Cabozantinib and Nivolumab for Carcinoid Tumors
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Dana-Farber Cancer Institute
- Study ID
- NCT04197310
- Phase
- PHASE2
- Status
- Completed
Conditions
- Carcinoid Tumor
- Carcinoid Tumor of GI System
- Neuroendocrine Tumors
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Nivolumab — DRUG240mg, intravenously, Day 1 and 15 of a 28 day cycle
- Cabozantinib — DRUG40mg, orally, Daily for a 28 day cycle
Study Details
This research study, is studying the combination of cabozantinib and nivolumab in treating advanced carcinoid tumors. \- Carcinoid tumor is another term used to refer to neuroendocrine tumors that arise in organs such as the gastrointestinal tract, lungs, or thymus.
Key Dates
- Start date
- Dec 26, 2019
- Status verified
- Jan 2025
- Primary completion
- Dec 27, 2023
- Completion
- Jan 31, 2024
Study Design
- Enrollment
- 19 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Nivolumab and CabozantinibThe research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. * Cabozantinib will be administered at a dose of 40mg orally, once daily * Nivolumab will be given at a dose of 240mg every 14 days, intravenously Retreat Phase (Optional) * Participants may elect to stop nivolumab and cabozantinib with confirmed CR after at least 24 weeks of treatment. * Participants who elect to stop and then the condition progresses after stopping study treatment may be eligible to resume nivolumab and cabozantinib therapy. * This resumption will be termed as a retreatment second course phase and is available only while the study remains open and the subject meets specified criteria.
Primary Outcome Measure
Objective Response Rate (ORR) [ Time Frame: 46 months ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Boston Medical Center | Boston | Massachusetts | 02118 | - |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | - |
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