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 — OTHER
    Correlative studies
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Sunitinib Malate — DRUG
    Given 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)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612-
Indiana UniversityIndianapolisIndiana46202-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-

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