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

NCT04088500 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: CA209-73M
• Study Type: interventional
• Target: 5
• Locations: 2 countries
• Sites: 12

Brief Summary

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

Conditions

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Overall Survival (OS)

  From first dose to the date of death from any cause (up to approximately 14 months)

• Overall Response Rate (ORR)

  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)

• Duration of Response (DOR)

  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)

• Progression Free Survival (PFS)

  From first dose to the first date of documented progression or death due to any cause, whichever occurs first (up to approximately 14 months)

• Time to Objective Response (TTR)

  From first dose to the first confirmed documented response (up to approximately 14 months)

Study Arms (1)

Nivolumab + Ipilimumab (combination)

EXPERIMENTAL

Nivolumab + Ipilimumab (combination) Q3W for 4 doses

Biological: Nivolumab; Biological: Ipilimumab

Interventions

Nivolumab BIOLOGICAL

Specific dose on specific days

Also known as: Opdivo

Nivolumab + Ipilimumab (combination)

Ipilimumab BIOLOGICAL

Specific dose on specific days

Nivolumab + Ipilimumab (combination)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (12)

Washington University School of Medicine in St. Louis WUSTL

St Louis, Missouri, 63108, United States

Location

Local Institution

Calgary, Alberta, T3B 3L1, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

BC Cancer Agency - Vancouver Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Atlantic Clinical Cancer Research Unit

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Hamilton Health Sciences (HHS) - Juravinski Cancer Centre (JCC)

Hamilton, Ontario, L8V 5C2, Canada

Location

Toronto Sunnybrook Regional Cancer Ctr

Toronto, Ontario, M4N 3M5, Canada

Location

Local Institution

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution

Montreal, Quebec, H2X 3E4, Canada

Location

Local Institution - 0005

Montreal, Quebec, H3T 1E2, Canada

Location

Local Institution

Québec, Quebec, G2L 2Z3, Canada

Location

Local Institution - 0006

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Links

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

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Nivolumab; Ipilimumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

The study was terminated early, leading to small numbers of participants analyzed.

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 12, 2019
• Study Start: September 3, 2020
• Primary Completion: November 15, 2021
• Study Completion: November 15, 2021
• Last Updated: January 10, 2023
• Results First Posted: January 10, 2023

Record last verified: 2022-12

Locations

US (1); CA (11)