A Study of Subcutaneous Nivolumab in Previously Treated Advanced or Metastatic Clear Cell Renal Cell Carcinoma
- Conditions
- Metastatic Clear Cell Renal Cell CarcinomaMedDRA version: 21.1Level: LLTClassification code 10050076Term: Metastatic renal carcinomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-003655-15-IT
- Lead Sponsor
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 458
- 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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate PK noninferiority of SC nivolumab vs IV nivolumab administration;Secondary Objective: 1 To demonstrate the ORR noninferiority of SC nivolumab vs IV nivolumab administration.<br>2. To evaluate efficacy of SC nivolumab over 12 months.<br>3. To evaluate PK of SC nivolumab and IV nivolumab administration.<br>4. To evaluate the safety profile of SC nivolumab and IV nivolumab administration.;Primary end point(s): Cmind28;Timepoint(s) of evaluation of this end point: Minimum of 06 months
- Secondary Outcome Measures
Name Time Method