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Multi-center Trial of ESK981 in Combination With Nivolumab in Patients With Metastatic Renal Cell Carcinoma

NCT03562507 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-05-20

Study results available
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Summary

The objective of the trial is to determine the clinical efficacy of ESK981 in combination with nivolumab therapy in patients with metastatic renal cell carcinoma (RCC).

Conditions

  • Renal Cell Carcinoma, Metastatic

Interventions

DRUG

ESK981

ESK981: 160 mg (4 capsules) PO daily for 5 consecutive days followed by a 2-day off drug in each week, repeated weekly in 4-week (28-day) cycles

DRUG

Nivolumab

480 mg/dose IV, Day 1 of each 28-day cycle

Sponsors & Collaborators

  • University of Michigan Rogel Cancer Center

    lead OTHER

Principal Investigators

  • Ajjai Alva, MD · Rogel Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-11
Primary Completion
2022-10-18
Completion
2022-10-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT03562507 on ClinicalTrials.gov