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Cemiplimab Plus Gemcitabine

Phase 2

Pancreatic Ductal Adenocarcinoma (mPDAC) | Small molecule | Oncology |Regeneron Pharmaceuticals, Inc.|Last Updated: Apr 9, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment43
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06790602Cemiplimab Plus Gemcitabine in Patients With Metastatic Pancreatic AdenocarcinomaPHASE2 RECRUITING 43Apr 1, 2026Dec 1, 2029Apr 9, 20261 United States
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Study Endpoints
Primary Endpoints
Overall survival
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.

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cemiplimab Plus GemcitabineEXPERIMENTALCombination 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.
Interventions
NameTypeDescription
Cemiplimab Plus GemcitabineDRUGCemiplimab Plus Gemcitabine
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. At least 18 years of age. 2. Ability to understand the nature of this study, comply with study and follow-up procedures, and give written informed consent. 3. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma. Primary tumor can be intact or post-resec...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06790602studyFirstPostDate: changed