Exploratory Platform Trial to Evaluate Immunotherapy Combinations With Chemotherapy for the Treatment of Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

August 9, 2021

Primary Completion Date

October 31, 2024

Study Completion Date

January 11, 2025

Conditions
Metastatic Pancreatic Adenocarcinoma
Interventions
DRUG

Nivolumab (Cohort A)

Nivolumab will be administered intravenously at 360 mg every 3 weeks for up to 2 years.

DRUG

Ipilimumab (Cohort A, B and C)

For Cohort A and B, ipilimumab will be administered intravenously at 1mg/kg every 6 weeks for up to 2 cycles. For Cohort C, ipilimumab will be administered intravenously at 1mg/kg on C2D1 and C4D1.

DRUG

Hydroxychloroquine (HCQ) (Cohort B)

Hydroxychloroquine will be administered orally daily for up to 2 years.

DRUG

Nab-paclitaxel (nP) (Cohort A, B and C)

Nab-paclitaxel will be administered intravenously at 125 mg/m2 for 2 weeks on and 1 week off, for at least 24 weeks, unless treatment discontinuation criteria are met.

DRUG

Gemcitabine (gem) (Cohort A, B and C)

Gemcitabine will be administered intravenously at 1000 mg/m2 for 2 weeks on and 1 week off, for at least 24 weeks, unless treatment discontinuation criteria are met.

DRUG

NG350A (Cohort C)

NG-350A will be administered intravenously on Cycle 1 Days 15 (1e12 viral particles), 17 (3e12 viral particles), and 19 (3e12 viral particles).

Trial Locations (6)

10065

Memorial Sloan Kettering Cancer Center, New York

19104

University of Pennsylvania, Abramson Cancer Center, Philadelphia

77030

M.D. Anderson Cancer Center, Houston

90095

University of California, Los Angeles, Los Angeles

94143

University of California, San Francisco, San Francisco

94305

Stanford University, Stanford

Sponsors
All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

collaborator

Cancer Research Institute, New York City

OTHER

collaborator

Akamis Bio

INDUSTRY

lead

Cancer Insight, LLC

INDUSTRY

NCT04787991 - Exploratory Platform Trial to Evaluate Immunotherapy Combinations With Chemotherapy for the Treatment of Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma | Biotech Hunter | Biotech Hunter