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

Renal Cell Carcinoma Clinical Trial

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Official title:

Phase II, Randomized, Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Renal Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03029780
• Other study ID #: CA209-800
• Status: Completed
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

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

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls