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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)

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03029780
Recruitment Status : Active, not recruiting
First Posted : January 24, 2017
Last Update Posted : January 22, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Renal Cell Carcinoma Biological: Opdivo Biological: Yervoy Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
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
Actual Study Start Date : February 9, 2017
Primary Completion Date : November 27, 2017
Estimated Study Completion Date : February 21, 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Incidence of AEs in anaphylactic reaction SMQ (Standardized Medical Dictionary for Regulatory Activities Queries) [ Time Frame: Up to 20 weeks ]
    Narrow Scope

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

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

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

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

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

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

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

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

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

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


Eligibility Criteria

Information from the National Library of Medicine

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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


Locations
United States, Florida
Cancer Specialists of North FL
Jacksonville, Florida, United States, 32256
United States, Iowa
University Of Iowa Hospitals And Clinics
Iowa City, Iowa, United States, 52242
United States, North Carolina
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
United States, Pennsylvania
Local Institution
Pittsburgh, Pennsylvania, United States, 15212-0000
United States, Tennessee
Local Institution
Nashville, Tennessee, United States, 37232
United States, Texas
Local Institution
San Antonio, Texas, United States, 78229
Australia, New South Wales
Local Institution
Waratah, New South Wales, Australia, 2298
Local Institution
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Local Institution
Herston, Queensland, Australia, 4029
Australia, South Australia
Local Institution
Elizabeth Vale, South Australia, Australia, 5112
Australia, Victoria
Local Institution
Malvern, Victoria, Australia, 3144
Chile
Fundacion Arturo Lopez Perez
Santiago, Metropolitana, Chile, 7500921
Centro Internacional de Estudios Clinicos
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 Posted: January 24, 2017    Key Record Dates
Last Update Posted: January 22, 2018
Last Verified: January 2018

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
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs