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NCT05136196 · ClinicalTrials.gov registry record · Phase 2
BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study
A Phase 2 study of Clinical Stage IV Cutaneous Melanoma AJCC v8 and Metastatic Head-and-neck Squamous-cell Carcinoma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 20
- Study locations
NCT05136196: Recruiting Phase 2 study of Clinical Stage IV Cutaneous Melanoma AJCC v8 and Metastatic Head-and-neck Squamous-cell Carcinoma, sponsored by National Cancer Institute (NCI).
NCT05136196 is a Phase 2 study of Clinical Stage IV Cutaneous Melanoma AJCC v8 and Metastatic Head-and-neck Squamous-cell Carcinoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 150 participants, roughly in line with the 147-participant average among 32 other Clinical Stage IV Cutaneous Melanoma AJCC v8 trials with a reported enrollment target. The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05136196, a Phase 2 study of Clinical Stage IV Cutaneous Melanoma AJCC v8 and Metastatic Head-and-neck Squamous-cell Carcinoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies the good and bad effects of the combination of drugs called cabozantinib and nivolumab in treating patients with melanoma or squamous cell head and neck cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). 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. This trial may help doctors determine how quickly patients can be divided into groups based on biomarkers in their tumors. A biomarker is a biological molecule found in the blood, other body fluids, or in tissues that is a sign of a normal or abnormal process or a sign of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition. The two biomarkers that this trial is studying are "tumor mutational burden" and "tumor inflammation signature." Another purpose of this trial is to help doctors learn if cabozantinib and nivolumab shrink or stabilize the cancer, and whether patients respond differently to the combination depending on the status of the biomarkers.
Primary Outcome
A biomarker turnaround time estimate of at least 75% less than or equal to 21 days will be considered successful with respect to feasibility. For melanoma participants prior to Revision #7, turnaround time is defined as the time-period between date of tissue submission by the site to central repository and date the site was sent notification of participant molecular group determination. For head and neck squamous cell carcinoma (HNSCC) and melanoma participants after Revision #7, turnaround time
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- PROCEDURE Biopsy Procedure
- DRUG Cabozantinib S-malate
Study Locations (20)
Colorado
- Rocky Mountain Regional VA Medical Center - Aurora
- UCHealth Memorial Hospital Central - Colorado Springs
- Memorial Hospital North - Colorado Springs
- Poudre Valley Hospital - Fort Collins
- Cancer Care and Hematology-Fort Collins - Fort Collins
- UCHealth Greeley Hospital - Greeley
- Medical Center of the Rockies - Loveland
California
- Tower Cancer Research Foundation - Beverly Hills
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
- The Angeles Clinic and Research Institute - West Los Angeles Office - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
Hawaii
- Hawaii Cancer Care Inc - Waterfront Plaza - Honolulu
- Queen's Cancer Cenrer - POB I - Honolulu
- Queen's Medical Center - Honolulu
Delaware
- Helen F Graham Cancer Center - Newark
- Medical Oncology Hematology Consultants PA - Newark
Arizona
- Mayo Clinic Hospital in Arizona - Phoenix
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Florida
- Mayo Clinic in Florida - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2022-12-06 |
| Est. Completion | 2027-01-01 |
| Phase | Phase 2 |
What NCT05136196 shows while recruiting
NCT05136196 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 147-participant average among 32 other Clinical Stage IV Cutaneous Melanoma AJCC v8 trials with a reported enrollment target.
The record links to 10 conditions, with Clinical Stage IV Cutaneous Melanoma AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05136196 names 20 study sites across 7 states, led by Colorado, California, Hawaii.
Frequently Asked Questions
What is clinical trial NCT05136196 about?
NCT05136196 is a clinical study titled "BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study". This phase II trial studies the good and bad effects of the combination of drugs called cabozantinib and nivolumab in treating patients with melanoma or squamous cell head and neck cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (ad...
What is the current status of trial NCT05136196?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2022-12-06. Estimated completion is 2027-01-01.
What conditions does trial NCT05136196 study?
This clinical trial studies the following conditions: Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Head-and-neck Squamous-cell Carcinoma, Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8.
What interventions are being tested in trial NCT05136196?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Biopsy Procedure (PROCEDURE), Cabozantinib S-malate (DRUG).
Who is sponsoring clinical trial NCT05136196?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05136196 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05136196's enrollment target sits among peer trials
150 6th of 32 higher than 26 of 32 other Clinical Stage IV Cutaneous Melanoma AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Clinical Stage IV Cutaneous Melanoma AJCC v8 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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