Study of Front Line Therapy With Nivolumab and Salvage Nivolumab + Ipilimumab in Patients With Advanced Renal Cell Carcinoma

Completed · Phase 2

Conditions studied: Advanced Renal Cell Carcinoma

In brief

Phase II trial of nivolumab in 120 treatment naïve patients with ccRCC.

Key facts

Study ID: NCT03117309
Run by: Michael B. Atkins, MD
People needed: 164
Starts: 2017-04-24
Expected to finish: 2025-01-23
Last updated by the study team: 2025-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Patients are excluded if they have active brain metastases or leptomeningeal metastases. Subjects with brain metastases are eligible if metastases have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for 2 weeks of more after treatment is complete and within 28 days prior to the first dose of nivolumab administration. There must also be no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration.
Patients with controlled brain metastases are allowed on protocol if they had solitary brain metastases that was surgically resected without recurrence or treated with SRS without progression x 4 weeks.
Patients should be excluded if they have an active, known or suspected autoimmune disease. Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
As there is potential for hepatic toxicity with nivolumab or nivolumab/ipilimumab combinations, drugs with a predisposition to hepatoxicity should be used with caution in patients treated with nivolumab-containing regimen
Active infection requiring systemic therapy
Has any other medical or personal condition that, in the opinion of the site investigator, may potentially compromise the safety or compliance of the patient, or may preclude the patient's successful completion of the clinical trial
Patients should be excluded if they are positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
Patients should be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
Allergies and Adverse Drug Reaction
History of allergy to study drug components
History of severe hypersensitivity reaction to any monoclonal antibody
Known additional malignancies within the past 3 years (excluding basal of squamous cell skin cancers, CIS or localized prostate cancer that has been treated or is being observed)
Inclusion/Exclusion Criteria- Part B
Must meet eligibility criteria for initiation of Part A with the exception of being allowed to have prior nivolumab in Part A of this protocol
Must have evidence of either RECIST 1.1 defined Disease Progression or Stable Disease 1 year after initiating nivolumab therapy
Tumor biopsy prior to combination treatment is mandatory. If a biopsy/resection of a new lesion or primary tumor and slow freezing of fresh tissue for single cell RNAseq study (as specified in the CLM) is not feasible, the subject is not eligible for the study. All biopsies must be core needle or excisional. Fine needle aspirate is not acceptable.
Must not have had a Grade ≥ 3 irAE on nivolumab monotherapy
Must not have untreated brain metastases
Must not have had major surgery or radiation therapy within 14 days of starting study treatment
Must not have active autoimmune disease
Must not have a concurrent medical condition requiring use of systemic corticosteroids with prednisone >10 mg per day
Must not have had prior systemic therapy for Stage IV RCC (except for nivolumab as part of part A of this protocol)
Prior solid organ or stem cell transplant

Where it is running

Yale University, Yale Cancer Center — New Haven, Connecticut, United States
Georgetown University — Washington D.C., District of Columbia, United States
Winship Cancer Institute of Emory University — Atlanta, Georgia, United States
Northwestern University Feinberg Schooll Of Medicine — Chicago, Illinois, United States
University of Illinois Cancer Center — Chicago, Illinois, United States
Beth Isreal Deaconess Medical Center — Boston, Massachusetts, United States
Hackensack University Medical Center — Hackensack, New Jersey, United States
Columbia University — New York, New York, United States
Cleveland Clinic — Cleveland, Ohio, United States
Univeristy of Pennsylvania — Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
University of Texas Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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