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OpenTrials
Active, Not Recruiting

NCT Number: NCT03141177

A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

The purpose of this study is to determine whether Nivolumab Combined with Cabozantinib is safe and effective compared to Sunitinib in previously untreated advanced or metastatic renal cell carcinoma

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Renal Cell Carcinoma Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution - 0046, CABA, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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

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
  • Participants who have received a live/attenuated vaccine within 30 days of first treatment

Other protocol defined inclusion/exclusion criteria could apply

Treatment and study plan

Nivolumab

Biological

Specified dose on specified day

Other names: Opdivo, BMS-936558

Cabozantinib

Drug

Specified dose on specified days

Other names: Cabometyx

Sunitinib

Drug

Specified dose on specified days.

Other names: Sutent

Ipilimumab

Biological

Specified dose on specified days

Other names: Yervoy, BMS-734016

Primary outcomes

  1. Progression Free Survival (PFS)

    Time frame: From randomization date to date of first documented tumor progression or death, whichever occurs first (Up to 31 months)

    PFS is defined as the time from date of randomization to the first documented tumor progression date or death due to any cause, whichever occurs first based on BICR assessment using RECIST v1.1. Participants who die without a reported progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment on or prior to initiation of subsequent anti-cancer therapy. Progressive disease (PD); 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: From randomization date to death date (Up to 31 months)

    Overall Survival is defined as the time between the date of randomization and the date of death due to any cause. For participants that are alive, their survival time will be censored at the date of last contact date (or "last known alive date").

  2. Objective Response Rate (ORR)

    Time frame: Up to 31 Months

    Objective Response Rate (ORR) is defined as the percentage of randomized participants who achieve a best response of confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments (using RECIST v1.1 criteria) divided by the number of all randomized participants.

    Complete response (CR): Disappearance of all target lesions. Partial response (PR): 30% decrease in the sum of diameters of target lesions.

  3. Number of Participants Experiencing Adverse Events (AEs)

    Time frame: From first dose to 100 days following last dose (Up to 32 Months)

    Number of participants experiencing various types of any grade adverse events (AEs) during the specified time frame.

  4. Number of Participants Experiencing Serious Adverse Events (SAEs)

    Time frame: From first to dose to 100 days following last dose (Up to 32 months)

    Number of participants experiencing various types of any grade serious adverse events (SAEs) during the specified time frame.

  5. Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation

    Time frame: From first dose to 30 days following last dose (Up to 30 months)

    Number of participants experiencing various types of any grade adverse events (AEs) leading to discontinuation during the specified time frame.

  6. Number of Deaths

    Time frame: From first dose to (up to 31 months) following first dose

    Number of deaths due to any cause during the specified time frame.

  7. Number of Participants With Laboratory Abnormalities

    Time frame: From first dose to 30 days following last dose (Up to 30 Months)

    Number of participants experiencing laboratory abnormalities in hematology, serum chemistry and electrolytes with grade 3 or higher during the specified time frame.

  8. Number of Participants With Laboratory Values Grade Shifting From Baseline

    Time frame: From first dose to 30 days following last dose (Up to 30 Months)

    Number of participants experiencing worsening shift from baseline in any grade and grade 3-4 of laboratory values during the specified time frame.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Exelixis
  • Ono Pharmaceutical Co., Ltd.

Registry information

Official study title

A Phase 3, Randomized, Open-Label Study of Nivolumab Combined With Cabozantinib Versus Sunitinib in Participants With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

Acronym: CheckMate 9ER

Important dates

Study start
2017
Primary completion
2020
Study completion
2026
First posted
May 4, 2017
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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