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
Trial Overview
The Phase 2 trial tests a combination of cemiplimab (an immune checkpoint inhibitor) with gemcitabine (a standard chemotherapy drug) in patients whose tumors show SWI/SNF chromatin remodeling gene alterations and who've had prior chemo like FOLFIRINOX or gemcitabine/nab-paclitaxel.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
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
Citations
Cemiplimab Plus Gemcitabine in Patients With Metastatic ...
The investigators hypothesize that the combination cemiplimab plus gemcitabine will lead to better overall survival, progression free survival, and overall ...
CheMo4METPANC: A randomized phase 2 study with ...
Seven patients (64%) achieved a partial response, including 6 confirmed partial responses, and 10 patients (91%) had disease control, compared ...
CheMo4METPANC
Conclusions: Preliminary results from this pilot study of MCGN in mPDAC were promising, with a PR rate of 63% and disease control rate (DCR) of 91%. Based on ...
The Next Frontier in Pancreatic Cancer: Targeting ...
In this review, we discuss the evolving landscape of therapeutic targets in PDAC, including selected clinical data from corresponding trials. 2. Immunotherapy.
Study Details | NCT04543071 | Chemo4METPANC ...
Cemiplimab is FDA approved for treatment of skin cancer but not for pancreas cancer. Participants will also receive Motixafortide, a new medication which has ...
The efficacy and safety of gemcitabine-based combination ...
This article collects the efficacy and safety outcomes of GEM-based combination therapy vs. GEM alone for advanced pancreatic cancer, and ...
Cemiplimab + Gemcitabine for Pancreatic Cancer ...
This is a Phase 2 trial evaluating the combination of cemiplimab with the standard of care chemotherapy agent gemcitabine for the treatment ...
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