An Investigational Immuno-Therapy Safety and Efficacy Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Renal Cell Carcinoma (CheckMate 800)
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ClinicalTrials.gov Identifier: NCT03029780 |
Recruitment Status : Unknown
Verified November 2018 by Bristol-Myers Squibb.
Recruitment status was: Active, not recruiting
First Posted : January 24, 2017
Results First Posted : December 19, 2018
Last Update Posted : December 19, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Renal Cell Carcinoma | Biological: Opdivo Biological: Yervoy | Phase 2 |
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 |
Actual Primary Completion Date : | November 27, 2017 |
Estimated Study Completion Date : | February 21, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Co-Administration
Nivolumab and Ipilimumab Co-Administration
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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 |
- Incidence Rate of Adverse Events (AEs) in the Broad Scope MedDRA Anaphylactic Reaction SMQ Within 2 Days After Any Dose in Combination Period. [ Time Frame: From the time of randomization to end of combination period (assessed up to November 24th, 2017, approximately 9 months) ]This incidence rate is defined as the number of participants who experienced at least 1 AE 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) divided by number of treated participants.
- Incidence Rate of AEs in the Narrow Scope MedDRA Anaphylactic Reaction SMQ Occurring Within 2 Days After Any Dose in the Part 1 Period [ Time Frame: From the time of randomization to end of combination period (assessed up to November 24th, 2017, approximately 9 months) ]This incidence rate is defined similarly to the primary endpoint except that the event rate will be based on terms within the narrow scope SMQ rather than the broad scope.
- Incidence Rate of Drug Related Grade 3-5 AEs. [ Time Frame: From the time of randomization to end of combination period (assessed up to November 24th, 2017, approximately 9 months) ]The drug-related Grade 3 - 5 AE rate is defined as number of participants who experienced at least 1 AE of Grade 3 or higher, judged to be related to study treatment by the investigator, with onset on or after the first dose of study treatment and within 30 days of the last dose of study treatment, divided by number of treated participants. Evaluated using Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 criteria.
- Incidence Rate of All Causality Grade 3-5 AE [ Time Frame: From the time of randomization to end of combination period (assessed up to November 24th, 2017, approximately 9 months) ]The all causality Grade 3 - 5 AE rate is defined as number of participants who experienced at least 1 AE of Grade 3 or higher with onset on or after the first dose of study treatment and within 30 days of the last dose of study treatment, divided by number of treated participants. Evaluated using the NCI CTCAE version 4.0 criteria
- Nivolumab and Ipilimumab Geometric Mean Concentrations at End of Infusion (EOI) and Predose at Cycle 1, 2 and 4 [ Time Frame: From the date of first dose to end of combination stage approximately 9 months ]To determine pharmacokinetics (PK) comparisons of Nivolumab and Ipilimumab administered as FRC to that of sequentially administered Nivolumab and Ipilimumab. PK will be measured using serum concentration-time data.
- Objective Response Rate (ORR) [ Time Frame: From the date of first dose to end of combination stage approximately 9 months ]The ORR is defined as the number of participants with a BOR of CR or PR divided by the number of treated participants. The BOR is defined as the best response designation, as determined by the investigator, recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of first subsequent anti-cancer therapy including radiotherapy, tumor-directed surgery, or systemic anticancer therapy, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR assessment
- Progression Free Survival (PFS) [ Time Frame: From the date of first dose to end of combination stage approximately 9 months ]PFS is defined as the time between the date of randomization and the first date of documented progression, as determined by the investigator, or death due to any cause, whichever occurs first

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

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
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 | |
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, Victoria | |
Local Institution | |
Malvern, Victoria, Australia, 3144 | |
Australia | |
Local Institution | |
Elizabeth Vale, Australia, 5112 | |
Chile | |
Fundacion Arturo Lopez Perez | |
Santiago, Metropolitana, Chile, 7500921 | |
Centro Internacional de Estudios Clinicos | |
Recoleta, Santiago DE Chile, Chile |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Documents provided by Bristol-Myers Squibb:
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT03029780 |
Other Study ID Numbers: |
CA209-800 |
First Posted: | January 24, 2017 Key Record Dates |
Results First Posted: | December 19, 2018 |
Last Update Posted: | December 19, 2018 |
Last Verified: | November 2018 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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 Ipilimumab Antineoplastic Agents, Immunological Antineoplastic Agents |