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An Investigational Immuno-Therapy Safety and Efficacy Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Renal Cell Carcinoma (CheckMate 800)

This study is currently recruiting participants.
Verified November 2017 by Bristol-Myers Squibb
Sponsor:
ClinicalTrials.gov Identifier:
NCT03029780
First Posted: January 24, 2017
Last Update Posted: November 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Bristol-Myers Squibb
  Purpose
The purpose of this study is to evaluate safety and efficacy of different administration regimens of nivolumab plus ipilimumab in subjects with renal cell carcinoma.

Condition Intervention Phase
Renal Cell Carcinoma Biological: Opdivo Biological: Yervoy Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II, Randomized, Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Incidence of adverse events (AEs) in anaphylactic reaction SMQ (Standardized Medical Dictionary for Regulatory Activities Queries) [ Time Frame: Up to 20 weeks ]
    Broad Scope


Secondary Outcome Measures:
  • Incidence of AEs in anaphylactic reaction SMQ (Standardized Medical Dictionary for Regulatory Activities Queries) [ Time Frame: Up to 20 weeks ]
    Narrow Scope

  • Incidence of grade 3-5 AEs [ Time Frame: Up to 20 weeks ]
    measured by number of pateints

  • Nivolumab as measured using serum concentration- time data [ Time Frame: Up to 16 weeks ]
    Predose

  • Nivolumab as measured using serum concentration- time data [ Time Frame: Up to 10 weeks ]
    End of infusion

  • Ipilimumab as measured using serum concentration- time data [ Time Frame: Up to 16 weeks ]
    Predose

  • Ipilimumab as measured using serum concentration- time data [ Time Frame: Up to 10 weeks ]
    End of infusion

  • Anti-nivolumab antibody [ Time Frame: Up to 20 weeks ]
    measured by immunoassay

  • Anti-ipilimumab antibody [ Time Frame: Up to 20 weeks ]
    measured by immunoassay

  • Maximum observed serum concentration (Cmax) [ Time Frame: Up to 10 weeks ]
    End of Infusion

  • Objective Response Rate (ORR) [ Time Frame: Up to 20 weeks ]
    measured by time

  • Progression Free Survival (PFS) [ Time Frame: Up to 20 weeks ]
    measured by number of patients


Estimated Enrollment: 100
Actual Study Start Date: February 9, 2017
Estimated Study Completion Date: February 21, 2021
Estimated Primary Completion Date: November 24, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Co-Administration
Nivolumab and Ipilimumab Co-Administration
Biological: Opdivo
Specified dose on specified days
Other Name: Nivolumab
Biological: Yervoy
Specified dose on specified days
Other Name: Ipilimumab
Experimental: Sequential Administration
Nivolumab and Ipilimumab Sequential Administration
Biological: Opdivo
Specified dose on specified days
Other Name: Nivolumab
Biological: Yervoy
Specified dose on specified days
Other Name: Ipilimumab

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Inclusion Criteria:

  • Advanced Renal Cell Carcinoma
  • Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
  • Must have at least 1 lesion with measurable disease

Exclusion Criteria:

  • Subjects with active central nervous system metastases
  • Subjects who received prior therapy with checkpoint inhibitor
  • Subjects with active, known or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria could apply

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03029780


Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

Locations
United States, Florida
Cancer Specialists of North FL Active, not recruiting
Jacksonville, Florida, United States, 32256
United States, Illinois
Loyola University Chicago Withdrawn
Maywood, Illinois, United States, 60153
United States, Iowa
University Of Iowa Hospitals And Clinics Active, not recruiting
Iowa City, Iowa, United States, 52242
United States, New Jersey
Meridan Health System-Jersey Shore Medical Center Withdrawn
Neptune City, New Jersey, United States, 07753
United States, North Carolina
Levine Cancer Institute Active, not recruiting
Charlotte, North Carolina, United States, 28204
United States, Pennsylvania
Local Institution Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15212-0000
Contact: Site 0015         
United States, South Carolina
Medical University Of South Carolina Withdrawn
Charleston, South Carolina, United States, 29425
United States, Tennessee
Local Institution Not yet recruiting
Nashville, Tennessee, United States, 37232
Contact: Site 0017         
United States, Texas
Local Institution Not yet recruiting
San Antonio, Texas, United States, 78229
Contact: Site 0016         
Australia, New South Wales
Local Institution Recruiting
Waratah, New South Wales, Australia, 2298
Contact: Site 0003         
Local Institution Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Site 0001         
Australia, Queensland
Local Institution Recruiting
Herston, Queensland, Australia, 4029
Contact: Site 0004         
Australia, South Australia
Local Institution Recruiting
Elizabeth Vale, South Australia, Australia, 5112
Contact: Site 0005         
Australia, Victoria
Local Institution Recruiting
Malvern, Victoria, Australia, 3144
Contact: Site 0002         
Chile
Fundacion Arturo Lopez Perez Active, not recruiting
Santiago, Metropolitana, Chile, 7500921
Centro Internacional de Estudios Clinicos Active, not recruiting
Recoleta, Santiago DE Chile, Chile
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03029780     History of Changes
Other Study ID Numbers: CA209-800
First Submitted: January 20, 2017
First Posted: January 24, 2017
Last Update Posted: November 8, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Adenocarcinoma
Urologic Diseases
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs