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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
501
Progression free survival (PFS) in the RAS G12-mutant population
PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is per response evaluation criteria in solid tumors (RECIST) v1.1 and as assessed by blinded independent central review (BICR)
Time frame: Up to approximately 3 years
Overall survival (OS) in the RAS G12-mutant population
OS is defined as the time from randomization until death from any cause.
Time frame: Up to approximately 3 years
PFS in the all-patient population
PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is per RECIST v1.1 and as assessed by BICR.
Time frame: Up to approximately 3 years
OS in the all-patient population
OS is defined as the time from randomization until death from any cause.
Time frame: Up to approximately 3 years
Objective response in the RAS G12 and all-patient populations
Objective response is defined as partial response (PR) or completed response (CR) per RECIST v1.1, assessed by BICR.
Time frame: Up to approximately 3 years
Time to deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Pancreatic Cancer Module (EORTC QLQ-PAN26) in the RAS G12 and all-patient populations
TTD is defined as the time from randomization to the first occurrence of deterioration as defined by a change of at least 10 points, or death, whichever occurs first, in each subscale in EORTC QLQ-PAN26.
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Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Mayo Clinic Cancer Center - Phoenix
Phoenix, Arizona, United States
City of Hope-Duarte
Duarte, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
UCLA
Los Angeles, California, United States
UC San Diego Health Moores Cancer Center
San Diego, California, United States
Mission Hall UCSF
San Francisco, California, United States
Rocky Mountain Cancer
Aurora, Colorado, United States
Mayo Clinic Cancer Center - Florida
Jacksonville, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
...and 50 more locations
Time frame: Up to approximately 3 years
Time to deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in the RAS G12 and all-patient populations
TTD is defined as the time from randomization to the first occurrence of deterioration as defined by a change of at least 10 points, or death, whichever occurs first, in each subscale and global QoL score in EORTC QLQ-C30.
Time frame: Up to approximately 3 years
Objective response per investigator in RAS G12 and all- patient populations
Objective response is defined as PR or CR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, as assessed by the investigator.
Time frame: Up to approximately 3 years
Duration of response (DOR) in RAS G12 and all-patient populations
DOR is defined as time from first evidence of objective response (PR or CR) to disease progression or death due to any cause, whichever occurs first, as assessed by BICR and by the investigator.
Time frame: Up to approximately 3 years
Time to response (TTR) in RAS G12 and all-patient populations
TTR is defined as time from randomization to first evidence of objective response (PR or CR), as assessed by BICR and by the investigator.
Time frame: Up to approximately 3 years
Percentage of patients with adverse events (AEs)
Time frame: Up to approximately 3 years
Pharmacokinetics of RMC-6236 in RAS G12 and all-patient populations
Pharmacokinetics are defined by blood concentrations of RMC-6236 over time.
Time frame: Up to approximately 3 years