A randomised phase II trial of nivolumab in combination with alternatively scheduled ipilimumab in first-line treatment of patients with advanced or metastatic renal cell carcinoma - PRISM

niversity of Leeds0 sites189 target enrollmentMay 10, 2018

ConditionsPreviously untreated metastatic clear cell renal cell carcinoma.MedDRA version: 20.0Level: PTClassification code 10050513Term: Metastatic renal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10067946Term: Renal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

DrugsYervoy OPDIVO

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Previously untreated metastatic clear cell renal cell carcinoma.
Sponsor: niversity of Leeds
Enrollment: 189
Status: Active, not recruiting
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 10, 2018

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

niversity of Leeds

Eligibility Criteria

Inclusion Criteria

•Aged 18 years or over
•Diagnosed with advanced (not amenable to curative surgery) or metastatic RCC
•Histopathologically confirmed clear cell renal cell cancer (or with a component of clear cell)
•Evidence of measurable disease as per RECIST v1\.1 (ie, \=1 malignant tumour mass that can be accurately measured in at least 1 dimension \= 20 mm with conventional computerized tomography scan or Magnetic Resonance Imaging \[MRI], or \=10 mm with spiral CT scan using a 5 mm or smaller contiguous reconstruction algorithm). Bone lesions, ascites, peritoneal carcinomatosis or miliary lesions, pleural or pericardial effusions, lymphangitis of the skin or lung, cystic lesions, or irradiated lesions are not considered measurable
•Life expectancy of \= 6 months
•Karnofsky Performance Status (KPS) of at least 70%
•Required laboratory values within 14 days prior to registration:
•oWBC \= 2000/µL
•oNeutrophils \= 1500/µL
•oPlatelets \= 100 x103/µL

Exclusion Criteria

•Participants meeting any of the following exclusion criteria are not eligible to enrol in this trial.
•Breast feeding
•Prior systemic therapy for RCC (previous participation in adjuvant studies allowed, providing the patient was on the observation/placebo arm – this may require unblinding of the patient)
•Participants who have undergone any prior systemic anti\-cancer treatment, including with an anti\-PD\-1, anti\-PD\-L1, anti\-PD\-L2, anti\-CTLA\-4 antibody, or any other antibody or drug specifically targeting T\-cell co\-stimulation or immune checkpoint pathways (previous participation in adjuvant studies allowed, providing the patient was on the observation/placebo arm – this may require unblinding of the patient)
•Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
•Participants who test positive for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
•Participants who test positive for human immunodeficiency virus (HIV) or have known acquired immunodeficiency syndrome (AIDS)
•Untreated brain metastases. (Patients are not eligible if brain metastases treated only with whole brain radiotherapy. Patients are eligible if previous brain metastases treated with complete surgical resection, Stereotactic Brain Radiation Therapy (SBRT), or gamma knife with no subsequent evidence of progression and asymptomatic. Patients are not eligible if brain metastases treated only with whole brain radiotherapy).
•Active, known or suspected autoimmune disease. (Subjects are permitted to enrol 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 or equivalent) 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).