Cemiplimab Plus Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma

NCT06790602 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 810575
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Ductal Adenocarcinoma (mPDAC)

Keywords

cemiplimab; gemcitabine; immune checkpoint inhibitors; pancreatic ductal adenocarcinoma; SWI/SNF; combination therapy; PDAC; Phase 2; metastatic

Outcome Measures

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.

  7 months

Study Arms (1)

Cemiplimab Plus Gemcitabine

EXPERIMENTAL

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.

Drug: Cemiplimab Plus Gemcitabine

Interventions

Cemiplimab Plus Gemcitabine DRUG

Cemiplimab Plus Gemcitabine

Also known as: Cemiplimab, Libtayo, REGN2810, Gemzar

Cemiplimab Plus Gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Alterations in SWI/SNF complex chromatin remodeling genes (ARID1A, ARID1B, PBRM1, SMARCA4 and SMARCB1, etc.) detected by next generation sequencing performed prior to enrollment on an ultrasound-guided core biopsy of the primary tumor.
• One previous line of therapy for pancreatic ductal adenocarcinoma (NOT immunotherapy or cellular therapy).
• Last dose of chemotherapy administered \> 14 days prior to the initiation of study therapy.
• Last dose of radiation therapy or administered \> 28 days prior to the initiation of study therapy.
• Eastern Cooperative Oncology Group performance score of 0-1.
• 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.
• Participants not of child-bearing potential, or participants of child-bearing potential who agree to use adequate contraceptive measures during the study and for at least 6 months after the last cemiplimab dose; who are not breastfeeding, and who have a negative serum or urine pregnancy test within 72 hours prior to initiation of study therapy.
• For participants able to cause a pregnancy: use of condoms or other methods to ensure effective contraception with partner during study participation and for at least 6 months after the last cemiplimab dose.

You may not qualify if:

• 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.
• History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
• History of previous malignancy (except in-situ cancer or basal or squamous cell skin cancer) within past 3 years prior to enrollment.
• History of immune checkpoint inhibitor therapy, ever.
• Known bleeding disorders (e.g., van Willebrand's disease or hemophilia).
• Current use of warfarin or other vitamin K antagonists. NOTE: if therapeutic anticoagulation is necessary, low molecular weight heparin or oral factor Xa inhibitors are the anticoagulants of choice.
• Current use of a strong cytochrome P450 3A inhibitor (for example, antifungal medications, grapefruit juice, amiodarone, etc.).
• Presence of known central nervous system or brain metastases.
• History of other diseases, metabolic dysfunction, physical examination findings, or clinical laboratory findings giving reasonable suspicion of a disease or condition that, in the opinion of the investigator, renders the subject at high risk from treatment complications or might affect the interpretation of the results of the study.
• Life expectancy of \<3 months.
• Known active, not-controlled human immunodeficiency virus, hepatitis B or hepatitis C infection or diagnosis of immunodeficiency.
• Receipt of a live vaccine within 4 weeks of start of study medication.

Sponsors & Collaborators

• University of California, San Diego: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

RECRUITING

Related Publications (1)

• Botta GP, Kato S, Patel H, Fanta P, Lee S, Okamura R, Kurzrock R. SWI/SNF complex alterations as a biomarker of immunotherapy efficacy in pancreatic cancer. JCI Insight. 2021 Sep 22;6(18):e150453. doi: 10.1172/jci.insight.150453.

  PMID: 34375311 BACKGROUND

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

cemiplimab; Gemcitabine

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Gregory P Botta, MD, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregory P Botta, MD, PhD

CONTACT

858-822-5354; CancerCTO@health.ucsd.edu

Gastrointestinal Research Team

CONTACT

858-822-5354; CancerCTO@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor

Model Details: Study participants will be treated with intravenous cemiplimab 3mg/kg every 2 weeks and intravenous gemcitabine 1000mg/m\^2 on days 1, 8,15 of every 28-day cycle.

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 24, 2025
• Study Start: May 6, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: June 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)