Health Trials

Zanzalintinib for Metastatic Clear Cell Renal Cell Carcinoma With Bone Metastases

ConditionsClear Cell Renal Cell Cancer (ccRCC)Clear Cell Renal CarcinomaClear Cell Renal Cell Carcinoma MetastaticClear Cell Renal CancerBone Metastases of a Malignant TumorClear Cell Renal Cell CarcinomaBone, Metastatic CancerMetastatic CancerMetastatic Renal Cell CarcinomaMetastases to Bone
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorKelly Fitzgerald, MD

About this trial

This is a single-institution, phase 2 trial of zanzalintinib plus investigator-choice bone-strengthening agent in patients with metastatic renal cell carcinoma (RCC) with bone metastases whose disease has advanced on 1-3 prior lines of therapy, including at least one immune oncology-based (IO) therapy in the adjuvant or first-line metastatic setting.

Eligibility criteria

Qualifiers

Participants must have unresectable advanced or metastatic RCC with a predominant clear cell histologic component .

At least three bone metastases are present and detectable on bone scan, and at least one bone metastasis is NOT planned to be treated with radiation therapy.

Metastatic setting; must have received combination therapy containing either programmed cell death protein 1 (PD-1) inhibitor/cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor or PD-1 inhibitor/vascular endothelial growth factor receptor (VEGFR)-targeting tyrosine kinase inhibitors (TKI).

Adjuvant setting; must have received pembrolizumab and have had documented progression of disease within 1 year of the first dose of pembrolizumab .

Disqualifiers

Prior treatment with zanzalintinib for RCC.

Receipt of any small molecule kinase inhibitor (including investigational) or vascular endothelial growth factor (VEGF)-targeted therapy within 2 weeks before the first dose of study treatment.

Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment. Note: Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of enrollment. Note: Base of skull lesions without definitive evidence of dural or brain parenchymal involvement are allowed.

Participants requiring whole brain radiotherapy (WBRT).

Trial design

Treatments tested in this trial

  • Zanzalintinib
  • Investigator Choice of Bone Strengthening Agents (BSA)
  • Non-Investigational Radiation Therapy (RT)
  • Bone Scan
  • Computerized tomography (CT) Scan

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators

Kelly Fitzgerald, MD

Lead sponsor

University of California, San Francisco

Sponsor institution

Exelixis

Collaborator

Source ClinicalTrials.gov