Pembrolizumab and Sunitinib Malate in Treating Participants With Refractory Metastatic or Unresectable Thymic Cancer
Part of paid clinical trials in Tampa, Florida.
- Sponsor
- Dwight Owen
- Study ID
- NCT03463460
- Phase
- PHASE2
- Status
- Active Not Recruiting
Conditions
- Thymic Carcinoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Laboratory Biomarker Analysis — OTHERCorrelative studies
- Pembrolizumab — BIOLOGICALGiven IV
- Sunitinib Malate — DRUGGiven PO
Study Details
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.
Key Dates
- First listed
- Mar 13, 2018
- Start date
- Jun 19, 2018
- Status verified
- Jul 2026
- Primary completion
- Jul 17, 2026
- Completion
- Apr 30, 2027
Study Design
- Enrollment
- 9 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment (pembrolizumab, sunitinib malate)Participants receive pembrolizumab IV over 30 minutes on day 1 and sunitinib malate PO daily on days 1-14. Courses repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity.
Primary Outcome Measure
Response defined by a complete response (CR) or partial response (PR) evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ Time Frame: Up to 24 months ]
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | - |
| Indiana University | Indianapolis | Indiana | 46202 | - |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | - |
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