Exploratory Platform Trial to Evaluate Immunotherapy Combinations With Chemotherapy for the Treatment of Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma
NCT ID: NCT04787991
Last Updated: 2025-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
45 participants
INTERVENTIONAL
2021-08-09
2025-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort A: Nivolumab + Ipilimumab + nP/gem
Nivolumab (Cohort A)
Nivolumab will be administered intravenously at 360 mg every 3 weeks for up to 2 years.
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.
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.
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.
Cohort B: Hydroxychloroquine + Ipilimumab + nP/gem
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.
Hydroxychloroquine (HCQ) (Cohort B)
Hydroxychloroquine will be administered orally daily for up to 2 years.
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.
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.
Cohort C: NG-350A + Ipilimumab + nP/gem
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.
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.
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.
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).
Interventions
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Nivolumab (Cohort A)
Nivolumab will be administered intravenously at 360 mg every 3 weeks for up to 2 years.
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.
Hydroxychloroquine (HCQ) (Cohort B)
Hydroxychloroquine will be administered orally daily for up to 2 years.
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.
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.
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
2. Participant must have measurable disease by RECIST v1.1.
3. Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. A baseline tumor tissue sample is mandatory for enrollment. If archival tumor tissue is not available, then a fresh tumor biopsy must be provided.
5. Participant must be age 18 years or older.
6. Participant must have adequate organ function.
Exclusion Criteria
1. Participants who have received prior neoadjuvant or adjuvant therapy for pancreatic adenocarcinoma are eligible if neoadjuvant and adjuvant therapy (including chemotherapy and/or radiotherapy) was completed more than 4 months before the start of study intervention.
2. Prior surgical resection is permitted.
3. Participants who have received treatment with any other enadenotucirev-based therapy or anti-CD40 antibody at any time are not eligible for the study (cohort C only).
2. Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
3. Participants with an active, known or suspected autoimmune disease. Participants with: type I diabetes mellitus; hypothyroidism only requiring hormone replacement; a history of Hashimoto syndrome, within 3 years of the first dose of study intervention, which resolved to hypothyroidism alone; skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment; or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Cancer Research Institute, New York City
OTHER
Akamis Bio
INDUSTRY
Cancer Insight, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Parker Institute for Cancer Immunotherapy
Role: STUDY_DIRECTOR
Parker Institute for Cancer Immunotherapy
Locations
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University of California, Los Angeles
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
Stanford University
Stanford, California, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, United States
M.D. Anderson Cancer Center
Houston, Texas, United States
Countries
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References
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Other Identifiers
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PICI0044
Identifier Type: -
Identifier Source: org_study_id
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