Study on Nivolumab/Ipilimumab and Cabozantinib for Patients with Advanced Melanoma That Cannot Be Surgically Removed
Sponsor: Georgetown University
ClinicalTrials ID:NCT04091750
This clinical trial is testing a combination of drugs, nivolumab, ipilimumab, and cabozantinib, to see if they can help control advanced melanoma that cannot be removed by surgery. The study will last up to two years unless the cancer progresses or side effects become too severe.
Patient Parameters
| Parameter | Options |
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Program Overview
The study aims to find out if a combination of the drugs nivolumab, ipilimumab, and cabozantinib can help control advanced melanoma that cannot be surgically removed. Patients will receive these drugs for an initial 12-week period, followed by maintenance treatment with nivolumab and cabozantinib for up to two years, unless the cancer progresses or side effects become too severe. The main goal is to see how many patients remain free of cancer progression after one year. Patients will have scans every 12 weeks to monitor the cancer, and safety checks will be done at each visit.
Description
Participants in this study will receive a combination of the drugs nivolumab, ipilimumab, and cabozantinib. Treatment will continue for up to two years unless the cancer progresses, side effects become too severe, or other reasons for stopping treatment arise. If patients show a complete or partial response to the treatment, they may stop after one year, based on the doctor's decision. The study will involve regular scans and safety evaluations, including lab tests and physical exams, to monitor the patient's health and the cancer's response to the treatment.
Eligibility Criteria
Inclusion Criteria
- Must have advanced melanoma that cannot be surgically removed (stage IIIb-IIId or IV), except for uveal melanoma.
- Must be 18 years or older with a good performance status (ECOG 0 or 1).
- Must have measurable cancer based on specific criteria.
- Must provide a tumor sample before starting treatment.
- Must have recovered from any side effects of previous treatments to a certain level.
- Must have adequate organ and bone marrow function.
- Must understand and agree to the study requirements and sign a consent form.
- Sexually active participants must agree to use effective contraception during the study and for four months after the last dose.
- Women of childbearing potential must not be pregnant at the start of the study.
Exclusion Criteria
- Previous treatment with similar drugs (anti-PD-1/PD-L1, anti-CTLA-4, or cabozantinib), unless certain conditions are met.
- Recent use of certain cancer treatments or radiation therapy.
- Large or untreated brain metastases, unless adequately treated and stable.
- Active autoimmune disorders requiring immunosuppressive treatment, except for low-risk conditions like vitiligo.
- Use of certain blood thinners, unless specific conditions are met.
- Recent major surgery or significant health issues.
- Heart rhythm issues as shown by an ECG.
- Pregnant or breastfeeding women.
- Inability to swallow tablets.
- Allergies to study drugs.
- Recent diagnosis of another cancer, except for certain low-risk types.
- Use of high-dose steroids or other immunosuppressive drugs within 14 days of starting the study, except for certain conditions.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Lombardi Comprehensive Cancer Center | 20007 | Washington D.C. | District of Columbia |
| Medstar Franklin Square Medical Center, Harry and Jeanette Weinberg Cancer Institute | 21237 | Baltimore | Maryland |
| John Theurer Cancer Center at Hackensack University Medical Center | 07601 | Hackensack | New Jersey |
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