A Study of Autogene Cevumeran (RO7198457) as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Tumors

Conditions

• Bladder Cancer
• Colorectal Cancer
• Head and Neck Cancer
• Melanoma
• Non-Small Cell Lung Cancer
• Other Solid Cancers
• Renal Cancer
• Triple Negative Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Autogene cevumeran — DRUG
  Autogene cevumeran will be administered by intravenous (IV) infusion, in 21-day cycles.
• Atezolizumab — DRUG
  Atezolizumab will be administered by IV infusion on Day 1 of every 21-day cycle.

Study Details

This is a Phase 1a/1b, open-label, multicenter, global, dose-escalation study designed to evaluate the safety, tolerability, immune response, and pharmacokinetics of autogene cevumeran (RO7198457) as a single agent and in combination with atezolizumab (MPDL3280A, an engineered anti-programmed death-ligand 1 \[anti-PD-L1\] antibody).

Key Dates

Start date

Dec 21, 2017

Status verified

Jun 2026

Primary completion

Jul 1, 2025

Completion

Jul 1, 2025

Study Design

Enrollment

273 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Phase 1a Flat Dose Escalation: Autogene Cevumeran
  Participants will receive autogene cevumeran at escalated dosages.
• Experimental: Phase 1b Flat Dose Escalation: Autogene Cevumeran + Atezolizumab
  Participants will receive autogene cevumeran at escalated dosages along with atezolizumab at a fixed dose of 1200 milligrams (mg)
• Experimental: Phase Ib: Dose Exploration: Autogene Cevumeran + Atezolizumab
  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.
• Experimental: Phase 1b Expansion: Autogene Cevumeran + Atezolizumab
  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.
• Experimental: Phase 1b Expansion: Autogene Cevumeran + Atezolizumab (Serial Biopsy)
  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.

Primary Outcome Measure

Percentage of Participants with Dose-Limiting Toxicities (DLTs) [ Time Frame: Phase 1a: Days 1 to 14 / Phase 1b: Days 1 to 21 ]

Locations (15)

Find similar trials in Scottsdale, AZ

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