A Study of Nivolumab Combined with Cabozantinib compared to Sunitinib in Patients with Kidney Cancer that was Previously Untreated, Advanced, or that has Spread (CheckMate 9ER)

Phase 1

• Conditions: Advanced or Metastatic Renal Cell Carcinoma; MedDRA version: 21.1Level: 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: EUCTR2017-000759-20-IT
• Lead Sponsor: BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-17
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 850

Inclusion Criteria

- Histological confirmation of RCC with a clear-cell component, including
participants who may also have sarcomatoid features
- 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:
i) 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
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 510
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 340

Exclusion Criteria

- Any active CNS metastases
- Any active, known or suspected autoimmune disease
- Any condition requiring systemic treatment with either corticosteroids
(> 10 mg daily prednisone equivalent) or other immunosuppressive
medications within 14 days of randomization

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The purpose of this study is to determine whether Nivolumab Combined with Cabozantinib is safe and effective compared to Sunitinib in the treatment of Kidney cancer in patients with previously untreated, advanced, or cancer that has spread;Secondary Objective: To compare overall survival (OS) of Arm A with Arm C in all randomized participants. To evaluate the objective response rate (ORR) per BICR in all randomized participants. To assess overall safety and tolerability in all treated participants.;Primary end point(s): 1. Progression Free Survival (PFS) per blinded independent central review (BICR) of Arm A versus Arm C in all randomized participants;Timepoint(s) of evaluation of this end point: 1. Time Frame: Up to 22 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1.Overall Survival (OS) of Arm A versus Arm C <br>2. Objective Response Rate (ORR) <br>3. Incidence of adverse events (AEs) <br>4. Incidence of Serious Adverse Events (SAEs) <br><br>;Timepoint(s) of evaluation of this end point: 1. Time Frame: Up to 34 months <br>2. Time Frame: Approximately 16 months <br>3. Time Frame: Up to 34 months <br>4. Time Frame: Up to 34 months<br><br>