Cemiplimab Plus Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT06790602
Phase
PHASE2
Status
Recruiting
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Conditions

  • Pancreatic Ductal Adenocarcinoma (mPDAC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a Phase 2 trial evaluating the combination of cemiplimab with the standard of care chemotherapy agent gemcitabine for the treatment of patients with metastatic pancreatic ductal adenocarcinoma with SWItch/Sucrose Non-Fermentable (SWI/SNF) alterations who have already been treated with FOLFIRINOX (5-fluoruracil, leucovorin, irinotecan, oxaliplatin) or gemcitabine/nab-paclitaxel chemotherapy.

Key Dates

Start date
May 6, 2026
Status verified
May 2026
Primary completion
Jul 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
43 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cemiplimab Plus Gemcitabine
    Combination therapy of cemiplimab plus gemcitabine. Cemiplimab will be supplied as 350 mg vials for intravenous administration at 3 mg/Kg every 2 weeks. Gemcitabine will be administered intravenously per standard of care at 1000mg/m\^2 on days 1, 8, 15 of every 28-day cycle. Cemiplimab plus gemcitabine will be administered until disease progression or other reasons that warrant discontinuation.

Primary Outcome Measure

Overall survival [ Time Frame: 7 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San DiegoLa JollaCalifornia92093
Gregory Botta, MD, PhD
[email protected]
858-822-5354
Gastrointestinal Research Team
[email protected]
858-822-5354

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By research site
University of California, San Diego· La Jolla, CA