Autogene Cevumeran + Pembrolizumab for Melanoma
(IMCODE001 Trial)
Trial Summary
What is the purpose of this trial?
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.
Research Team
Clinical Trials
Principal Investigator
Hoffmann-La Roche
Eligibility Criteria
This trial is for adults with advanced melanoma that hasn't been treated before. They should have a certain level of physical fitness (ECOG 0 or 1), a life expectancy of at least 12 weeks, and their major organs must be functioning well. People can't join if they've had organ transplants, significant heart disease, liver problems, eye melanoma, untreated brain metastases, autoimmune diseases, HIV/AIDS, hepatitis B or C.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Safety Run-in
Participants receive at least one cycle of 200 mg pembrolizumab monotherapy by IV infusion followed by 200 mg pembrolizumab IV infusion every 3 weeks plus a recommended dose of autogene cevumeran
Randomized Treatment
Participants receive either pembrolizumab alone or in combination with autogene cevumeran, with the option to cross over to combination treatment after confirmed disease progression
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Pembrolizumab
- RO7198457
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
Find a Clinic Near You
Who Is Running the Clinical Trial?
Genentech, Inc.
Lead Sponsor
Ashley Magargee
Genentech, Inc.
Chief Executive Officer since 2024
MBA from Harvard University, BA from Princeton University
Levi Garraway
Genentech, Inc.
Chief Medical Officer since 2021
MD, PhD
BioNTech SE
Industry Sponsor
Prof. Dr. Ugur Sahin
BioNTech SE
Chief Executive Officer since 2008
MD from University of Cologne
Prof. Özlem Türeci
BioNTech SE
Chief Medical Officer since 2018
MD from Saarland University