Study on Pembrolizumab and Sunitinib Malate for Treating Thymic Cancer That Has Spread or Cannot Be Removed by Surgery
Sponsor: Dwight Owen
ClinicalTrials ID:NCT03463460
This clinical trial is testing a combination of two drugs, pembrolizumab and sunitinib malate, to see if they can effectively treat thymic cancer that has spread or cannot be surgically removed and does not respond to other treatments.
Patient Parameters
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Program Overview
This study is exploring how well the drugs pembrolizumab and sunitinib malate work together to treat thymic cancer that has spread to other parts of the body or cannot be removed by surgery. Pembrolizumab is a type of monoclonal antibody that may help stop cancer cells from growing and spreading. Sunitinib malate may block certain enzymes that cancer cells need to grow. The study aims to find out if using these two drugs together is more effective in treating thymic cancer.
Description
The main goal of this study is to see how effective the combination of pembrolizumab and sunitinib malate is in treating patients with thymic carcinoma that has worsened after previous treatments. Researchers will measure how many patients experience a reduction in tumor size.
The study will also look at the safety and side effects of this drug combination, as well as how long patients live without the cancer getting worse and their overall survival.
Participants will receive pembrolizumab through an IV on the first day and take sunitinib malate by mouth daily for 14 days. This cycle repeats every 21 days for up to 24 months, as long as the cancer does not progress and side effects are manageable.
After finishing the treatment, participants will have follow-up visits 30 days later, then every 6 weeks for a year, and every 9 to 12 weeks after that.
Eligibility Criteria
Inclusion Criteria
- Be willing and able to provide written consent to participate in the study.
- Have a confirmed diagnosis of advanced thymic carcinoma that cannot be cured with surgery or other treatments.
- Have experienced cancer progression after at least one previous treatment with platinum-based chemotherapy.
- Have measurable cancer based on specific medical criteria.
- Be able to provide a recent tumor tissue sample for analysis.
- Be willing to provide a blood sample at the start of the study and during specific treatment cycles.
- Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Have a life expectancy of more than 3 months.
- Be able to swallow and retain oral medication.
- Have controlled blood pressure, with or without medication.
- Have normal heart function as determined by specific tests.
- Have adequate blood cell counts and organ function as indicated by specific blood tests.
- Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to use effective contraception during the study and for 120 days after the last dose.
- Men must agree to use effective contraception during the study and for 120 days after the last dose.
Exclusion Criteria
- Currently participating in another study or have recently received an investigational treatment.
- Have previously received pembrolizumab or sunitinib for cancer treatment.
- Have an immune system deficiency or are taking medications that suppress the immune system.
- Have a history of active tuberculosis.
- Have allergies to pembrolizumab or sunitinib.
- Have had recent chemotherapy, targeted therapy, or radiation therapy and have not recovered from side effects.
- Have another active cancer that requires treatment, except for certain skin cancers or in situ cervical cancer.
- Have active cancer spread to the brain or spinal cord, unless stable and not requiring steroids.
- Have an active autoimmune disease requiring treatment in the past 2 years.
- Have an active infection requiring treatment.
- Have any condition that might interfere with the study or is not in the best interest of the participant.
- Have psychiatric or substance abuse disorders that would interfere with study participation.
- Are pregnant or breastfeeding, or planning to conceive or father a child during the study and for 120 days after.
- Have a history of HIV or active hepatitis B or C.
- Have received a live vaccine within 30 days before starting the study.
- Have significant protein in the urine or serious non-healing wounds.
- Have had recent serious heart or blood vessel problems.
- Are taking medications that strongly affect certain liver enzymes.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Moffitt Cancer Center | 33612 | Tampa | Florida |
| Indiana University | 46202 | Indianapolis | Indiana |
| Ohio State University Comprehensive Cancer Center | 43210 | Columbus | Ohio |
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