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NCT07252232PHASE3Recruiting

Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC)

Revolution Medicines, Inc.

Start Date

12/15/2025

Completion Date

7/10/2030

Summary

The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to standard of care (SOC) observation only.

Detailed Description

This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with daraxonrasib will improve disease-free survival (DFS) compared to SOC observation in patients with resected PDAC who have completed neoadjuvant and/or adjuvant chemotherapy.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * At least 18 years old and has provided informed consent. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Histologically confirmed PDAC with successful (R0/R1) curative intent surgical resection and no evidence of recurrent or metastatic disease. * Must have received perioperative (neoadjuvant, adjuvant, or a combination of both) multi-agent chemotherapy. * Must have completed most recent treatment within the past 12 weeks. * Adequate organ function (bone marrow, liver, kidney, coagulation). * Documented RAS mutation status. * Able to take oral medications. Exclusion Criteria: * Prior therapy with direct RAS-targeted therapy (eg. degraders and/or inhibitors). * Any conditions that may affect the ability to take or absorb study drug. * Major surgery within 28 days prior to randomization. * Patient is unable or unwilling to comply with protocol-required study visits or procedures.

Interventions

DRUG

daraxonrasib

Interested in This Trial?

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Conditions

Pancreatic CancerPDACPDAC - Pancreatic Ductal AdenocarcinomaResectable Pancreatic Ductal Adenocarcinoma (PDAC)Resected Pancreatic Adenocarcinoma

Locations

Mayo Clinic

Phoenix, Arizona 85054

United States

UC San Diego Moores Cancer Center

La Jolla, California 92037

United States

Cedars-Sinai Cancer at Cedars-Sinai Medical Center

Los Angeles, California 90048

United States

University of California, Los Angeles

Los Angeles, California 90404

United States

Stanford Cancer Institute

Palo Alto, California 94304

United States

University of California, San Francisco

San Francisco, California 94143

United States

Rocky Mountain Cancer Centers, LLP

Lakewood, Colorado 80228

United States

Hartford Healthcare

Hartford, Connecticut 06103

United States

Mayo Clinic

Jacksonville, Florida 32224

United States

University of Miami Hospital and Clinics, Sylvester Comprehensive Cancer Center

Miami, Florida 33136

United States

Florida Cancer Specialists

St. Petersburg, Florida 33701

United States

Winship Cancer Institute, Emory University

Atlanta, Georgia 30322

United States

Community Health Network

Indianapolis, Indiana 46250

United States

University of Kansas Medical Center Research Institute, Inc.

Lawrence, Kansas 66045

United States

Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins & Sibley Memorial Hospital

Baltimore, Maryland 21287

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Dana Farber Cancer Institute (DFCI)

Boston, Massachusetts 02215

United States

Mayo Clinic Cancer Center

Rochester, Minnesota 55905

United States

Saint Luke's Cancer Institute

Kansas City, Missouri 64111

United States

University of Nebraska Medical Center

Omaha, Nebraska 68198

United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada 89169

United States

Laura and Issac Perlmutter Cancer Center at NYU Langone-Ambulatory Care Center

New York, New York 10016

United States

Columbia University Medical Center

New York, New York 10032

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Duke Cancer Center

Durham, North Carolina 27710

United States

Taylor Cancer Research Center

Maumee, Ohio 43537

United States

Avera Cancer Institute

Sioux Falls, South Dakota 57105

United States

SCRI Oncology Partners

Nashville, Tennessee 37203

United States

Texas Oncology - DFW

Dallas, Texas 75246

United States

University of Texas MD Anderson Cancer Center

Houston, Texas 77030

United States

Texas Oncology - Northeast Texas

Longview, Texas 75601

United States

University of Utah, Huntsman Cancer Institute

Salt Lake City, Utah 94112

United States

Virginia Cancer Specialists

Fairfax, Virginia 22031

United States

CRLCC Eugene Marquis

Rennes, Cedex 35042

France

Hôpital Paul Brousse

Villejuif, Val-De- Marne 94804

France

Institut Gustave Roussy

Villejuif, Val-de-Marne 94805

France

Universitaetsklinikum Heidelberg

Heidelberg, 69120

Germany

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133

Italy

IEO - Instituto Europeo di Oncologia

Milan, 20141

Italy

IOV - Istituto Oncologico Veneto IRCCS

Padova, 35128

Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, 56126

Italy

Centro Ricerche Cliniche di Verona s.r.l.

Verona, 37134

Italy

Kanagawa Cancer Center

Yokohama, Kanagawa 241-8515

Japan

National Cancer Center Hospital East

Chiba, 277-8577

Japan

Kyoto University Hospital

Kyoto, 606-8507

Japan

Cancer Institute Hospital of JFCR

Tokyo, 135-8550

Japan

Pan American Oncology Trials, LLC

San Juan, 00909

Puerto Rico

Dong-A University Hospital

Busan, 49201

South Korea

Seoul National University Hospital

Seoul, 03080

South Korea

Asan Medical Center

Seoul, 05505

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

Hospital Universitari Vall d'Hebron - VHIO

Barcelona, 08035

Spain

Hospital Clinic de Barcelona

Barcelona, 08036

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

Hospital Universitario Virgen del Rocio

Seville, 41013

Spain

University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Medical Centre

Birmingham, B15 2TH

United Kingdom

Beatson West of Scotland Cancer Centre

Glasgow, G22 0YN

United Kingdom

The Royal Marsden NHS Foundation Trust, Royal Marsden Hospital-London

London, SW3 6JJ

United Kingdom

Imperial College Healthcare NHS Foundation Trust, Hammersmith Hospital

London, W12 0HS

United Kingdom

The Christie NHS Foundation Trust

Manchester, M20 4BX

United Kingdom