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Phase 3 Study of RMC-6236 in Patients with Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) (RASolute 302)

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Revolution Medicines

Status and phase

Enrolling
Phase 3

Conditions

PDAC - Pancreatic Ductal Adenocarcinoma
PDAC
Pancreatic Cancer

Treatments

Drug: 5-fluorouracil
Drug: leucovorin
Drug: Liposomal irinotecan
Drug: Oxaliplatin
Drug: Gemcitabine
Drug: nab-paclitaxel
Drug: Irinotecan
Drug: RMC-6236

Study type

Interventional

Funder types

Industry

Identifiers

NCT06625320
RMC-6236-302

Details and patient eligibility

About

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

Full description

This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with RMC-6236 will improve progression free survival (PFS) or overall survival (OS) compared to Investigator's choice of standard of care chemotherapy in patients with metastatic PDAC who were previously treated with one prior line of therapy with 5-fluorouracil (5-FU) based or gemcitabine-based regimen.

Patients will be randomized in a 1:1 ratio to receive RMC-6236 (Arm A) or Investigator's choice of standard of care chemotherapy (Arm B).

Enrollment

460 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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. Eligible 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

460 participants in 2 patient groups

RMC-6236
Experimental group
Description:
Study drug
Treatment:
Drug: RMC-6236
Investigator's choice of standard of care therapy
Active Comparator group
Description:
Patients randomized to Investigator's choice of standard of care chemotherapy will receive one of the following four treatments: * Gemcitabine and nab-paclitaxel (GnP) * Oxaliplatin, leucovorin, irinotecan, and 5-FU (Modified FOLFIRINOX: mFOLFIRINOX) * Liposomal irinotecan (Nal-IRI + 5-FU/LV) * Oxaliplatin, leucovorin and 5-FU IV (FOLFOX)
Treatment:
Drug: Irinotecan
Drug: nab-paclitaxel
Drug: Gemcitabine
Drug: Oxaliplatin
Drug: Liposomal irinotecan
Drug: leucovorin
Drug: 5-fluorouracil

Trial contacts and locations

5

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Central trial contact

Revolution Medicines

Data sourced from clinicaltrials.gov

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