Clinical trial NCT03029780: An Investigational Immuno-Therapy Safety and Efficacy Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Renal Cell Carcinoma
Official title: Phase II, Randomized, Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Cell Carcinoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-01-24
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: From randomization to 2 days following any dose in the combination period (assessed up to November 24th, 2017, approximately 9 months)
Secondary outcomes:
measure: 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
timeFrame: From randomization to 2 days following any dose in the combination period (assessed up to November 24th, 2017, approximately 9 months)
measure: The Percentage of Participants With Drug Related Grade 3-5 Adverse Events
timeFrame: From first dose to 30 days after last dose of study therapy (up to approximately 48 months)
measure: The Percentage of Participants With All Causality Grade 3-5 Adverse Events
timeFrame: From first dose to 30 days after last dose of study therapy (up to approximately 48 months)
measure: Objective Response Rate (ORR)
timeFrame: From randomization to the date of objectively documented progression or the date of first subsequent anti-cancer (up to approximately 52 months)
measure: Progression Free Survival (PFS)
timeFrame: From randomization to the first date of documented progression or death due to any cause (up to approximately 52 months)
measure: Geometric Mean Trough Concentrations of Nivolumab and Ipilimumab
timeFrame: pre-dose on day 1 of cycle 2 and 4
measure: Geometric Mean End of Infusion (EOI) Concentrations of Nivolumab and Ipilimumab
timeFrame: EOI on day 1 of cycle 1, 2, and 4
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Cancer Specialists of North FL
state: Florida
city: Iowa City
country: United States
facility: University Of Iowa Hospitals And Clinics
state: Iowa
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Pittsburgh
country: United States
facility: Local Institution
state: Pennsylvania
city: Waratah
country: Australia
facility: Local Institution
state: New South Wales
city: Westmead
country: Australia
facility: Local Institution
state: New South Wales
city: Herston
country: Australia
facility: Local Institution
state: Queensland
city: Elizabeth Vale
country: Australia
facility: Local Institution
state: South Australia
city: Malvern
country: Australia
facility: Local Institution
state: Victoria
city: Santiago
country: Chile
facility: Fundacion Arturo Lopez Perez
state: Metropolitana
city: Recoleta
country: Chile
facility: Centro Internacional de Estudios Clinicos
state: Santiago De Chile
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: