MedPath

A Study to Test Combination Treatments in People with Advanced Renal Cell Carcinoma

Phase 1
Conditions
Advanced renal cell carcinoma
MedDRA version: 21.1Level: PTClassification code 10038414Term: Renal cell carcinoma stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 21.1Level: PTClassification code 10067946Term: Renal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]
Registration Number
EUCTR2016-003082-26-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
300
Inclusion Criteria

For the master protocol:
- Advanced Renal Cell Carcinoma
- Must have at least 1 lesion with measurable disease
- Life expectancy of at least 3 months
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 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180

Exclusion Criteria

For the master protocol:
- Patients/subjects with suspected or known central nervous system metastases unless adequately treated
- Patients/subjects with autoimmune disease
- Patients/subjects who need daily oxygen therapy

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath