NCT03463460

Pembrolizumab and Sunitinib Malate in Treating Participants With Refractory Metastatic or Unresectable Thymic Cancer

A Multicenter, Phase II Trial of Pembrolizumab and Sunitinib in Refractory Advanced Thymic Carcinoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Dwight Owen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the efficacy of pembrolizumab and sunitinib malate (sunitinib) for the treatment of patients with thymic carcinoma that have progressed on prior treatment as measured by objective response rate. SECONDARY OBJECTIVES: I. To evaluate the safety profile and toxicity of combination pembrolizumab and sunitinib malate as per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0. II. To evaluate the progression free survival (PFS) and overall survival (OS) of patients treated with combination pembrolizumab and sunitinib. EXPLORATORY OBJECTIVES: I. To determine objective response rate (ORR), PFS, and OS by PD-L1 expression \> 50% tumor proportion score (TPS) (by 22C3 assay) II. To determine whether sunitinib treatment leads to increase in PD-L1 expression and tumor infiltrating lymphocytes and decrease in myeloid-derived suppressor cells (MDSC) in both tumor and peripheral blood. OUTLINE: Participants receive pembrolizumab intravenously (IV) over 30 minutes on day 1 and sunitinib malate orally (PO) daily on days 1-14. Courses repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity. After completion of the study treatment, participants are followed up for 30 days, every 6 weeks for 1 year, and every 9 or 12 weeks thereafter.

Conditions

• Thymic Carcinoma

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
BIOLOGICAL	Pembrolizumab	Given IV
DRUG	Sunitinib Malate	Given PO

Timeline

• Start date: 2018-06-19
• Primary completion: 2027-04-30
• Completion: 2027-04-30
• First posted: 2018-03-13
• Last updated: 2026-03-23

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study