Autogene Cevumeran + Pembrolizumab for Melanoma

(IMCODE001 Trial)

Recruiting at76 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Genentech, Inc.

No Placebo Group

Prior Safety Data

Breakthrough Therapy

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

Your disease can be measured using a specific method called RECIST v1.1.

I have advanced melanoma and haven't received systemic anti-cancer treatments, with some exceptions.

My blood and organs are functioning well.

Exclusion Criteria

I have had my spleen removed.

I have active hepatitis B, C, or tuberculosis.

I have not had any cancer treatment except those allowed in the study.

Treatment Details

Interventions

• Pembrolizumab (Checkpoint Inhibitor)
• RO7198457 (CAR T-cell Therapy)

Trial Overview The study is testing the combination of Autogene cevumeran (RO7198457) with Pembrolizumab versus using Pembrolizumab alone in patients who haven't received treatment for their advanced melanoma. It aims to see which approach works better and how safe it is.

Participant Groups

Group I: Safety Run-in Period: Autogene Cevumeran + Pembrolizumab Experimental Treatment 2 Interventions

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 autogene cevumeran.

Group II: Randomized Period: Arm B: Autogene Cevumeran + Pembrolizumab Experimental Treatment 2 Interventions

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 autogene cevumeran.

Group III: Randomized Period: Arm A: Pembrolizumab Active Control 1 Intervention

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 autogene cevumeran plus pembrolizumab (Arm B) after confirmed disease progression.

Who Is Running the Clinical Trial?

Genentech, Inc.

Lead Sponsor

Trials

1,578

Recruited

569,000+

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

Trials

84

Recruited

120,000+

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