Status:
COMPLETED
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.
Lead Sponsor:
Genentech, Inc.
Collaborating Sponsors:
BioNTech SE
Conditions:
Advanced Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 21 2025
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT03815058
Start Date
January 8 2019
End Date
January 21 2025
Last Update
February 7 2025
Active Locations (41)
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1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
2
University of California San Diego Moores Cancer Center
La Jolla, California, United States, 92037
3
UCSF Comprehensive Cancer Ctr
San Francisco, California, United States, 94115
4
University of Colorado
Denver, Colorado, United States, 80262