A Study of Subcutaneous Nivolumab in Previously Treated Advanced or Metastatic Clear Cell Renal Cell Carcinoma

Phase 1

• Conditions: Metastatic Clear Cell Renal Cell Carcinoma; MedDRA version: 21.1Level: LLTClassification code 10050076Term: Metastatic renal carcinomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-003655-15-CZ
• 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: 2021-03-30
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 458

Inclusion Criteria

- Histological confirmation of renal cell carcinoma (RCC)
- Advanced RCC (not amenable to curative surgery or radiation therapy) or metastatic RCC (Stage IV)
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumor
- Received no more than 2 prior systemic treatment regimens
- Progression or intolerance on or after the last treatment regimen received

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 275
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 183

Exclusion Criteria

- Untreated, symptomatic central nervous system (CNS) metastases.
- Prior immunotherapy (medications which are target the immune system) known as PDL1 or CTLA4 or any other medications working similarly Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to randomization
- Active, known, or suspected autoimmune disease

Study & Design

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