OncoMatch/Clinical Trials/NCT06790602
Cemiplimab Plus Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma
Is NCT06790602 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Cemiplimab Plus Gemcitabine for pancreatic ductal adenocarcinoma (mpdac).
Treatment: Cemiplimab Plus Gemcitabine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Pancreatic Cancer
Biomarker criteria
Required: ARID1A alteration
Required: ARID1B alteration
Required: PBRM1 alteration
Required: SMARCA4 alteration
Required: SMARCB1 alteration
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy — for pancreatic ductal adenocarcinoma
One previous line of therapy for pancreatic ductal adenocarcinoma (NOT immunotherapy or cellular therapy)
Cannot have received: immunotherapy
One previous line of therapy for pancreatic ductal adenocarcinoma (NOT immunotherapy or cellular therapy)
Cannot have received: cellular therapy
One previous line of therapy for pancreatic ductal adenocarcinoma (NOT immunotherapy or cellular therapy)
Cannot have received: immune checkpoint inhibitor
History of immune checkpoint inhibitor therapy, ever.
Cannot have received: investigational therapy
Two or more lines of systemic or previous investigational therapy for metastatic pancreatic ductal adenocarcinoma
Lab requirements
Blood counts
ANC ≥ 1,500/μL; Platelet count ≥ 100,000/μL; Hemoglobin ≥ 9.0 g/dL
Kidney function
Serum creatinine ≤ 1.5x ULN
Liver function
Total bilirubin ≤ 1.5x ULN (Gilbert's syndrome allowed); AST ≤ 3.0x ULN (≤5.0x ULN if liver metastases present); ALT ≤ 3.0x ULN (≤5.0x ULN if liver metastases present)
Cardiac function
QTcF average of triplicate ECGs <470 ms
Adequate bone marrow function: Absolute neutrophil count ≥ 1,500 cells per microliter; Platelet count ≥ 100,000 cells per microliter; Hemoglobin ≥ 9.0 grams per deciliter. Adequate hepatic function: Total bilirubin ≤ 1.5 times upper limit of normal (NOTE high bilirubin levels due to Gilbert's syndrome are allowed); Aspartate transaminase ≤ 3.0 times upper limit of normal (≤5.0 times upper limit of normal if liver metastases are present); Alanine transaminase ≤ 3.0 times upper limit of normal (≤5.0 times upper limit of normal if liver metastases are present). Adequate renal function: Serum creatinine ≤ 1.5 times upper limit of normal. Calculated corrected QT Interval (QTcF) average of the triplicate electrocardiograms <470 milliseconds.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California, San Diego · La Jolla, California
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