Loading clinical trials...

COMPLETEDPHASE1

Cabometyx and Avelumab in Patients With Metastatic Renal Cell Carcinoma (mRCC)

A Phase 1B, Open Label, Dose-finding Study to Evaluate the Safety and Tolerability of Cabometyx and Avelumab in Patients With Metastatic Renal Cell Carcinoma (mRCC)

NCT03200587•University of Utah

View on ClinicalTrials.gov

Summary

This is an open-label, non-controlled, non-randomized, phase I dose-finding, of Cabometyx + Avelumab, to establish safety, feasibility, and the maximum tolerated dose (MTD) or Recommended Phase 2 Dose (RP2D) of Cabometyx in combination with Avelumab, and to investigate preliminary efficacy. The MTD or RP2D determined in this study will be used for a future study to formally test efficacy. The MTD determined by dose escalation will be the recommended Phase 2 dose.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Optional Pre-Screening Eligibility for Patients Scheduled for Cytoreductive Nephrectomy
•Male or female subject aged ≥ 18 years.
•Clinically, subject is a candidate for RCC diagnostic procedure (biopsy or surgery).
•Subject meets standard of care eligibility criteria for consideration of treatment with immunotherapy using a checkpoint inhibitor following surgical resection or biopsy.
•Treatment Inclusion
•Male or female subject aged ≥ 18 years.
•Histologically proven renal cell carcinoma with a clear cell component.
•Radiographic evidence of metastatic disease.
•Measurable disease by RECIST 1.1
•Eastern Cooperative Oncology Group (ECOG) Score 0-2
+4 more criteria

Exclusion Criteria

•Current use of immunosuppressive medication, EXCEPT for the following:
•1. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection);
•2. Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent;
•3. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
•Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent per treating physician's clinical judgment. Subjects with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.
•Prior organ transplantation including allogenic stem-cell transplantation.
•Active infection requiring intravenous antibiotics (antibiotics should have been completed prior to registration).
•Known history of testing positive for HIV or known acquired immunodeficiency syndrome.
•Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. If the patient has a history of HBV or HCV then confirmatory polymerase chain reaction (PCR) testing is required to confirm the disease is not active.
•Live vaccinations within 4 weeks of the first dose of Avelumab and while on trial is prohibited.
+10 more criteria

Locations (1)

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Key Dates

Start Date

June 21, 2018

Primary Completion Date

April 14, 2020

Completion Date

November 25, 2021

Last Updated

July 3, 2024

Enrollment

ACTUAL participants

Conditions

Renal Cell Carcinoma

Interventions

Avelumab

DRUG

Cabozantinib

DRUG

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

NCT07485114

Renal Cell Carcinoma (Kidney Cancer)Non Small Cell Lung Cancer+2 more

View study

RECRUITINGNA

Ketogenic Dietary Intervention to Improve Response to Immunotherapy in Patients With Metastatic Melanoma and Metastatic Kidney Cancer

NCT06391099

Clinical Stage IV Cutaneous Melanoma AJCC v8Metastatic Cutaneous Melanoma+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 3, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Cabometyx and Avelumab in Patients With Metastatic Renal Cell Carcinoma (mRCC)

Inclusion Criteria

Exclusion Criteria

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

Ketogenic Dietary Intervention to Improve Response to Immunotherapy in Patients With Metastatic Melanoma and Metastatic Kidney Cancer

Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma

A Clinical Study of Belzutifan and Zanzalintinib in People With Recurrent Kidney Cancer Following Adjuvant Therapy (MK-6482-033)

Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform

Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma