NCI Community Oncology Research Program - Protocol Summary
ECOG-ACRIN EA8143 - "A Phase 3 Randomized Study Comparing Perioperative Nivolumab vs. Observation in Patients with Localized Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)"
The summary below serves as a brief review of the treatment plan and eligibility for the protocol.
This summary is not intended to be used in place of the full eligibility & treatment information in the protocol.
Please contact NCORP-KC for complete protocol information.
GU Clinical Trial
CANCER TYPE: Renal
RESEARCH BASE: ECOG-ACRIN
NCT NUMBER: NCT03055013
HIPPA FORM: DOWNLOAD HIPPA FORM
Consent Form: VIEW CONSENT FORM
UPDATED ON 09/13/2018 (21:14:30)
Stage I,II or III RCC with planned nephrectomy, nivolumab + nephrectomy vs. nephrectomy + observation. DCP-001 Eligible
Treatment (Supplied drug: nivolumab)
First dose of nivolumab must be administered within 1 week after randomization
Neoadjuvant Nivolumab 240mg IV every 2 weeks, total of 2 doses THEN
Partial or radical nephrectomy THEN
Adjuvant Nivolumab 240mg IV every 2 weeks for 3 months THEN
Adjuvant Nivolumab 480mg IV every 4 weeks for 6 months
Partial or radical nephrectomy (within 8 weeks of randomization)
- Preoperative biopsy for confirmation of RCC must be performed within four (4) months prior to randomization.
- If biopsy was performed as part of patients standard care, and will not be performed during Step 0 proceed directly to randomization.
- Patients with newly diagnosed higher risk RCC of any histology including sarcomatoid or (if preoperative biopsy was uninformative) – “unknown” histology.
- Clinical stage ≥ T2NxM0 disease or TanyN+ disease for which radical or partial nephrectomy is planned.
- Patients must have no clinical or radiological evidence of distant metastases (M0)
- No concurrent or prior systemic or local anti-cancer therapy for RCC is permitted. Examples of these prohibited therapies include:
- Radical or partial nephrectomy for prior RCC
- Metastectomy for RCC
- Radiation therapy to the renal bed or any distant metastatic sites.
- Antineoplastic systemic therapies for RCC: i.e., chemotherapy, hormonal therapy, immunotherapy, or standard or investigational agents for treatment of RCC
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
- Age ≥ 18 years.
- ECOG Performance Status: 0 or 1
- Women must not be pregnant or breast-feeding
- Patient must have no prior history of RCC that was resected with curative intent within the past 5 years.
- Patients must not have other current malignancies
- No active known or suspected autoimmune disease. The following are permitted: patients with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune or non-autoimmune condition requiring hormone replacement, asymptomatic hypothyroidism not requiring treatment, psoriasis not requiring systemic treatment, or conditions not expected to recur.
- No ongoing condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications.
- No uncontrolled adrenal insufficiency
- No known chronic active liver disease or evidence of acute or chronic Hepatitis B Virus (HBV) or Hepatitis C (HCV)
- Patients must not have a serious intercurrent illness, including ongoing or active infection requiring parental antibiotics.
- No known evidence of HIV infection, since the effects of nivolumab on anti-retroviral therapy have not been studied.
- No known medical condition (e.g. a condition associated with uncontrolled diarrhea such as ulcerative colitis or acute diverticulitis) that, in the investigator’s opinion, would increase the risk associated with study participation or interfere with the interpretation of safety results
- No major surgery within 28 days prior to randomization
- Patients currently enrolled in other clinical trials testing a therapeutic intervention
- Patients must have the following baseline laboratory values within 4 weeks of randomization:
- White blood cells ≥ 2000/uL
- Absolute Granulocyte Count (AGC) ≥ 1,500/mm3
- Platelet Count ≥ 100,000/mm3
- Hemoglobin ≥ 9.0g/dL
- Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance (CrCl) ≥ 40mL/min (CrCl= Wt (kg) x (140-age)*/72 x Cr. level, *female x 0.85)
- Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 x ULN)
- AST and ALT ≤ 2.5 x ULN
- No history of severe hypersensitivity to a monoclonal antibody