Exploratory Platform Trial To Evaluate Immunotherapy Combinations With Chemotherapy For The Treatment Of Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma

Study Overview

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

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).

This is an open-label, non-randomized, exploratory platform trial designed to assess the safety and antitumor activity of immunotherapy, in combination with standard of care chemotherapy, in participants with mPDAC who have not received prior therapy. Where supportive mechanistic data are available, immunotherapy may also be combined with other treatment modalities (eg, radiation). Each cohort of this platform trial will test a different immunotherapy combination and consist of up to 2 stages: an initial stage (Stage 1) to evaluate safety, biomarkers, and/or clinical activity of the combination and an expanded cohort (Stage 2), when warranted, based on the safety, clinical activity, and/or biomarker results from Stage 1. The Sponsor intends to modify and/or add new combinations to the protocol as data emerge from scientific findings, in this and other trials. This trial will be conducted in participants with histologically or cytologically documented diagnosis of mPDAC, with measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, who have not received prior systemic therapy for their disease in the metastatic setting. Participants must have adequate organ and hematologic function and acceptable performance status. Participants must consent to tumor biopsies, including a pre-treatment (baseline) and on-treatment samples.

Metastatic Pancreatic Adenocarcinoma

DRUG: Nivolumab (Cohort A)
DRUG: Ipilimumab (Cohort A, B and C)
DRUG: Hydroxychloroquine (HCQ) (Cohort B)
DRUG: Nab-paclitaxel (nP) (Cohort A, B and C)
DRUG: Gemcitabine (gem) (Cohort A, B and C)
DRUG: NG350A (Cohort C)

PICI0044

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2021-03-04	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-01-12
First Submitted that Met QC Criteria 2021-03-04	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-01-17
First Posted (ACTUAL) 2021-03-09	Results First Posted N/A	Last Verified 2024-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Cohort A: Nivolumab + Ipilimumab + nP/gem	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: 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.
EXPERIMENTAL: Cohort B: Hydroxychloroquine + Ipilimumab + nP/gem	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.
EXPERIMENTAL: Cohort C: NG-350A + Ipilimumab + nP/gem	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: 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).

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Cohort A: Nivolumab + Ipilimumab + nP/gem

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: 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.

EXPERIMENTAL: Cohort B: Hydroxychloroquine + Ipilimumab + nP/gem

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.

EXPERIMENTAL: Cohort C: NG-350A + Ipilimumab + nP/gem

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: 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).

Primary Outcome Measures	Measure Description	Time Frame
Incidence and severity of adverse events		Up to 2.5 years

Secondary Outcome Measures	Measure Description	Time Frame
Objective response rate (ORR)	Defined as the proportion of participants who achieve a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.	Up to 2.5 years
Disease control rate (DCR)	Defined as the proportion of participants who achieve confirmed CR or PR or stable disease (SD) lasting at least 16 weeks	At 9 months
Duration of response (DOR)	Defined as the time from first documentation of response (CR or PR) to first radiographic documentation of progressive disease (PD) or death due to any cause.	Up to 2.5 years
Progression-free survival (PFS)	Defined as the time from initiation of study intervention to date of first documented radiographic progression of disease or death due to any cause.	Up to 2.5 years
Overall survival (OS)	Defined as the time from initiation of study intervention until death due to any cause.	Up to 2.5 years
Overall survival (OS) at 12 months	Defined as the time from initiation of study intervention until death due to any cause.	At 12 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Bristol-Myers Squibb
Cancer Research Institute, New York City
Akamis Bio

Investigators

STUDY_DIRECTOR: Parker Institute for Cancer Immunotherapy, Parker Institute for Cancer Immunotherapy

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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