Study of Nivolumab (BMS-936558) vs. Everolimus in Pre-Treated Advanced or Metastatic Clear-cell Renal Cell Carcinoma (CheckMate 025)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01668784
First received: August 16, 2012
Last updated: October 13, 2014
Last verified: April 2014
  Purpose

The purpose of the study is to compare the clinical benefit, as measured by duration of overall survival, of Nivolumab vs. Everolimus in subjects with advanced or metastatic clear-cell renal cell carcinoma who have received prior anti-angiogenic therapy


Condition Intervention Phase
Advanced or Metastatic (Medically or Surgically Unresectable) Clear-cell Renal Cell Carcinoma
Biological: Nivolumab
Drug: Everolimus
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Phase 3 Study of Nivolumab (BMS-936558) vs. Everolimus in Subjects With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Every clinic visit (every 2-4 weeks) up to 42 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Every 3 months up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: Disease assessments every 8 weeks after randomization for every 12 months then 12 weeks until progression of disease ] [ Designated as safety issue: No ]
  • Objective response rate [ Time Frame: Disease assessments every 8 weeks after randomization for every 12 months then 12 weeks until progression of disease ] [ Designated as safety issue: No ]
  • Duration of objective response [ Time Frame: Disease assessments every 8 weeks after randomization for every 12 months then 12 weeks until progression of disease ] [ Designated as safety issue: No ]
  • Duration of overall survival (OS) in Programmed death-ligand 1 (PD-L1) positive vs negative subgroups [ Time Frame: At every clinic visit (every 2-4 weeks) while on treatment and then every 3 months ] [ Designated as safety issue: No ]
  • Safety will be analyzed through the incidence of adverse events, serious adverse events [ Time Frame: Continuously throughout study treatment and up to 100 days from last dose ] [ Designated as safety issue: Yes ]
  • Safety will be analyzed through the incidence of laboratory abnormalities [ Time Frame: Continuously throughout study treatment and up to 100 days from last dose ] [ Designated as safety issue: Yes ]
  • Disease related symptom progression rate [ Time Frame: Baseline, Day 1 of each cycle (starting with cycle 2), then at first 2 follow-up visits ] [ Designated as safety issue: No ]

Estimated Enrollment: 822
Study Start Date: September 2012
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: Nivolumab
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Biological: Nivolumab
Other Name: BMS-936558
Active Comparator: Arm 2: Everolimus
Everolimus 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Drug: Everolimus
Other Name: Afinitor

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Men & women ≥18 years of age
  • Histologic confirmation of renal cell carcinoma (RCC) with clear-cell component
  • Advanced/metastatic RCC
  • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
  • Received 1 or 2 prior anti-angiogenic therapy regimens in advanced or metastatic setting
  • No more than 3 total prior systemic treatment regimens in the advanced or metastatic setting, and evidence of progression on or after last treatment regimen received and within 6 months of enrollment
  • Karnofsky Performance Score ≥70%

Exclusion Criteria:

  • Any Central Nervous System (CNS) metastases or history of CNS metastases
  • Prior therapy with an Mammalian target of rapamycin (mTOR) inhibitor
  • Any active known or suspected autoimmune disease
  • Uncontrolled adrenal insufficiency
  • Active chronic liver disease
  • Prior malignancy active within past 3 years, except for locally curable cancers
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01668784

  Show 160 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01668784     History of Changes
Other Study ID Numbers: CA209-025, 2011‐005132‐26
Study First Received: August 16, 2012
Last Updated: October 13, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Federal Office for Safety in Health Care
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Brazil: National Health Surveillance Agency
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Denmark: Danish Dataprotection Agency
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Ireland: Irish Medicines Board
Italy: Ministry of Health
Israel: Israeli Health Ministry Pharmaceutical Administration
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Norway: Data Protection Authority
Norway: Directorate of Health
Poland: National Institute of Medicines
Portugal: National Pharmacy and Medicines Institute
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents

ClinicalTrials.gov processed this record on October 16, 2014