Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
1. Age ≥ 18 years
2. Advanced disease histologically assessed as RCC, with predominantly clear cell
histology
3. Metastatic disease (measurable or non-measurable) that can be monitored throughout the
course of study participation per iRECIST
4. Subjects who are candidates for standard first-line therapy
5. Time from initial RCC diagnosis to initiation of systemic treatment
(Nivolumab+Ipilimumab) of <1 year
6. Karnofsky Performance Status (KPS) ≥ 70%
7. Resolution of all acute toxic effects of prior radiotherapy or surgical procedures to
Grade ≤ 1 according to National Cancer Institute (NCI) Common Terminology Criteria for
Adverse Events (CTCAE) Version 4.0
8. Adequate hematologic function, as defined by central laboratory values for all three
of the following criteria:
1. Absolute neutrophil count (ANC) LLN, and
2. Platelets 75,000/mm3 or 75.0 x 109/L, and
3. Hemoglobin (Hgb) 8.0 g/dL
9. Adequate renal function, as defined by either of the following criteria:
1. Serum creatinine 1.5 x upper limit of normal (ULN),
2. OR, if serum creatinine greater than 1.5 x ULN, estimated glomerular filtration
rate (eGFR) 30 mL/min
10. Adequate hepatic function, as defined by both of the following:
1. Total serum bilirubin 1.5 x ULN
2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 2.5 x ULN or,
AST and ALT 5 x ULN if liver function abnormalities are due to underlying
malignancy
11. Adequate coagulation function as defined by either of the following criteria:
1. INR < 1.5 x ULN
2. For subjects receiving warfarin or LMWH, the subjects must, in the investigator's
opinion, be clinically stable with no evidence of active bleeding while receiving
anticoagulant therapy. The INR for these patients may exceed 1.5 x ULN if that is
the goal of anticoagulant therapy.
12. Negative serum pregnancy test for female subjects with reproductive potential, and
agreement of all male and female subjects of reproductive potential to use a reliable
form of contraception during the study and for 12 weeks after the last dose of study
drug
13. Normal ECG or clinically non-significant finding(s) at Screening, in the
Investigator's opinion
14. Able to abstain from taking prohibited drugs, either prescription or non-prescription,
during the treatment phase of the study
15. Willingness and ability to comply with scheduled visits, treatment plans, laboratory
tests, and other study procedures
16. Signed and dated informed consent document indicating that the subject (or legally
acceptable representative) has been informed of all pertinent aspects of the trial
prior to enrollment
Exclusion Criteria:
1. Prior history of malignancy within the preceding 3 years, except for adequately
treated in situ carcinomas or non-melanoma skin cancer, adequately treated early stage
breast cancer, superficial bladder cancer, and non-metastatic prostate cancer with a
normal PSA.
2. History of or known brain metastases, spinal cord compression, or carcinomatous
meningitis, or evidence of brain or leptomeningeal disease
3. Patients will be excluded if they have <2 of the following risk factors at Screening:
1. Time from diagnosis to systemic treatment < 1 year
2. Hgb < LLN
3. Corrected calcium > 10.0 mg/dL
4. KPS < 80%
5. Neutrophils > ULN
6. Platelets > ULN
4. NCI CTCAE Grade 3 hemorrhage < 28 days before Visit 1 (Week 0)
5. Clinically significant cardiovascular conditions within 3 months prior to
Randomization, which in the Investigator's opinion prohibits the initiation of
standard targeted therapy, initiating with sunitinib, including:
1. Cardiac angioplasty
2. Myocardial infarction
3. Unstable angina
4. Coronary artery by-pass graft or stenting
5. Class III or IV congestive heart failure (CHF), per NYHA Classification NOTE:
Patients with left ventricular ejection fraction (LVEF) < LLN as assessed by
either echocardiography or multiple gated acquisition (MUGA) scan, who are
asymptomatic and are NOT classified as having NYHA Class III or IV CHF, may be
eligible but should be monitored for LVEF changes while on sunitinib therapy as
recommended in the current sunitinib prescribing information.
6. Symptomatic peripheral vascular disease
7. Cerebrovascular accident (CVA) or transient ischemic attack (TIA)
8. Symptomatic or uncontrolled pulmonary embolism or deep vein thrombosis (DVT)
9. Uncontrolled cardiac dysrhythmias of NCI CTCAE Grade ≥ 2, or prolongation of the
QTc for males > 450 msec and for females > 470 msec as corrected by either the
Fridericia or Bazett formula
10. Uncontrolled or untreated atrial fibrillation
11. Poorly controlled hypertension, defined as a systolic blood pressure (SBP), ≥ 150
mm Hg or diastolic blood pressure (DBP) ≥ 90 mm Hg NOTE: Initiation of
antihypertensive medication(s) is permitted prior to study entry. Blood pressure
must be re-assessed on 2 occasions separated by at least 1 hour. Mean SBP/DBP
values must be less than 150/90 for eligibility.
12. Evidence of active bleeding or a bleeding diathesis at Screening
6. Significant gastrointestinal abnormalities:
1. Any history of major resection of the stomach or small bowel with ongoing
impaired healing.
2. Malabsorption syndrome with active symptoms in the Investigator's opinion, within
3 months prior to Randomization
3. Active peptic ulcer, which cannot be appropriately managed in the Investigator's
opinion, within 3 months prior to Randomization
4. Intra-luminal bleeding lesions within 3 months prior to Randomization
5. History of abdominal fistula or intra-abdominal abscess within 3 months prior to
Randomization
7. Pre-existing thyroid abnormality with thyroid function that cannot be appropriately
managed with medication, in the Investigator's opinion.
8. Active autoimmune disease or condition requiring chronic immunosuppressive therapy,
such as rheumatoid arthritis, systemic lupus erythematous, multiple sclerosis, organ
transplant recipient, etc.
NOTE: Abnormal laboratory values for autoimmunity markers in the absence of other
signs/symptoms of autoimmune disease are not exclusionary.
9. Clinically significant infections, including human immunodeficiency virus (HIV),
syphilis, and active hepatitis B or C
10. Current treatment with an investigational therapy on another clinical trial
11. Pregnancy or breastfeeding
12. Any serious medical condition or illness considered by the investigator to constitute
an unwarranted high risk for investigational treatment
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 5/31/23. Questions regarding updates should be directed to the study team contact.