A Multi-center Trial to Evaluate Multiple Regimens in Metastatic Pancreatic Cancer

Part of paid clinical trials in La Jolla, California.

Sponsor
Pancreatic Cancer Action Network
Study ID
NCT04229004
Phase
PHASE3
Status
Completed

Conditions

  • Metastatic Pancreatic Adenocarcinoma
  • Metastatic Pancreatic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gemcitabine combined with nab-paclitaxel — DRUG
    Arm is closed to recruitment. Nab-paclitaxel is infused over 30-40 min on days 1, 8, 15 of each 28-day cycle. Gemcitabine is infused over 30 min, immediately after completion of nab-paclitaxel infusion, on days 1, 8, 15 of each 28-day cycle. If one of the chemotherapy medications is held, the other study medications may be given. Doses should be re-adjusted if the participant's weight changes by +/- \>10%. If the participant's weight changes by \<10%, no adjustment is necessary unless the site has a standard procedure to adjust doses based upon current weight according to institutional guidelines.
  • Dose -mFOLFIRINOX — DRUG
    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. Oxaliplatin and leucovorin are administered concurrently over 30-120 minutes, followed by irinotecan over 30-90 minutes, followed by the infusion of 5-flurouracil. If one of the chemotherapy medications is held, the other study medications may be given. Doses should be re-adjusted if the participant's weight changes by +/- \>10%. If the participant's weight changes by \<10%, no adjustment is necessary unless the site has a standard procedure to adjust doses based upon current weight according to institutional guidelines.
  • Dose - Pamrevlumab combined with gemcitabine and nab-paclitaxel — DRUG
    Arm is closed to recruitment. Pamrevlumab 35mg/kg IV - Cycle 1 (Day 1, 8, 15 of the 28 day cycle) and Cycle 2 and Onward (Day 1 and 15) Nab-paclitaxel 125mg/m2 IV - Day 1, 8, 15 for every 28 day cycle Gemcitabine 1000mg/m2 IV - Day 1, 8, 15 for every 28 day cycle
  • Dose- Canakinumab and Spartalizumab combined with nab-paclitaxel and gemcitabine — DRUG
    Arm is closed to recruitment. Canakinumab 250mg SC- Day 1 of every 28 day cycle Spartalizumab 400 mg IV - Day 1 of every 28 day cycle Nab-paclitaxel 125mg/m2 IV - Day 1, 8, 15 of every 28 day cycle Gemcitabine 1000mg/m2 IV - Day 1, 8, 15 of every 28 day cycle
  • Drug: Dose -SM-88 — DRUG
    Arm is closed to recruitment. 460 mg (2 capsules) twice daily of a 28-day cycle along with the administration of methoxsalen, phenytoin and sirolimus.

Study Details

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.

Key Dates

Start date
Jan 31, 2020
Status verified
Apr 2025
Primary completion
Feb 5, 2025
Completion
Feb 5, 2025

Study Design

Enrollment
502 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 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.
  • Active Comparator: 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
  • Experimental: pamrevlumab (FibroGen)
    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.
  • Experimental: Canakinumab and Spartalizumab
    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.
  • Experimental: Experimental: SM-88
    Arm is closed to recruitment. 460 mg (2 capsules) twice daily of a 28-day cycle along with the administration of methoxsalen, phenytoin and sirolimus. All four agents (SM-88, methoxsalen, phenytoin, and sirolimus) should be dosed with approximately 240 mL (8 fl. oz.) of water in the morning. All four agents should be taken together consistently. SM-88 used with MPS should ideally be taken approximately 1 hour before or 2 hours after a meal.

Primary Outcome Measure

Overall Survival [ Time Frame: 0 weeks ]

Locations (25)

FacilityCityStateZIPSite coordinators
University of California, San Diego (UCSD) - Moores Cancer CenterLa JollaCalifornia92037-
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-1804-
University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer CenterSan FranciscoCalifornia94158-
University of Florida College of MedicineGainesvilleFlorida32610-
Sylvester Comprehensive Cancer CenterMiamiFlorida33136-1002-
The University of Chicago Medical CenterChicagoIllinois60637-
Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21231-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
University of Michigan - Rogel Cancer CenterAnn ArborMichigan48109-
Mayo Clinic Cancer Center (MCCC)RochesterMinnesota55905-0001-
Siteman Cancer Center - Washington University Medical CampusSt LouisMissouri63110-1010-
University of New Mexico Comprehensive Cancer CenterAlbuquerqueNew Mexico87102-
Evelyn H. Lauder Breast Center - Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
New York University Langone Medical Center - Perlmutter Cancer CenterNew YorkNew York10016-
Weill Cornell Physicians - Solid Tumor/Gastrointestinal OncologyNew YorkNew York10065-
University of Cincinnati Cancer InstituteCincinnatiOhio45267-
University of Pennsylvania - Abramson Cancer CenterPhiladelphiaPennsylvania19104-5127-
The University of Texas Southwestern Medical CenterDallasTexas75390-
Baylor College of MedicineHoustonTexas77030-3411-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
Huntsman Cancer InstituteSalt Lake CityUtah84112-
Virginia Commonwealth University School of MedicineRichmondVirginia23219-
Fred Hutchinson Cancer Research CenterSeattleWashington98109-
Virginia Mason Hospital & Seattle Medical CenterSeattleWashington98101-
Medical College of WisconsinMilwaukeeWisconsin53226-3522-

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By research site
University of California, San Diego (UCSD) - Moores Cancer Center· La Jolla, CACedars-Sinai Medical Center· Los Angeles, CAUniversity of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center· San Francisco, CAUniversity of Florida College of Medicine· Gainesville, FLSylvester Comprehensive Cancer Center· Miami, FLThe University of Chicago Medical Center· Chicago, IL

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