Autogene Cevumeran + Pembrolizumab for Melanoma

(IMCODE001 Trial)

Recruiting at 76 trial locations

Overseen By Reference Study ID Number: IMCODE001(GO40558) https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Genentech, Inc.

Disqualifiers: Ocular melanoma, CNS metastases, Autoimmune disease, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 10

131 Participants Needed

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

6 weeks

2 visits (in-person)

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

24 months

8 visits (in-person) every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Pembrolizumab
• RO7198457

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.

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

Approved in United States as KEYTRUDA for:

• 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

Approved in European Union as KEYTRUDA for:

• 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

Approved in United Kingdom as KEYTRUDA for:

• Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1

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