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.
Completed · Phase 2
Conditions studied: Advanced Melanoma
In brief
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.
Key facts
- Study ID
- NCT03815058
- Run by
- Genentech, Inc.
- People needed
- 131
- Starts
- 2018-12-21
- Expected to finish
- 2025-01-21
- Last updated by the study team
- 2026-01-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- City of Hope Comprehensive Cancer Center — Duarte, California, United States
- University of California San Diego Moores Cancer Center — La Jolla, California, United States
- UCSF Comprehensive Cancer Ctr — San Francisco, California, United States
- University of Colorado — Denver, Colorado, United States
- Cancer Specialists — Jacksonville, Florida, United States
- Moffitt McKinley Outpatient Center — Tampa, Florida, United States
- Atlanta Cancer Care — Alpharetta, Georgia, United States
- Northwestern University — Chicago, Illinois, United States
- Massachusetts General Hospital. — Boston, Massachusetts, United States
- Washington University — St Louis, Missouri, United States
- Case Western Research University — Cleveland, Ohio, United States
- Oregon Health and Science University — Portland, Oregon, United States
- Sarah Cannon Research Institute / Tennessee Oncology — Nashville, Tennessee, United States
- Intermountain Surgical Oncology — Murray, Utah, United States
- Huntsman Cancer Institute — Salt Lake City, Utah, United States
- University of Virginia — Charlottesville, Virginia, United States
- Seattle Cancer Care Alliance — Seattle, Washington, United States
- Liverpool Hospital — Liverpool, New South Wales, Australia
- The Queen Elizabeth Hospital — Woodville South, South Australia, Australia
- Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia
- Alfred Hospital — Melbourne, Victoria, Australia
- St. John of God - Subiaco Hospital — Subiaco, Western Australia, Australia
- Antwerp University Hospital — Edegem, Belgium
- ZAS Sint Augustinus Wilrijk — Wilrijk, Belgium
- Elbe Kliniken Stade-Buxtehude GmbH — Buxtehude, Germany
Full record on ClinicalTrials.gov
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