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NCT03211416 · ClinicalTrials.gov registry record · Phase 1
Sorafenib Tosylate and Pembrolizumab in Treating Patients With Advanced or Metastatic Liver Cancer
A Phase 1 study of Advanced Adult Hepatocellular Carcinoma and Stage IIIA Hepatocellular Carcinoma, sponsored by Roswell Park Cancer Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
- 2
- Study locations
NCT03211416: Completed Phase 1 study of Advanced Adult Hepatocellular Carcinoma and Stage IIIA Hepatocellular Carcinoma, sponsored by Roswell Park Cancer Institute.
NCT03211416 is a Phase 1 study of Advanced Adult Hepatocellular Carcinoma and Stage IIIA Hepatocellular Carcinoma that has completed, run by Roswell Park Cancer Institute. The registered enrollment target is 37 participants, above the 25-participant average among 3 other Advanced Adult Hepatocellular Carcinoma trials with a reported enrollment target (48% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03211416, a Phase 1 study of Advanced Adult Hepatocellular Carcinoma and Stage IIIA Hepatocellular Carcinoma, has completed, sponsored by Roswell Park Cancer Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase Ib/II trial studies how well sorafenib tosylate and pembrolizumab work in treating patients with liver cancer that has spread to other parts of the body. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving sorafenib tosylate and pembrolizumab may work better in treating patients with liver cancer.
Primary Outcome
The response rate will be estimated as the binomial proportion of responders among evaluable patients, and supported by Jeffreys? 95% confidence interval.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- OTHER Laboratory Biomarker Analysis
- DRUG Sorafenib Tosylate
Study Locations (2)
Illinois
- Robert H Lurie Comprehensive Cancer Center - Chicago
New York
- Roswell Park Cancer Institute - Buffalo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2017-12-07 |
| Est. Completion | 2025-08-15 |
| Phase | Phase 1 |
What the finished NCT03211416 record still lists
NCT03211416 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, above the 25-participant average among 3 other Advanced Adult Hepatocellular Carcinoma trials with a reported enrollment target (48% higher).
The record links to 9 conditions, with Advanced Adult Hepatocellular Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT03211416 reports a single indexed study location in Illinois, New York.
Frequently Asked Questions
What is clinical trial NCT03211416 about?
NCT03211416 is a clinical study titled "Sorafenib Tosylate and Pembrolizumab in Treating Patients With Advanced or Metastatic Liver Cancer". This phase Ib/II trial studies how well sorafenib tosylate and pembrolizumab work in treating patients with liver cancer that has spread to other parts of the body. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, su...
What is the current status of trial NCT03211416?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2017-12-07. Estimated completion is 2025-08-15.
What conditions does trial NCT03211416 study?
This clinical trial studies the following conditions: Advanced Adult Hepatocellular Carcinoma, Stage IIIA Hepatocellular Carcinoma, Stage IIIB Hepatocellular Carcinoma, Stage IIIC Hepatocellular Carcinoma, Stage IVA Hepatocellular Carcinoma.
What interventions are being tested in trial NCT03211416?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Laboratory Biomarker Analysis (OTHER), Sorafenib Tosylate (DRUG).
Who is sponsoring clinical trial NCT03211416?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03211416 being conducted?
This trial has 2 study locations across Illinois, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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