RecruitingPhase 2NCT06790602

Cemiplimab Plus Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma

A Single-arm, Open-label, Phase II Trial of Cemiplimab Plus Gemcitabine as Second-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma Harboring SWItch/Sucrose Non-Fermentable (SWI/SNF) Alterations.


Sponsor

University of California, San Diego

Enrollment

43 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining cemiplimab (an immunotherapy drug) with gemcitabine (a chemotherapy drug) can help patients with metastatic pancreatic cancer whose tumors have specific genetic changes in a group of genes called SWI/SNF. These mutations may make tumors more sensitive to immune-based treatments. **You may be eligible if...** - You are 18 years or older - You have metastatic pancreatic ductal adenocarcinoma (the most common type of pancreatic cancer, which has spread to other parts of the body) - Your tumor has specific genetic mutations in the SWI/SNF chromatin remodeling complex (such as ARID1A, ARID1B, PBRM1, SMARCA4, or SMARCB1), detected by genetic sequencing - You have received exactly one prior line of treatment for pancreatic cancer (not immunotherapy or cell therapy) - You have measurable disease on a scan **You may NOT be eligible if...** - Your tumor does not have SWI/SNF gene mutations - You have not received any prior treatment, or you have received more than one line of prior therapy - You have previously received immunotherapy or cell-based therapy - You do not have measurable disease Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCemiplimab Plus Gemcitabine

Cemiplimab Plus Gemcitabine


Locations(1)

University of California, San Diego

La Jolla, California, United States

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NCT06790602


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