Evaluating a new treatment for metastatic pancreatic cancer
RASolute 302: A Phase 3 Multicenter, Open-label, Randomized Study of Daraxonrasib (RMC-6236) Versus Investigator's Choice of Standard of Care Therapy in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
This study is testing a new drug called RMC-6236 to see if it can help people with advanced pancreatic cancer live longer and feel better compared to standard chemotherapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 460 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Revolution Medicines, Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 47 sites (Gilbert, Arizona and 46 other locations) |
| Trial ID | NCT06625320 on ClinicalTrials.gov |
What this trial studies
This global, randomized, open-label Phase 3 study aims to assess the safety and efficacy of RMC-6236, a novel RAS(ON) inhibitor, in patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). Participants will be randomly assigned to receive either RMC-6236 or the investigator's choice of standard chemotherapy. The primary focus is to determine if RMC-6236 can improve progression-free survival (PFS) or overall survival (OS) compared to standard treatments. Eligible patients must have measurable disease and documented RAS mutation status.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed metastatic PDAC who have previously received one line of chemotherapy.
Not a fit: Patients with prior therapy involving direct RAS-targeted treatments or those with central nervous system metastases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option that improves survival outcomes for patients with metastatic pancreatic cancer.
How similar studies have performed: While this approach is novel in targeting RAS mutations specifically, similar studies have shown promise in treating other cancers with targeted therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * At least 18 years old and has provided informed consent. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Histologically or cytologically confirmed PDAC with metastatic disease. * Measurable disease per RECIST 1.1. * Adequate organ function (bone marrow, liver, kidney, coagulation) * Documented RAS mutation status, either mutant or wild-type. RAS mutations defined as nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61). * Able to take oral medications. Exclusion Criteria: * Prior therapy with direct RAS-targeted therapy (eg. degraders and/or inhibitors). * History of or known central nervous system metastatic disease. * Any conditions that may affect the ability to take or absorb study treatment * Major surgery within 4 weeks prior to randomization. * Patient is unable or unwilling to comply with protocol-required study visits or procedures
Where this trial is running
Gilbert, Arizona and 46 other locations
- Banner MD Anderson Cancer Center — Gilbert, Arizona, United States (Recruiting)
- Mayo Clinic — Phoenix, Arizona, United States (Recruiting)
- City of Hope-Duarte — Duarte, California, United States (Recruiting)
- Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)
- UCLA — Los Angeles, California, United States (Recruiting)
- UC San Diego Health Moores Cancer Center — San Diego, California, United States (Recruiting)
- Mission Hall UCSF — San Francisco, California, United States (Recruiting)
- Rocky Mountain Cancer — Aurora, Colorado, United States (Recruiting)
- Mayo Clinic Cancer Center — Jacksonville, Florida, United States (Recruiting)
- University of Miami Sylvester Comprehensive Cancer Center — Miami, Florida, United States (Recruiting)
- Cancer Care Centers of Brevard Inc — Palm Bay, Florida, United States (Recruiting)
- The University of Chicago Medical Center — Chicago, Illinois, United States (Recruiting)
- Johns Hopkins — Baltimore, Maryland, United States (Recruiting)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- Karmanos Cancer Institute — Detroit, Michigan, United States (Recruiting)
- Mayo Clinic Rochester — Rochester, Minnesota, United States (Recruiting)
- Washington University — Saint Louis, Missouri, United States (Recruiting)
- Roswell Park Cancer Institute — Buffalo, New York, United States (Recruiting)
- NYU Lagone Health — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Columbia University Medical Center — New York, New York, United States (Recruiting)
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
- University of Cincinnati Medical Center — Cincinnati, Ohio, United States (Recruiting)
- Stephenson Cancer Center — Oklahoma City, Oklahoma, United States (Recruiting)
- Abramson Cancer Center Clinical Research Unit — Philadelphia, Pennsylvania, United States (Recruiting)
- Sarah Cannon Research Institute (Tennessee) — Nashville, Tennessee, United States (Recruiting)
- Texas Oncology Sammons — Dallas, Texas, United States (Recruiting)
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- Texas Oncology - Central South — Irving, Texas, United States (Recruiting)
- Huntsman Cancer Institute — Salt Lake City, Utah, United States (Recruiting)
- Virginia Cancer Specialists — Fairfax, Virginia, United States (Recruiting)
- Institut Paoli Calmettes — Marseille, France (Recruiting)
- Centre Eugene Marquis — Rennes, France (Recruiting)
- Hopital Paul Brousse — Villejuif, France (Recruiting)
- Gustave Roussy — Villejuif, France (Recruiting)
- Fondazione IRCCS Istituto Nazionale dei Tumori — Milan, Italy (Recruiting)
- IEO-Istituto Europeo di Oncologia — Milan, Italy (Recruiting)
- Azienda Ospedaliera — Pisa, Italy (Recruiting)
- Osaka International Cancer — Osaka, Japan (Recruiting)
- National Cancer Center Hospital — Tokyo, Japan (Recruiting)
- Cancer Institute Hospital of JFCR — Tokyo, Japan (Recruiting)
- Kanagawa Cancer Center — Yokohama, Japan (Recruiting)
- Pan-American Center for Oncology Trials — San Juan, Puerto Rico (Recruiting)
- Hospital Unversitari — Barcelona, Spain (Recruiting)
- Hospital 12 de Octubre — Madrid, Spain (Recruiting)
- Clinica Universidad de Navarra — Pamplona, Spain (Recruiting)
- Hospital Clinico de Valencia — Valencia, Spain (Recruiting)
Study contacts
- Study coordinator: Revolution Medicines
- Email: medinfo@revmed.com
- Phone: 1-844-2-REVMED
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.