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

NCT04787991 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-10-30

No results posted yet for this study

Summary

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).

Conditions

  • Metastatic Pancreatic Adenocarcinoma

Interventions

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).

DRUG

Hydroxychloroquine (HCQ) (Cohort B)

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

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.

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Cancer Research Institute, New York City

    collaborator OTHER

  • Akamis Bio

    collaborator INDUSTRY

  • Cancer Insight, LLC

    lead INDUSTRY

Principal Investigators

  • Parker Institute for Cancer Immunotherapy · Parker Institute for Cancer Immunotherapy

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-09
Primary Completion
2024-11-12
Completion
2025-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04787991 on ClinicalTrials.gov