Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Disease Progression

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Nivolumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

cabozantinib 40mg PO daily + nivolumab 480 mg IV every 4 weeks (q4w)

Cabozantinib 80 MG

Cabozantinib 40Mg Tab

Amy Rowell, MBA,CCRP

Tian Zhang, MD

The goal of this clinical trial is to learn about the effects of a higher dose of cabozantinib or the effects of cabozantinib-nivolumab combination in patients with advanced renal cell carcinoma who have progressed on or after receiving cabozantinib treatment. The study will have two parts or "cohorts".

* Cohort 1: cabozantinib 80mg daily
* Cohort 2: cabozantinib 40mg daily with nivolumab The cohort assignment will be determined by investigator, based on how much cabozantinib the participant is able to safely receive.

This is a multi-center, open-label, 2 cohort, phase II study to assess the efficacy of cabozantinib dose escalation and cabozantinib/nivolumab combination at the time of progression on/after cabozantinib monotherapy. The study will enroll subjects with advanced RCC (defined as locally advanced, unresectable or metastatic) who have disease progression on/after cabozantinib monotherapy in any line of treatment

Sequential Treatment of Cabozantinib or Cabozantinib With Nivolumab for Advanced Renal Cell Carcinoma (RCC)

Phase 2, Open-label, Two Cohort, Multicenter Trial for Sequential Treatment of High Dose Cabozantinib or Cabozantinib Plus Nivolumab on/After Progression on Cabozantinib Monotherapy in Advanced Renal Cell Carcinoma (Seq-Cabo)

Progression free survival (PFS) will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST v 1.1)

To determine the Objective Response Rate (including stable disease/partial response/complete response) of of cabozantinib or cabozantinib-nivolumab combination assessed by RECIST (version 1.1)

To determine the disease control rate (including stable disease/partial response/complete response) of of cabozantinib or cabozantinib-nivolumab combination assessed by RECIST (version 1.1)

To determine the duration of response of of cabozantinib or cabozantinib-nivolumab combination compared to historical controls assessed by RECIST (version 1.1)

To determine the overall survival rate of response of of cabozantinib or cabozantinib-nivolumab combination compared to historical controls assessed by RECIST (version 1.1)

Exelixis

University of Texas Southwestern Medical Center

Associate Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Sequential Treatment of Cabozantinib or Cabozantinib With Nivolumab for Advanced Renal Cell Carcinoma (RCC)	NCT05931393	RCC Renal Cell Carc...	Cabozantinib 80... Cabozantinib 40... Nivolumab	18 Years -	University of Texas Southwestern Medical Center
Sequential Treatment of Cabozantinib or Cabozantinib With Nivolumab for Advanced Renal Cell Carcinoma (RCC)	NCT05931393	RCC Renal Cell Carc...	Cabozantinib 80... Cabozantinib 40... Nivolumab	18 Years -	University of Texas Southwestern Medical Center

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