A Study of Combination Nivolumab and Ipilimumab Retreatment in Patients With Advanced Renal Cell Carcinoma

Renal Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04088500
• Other study ID #: CA209-73M
• Status: Terminated
• Phase: Phase 2
• Start date: September 3, 2020
• Est. completion date: November 15, 2021

Study information

• Verified date: December 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: November 15, 2021
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Biological:
• Nivolumab
Specific dose on specific days
• Ipilimumab
Specific dose on specific days

Locations

Country	Name	City	State
Canada	Local Institution	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Atlantic Clinical Cancer Research Unit	Halifax	Nova Scotia
Canada	Hamilton Health Sciences (HHS) - Juravinski Cancer Centre (JCC)	Hamilton	Ontario
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution - 0005	Montreal	Quebec
Canada	Local Institution	Quebec City	Quebec
Canada	Local Institution - 0006	Sherbrooke	Quebec
Canada	Local Institution	Toronto	Ontario
Canada	Toronto Sunnybrook Regional Cancer Ctr	Toronto	Ontario
Canada	BC Cancer Agency - Vancouver Centre	Vancouver	British Columbia
United States	Washington University School of Medicine in St. Louis WUSTL	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Control Rate (DCR)	Disease Control Rate (DCR) is defined as the percentage of participants who achieve a confirmed best response of complete response (CR), partial response (PR), or stable disease (SD) for at least 6 months after first treatment dose per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.; Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.	From first dose up to approximately 14 months
Secondary	Overall Survival (OS)	Overall Survival (OS) is defined as the time from first dose to the date of death from any cause. For participants that are alive, their survival time will be censored at the date of last contact ("last known alive date"). OS will be censored for participants at the date of first dose if they were treated but had no follow-up.	From first dose to the date of death from any cause (up to approximately 14 months)
Secondary	Overall Response Rate (ORR)	Overall Response Rate (ORR) is defined as the percentage of participants who achieve a best response of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.; Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.	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)
Secondary	Duration of Response (DOR)	Duration of Response (DOR) is defined as the time between the date of first documented response (complete response (CR) or partial response (PR)) to the date of the first documented progression, per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, or death due to any cause, whichever occurs first.; Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.	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)
Secondary	Progression Free Survival (PFS)	Progression Free Survival (PFS) is defined as the time between the date of first dose and the first date of documented progression, as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, or death due to any cause, whichever occurs first. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, 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 first dose to the first date of documented progression or death due to any cause, whichever occurs first (up to approximately 14 months)
Secondary	Time to Objective Response (TTR)	Time to Objective Response (TTR) is defined as the time between the date of the first dose and the first confirmed documented response (complete response (CR) or partial response (PR)) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.; Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.	From first dose to the first confirmed documented response (up to approximately 14 months)
Secondary	The Number of Participants Experiencing Adverse Events (AEs)	The number of participants with any grade adverse events (AEs). An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.	From first dose and 100 days after lost dose (up to approximately 14 months)

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