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Biomarker Stratified CaboZantinib (NSC#761968) and NivOlumab (NSC#748726) (BiCaZO) - Phase II Study of Combining Cabozantinib and Nivolumab in Patients With Advanced Solid Tumors (IO Refractory Melanoma or HNSCC) Stratified by Tumor Biomarkers - an immunoMATCH Pilot Study

Objective

I. To evaluate the feasibility of molecular characterization based on tumor mutation burden (TMB) and gene expression profiling (GEP) (for Tumor Inflammation Score [TIS]) for upfront participant stratification, as assessed by the proportion of participants with less than or equal to a 21-day turnaround time for biopsy results in stage I of the study.

Protocol #

S2101

Trial Phase:

Phase II

Principal Investigator:

Poklepovic, Andrew

Cancer Type
  • Larynx
  • Lip
  • Oral Cavity and Pharynx
  • Melanoma
  • Skin
Study Site
  • Lynchburg Hematology Oncology Clinic
  • Inc.
  • Stony Point
  • Virginia Commonwealth University

- Participants must have histologically confirmed melanoma that is Stage III or IV, unresectable, recurrent, or metastatic non-uveal melanoma
- 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
- Participants must have disease presentation consistent with measurable disease
- Participants must have had documented progression 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 prior to progression.
- Participants must be >/= 18 years of age

Get more detailed information at ClinicalTrials.gov

  • Enrollment Status 1
  • Age Group Adult
  • Protocol Type Treatment
  • Research Study Team Faith McFadden, MSN, RN
    Phone: +1 804-628-0616
    Email Study Contact

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