Cemiplimab + Gemcitabine for Pancreatic Cancer
(SWITCH Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new combination of treatments for individuals with a specific type of advanced pancreatic cancer. Researchers aim to determine if adding cemiplimab, an immunotherapy drug, to the usual chemotherapy drug gemcitabine can effectively treat cancer with specific genetic changes known as SWI/SNF alterations. The trial targets those previously treated with certain chemotherapy regimens but not with immunotherapy. Individuals diagnosed with stage IV pancreatic ductal adenocarcinoma and possessing these genetic changes might be suitable for this study. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot use warfarin, strong cytochrome P450 3A inhibitors, or certain other medications. It's best to discuss your current medications with the trial team to see if they are allowed.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that combining cemiplimab and gemcitabine may help treat advanced pancreatic cancer. In earlier studies, 64% of patients experienced tumor shrinkage, and 91% had stable cancer without progression during the study.
Regarding safety, the FDA has already approved cemiplimab for other uses, indicating a well-understood safety profile. Gemcitabine is a common chemotherapy drug used in cancer treatment. Both drugs have side effects, but studies have found that their combination is generally manageable.
This trial is in Phase 2, meaning the treatment's safety is still under careful evaluation, but some evidence suggests it is well-tolerated. Participants will be closely monitored to ensure safety and manage any side effects.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for pancreatic cancer, which often include chemotherapy drugs like gemcitabine alone, the combination of cemiplimab and gemcitabine introduces an innovative approach. Cemiplimab is an immune checkpoint inhibitor that works by unleashing the body’s immune system to better recognize and attack cancer cells. Researchers are excited about this combination because cemiplimab could enhance the effectiveness of gemcitabine, potentially leading to improved outcomes for patients. This dual approach may offer a new hope by targeting the cancer more aggressively than existing options.
What evidence suggests that cemiplimab plus gemcitabine might be an effective treatment for pancreatic cancer?
Research has shown that using cemiplimab and gemcitabine together may help treat advanced pancreatic cancer. In one study, 64% of patients experienced significant tumor shrinkage, known as a partial response. Additionally, 91% of patients achieved disease control, meaning their cancer did not worsen. In this trial, participants will receive a combination therapy of cemiplimab, an immunotherapy that aids the body's immune system in fighting cancer, and gemcitabine, a chemotherapy drug that kills cancer cells. Together, they might offer a stronger treatment option for this challenging cancer.12567
Who Is on the Research Team?
Gregory P Botta, MD, PhD
Principal Investigator
University of California, San Diego
Are You a Good Fit for This Trial?
This trial is for patients with metastatic pancreatic ductal adenocarcinoma who have specific genetic alterations and have already undergone certain chemotherapy treatments. Participants must have measurable Stage IV disease, good performance status, and adequate bone marrow function. They should not be on recent chemotherapy or radiation therapy and must understand the study procedures.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive cemiplimab plus gemcitabine until disease progression or other reasons for discontinuation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cemiplimab
- Gemcitabine
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Diego
Lead Sponsor
Regeneron Pharmaceuticals
Industry Sponsor
Leonard Schleifer
Regeneron Pharmaceuticals
Chief Executive Officer since 1988
MD and PhD in Medicine
George Yancopoulos
Regeneron Pharmaceuticals
Chief Medical Officer since 1997
MD from Harvard Medical School