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

PHASE3CompletedINTERVENTIONAL
Enrollment

502

Participants

Timeline

Start Date

January 31, 2020

Primary Completion Date

February 5, 2025

Study Completion Date

February 5, 2025

Conditions
Metastatic Pancreatic CancerMetastatic Pancreatic Adenocarcinoma
Interventions
DRUG

Gemcitabine combined with nab-paclitaxel

"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."

DRUG

Dose -mFOLFIRINOX

"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."

DRUG

Dose - Pamrevlumab combined with gemcitabine and nab-paclitaxel

"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"

DRUG

Dose- Canakinumab and Spartalizumab combined with nab-paclitaxel and gemcitabine

"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

Drug: Dose -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."

Trial Locations (25)

10016

New York University Langone Medical Center - Perlmutter Cancer Center, New York

10065

Evelyn H. Lauder Breast Center - Memorial Sloan Kettering Cancer Center, New York

Weill Cornell Physicians - Solid Tumor/Gastrointestinal Oncology, New York

21231

Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center, Baltimore

23219

Virginia Commonwealth University School of Medicine, Richmond

32610

University of Florida College of Medicine, Gainesville

45267

University of Cincinnati Cancer Institute, Cincinnati

48109

University of Michigan - Rogel Cancer Center, Ann Arbor

60637

The University of Chicago Medical Center, Chicago

75390

The University of Texas Southwestern Medical Center, Dallas

77030

The University of Texas MD Anderson Cancer Center, Houston

84112

Huntsman Cancer Institute, Salt Lake City

87102

University of New Mexico Comprehensive Cancer Center, Albuquerque

92037

University of California, San Diego (UCSD) - Moores Cancer Center, La Jolla

94158

University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center, San Francisco

98101

Virginia Mason Hospital & Seattle Medical Center, Seattle

98109

Fred Hutchinson Cancer Research Center, Seattle

90048-1804

Cedars-Sinai Medical Center, Los Angeles

33136-1002

Sylvester Comprehensive Cancer Center, Miami

02215

Dana-Farber Cancer Institute, Boston

55905-0001

Mayo Clinic Cancer Center (MCCC), Rochester

63110-1010

Siteman Cancer Center - Washington University Medical Campus, St Louis

19104-5127

University of Pennsylvania - Abramson Cancer Center, Philadelphia

77030-3411

Baylor College of Medicine, Houston

53226-3522

Medical College of Wisconsin, Milwaukee

All Listed Sponsors
lead

Pancreatic Cancer Action Network

OTHER

NCT04229004 - A Multi-center Trial to Evaluate Multiple Regimens in Metastatic Pancreatic Cancer | Biotech Hunter | Biotech Hunter