Status:
COMPLETED
Exploratory Platform Trial to Evaluate Immunotherapy Combinations With Chemotherapy for the Treatment of Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma
Lead Sponsor:
Cancer Insight, LLC
Collaborating Sponsors:
Bristol-Myers Squibb
Cancer Research Institute, New York City
Conditions:
Metastatic Pancreatic Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 participa...
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 participa...
Eligibility Criteria
Inclusion
- 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.
- Participant must have measurable disease by RECIST v1.1.
- Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- A baseline tumor tissue sample is mandatory for enrollment. If archival tumor tissue is not available, then a fresh tumor biopsy must be provided.
- Participant must be age 18 years or older.
- Participant must have adequate organ function.
- 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:
- 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.
- Prior surgical resection is permitted.
- 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).
- 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.
- 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.
Exclusion
Key Trial Info
Start Date :
August 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2025
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04787991
Start Date
August 9 2021
End Date
July 31 2025
Last Update
October 30 2025
Active Locations (6)
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1
University of California, Los Angeles
Los Angeles, California, United States, 90095
2
University of California, San Francisco
San Francisco, California, United States, 94143
3
Stanford University
Stanford, California, United States, 94305
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065