Cabozantinib and Pembrolizumab as First Line Therapy in Treating Patients with Cisplatin-Ineligible Metastatic, Locally Advanced, or Unresectable Urothelial Cancer

Active:	No
Cancer Type:	Unknown Primary	NCT ID:	NCT03534804
Trial Phases:	Phase II	Protocol IDs:	HCI104688 (primary) NCI-2018-02081
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Huntsman Cancer Institute/University of Utah
NCI Full Details:	http://clinicaltrials.gov/show/NCT03534804

Summary

This phase II trial studies the side effects and best dose of cabozantinib when given together with pembrolizumab and how well it works as first line therapy in treating patients with cisplatin-ineligible urothelial cancer that has spread to nearby tissue or lymph nodes (locally advanced) or has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib and pembrolizumab may work better in treating patients with cisplatin-ineligible metastatic, locally advanced, or unresectable urothelial cancer.

Objectives

PRIMARY OBJECTIVE:
I. To evaluate measurable disease overall response rate (ORR).

SECONDARY OBJECTIVES:
I. To evaluate progression-free survival (PFS) at 6 months (PFS6).
II. To evaluate overall survival (OS).
III. To evaluate toxicities associate with the combination treatment.

EXPLORATORY OBJECTIVES:
I. To evaluate molecular markers for pharmacodynamic pathways associated with response.
II. To evaluate ORR and PFS6 using immune specific disease assessment criteria.

OUTLINE:
Patients receives cabozantinib orally (PO) daily (followed by every other day as needed for tolerability) on days 1-21 and pembrolizumab intravenously (IV) over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Treatment may continue beyond initial radiographic or clinical disease progression as long as the patient is deriving clinical benefit per physician discretion.

After completion of study treatment, patients are followed up to 6 months.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.