Pembrolizumab + Sunitinib for Thymic Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications. However, you cannot use certain drugs that strongly affect liver enzymes (CYP3A4/5 inhibitors or inducers) within 10 days before starting the trial. It's best to discuss your current medications with the trial team.
Is the combination of Pembrolizumab and Sunitinib safe for treating thymic cancer?
Pembrolizumab has been used in treating thymic cancer, but it can cause severe immune-related side effects, especially in thymic epithelial tumors, so close monitoring is necessary. There is no specific safety data available for the combination of Pembrolizumab and Sunitinib in thymic cancer, but Pembrolizumab alone has shown both effectiveness and potential for serious side effects.12345
What makes the drug combination of Pembrolizumab and Sunitinib unique for treating thymic cancer?
The combination of Pembrolizumab and Sunitinib is unique for treating thymic cancer because Pembrolizumab is an immune checkpoint inhibitor that targets PD-1, showing promise in tumors with high PD-L1 expression, while Sunitinib is a multi-targeted tyrosine kinase inhibitor that has shown potential in various cancers, including thymic malignancies. This combination leverages both immune modulation and targeted cancer cell inhibition, offering a novel approach for a condition with limited treatment options.13678
What data supports the effectiveness of the drug Pembrolizumab for treating thymic cancer?
Research shows that Pembrolizumab, when used alone or with chemotherapy, has been effective in treating thymic cancer, especially in cases with high PD-L1 expression (a protein that helps cancer cells hide from the immune system). Some patients experienced significant tumor reduction and long-term remission, suggesting it could be a promising option for this aggressive cancer.12358
Who Is on the Research Team?
Dwight Owen, MD
Principal Investigator
Ohio State University Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with advanced thymic cancer that has spread or can't be surgically removed and hasn't responded to platinum-based chemotherapy. Participants must have a life expectancy over 3 months, stable blood pressure, adequate organ function, no severe active infections or autoimmune diseases, not pregnant or breastfeeding, and willing to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pembrolizumab intravenously on day 1 and sunitinib malate orally daily on days 1-14. Courses repeat every 21 days for up to 24 months.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion. Follow-up occurs every 6 weeks for 1 year, then every 9 or 12 weeks thereafter.
What Are the Treatments Tested in This Trial?
Interventions
- Pembrolizumab
- Sunitinib Malate
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dwight Owen
Lead Sponsor
National Cancer Institute (NCI)
Collaborator