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NCT03463460 · ClinicalTrials.gov registry record · Phase 2
Pembrolizumab and Sunitinib Malate in Treating Participants With Refractory Metastatic or Unresectable Thymic Cancer
A Phase 2 study of Thymic Carcinoma, sponsored by Dwight Owen.
- Active
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
- 3
- Study locations
NCT03463460: Active Phase 2 study of Thymic Carcinoma, sponsored by Dwight Owen.
NCT03463460 is a Phase 2 study of Thymic Carcinoma that is active but no longer recruiting, run by Dwight Owen. The registered enrollment target is 9 participants, below the 46-participant average among 4 other Thymic Carcinoma trials with a reported enrollment target (80% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03463460, a Phase 2 study of Thymic Carcinoma, is active but no longer recruiting, sponsored by Dwight Owen.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase II trial studies how well pembrolizumab and sunitinib malate work in treating participants with thymic cancer that has spread to other places in the body or cannot be removed by surgery and does not respond to treatment. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and sunitinib malate may work better in treating thymic cancer.
Primary Outcome
Response will be defined for patients with measurable disease and who receive at least one dose of combination treatment. Exact binomial 95% confidence intervals for the true PR + CR response rate will be calculated.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- OTHER Laboratory Biomarker Analysis
- DRUG Sunitinib Malate
Study Locations (3)
Florida
- Moffitt Cancer Center - Tampa
Indiana
- Indiana University - Indianapolis
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2018-06-19 |
| Est. Completion | 2027-04-30 |
| Phase | Phase 2 |
What the registry record for NCT03463460 still lists
NCT03463460 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 46-participant average among 4 other Thymic Carcinoma trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Thymic Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT03463460 reports a single indexed study location in Florida, Indiana, Ohio.
Frequently Asked Questions
What is clinical trial NCT03463460 about?
NCT03463460 is a clinical study titled "Pembrolizumab and Sunitinib Malate in Treating Participants With Refractory Metastatic or Unresectable Thymic Cancer". This phase II trial studies how well pembrolizumab and sunitinib malate work in treating participants with thymic cancer that has spread to other places in the body or cannot be removed by surgery and does not respond to treatment. Monoclonal antibodies, such as pembrolizumab, may interfere with the...
What is the current status of trial NCT03463460?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2018-06-19. Estimated completion is 2027-04-30.
What conditions does trial NCT03463460 study?
This clinical trial studies the following conditions: Thymic Carcinoma.
What interventions are being tested in trial NCT03463460?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Laboratory Biomarker Analysis (OTHER), Sunitinib Malate (DRUG).
Who is sponsoring clinical trial NCT03463460?
This trial is sponsored by Dwight Owen, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03463460 being conducted?
This trial has 3 study locations across Florida, Indiana, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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