An Investigational Immuno-Therapy Safety and Efficacy Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Renal Cell Carcinoma
CheckMate 800
Phase II, Randomized, Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Renal Cell Carcinoma
1 other identifier
interventional
104
3 countries
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2017
Typical duration for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2017
CompletedFirst Posted
Study publicly available on registry
January 24, 2017
CompletedStudy Start
First participant enrolled
February 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 27, 2017
CompletedResults Posted
Study results publicly available
December 19, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2021
CompletedJune 29, 2022
June 1, 2022
9 months
January 20, 2017
November 27, 2018
June 1, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
The Percentage of Participant With Adverse Events (AEs) in the Broad Scope MedDRA Anaphylactic Reaction Standardized MedDRA Queries (SMQ) Within 2 Days After Any Dose in the Combination Period
The percentage of participants who experienced at least 1 adverse event in the MedDRA Anaphylactic Reaction broad scope SMQ with onset on the day of or within 2 days after any study therapy infusion during the combination period (Part 1).
From randomization to 2 days following any dose in the combination period (assessed up to November 24th, 2017, approximately 9 months)
Secondary Outcomes (7)
The Percentage of Participant With Adverse Events in the Narrow Scope MedDRA Anaphylactic Reaction Standardized MedDRA Queries (SMQ) Occurring Within 2 Days After Any Dose in the Combination Period
From randomization to 2 days following any dose in the combination period (assessed up to November 24th, 2017, approximately 9 months)
The Percentage of Participants With Drug Related Grade 3-5 Adverse Events
From first dose to 30 days after last dose of study therapy (up to approximately 48 months)
The Percentage of Participants With All Causality Grade 3-5 Adverse Events
From first dose to 30 days after last dose of study therapy (up to approximately 48 months)
Objective Response Rate (ORR)
From randomization to the date of objectively documented progression or the date of first subsequent anti-cancer (up to approximately 52 months)
Progression Free Survival (PFS)
From randomization to the first date of documented progression or death due to any cause (up to approximately 52 months)
- +2 more secondary outcomes
Study Arms (2)
Co-Administration
EXPERIMENTALNivolumab and Ipilimumab Co-Administration
Sequential Administration
EXPERIMENTALNivolumab and Ipilimumab Sequential Administration
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Subjects with active central nervous system metastases
- Subjects who received prior therapy with checkpoint inhibitor
- Subjects with active, known or suspected autoimmune disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Cancer Specialists of North FL
Jacksonville, Florida, 32256, United States
University Of Iowa Hospitals And Clinics
Iowa City, Iowa, 52242, United States
Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
Local Institution
Pittsburgh, Pennsylvania, 15212-0000, United States
Local Institution
Waratah, New South Wales, 2298, Australia
Local Institution
Westmead, New South Wales, 2145, Australia
Local Institution
Herston, Queensland, 4029, Australia
Local Institution
Elizabeth Vale, South Australia, 5112, Australia
Local Institution
Malvern, Victoria, 3144, Australia
Centro Internacional de Estudios Clinicos
Recoleta, Santiago de Chile, Chile
Fundacion Arturo Lopez Perez
Santiago, Santiago Metropolitan, 7500921, Chile
Related Publications (1)
Menzies AM, Salman P, Frontera OA, Pook D, Hocking CM, Zakharia Y, Gurney H, Gedye C, Goh JC, Telivala B, Grob JJ, Lebbe C, de la Cruz Merino L, Machet L, Neidhardt EM, Qureshi A, Hosein F, Hamuro L, Simsek B, Amin A. Administration of nivolumab plus ipilimumab: Infusion of the fixed-ratio combination versus sequential infusions in two randomized controlled trials of metastatic melanoma (CheckMate 742) and renal cell carcinoma (CheckMate 800). Cancer. 2025 Jul 15;131(14):e35962. doi: 10.1002/cncr.35962.
PMID: 40614118DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2017
First Posted
January 24, 2017
Study Start
February 16, 2017
Primary Completion
November 27, 2017
Study Completion
June 15, 2021
Last Updated
June 29, 2022
Results First Posted
December 19, 2018
Record last verified: 2022-06