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Multi-center Trial of ESK981 in Combination With Nivolumab in Patients With Metastatic Renal Cell Carcinoma | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

ERICA: Phase 2 Multi-center Trial of ESK981 in Combination With Nivolumab in Patients With Metastatic Renal Cell Carcinoma

NCT03562507•University of Michigan Rogel Cancer Center

View on ClinicalTrials.gov

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).

Detailed Description

The study was terminated early due to changes in the RCC treatment landscape which limited the patient population. Due to this early termination no subjects were enrolled into Cohort B.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologic diagnosis of renal cell carcinoma (any histology except medullary carcinoma or collecting duct carcinoma is acceptable) with radiologic or histologic evidence of metastatic disease.
•Prior treatment with up to one (and only one) anti-VEGF or VEGFR inhibitor (small molecule or antibody).
•Must have measurable disease as per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) criteria.
•Must be of age ≥ 18 years at time of informed consent.
•Ability to understand and the willingness to sign a written informed consent.
•Karnofsky Performance Status ≥60. (The Karnofsky Performance Status Scale is an assessment tool for functional impairment. It can be used to compare effectiveness of different therapies and to assess the prognosis in individual patients. In most serious illnesses, the lower the Karnofsky score, the worse the likelihood of survival.)
•Most recent systemic therapy or most recent radiation therapy ≥ 2 weeks of first study drug dose.
•Recovery to baseline or \< Grade 1 CTCAE v.4.03 from toxicities related to any prior treatments, unless AE(s) are clinically non-significant and/or stable on supportive therapy.
•Women of childbearing potential must have a negative serum or urine pregnancy test within 28 days prior to registration.
•Adequate organ and marrow function

Exclusion Criteria

•Prior treatment for metastatic disease with \>1 anti-VEGF/VEGFR inhibitor.
•Prior treatment with anti-PD/PD-L1/CTLA4/IDO antibody (for Cohort B patients only) or ESK981 (for Cohort A and Cohort B patients).
•Prior mTOR inhibitors or glutaminase inhibitors are allowed.
•Untreated brain metastases or spinal cord compression.
•Uncontrolled hypertension defined as blood pressure \>150/90 despite at least 2 anti-hypertensive medication(s) as assessed by 2 blood pressure readings taken at least 1 hour apart during screening.
•Major surgical procedure or significant traumatic injury within 6 weeks prior to study registration (\> 6 weeks prior to registration is permitted as long as they have fully recovered from any such procedure).
•History of another primary malignancy except for: malignancy treated with curative intent and no known active disease for ≥2 years, adequately treated non-melanoma skin cancer without current evidence of active disease, adequately treated carcinoma in situ without current evidence of active disease, Gleason ≤6 prostate cancer.
•Angina, myocardial infarction symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, arterial embolism, pulmonary embolism, percutaneous angioplasty or coronary arterial bypass surgery within the past 3 months.
•History of gastrointestinal perforation or fistula in the past 6 months, or while previously on antiangiogenic therapy, unless underlying risk has been resolved (e.g. through surgical resection or repair).
•The patient has known hypersensitivity to gelatin or lactose monohydrate.
+5 more criteria

Locations (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Key Dates

Start Date

April 11, 2019

Primary Completion Date

October 18, 2022

Completion Date

October 18, 2022

Last Updated

May 20, 2024

Enrollment

ACTUAL participants

Conditions

Renal Cell Carcinoma, Metastatic

Interventions

ESK981

DRUG

Nivolumab

DRUG