Pancreatic Ductal Adenocarcinoma (mPDAC)Phase 2SWITCHNCT06790602
Cemiplimab Plus Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma
A Phase 2 study testing Cemiplimab Plus Gemcitabine in people with Pancreatic Ductal Adenocarcinoma (mPDAC), run by University of California, San Diego at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma (mPDAC)
- What is being tested?
- Cemiplimab Plus Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2026to Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
- Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to enrollment.
- Major surgery within 4 weeks of the start of study treatment. Major surgeries are defined as those surgeries that require general anesthesia. Insertion of a vascular access device, biliary drainage tube, gastrointestinal stent are NOT considered major surgery.
- Pregnancy or lactation.
- Known allergic reactions to components of the study intervention, cemiplimab and/or gemcitabine.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Diego
La Jolla, California, 92093
Gregory Botta, MD, PhD, 858-822-5354, CancerCTO@health.ucsd.edu
Gastrointestinal Research Team, 858-822-5354, CancerCTO@health.ucsd.edu
About this study
Official title: 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.
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.
Read the detailed description
Chemotherapy with FOLFIRINOX (5-fluoruracil, leucovorin, irinotecan, oxaliplatin) or gemcitabine/nab-paclitaxel is the backbone of modern therapy of metastatic pancreatic ductal adenocarcinoma. Generally, the chemotherapy regimen is chosen based on the patient's performance status and ability to tolerate the specific side effect profiles of the two regimens. As many patients with metastatic pancreatic ductal adenocarcinoma suffer from multiple co-morbidities that develop with the disease, they are often subjected to treatment interruptions, dose reductions, and palliative single-agent therapies. Thus, better treatments are needed for this disease. A treatment modality for many cancer types is represented by immune checkpoint inhibitors. However, over 98% of pancreatic ductal adenocarcinoma are deemed 'cold', which means that they have an uninflamed tumor microenvironment incapable of spurring an immune response during therapy with immune checkpoint inhibitors. In fact, immune checkpoint inhibitors such as ipilimumab (Cytotoxic T-lymphocyte Associated protein 4 blocker) and nivolumab (Programmed Cell Death 1 blocker) have not shown efficacy in pancreatic ductal adenocarcinoma as single agents.
Alterations in the chromatin remodeling complex SWI/SNF appear to sensitize tumors to immune checkpoint inhibitors and may be a surrogate biomarker of efficacy of these compounds. In retrospective studies, immune checkpoint inhibitors in SWI/SNF altered pancreatic ductal adenocarcinoma resulted in improved tumor responses and longer progression-free survival and overall survival. In addition, preclinical studies of immune checkpoint inhibitors plus gemcitabine show superior antitumor effects compared to gemcitabine alone in both orthotopic murine pancreatic cancer cell line grafts and in genetically engineered mouse models.
Thus, the investigators propose a clinical trial of the immune checkpoint inhibitor cemiplimab plus standard of care gemcitabine to evaluate efficacy and safety of this combination in patients with metastatic pancreatic ductal adenocarcinoma harboring SWI/SNF alterations who did not respond or were intolerant to the standard of care chemotherapies (FOLFIRINOX or gemcitabine/nab-paclitaxel). The investigators hypothesize that the combination cemiplimab plus gemcitabine will lead to better overall survival, progression free survival, and overall response rate compared to historical controls.
- Conditions
- Pancreatic Ductal Adenocarcinoma (mPDAC)
- Being tested
- Cemiplimab Plus Gemcitabine
- Keywords
- cemiplimab, gemcitabine, immune checkpoint inhibitors, pancreatic ductal adenocarcinoma, SWI/SNF, combination therapy, PDAC, Phase 2, metastatic
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cemiplimab Plus GemcitabineDrug
Also called Cemiplimab, Libtayo, REGN2810, Gemzar
Cemiplimab Plus Gemcitabine
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Cemiplimab Plus Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start6 May 2026
- Primary completionJul 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Ductal Adenocarcinoma (mPDAC)Studies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Principal investigator, Gregory Botta, University of California, San Diego
- Investigators
- Gregory P Botta, MD, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06790602
- Sponsor's protocol ID
- 810575
- Acronym
- SWITCH
- Status last verified
- May 2026
- First submitted
- 16 Jan 2025
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make individual participant data (IPD) available.
