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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Cancer Insight, LLC
Study ID
NCT04787991
Phase
PHASE1
Status
Completed

Conditions

  • Metastatic Pancreatic Adenocarcinoma

Eligibility Criteria

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

Interventions

  • Nivolumab (Cohort A) — DRUG
    Nivolumab will be administered intravenously at 360 mg every 3 weeks for up to 2 years.
  • Ipilimumab (Cohort A, B and C) — DRUG
    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.
  • Hydroxychloroquine (HCQ) (Cohort B) — DRUG
    Hydroxychloroquine will be administered orally daily for up to 2 years.
  • Nab-paclitaxel (nP) (Cohort A, B and C) — DRUG
    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.
  • Gemcitabine (gem) (Cohort A, B and C) — DRUG
    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.
  • NG350A (Cohort C) — DRUG
    NG-350A will be administered intravenously on Cycle 1 Days 15 (1e12 viral particles), 17 (3e12 viral particles), and 19 (3e12 viral particles).

Study Details

This trial is designed to evaluate multiple clinical hypotheses and mechanistically-defined combinations to evaluate the safety and efficacy of first-line chemo-immunotherapy combinations in participants with metastatic pancreatic ductal adenocarcinoma (mPDAC).

Key Dates

Start date
Aug 9, 2021
Status verified
Oct 2025
Primary completion
Nov 12, 2024
Completion
Jul 31, 2025

Study Design

Enrollment
45 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: Nivolumab + Ipilimumab + nP/gem
  • Experimental: Cohort B: Hydroxychloroquine + Ipilimumab + nP/gem
  • Experimental: Cohort C: NG-350A + Ipilimumab + nP/gem

Primary Outcome Measure

Incidence and severity of adverse events [ Time Frame: Up to 2.5 years ]

Locations (6)

FacilityCityStateZIPSite coordinators
University of California, Los AngelesLos AngelesCalifornia90095-
University of California, San FranciscoSan FranciscoCalifornia94143-
Stanford UniversityStanfordCalifornia94305-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
University of Pennsylvania, Abramson Cancer CenterPhiladelphiaPennsylvania19104-
M.D. Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Los Angeles, CA

By research site
University of California, Los Angeles· Los Angeles, CAUniversity of California, San Francisco· San Francisco, CAStanford University· Stanford, CAMemorial Sloan Kettering Cancer Center· New York, NYUniversity of Pennsylvania, Abramson Cancer Center· Philadelphia, PAM.D. Anderson Cancer Center· Houston, TX

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