Exploratory Platform Trial to Evaluate Immunotherapy Combinations With Chemotherapy for the Treatment of Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma
- Conditions
- Metastatic Pancreatic Adenocarcinoma
- Interventions
- Drug: Nab-paclitaxel (nP) (Cohort A, B and C)Drug: NG350A (Cohort C)
- Registration Number
- NCT04787991
- Lead Sponsor
- Cancer Insight, LLC
- Brief 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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 45
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort C: NG-350A + Ipilimumab + nP/gem Ipilimumab (Cohort A, B and C) - Cohort C: NG-350A + Ipilimumab + nP/gem Gemcitabine (gem) (Cohort A, B and C) - Cohort B: Hydroxychloroquine + Ipilimumab + nP/gem Hydroxychloroquine (HCQ) (Cohort B) - Cohort A: Nivolumab + Ipilimumab + nP/gem Gemcitabine (gem) (Cohort A, B and C) - Cohort B: Hydroxychloroquine + Ipilimumab + nP/gem Ipilimumab (Cohort A, B and C) - Cohort A: Nivolumab + Ipilimumab + nP/gem Ipilimumab (Cohort A, B and C) - Cohort A: Nivolumab + Ipilimumab + nP/gem Nab-paclitaxel (nP) (Cohort A, B and C) - Cohort B: Hydroxychloroquine + Ipilimumab + nP/gem Gemcitabine (gem) (Cohort A, B and C) - Cohort B: Hydroxychloroquine + Ipilimumab + nP/gem Nab-paclitaxel (nP) (Cohort A, B and C) - Cohort A: Nivolumab + Ipilimumab + nP/gem Nivolumab (Cohort A) - Cohort C: NG-350A + Ipilimumab + nP/gem Nab-paclitaxel (nP) (Cohort A, B and C) - Cohort C: NG-350A + Ipilimumab + nP/gem NG350A (Cohort C) -
- Primary Outcome Measures
Name Time Method Incidence and severity of adverse events Up to 2.5 years
- Secondary Outcome Measures
Name Time Method Overall survival (OS) at 12 months At 12 months Defined as the time from initiation of study intervention until death due to any cause.
Objective response rate (ORR) Up to 2.5 years 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.
Disease control rate (DCR) At 9 months Defined as the proportion of participants who achieve confirmed CR or PR or stable disease (SD) lasting at least 16 weeks
Progression-free survival (PFS) Up to 2.5 years Defined as the time from initiation of study intervention to date of first documented radiographic progression of disease or death due to any cause.
Overall survival (OS) Up to 2.5 years Defined as the time from initiation of study intervention until death due to any cause.
Duration of response (DOR) Up to 2.5 years 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.
Trial Locations
- Locations (6)
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Stanford University
🇺🇸Stanford, California, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
University of California, Los Angeles
🇺🇸Los Angeles, California, United States
University of Pennsylvania, Abramson Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
M.D. Anderson Cancer Center
🇺🇸Houston, Texas, United States