Autogene Cevumeran + Atezolizumab for Cancer

Recruiting at50 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Genentech, Inc.

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial tests a personalized cancer vaccine and an immune-boosting drug in cancer patients. The vaccine teaches the body to attack cancer, while the drug helps immune cells find and kill hidden cancer cells. This approach aims to induce strong anti-tumor responses by selecting suitable vaccines based on the patient's existing immune system.

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

This trial is for adults with certain advanced cancers (like melanoma, lung, bladder, colorectal) that have worsened after standard treatment or where such treatments aren't suitable. Participants should be relatively healthy otherwise (ECOG 0-1), have a life expectancy of at least 12 weeks, and not have had recent major surgeries or immune system issues.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

My kidneys are functioning well, with a creatinine clearance rate of at least 50 mL/min.

I have advanced NSCLC and haven't been treated with specific immune therapies.

Exclusion Criteria

I have not received neoantigen-specific or whole-tumor cancer vaccines, except as allowed.

I do not have an active brain tumor or untreated brain metastases.

I have had my spleen removed.

Treatment Details

Interventions

• Atezolizumab (PD-L1 Inhibitor)
• Autogene Cevumeran (Cancer Vaccine)

Trial Overview The study is testing Autogene Cevumeran alone and combined with Atezolizumab in patients with various advanced cancers. It's an early-phase trial to check the safety and how well these treatments work together while monitoring the body's immune response.

Participant Groups

Group I: Phase Ib: Dose Exploration: Autogene Cevumeran + Atezolizumab Experimental Treatment 2 Interventions

Non-small cell lung cancer (NSCLC) or melanoma cancer immunotherapy (CIT)-treated participants will receive autogene cevumeran (at dosage lower than maximum tolerated dose \[MTD\] based on available safety data) along with atezolizumab at a fixed dose of 1200 mg.

Group II: Phase 1b Flat Dose Escalation: Autogene Cevumeran + Atezolizumab Experimental Treatment 2 Interventions

Participants will receive autogene cevumeran at escalated dosages along with atezolizumab at a fixed dose of 1200 milligrams (mg)

Group III: Phase 1b Expansion: Autogene Cevumeran + Atezolizumab (Serial Biopsy) Experimental Treatment 2 Interventions

CIT-naive patients with selected tumor types who consent to optional serial biopsies will receive autogene cevumeran (at multiple dose levels below MTD based on available safety data) along with atezolizumab at a dixed dose of 1200 mg.

Group IV: Phase 1b Expansion: Autogene Cevumeran + Atezolizumab Experimental Treatment 2 Interventions

Participants with different indications as per inclusion criteria will receive autogene cevumeran (at multiple dose levels below MTD based on available safety data) along with atezolizumab at a fixed dose of 1200 mg.

Group V: Phase 1a Flat Dose Escalation: Autogene Cevumeran Experimental Treatment 1 Intervention

Participants will receive autogene cevumeran at escalated dosages.

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