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NCT04514484 · ClinicalTrials.gov registry record · Phase 1
Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV
A Phase 1 study of Advanced Malignant Solid Neoplasm and Advanced Melanoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
- 3
- Study locations
NCT04514484: Active Phase 1 study of Advanced Malignant Solid Neoplasm and Advanced Melanoma, sponsored by National Cancer Institute (NCI).
NCT04514484 is a Phase 1 study of Advanced Malignant Solid Neoplasm and Advanced Melanoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 8 participants, below the 177-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (95% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04514484, a Phase 1 study of Advanced Malignant Solid Neoplasm and Advanced Melanoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase I trial investigates the side effects of cabozantinib and nivolumab in treating patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and who are undergoing treatment for human immunodeficiency virus (HIV). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib and nivolumab may shrink or stabilize cancer in patients undergoing treatment for HIV.
Primary Outcome
Dose-limiting toxicity (DLT) were defined as any treatment-related grade 3 or 4 nonhematologic toxicity during the first cycle of therapy, including grade 3 nausea and/or vomiting and grade 3 diarrhea despite prophylaxis and/or treatment or any of the following grade 4 hematologic toxicities during the first cycle of therapy: thrombocytopenia and neutropenia of more than 7 days duration, neutropenia of any duration with fever or documented infection; additionally, treatment delay of 14 days or g
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- DRUG Cabozantinib S-malate
- BIOLOGICAL Nivolumab
Study Locations (3)
Illinois
- Northwestern University - Chicago
New York
- Montefiore Medical Center-Einstein Campus - The Bronx
Pennsylvania
- University of Pittsburgh Cancer Institute (UPCI) - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2021-11-22 |
| Est. Completion | 2027-02-06 |
| Phase | Phase 1 |
What the registry record for NCT04514484 still lists
NCT04514484 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 177-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (95% lower).
The record links to 10 conditions, with Advanced Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04514484 reports a single indexed study location in Illinois, New York, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04514484 about?
NCT04514484 is a clinical study titled "Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV". This phase I trial investigates the side effects of cabozantinib and nivolumab in treating patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and who are undergoing treatment for human immunodeficiency virus (H...
What is the current status of trial NCT04514484?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2021-11-22. Estimated completion is 2027-02-06.
What conditions does trial NCT04514484 study?
This clinical trial studies the following conditions: Advanced Malignant Solid Neoplasm, Advanced Melanoma, Advanced Hepatocellular Carcinoma, Advanced Lung Non-Small Cell Carcinoma, Advanced Ovarian Carcinoma.
What interventions are being tested in trial NCT04514484?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Cabozantinib S-malate (DRUG), Nivolumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04514484?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04514484 being conducted?
This trial has 3 study locations across Illinois, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Advanced Malignant Solid Neoplasm
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04514484's enrollment target sits among peer trials
8 106th of 108 higher than 3 of 108 other Advanced Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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