Cemiplimab Plus Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Diego
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
At least 18 years of age.
Ability to understand the nature of this study, comply with study and follow-up procedures, and give written informed consent.
Histologically or cytologically confirmed pancreatic ductal adenocarcinoma. Primary tumor can be intact or post-resection with newly developed metastatic disease.
Stage IV disease (measurable disease by Immunotherapeutics Response Evaluation Criteria in Solid Tumors is required).
Disqualifiers
Two or more lines of systemic or previous investigational therapy for metastatic pancreatic ductal adenocarcinoma.
History of any autoimmune disease requiring treatment within the past 12 months prior to enrollment.
History of transplanted organ/bone marrow.
History of interstitial lung disease.
Trial design
Design model
Single group
Treatments tested in this trial
Cemiplimab Plus Gemcitabine
DrugCemiplimab Plus Gemcitabine
Treatment groups
43 Participants
are divided into 1 treatment groupGroup A: Cemiplimab Plus GemcitabineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall survival
To evaluate the overall survival of participants with metastatic pancreatic adenocarcinoma harboring SWI/SNF alterations treated with cemiplimab in combination with gemcitabine as a second-line treatment.
Time frame
7 monthsSponsors and contacts
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University of California, San Diego
Lead sponsor
Regeneron Pharmaceuticals
Collaborator
Source ClinicalTrials.gov