A Multi-center Trial to Evaluate Multiple Regimens in Metastatic Pancreatic Cancer
- Conditions
- Metastatic Pancreatic AdenocarcinomaMetastatic Pancreatic Cancer
- Interventions
- Registration Number
- NCT04229004
- Lead Sponsor
- Pancreatic Cancer Action Network
- Brief Summary
Precision Promise is a multi-center, seamless Phase 2/3 platform trial designed to evaluate multiple regimens in metastatic pancreatic cancer.
Primary Objectives
* To compare each investigational arm versus standard of care (SOC) for superiority in overall survival in first and/or second line metastatic ductal adenocarcinoma (metastatic pancreatic cancer) participants and determine which, if any, participants benefit from each investigational arm.
Secondary Objectives
* To determine short and long-term safety signals of each investigational arm in metastatic pancreatic cancer participants vs. SOC.
* To determine progression-free survival (PFS) for each investigational arm vs. SOC.
* To determine rates of overall response, CR, and PR; duration of overall response, CR or PR (whichever occurs first).
* To determine rates of clinical benefit; duration of clinical benefit.
- Detailed Description
Precision Promise is a multi-center, seamless Phase 2/3 platform trial designed to evaluate multiple regimens in metastatic pancreatic cancer. The goal of the platform is to find effective therapies for pancreatic cancer. The platform will test multiple investigational drugs and combinations compared to standard of care therapy in first and second line metastatic participants. Bayesian response-adaptive randomization will be used to assign participants to arms based on their performance in subtypes of the disease. The primary endpoint is overall survival.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 502
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Gemcitabine combined with nab-paclitaxel Gemcitabine combined with nab-paclitaxel Arm is closed to recruitment. The following are recommended parameters for infusion timing and sequence, although institutional variation in the administration of the regimen are permitted as long as drug dosing and modification guidelines are followed. mFOLFIRINOX Dose -mFOLFIRINOX Arm is closed to recruitment. Oxaliplatin 85 mg/m2, Leucovorin 400 mg/m2, Irinotecan 150 mg/m2, 5-Fluorouracil 2400 mg/m2 46-48 hour infusion pamrevlumab (FibroGen) Dose - Pamrevlumab combined with gemcitabine and nab-paclitaxel Arm is closed to recruitment. Experimental: Pamrevlumab in combination with gemcitabine/nab-paclitaxel. Participants enrolled to this treatment arm will receive treatment with pamrevlumab in combination with gemcitabine and nab-paclitaxel. Gemcitabine and nab-paclitaxel are FDA approved therapies for metastatic pancreatic cancer and will be supplied or obtained according to local clinical study agreements and in accordance with local guidelines. Canakinumab and Spartalizumab Dose- Canakinumab and Spartalizumab combined with nab-paclitaxel and gemcitabine Arm is closed to recruitment. Canakinumab and Spartalizumab in Combination with Nab-Paclitaxel and Gemcitabine. Participants enrolled to this treatment arm will receive treatment with Canakinumab and Spartalizumab in combination with nab-paclitaxel and gemcitabine.
- Primary Outcome Measures
Name Time Method Overall Survival 0 weeks Overall survival (OS) is defined from the time of initiation of treatment until death due to any cause. Participants still alive at the time of an analysis will be considered censored at their date of last contact.
- Secondary Outcome Measures
Name Time Method Progression free survival (PFS) From initiation of therapy to clinically determined disease progression or death due to any cause, whichever came first, assessed up to 24 months. PFS will be presented with probability that the hazard ratio is less than 1.0 as well as the corresponding Kaplan-Meier curves and the log-rank test for the comparison with controls.
Duration of Overall Response Rate (ORR) From date of first occurrence of a documented objective response to date of clinically determined disease progression or death due to any cause, whichever came first, assessed up to 24 months. Duration of ORR is defined as the time from the date of response to the date of clinically determined disease progression or death due to any cause.
Duration of Clinical Benefit From screening through last dose of therapy, assessed up to 24 months. Duration of Clinical Benefit will be evaluated using a composite of measures including patient reported outcomes (PROs), supportive care regimens, and disease status.
Performance Status From screening through study completion, an average of 2 years. Changes in Performance Status will be evaluated using the Eastern Cooperative Oncology Group (ECOG) Performance Status, where the highest value is 0 (patient is fully active) and the lowest value is 5 (patient is deceased).
Overall Response Rate (ORR) From initiation of treatment to clinically determined tumor size reduction for a minimum of 4 weeks ORR is defined as the portion of subjects on an arm with a tumor size reduction of at least 30%.
Trial Locations
- Locations (25)
University of California, San Diego (UCSD) - Moores Cancer Center
🇺🇸La Jolla, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
University of Florida College of Medicine
🇺🇸Gainesville, Florida, United States
Sylvester Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
The University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
🇺🇸Baltimore, Maryland, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
University of Michigan - Rogel Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Mayo Clinic Cancer Center (MCCC)
🇺🇸Rochester, Minnesota, United States
Scroll for more (15 remaining)University of California, San Diego (UCSD) - Moores Cancer Center🇺🇸La Jolla, California, United States