A Phase 2 Dose-Ranging Study of BMS-936558 (MDX-1106) In Subjects With Advanced/Metastatic Clear-Cell Renal Cell Carcinoma

Active, not recruiting

• Conditions: Advanced/Metastatic renal cell carcinoma with a clear cell; MedDRA version: 14.1Level: PTClassification code 10038410Term: Renal cell carcinoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: PTClassification code 10050513Term: Metastatic renal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-002957-67-IT
• Lead Sponsor: BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-16
• Last Update Posted: 18 January 2016

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 181

Inclusion Criteria

Histologic confirmation of RCC with a clear cell component. • Previous treatment with at least one anti-angiogenic agent • Progressed within 6 months of study enrollment • Subjects should not have had more than 3 prior treatments for locally advanced or metastatic disease. • Must have available tumor tissue for submission • Subjects must also meet various laboratory parameters for inclusion (see Protocol section 3.3.1 item 4)
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 136
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

Exclusion Criteria

• Active CNS metastases within 30 days of study enrollment • Subjects with any active autoimmune disease or a history of known autoimmune disease • Subjects with uncontrolled adrenal insufficiency • Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured

Study & Design

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