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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04088500
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : July 24, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Biological: Nivolumab Biological: Ipilimumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 31, 2020
Estimated Primary Completion Date : June 17, 2022
Estimated Study Completion Date : July 16, 2026


Arm Intervention/treatment
Experimental: Nivolumab + Ipilimumab (combination)
Nivolumab + Ipilimumab (combination) Q3W for 4 doses
Biological: Nivolumab
Specific dose on specific days
Other Name: Opdivo

Biological: Ipilimumab
Specific dose on specific days




Primary Outcome Measures :
  1. Disease Control Rate (DCR) [ Time Frame: 6 months after 1st treatment ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 1st dose to specific time frame ]
  2. Objective Rate Response Rate (ORR) [ Time Frame: 24 months ]
  3. Duration of Response (DOR) [ Time Frame: 24 months ]
  4. Time to objective Response (TTR) [ Time Frame: 24 months ]
  5. Progression- free survival rate (PFSR) [ Time Frame: 24 months ]
  6. Incidence of adverse events (AEs) [ Time Frame: from first dose and up to 100 days following the last dose of study treatment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04088500


Locations
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United States, Missouri
Local Institution Not yet recruiting
Saint Louis, Missouri, United States, 63130
Contact: Site 0016         
United States, Ohio
Local Institution Not yet recruiting
Columbus, Ohio, United States, 43210
Contact: Site 0015         
United States, Washington
Local Institution Not yet recruiting
Seattle, Washington, United States, 98109
Contact: Site 0021         
Canada, Alberta
Local Institution Not yet recruiting
Calgary, Alberta, Canada, T2N4N2
Contact: Site 0012         
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Naveen Basappa, Site 0001    17804328757      
Canada, British Columbia
BC Cancer Agency - Vancouver Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Christian Kollmannsberger, Site 0008    16048776000      
Canada, