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

  • End date
    Oct 26, 2023
  • participants needed
  • sponsor
    University of Michigan Rogel Cancer Center
Updated on 26 January 2021
systemic therapy
measurable disease
karnofsky performance status
vascular endothelial growth factor


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.

Condition Renal Cell Carcinoma Metastatic
Treatment Nivolumab, ESK981
Clinical Study IdentifierNCT03562507
SponsorUniversity of Michigan Rogel Cancer Center
Last Modified on26 January 2021


Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Renal Cell Carcinoma Metastatic?
Do you have any of these conditions: Do you have Renal Cell Carcinoma Metastatic??
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
The patient has received any investigational drug within 28 days prior to registration or 5 half-lives of the investigational drug, whichever is shorter
History of bleeding disorders (e.g. pulmonary hemorrhage, significant hemoptysis, menometrorrhagia not responding to hormonal treatment) 6 weeks before Cycle 1 Day1
The patient is on a chronic daily medication known to be a severe or moderate inhibitor or inducer by Micromedex of CYP1A2, CYP2C8, or CYP3A4 at registration
Systemic corticosteroids greater than the equivalent of 10 mg of prednisone or equivalent alternative steroid (except physiologic dose for adrenal replacement therapy) or other immunosuppressive agents (such as cyclosporine or methotrexate) and any other medications that could potentially impact the efficacy or safety of the study as judged by the treating investigator are NOT permitted from time of registration to subjects completing protocol therapy unless clinically indicated to manage adverse events or life threatening or serious conditions as determined by the treating investigator
Have any condition that, in the opinion of the investigator, would compromise the ability of the subject to meet or perform study requirements
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