A Phase 3 Study of Nivolumab plus Ipilimumab Versus Sunitinib in untreated Subjects with Advanced or Metastatic Renal Cell Carcinoma (RCC)

Phase 1

Conditions: Advanced or metastatic renal cell carcinoma
MedDRA version: 21.1Level: PTClassification code: 10038414Term: Renal cell carcinoma stage IV Class: 100000004864
MedDRA version: 21.1Level: PTClassification code: 10050513Term: Metastatic renal cell carcinoma Class: 100000004864
Therapeutic area: Diseases [C] - Neoplasms [C04]

Registration Number: CTIS2023-504761-23-00

Lead Sponsor: Bristol Myers Squibb International Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1355

Inclusion Criteria

Histological confirmation of RCC with a clear-cell component, Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC, No prior systemic therapy for RCC with the following exception: a) One prior adjuvant or neoadjuvant therapy for completely resectable RCC if such therapy did not include an agent that targets VEGF or VEGF receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy., Karnofsky Performance Status (KPS) of at least 70%, Measurable disease as per RECIST 1.1, Tumor tissue (formalin-fixed paraffin-embedded (FFPE) archival or recent acquisition) must be received in order to randomize a subject to study treatment. (Note: Fine Needle Aspiration [FNA] and bone met by the central vendor (block or unstained slides) astases samples are not acceptable for submission)

Exclusion Criteria

Any history of or current CNS metastases. Baseline imaging of the brain is required within 28 days prior to randomization, Prior systemic treatment with VEGF or VEGF receptor targeted therapy (including, but not limited to, sunitinib, pazopanib, axitinib, tivozanib, and bevacizumab), Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways, Any active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids (> 10 mg daily prednisone equivalent) or immunosuppressive medications except for syndromes which would not be expected to recur in the absence of an external trigger. Subjects with vitiligo or type I diabetes mellitus or residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement are permitted to enroll, Any condition requiring systemic treatment with corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medication within 14 days prior to first dose of study drug. Inhaled steroids and adrenal replacement steroid doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease