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

• ClinicalTrials.gov Identifier: NCT03029780
• Recruitment Status: Unknown
• First Posted: January 24, 2017
• Results First Posted: December 19, 2018
• Last Update Posted: December 19, 2018
• Sponsor: Bristol-Myers Squibb
• Information provided by (Responsible Party): Bristol-Myers Squibb

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
• Actual Primary Completion Date: November 27, 2017
• Estimated Study Completion Date: February 21, 2021

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 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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
4. 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.
5. 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
6. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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

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

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:

Statistical Analysis Plan  [PDF] September 11, 2017

Study Protocol  [PDF] August 2, 2017

More Information

Additional Information:

BMS Clinical Trial Information 

BMS Clinical Trial Patient Recruiting 

FDA Safety Alerts and Recalls 

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT03029780
• Other Study ID Numbers: CA209-800
• First Posted: January 24, 2017
• 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

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; Ipilimumab; Antineoplastic Agents, Immunological; Antineoplastic Agents