Study of Nivolumab (BMS-936558) vs. Everolimus in Pre-Treated Advanced Or Metastatic Clear-cell RCC

Phase 1

• Conditions: Advanced or metastatic (medically or surgically unresectable) clear-cell Renal Cell Carcinoma; MedDRA version: 20.0 Level: PT Classification code 10038414 Term: Renal cell carcinoma stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: PT Classification code 10050513 Term: Metastatic renal cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: PT Classification code 10067946 Term: Renal cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-005132-26-GB
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-24
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 975

Inclusion Criteria

1.Men & women = 18 years of age
2.Histologic confirmation of RCC with clear-cell component
3.Advanced/metastatic RCC
4.Measurable disease per RECIST 1.1 criteria
5.Received 1 or 2 prior anti-angiogenic therapy regimens in advanced or metastatic setting
6.No more than 3 total prior systemic treatment regimens in the advanced or metastatic setting, and evidence of progression on or after last treatment regimen received and within 6 months of enrollment
7.Karnofsky Performance Score = 70%

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 585
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 390

Exclusion Criteria

1.Any CNS metastases or history of CNS metastases
2.Prior therapy with an mTOR inhibitor
3.Any active known or suspected autoimmune disease.
4.Uncontrolled adrenal insufficiency
5.Active chronic liver disease
6.Prior malignancy active within past 3 years, except for locally curable cancers

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified