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 (NCT05136196)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. STEP 1 - SPECIMEN SUBMISSION
2. Participants must have histologically confirmed melanoma that is stage III or IV, unresectable, recurrent, or metastatic non-uveal melanoma OR Participants must have histologically confirmed squamous cell carcinoma of the head and neck (HNSCC) that is either locally recurrent and non-amendable to curative therapy (e.g., radiation, surgery) or metastatic. The primary tumor location must be the oropharynx, oral cavity, hypopharynx, or larynx. Primary tumor site of nasopharynx (any histology) or unknown primary tumor are not eligible
3. Note: For participants with primary oropharyngeal cancer, human papillomavirus (HPV) or p16 status must be known prior to step 1 registration
4. Participants must have disease presentation consistent with measurable disease. Note: Current disease measurements will not be required until step 2 registration
5. Participants must have had documented progression during or within 12 weeks after the last dose of PD-1 checkpoint inhibition-based therapy. Participants must have been receiving checkpoint inhibition for a minimum of 6 weeks. Participants who recur during adjuvant anti-PD1 treatment or within 12 weeks of completion of adjuvant anti-PD1 treatment are eligible if they have measurable disease and are considered unresectable
6. Participants with known human immunodeficiency virus (HIV)-infection must be receiving anti-retroviral therapy and have an undetectable viral load test within 6 months prior to step 1 registration
7. Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load within 28 days prior to step 1 registration
8. Participants with a history of hepatitis C virus (HCV) infection must have no detectable viral load within 28 days prior to step 1 registration
9. Participants must not have an active infection requiring systemic therapy (except HBV, HCV or HIV as mentioned above)
10. Participants must not have experienced myocardial infarction or thromboembolic event requiring anticoagulation within 90 days prior to step 1 registration, unless clinically stable with ongoing medical management
11. Participants must have recovered to baseline or =\< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5 toxicities related to any prior treatments, unless adverse events are deemed clinically nonsignificant by the treating investigator or stable on supportive therapy
12. Participants must not have received more than one prior primary radiotherapy regimen, curative or adjuvant, to the mucosal surfaces of the head and neck, with the additional following criteria:

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (229 Sites)

• Mayo Clinic Hospital in Arizona — Phoenix, Arizona
• University of Arkansas for Medical Sciences — Little Rock, Arkansas
• Tower Cancer Research Foundation — Beverly Hills, California
• UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California
• The Angeles Clinic and Research Institute - West Los Angeles Office — Los Angeles, California
• Los Angeles General Medical Center — Los Angeles, California
• USC / Norris Comprehensive Cancer Center — Los Angeles, California
• Cedars-Sinai Medical Center — Los Angeles, California
• UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California
• Rocky Mountain Regional VA Medical Center — Aurora, Colorado
• UCHealth Memorial Hospital Central — Colorado Springs, Colorado
• Memorial Hospital North — Colorado Springs, Colorado
• Poudre Valley Hospital — Fort Collins, Colorado
• Cancer Care and Hematology-Fort Collins — Fort Collins, Colorado
• UCHealth Greeley Hospital — Greeley, Colorado
• Medical Center of the Rockies — Loveland, Colorado
• Helen F Graham Cancer Center — Newark, Delaware
• Medical Oncology Hematology Consultants PA — Newark, Delaware
• Mayo Clinic in Florida — Jacksonville, Florida
• Hawaii Cancer Care Inc - Waterfront Plaza — Honolulu, Hawaii
• Queen's Cancer Cenrer - POB I — Honolulu, Hawaii
• Queen's Medical Center — Honolulu, Hawaii
• Queen's Cancer Center - Kuakini — Honolulu, Hawaii
• Hawaii Cancer Care - Westridge — ‘Aiea, Hawaii
• Saint Alphonsus Cancer Care Center-Boise — Boise, Idaho

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.