Publications
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.
PubMed 34375311
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06790602
- Acronym / sponsor ID
- SWITCH / 810575
- Conditions
- Pancreatic Ductal Adenocarcinoma (mPDAC)
- Keywords
- cemiplimab, gemcitabine, immune checkpoint inhibitors, pancreatic ductal adenocarcinoma, SWI/SNF, combination therapy, PDAC, Phase 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 6 May 2026 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 24 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chemotherapy with FOLFIRINOX (5-fluoruracil, leucovorin, irinotecan, oxaliplatin) or gemcitabine/nab-paclitaxel is the backbone of modern therapy of metastatic pancreatic ductal adenocarcinoma. Generally, the chemotherapy regimen is chosen based on the patient's performance status and ability to tolerate the specific side effect profiles of the two regimens. As many patients with metastatic pancreatic ductal adenocarcinoma suffer from multiple co-morbidities that develop with the disease, they are often subjected to treatment interruptions, dose reductions, and palliative single-agent therapies. Thus, better treatments are needed for this disease. A treatment modality for many cancer types is represented by immune checkpoint inhibitors. However, over 98% of pancreatic ductal adenocarcinoma are deemed 'cold', which means that they have an uninflamed tumor microenvironment incapable of spurring an immune response during therapy with immune checkpoint inhibitors. In fact, immune checkpoint inhibitors such as ipilimumab (Cytotoxic T-lymphocyte Associated protein 4 blocker) and nivolumab (Programmed Cell Death 1 blocker) have not shown efficacy in pancreatic ductal adenocarcinoma as single agents.
Alterations in the chromatin remodeling complex SWI/SNF appear to sensitize tumors to immune checkpoint inhibitors and may be a surrogate biomarker of efficacy of these compounds. In retrospective studies, immune checkpoint inhibitors in SWI/SNF altered pancreatic ductal adenocarcinoma resulted in improved tumor responses and longer progression-free survival and overall survival. In addition, preclinical studies of immune checkpoint inhibitors plus gemcitabine show superior antitumor effects compared to gemcitabine alone in both orthotopic murine pancreatic cancer cell line grafts and in genetically engineered mouse models.
Thus, the investigators propose a clinical trial of the immune checkpoint inhibitor cemiplimab plus standard of care gemcitabine to evaluate efficacy and safety of this combination in patients with metastatic pancreatic ductal adenocarcinoma harboring SWI/SNF alterations who did not respond or were intolerant to the standard of care chemotherapies (FOLFIRINOX or gemcitabine/nab-paclitaxel). The investigators hypothesize that the combination cemiplimab plus gemcitabine will lead to better overall survival, progression free survival, and overall response rate compared to historical controls.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cemiplimab Plus Gemcitabine | Experimental | Drug: Cemiplimab Plus GemcitabineCombination 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cemiplimab Plus GemcitabineAlso: Cemiplimab, Libtayo, REGN2810, GemzarCemiplimab Plus Gemcitabine | Drug | Cemiplimab Plus Gemcitabine |
Primary outcome
Overall survival
Time frame: 7 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Background: PubMed 34375311Botta 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.
- Individual participant dataSharing planned: No. There is not a plan to make individual participant data (IPD) available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gregory P Botta, MD, PhD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cemiplimab Plus Gemcitabine in people with Pancreatic Ductal Adenocarcinoma (mPDAC), run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gregory P Botta, MD, PhD (858-822-5354, CancerCTO@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06790602, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.