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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03029780
Other study ID # CA209-800
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date February 16, 2017
Est. completion date June 15, 2021

Study information

Verified date June 2022
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 104
Est. completion date June 15, 2021
Est. primary completion date November 27, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Opdivo
Specified dose on specified days
Yervoy
Specified dose on specified days

Locations

Country Name City State
Australia Local Institution Elizabeth Vale South Australia
Australia Local Institution Herston Queensland
Australia Local Institution Malvern Victoria
Australia Local Institution Waratah New South Wales
Australia Local Institution Westmead New South Wales
Chile Centro Internacional de Estudios Clinicos Recoleta Santiago De Chile
Chile Fundacion Arturo Lopez Perez Santiago Metropolitana
United States Levine Cancer Institute Charlotte North Carolina
United States University Of Iowa Hospitals And Clinics Iowa City Iowa
United States Cancer Specialists of North FL Jacksonville Florida
United States Local Institution Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Chile, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 The percentage of participants who experienced at least 1 adverse event in the MedDRA Anaphylactic Reaction narrow 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 The Percentage of Participants With Drug Related Grade 3-5 Adverse Events The percentage of participants who experienced at least 1 adverse event 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. Evaluated using Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 criteria. From first dose to 30 days after last dose of study therapy (up to approximately 48 months)
Secondary The Percentage of Participants With All Causality Grade 3-5 Adverse Events The percentage of participants who experienced at least 1 adverse event 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. Evaluated using the NCI CTCAE version 4.0 criteria From first dose to 30 days after last dose of study therapy (up to approximately 48 months)
Secondary Objective Response Rate (ORR) The percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). 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, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR assessment. Complete Response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10mm. Partial Response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. From randomization to the date of objectively documented progression or the date of first subsequent anti-cancer (up to approximately 52 months)
Secondary Progression Free Survival (PFS) The time between the date of randomization and the first date of documented progression, or death due to any cause, whichever occurs first (per investigator). Participants who die without progression will be considered to have progressed on the date of their death. Participants who did not progress or die are censored on the date of their last evaluable tumor assessment. Participants with no on study tumor assessments and who did not die will be censored on their date of randomization. Participants who started anti-cancer therapy without a prior reported progression will be censored on the date of their last evaluable tumor assessment prior to the first subsequent anti-cancer therapy. Progression is defined as at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression) From randomization to the first date of documented progression or death due to any cause (up to approximately 52 months)
Secondary Geometric Mean Trough Concentrations of Nivolumab and Ipilimumab Serum concentration-time data of nivolumab and ipilimumab administered as a fixed ratio combination to that of sequentially administered nivolumab and ipilimumab is summarized prior to the next dose (predose). 1 Cycle = 3 weeks pre-dose on day 1 of cycle 2 and 4
Secondary Geometric Mean End of Infusion (EOI) Concentrations of Nivolumab and Ipilimumab Serum concentration-time data of nivolumab and ipilimumab administered as a fixed ratio combination to that of sequentially administered nivolumab and ipilimumab is summarized at the end of infusion (EOI). 1 Cycle = 3 weeks EOI on day 1 of cycle 1, 2, and 4
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