Gemcitabine + Cisplatin + Nab-paclitaxel + Cemiplimab for Biliary Tract Cancer
(GAP Cemi Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This study is being conducted to find out if treatment with gemcitabine, cisplatin, nab-paclitaxel, and cemiplimab can shrink previously inoperable tumors enough for surgery.
Who Is on the Research Team?
Linda Wu, MD
Principal Investigator
Columbia University
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive cemiplimab in addition to chemotherapy drugs (gemcitabine, cisplatin, and nab-paclitaxel) to shrink tumors for potential surgical resection
Follow-up
Participants are monitored for safety, effectiveness, and surgical resection outcomes after treatment
Long-term follow-up
Participants are monitored for recurrence-free survival and overall survival
What Are the Treatments Tested in This Trial?
Interventions
- Cemiplimab
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
All study participants will receive cemiplimab in addition to chemotherapy drugs (gemcitabine, cisplatin, and nab-paclitaxel).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Columbia University
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
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