter, Randomized Study of the Efficacy and Safety of RO7198457 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Previously Untreated Advanced Melanoma
Eligibility Criteria
All
Gender
≥18 Years
Age
No
Healthy Volunteers
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.
For the latest version of this information please go to www.forpatients.roche.com