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 (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. Thi

Trial Details

NCT ID
NCT05136196
Phase
PHASE2
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • Biopsy Procedure
  • Biospecimen Collection
  • Cabozantinib S-malate
  • Computed Tomography
  • Magnetic Resonance Imaging
  • Nivolumab
Locations (sample)
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Little Rock, Arkansas, United States|34.74648,-92.28959
  • Beverly Hills, California, United States|34.07362,-118.40036
  • Irvine, California, United States|33.66946,-117.82311
  • Los Angeles, California, United States|34.05223,-118.24368

Key Eligibility Criteria

  • STEP 1 - SPECIMEN SUBMISSION
  • Participants must have histologically confirmed melanoma that is stage III or IV, unresectable, recurrent, or metastatic non-uveal melanoma OR Part…
  • Note: For participants with primary oropharyngeal cancer, human papillomavirus (HPV) or p16 status must be known prior to step 1 registration
  • Participants must have disease presentation consistent with measurable disease. Note: Current disease measurements will not be required until step …

For full eligibility, visit ClinicalTrials.gov.

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