A Phase 1 interventional study of Nivolumab (Cohort A) and Ipilimumab (Cohort A, B and C) in Metastatic Pancreatic Adenocarcinoma, sponsored by Cancer Insight, LLC. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-30.
Sponsored by Cancer Insight, LLC · Phase 1, Interventional, and Treatment
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.
Cancer Insight, LLC is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Core Inclusion Criteria
Participant has histologically or cytologically documented diagnosis of pancreatic adenocarcinoma with metastatic disease. Participants with locally advanced disease are not eligible.
a. Participants with recurrent locally advanced disease are eligible, provided: i. the last dose of chemotherapy and/or radiotherapy occurred > 4 months prior to the first dose of study intervention, and; ii. no systemic or radiotherapy has been administered in the metastatic setting.
Core Exclusion Criteria
Participant must not have received any prior treatment, including chemotherapy, biological therapy, or targeted therapy for mPDAC, with the following exceptions and notes:
Drug: Nivolumab (Cohort A) · Drug: Ipilimumab (Cohort A, B and C) · Drug: Nab-paclitaxel (nP) (Cohort A, B and C) · Drug: Gemcitabine (gem) (Cohort A, B and C)
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: Ipilimumab (Cohort A, B and C) · Drug: Nab-paclitaxel (nP) (Cohort A, B and C) · Drug: Gemcitabine (gem) (Cohort A, B and C) · Drug: NG350A (Cohort C)
Nivolumab will be administered intravenously at 360 mg every 3 weeks for up to 2 years.
Also known as: Opdivo
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.
Also known as: Yervoy
Hydroxychloroquine will be administered orally daily for up to 2 years.
Also known as: Plaquenil
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.
Also known as: Abraxane
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.
Also known as: Gemzar
NG-350A will be administered intravenously on Cycle 1 Days 15 (1e12 viral particles), 17 (3e12 viral particles), and 19 (3e12 viral particles).
Incidence and severity of adverse events
Time frame: Up to 2.5 years
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Up to 2.5 years
Overall survival (OS)
Defined as the time from initiation of study intervention until death due to any cause.
Time frame: 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.
Time frame: At 12 months
Plan to share: Undecided
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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