Clinical trial NCT04088500: A Study of Combination Nivolumab and Ipilimumab Retreatment in Patients With Advanced Renal Cell Carcinoma
Official title: A Phase 2, Single-arm Open-label Study of Combination Nivolumab and Ipilimumab Retreatment in Advanced Renal Cell Carcinoma Patients Progressing on Nivolumab Maintenance Therapy After Nivolumab and Ipilimumab Induction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Renal Cell Carcinoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-09-12
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the effectiveness of re-induction with Nivolumab combined with ipilimumab.


Eligibility criteria: Inclusion Criteria:

-Participants and Target Disease Characteristics- -

* Confirmed disease progression by RECIST 1.1 criteria on nivolumab maintenance after induction with ipilimumab and nivolumab
* Progress of maintenance treatment of nivolumab by RECIST. Pathology report must be submitted for embedded tissue block or tumor tissue.

Age and Reproduction Sexually active males with WOCBP must agree to instructions for contraception and fetal protection.

WOCBP need to use contraception throughout the study and for 5 months post treatment.

Exclusion Criteria autoimmune disease statement

* Active central nervous system metastases
* Participants with an active autoimmune disease, diabetes mellitus, skin disorders, hyperthyroidism requiring hormone treatments are permitted to enroll.
* Any major surgery 28 days before 1st treatment Concomitant Therapy
* participants that have received a live vaccine within 30 days of treatment.
* use of investigational agent or device with in 28 days before first dosage study treatment.

Physical and Laboratory Test Findings Allergies and Adverse Drug Reaction Age and Reproduction

Primary outcomes:
measure: Disease Control Rate (DCR)
timeFrame: From first dose up to approximately 14 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From first dose to the date of death from any cause (up to approximately 14 months)
measure: Overall Response Rate (ORR)
timeFrame: From first dose and the date of objectively documented progression criteria or the date of subsequent therapy, whichever occurs first (up to approximately 14 months)
measure: Duration of Response (DOR)
timeFrame: From first dose to the date of the first documented progression or death due to any cause, whichever occurs first (up to approximately 14 months)
measure: Progression Free Survival (PFS)
timeFrame: From first dose to the first date of documented progression or death due to any cause, whichever occurs first (up to approximately 14 months)
measure: Time to Objective Response (TTR)
timeFrame: From first dose to the first confirmed documented response (up to approximately 14 months)
measure: The Number of Participants Experiencing Adverse Events (AEs)
timeFrame: From first dose and 100 days after lost dose (up to approximately 14 months)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine in St. Louis WUSTL
state: Missouri
city: Calgary
country: Canada
facility: Local Institution
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Vancouver
country: Canada
facility: BC Cancer Agency - Vancouver Centre
state: British Columbia
city: Halifax
country: Canada
facility: Atlantic Clinical Cancer Research Unit
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences (HHS) - Juravinski Cancer Centre (JCC)
state: Ontario
city: Toronto
country: Canada
facility: Toronto Sunnybrook Regional Cancer Ctr
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Montreal
country: Canada
facility: Local Institution - 0005
state: Quebec
city: Quebec City
country: Canada
facility: Local Institution
state: Quebec
city: Sherbrooke
country: Canada
facility: Local Institution - 0006
state: Quebec
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: