Neoplasms

All Conditions

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Irinotecan

Leucovorin

Fluorouracil

Oxaliplatin

Atezolizumab

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Participants will receive autogene cevumeran, atezolizumab and mFOLFIRINOX.

Autogene cevumeran will be administered intravenously (IV) at a recommended dose at specified timepoints.

Autogene cevumeran

Atezolizumab will be administered IV at a dose of 1680 milligrams (mg) at specified timepoints.

mFOLFIRINOX (oxaliplatin, leucovorin, irinotecan, 5-FU) will be administered IV at specified timepoints.

mFOLFIRINOX

Reference Study ID Number: GO44479 https://forpatients.roche.com/

Clinical Trials

The purpose of this study is to evaluate the efficacy and safety of adjuvant autogene cevumeran plus atezolizumab and modified leucovorin, 5-fluorouracil (5-FU), irinotecan, and oxaliplatin (mFOLFIRINOX) versus mFOLFIRINOX alone in participants with resected pancreatic ductal adenocarcinoma (PDAC) who have not received prior systemic anti-cancer treatment for PDAC and have no evidence of disease after surgery.

A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected Pancreatic Ductal Adenocarcinoma

A Phase II, Open-Label, Multicenter, Randomized Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Patients With Resected Pancreatic Ductal Adenocarcinoma

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

BioNTech SE

Genentech, Inc.

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Neoplasm Metastasis

Breast Neoplasms

Triple Negative Breast Neoplasms

Urinary Bladder Neoplasms

Melanoma

Carcinoma, Renal Cell

Head and Neck Neoplasms

Kidney Neoplasms

Skin Diseases

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urologic Diseases

Male Urogenital Diseases

Breast Diseases

Kidney Diseases

Neoplastic Processes

Renal Cell Carcinoma

Antibodies

Immunomodulating Agents

Immunoglobulins

Participants will receive autogene cevumeran at escalated dosages.

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

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.

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.

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.

Autogene cevumeran will be administered by intravenous (IV) infusion, in 21-day cycles.

Atezolizumab will be administered by IV infusion on Day 1 of every 21-day cycle.

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).

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

A Phase 1a/1b Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of RO7198457 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Tumors

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected Pancreatic Ductal Adenocarcinoma	NCT05968326	Adenocarcinoma,...	Autogene cevume... Atezolizumab mFOLFIRINOX	18 Years -	Genentech, Inc.
A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected Pancreatic Ductal Adenocarcinoma	NCT05968326	Adenocarcinoma,...	Autogene cevume... Atezolizumab mFOLFIRINOX	18 Years -	Genentech, Inc.
A Study of Autogene Cevumeran (RO7198457) as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Tumors	NCT03289962	Melanoma Non-Small Cell ... Bladder Cancer Colorectal Canc... Triple Negative... Renal Cancer Head and Neck C... Other Solid Can...	Autogene cevume... Atezolizumab	18 Years -	Genentech, Inc.

Spots Global Cancer Trial Database for autogene cevumeran