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Cabozantinib or Sunitinib Malate in Treating Participants With Metastatic Variant Histology Renal Cell Carcinoma

NCT03541902 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-01-09

No results posted yet for this study

Summary

The goal of this clinical research study is to compare the safety and effectiveness of cabozantinib and sunitinib when given to patients with metastatic (has spread) variant histology renal cell carcinoma (vhRCC), a type of kidney cancer.

This is an investigational study. Cabozantinib and sunitinib are both FDA approved and commercially available for the treatment of advanced kidney cancer, including vhRCC.

The study doctor can explain how the study drugs are designed to work.

Up to 84 participants will be enrolled in this study. All will take part at MD Anderson.

Conditions

  • Malignant Neoplasms of Urinary Tract
  • Renal Cell Carcinoma
  • Chromophobe Renal Cell Carcinoma
  • Metastatic Renal Cell Carcinoma
  • Papillary Renal Cell Carcinoma
  • Renal Cell Carcinoma Associated With Xp11.2 Translocations/TFE3 Gene Fusions
  • Sarcomatoid Renal Cell Carcinoma
  • Stage IV Renal Cell Cancer AJCC v8
  • Unclassified Renal Cell Carcinoma

Interventions

DRUG

Cabozantinib

Given PO

DRUG

Sunitinib Malate

Given PO

Sponsors & Collaborators

  • Exelixis

    collaborator INDUSTRY

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Matthew T Campbell · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-15
Primary Completion
2027-07-31
Completion
2027-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03541902 on ClinicalTrials.gov