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Also known as Cemiplimab, cemiplimab
Cemiplimab Plus Gemcitabine · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| Name | Type | Description |
|---|---|---|
| Cemiplimab Plus Gemcitabine | DRUG | Cemiplimab Plus Gemcitabine |
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...
Cemiplimab is an investigational oncology therapy being studied for locally advanced basal cell carcinoma, bladder cancer, cutaneous squamous cell carcinoma (CSCC), squamous cell carcinoma (SCC), cervical cancer, and advanced cutaneous squamous cell carcinoma. It is a small molecule antibody being developed by Regeneron Pharmaceuticals, Inc. (REGN).
Cemiplimab is an antibody, classified under the -mab (antibody) target class. It is being studied in combination with other agents, including fianlimab and chemotherapy, for various solid tumors. The specific molecular target is not disclosed in the available clinical trial information.
Cemiplimab is developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker REGN. The company is conducting multiple clinical trials to evaluate the drug's safety and efficacy across several oncology indications.
Cemiplimab is in Phase 1 clinical development, with ongoing trials ranging from Phase 2 to Phase 3. It is an investigational drug and has not been approved by regulatory authorities. The development program includes active and completed trials across multiple cancer types.
Cemiplimab is being studied in four clinical trials, including NCT06190951 (Phase 2, melanoma), NCT06585410 (Phase 3, cutaneous squamous cell carcinoma), NCT07234058 (Phase 2, pleural mesothelioma), and NCT07433673 (Phase 2, biliary tract cancer). These trials are conducted in the US, Australia, and Europe.
Cemiplimab is also known as Cemiplimab plus Fianlimab, referring to a fixed-dose combination of the two antibodies. It is also referred to as Cemiplimab 350 MG Intravenous Solution and Cemiplimab Plus Gemcitabine in various clinical contexts.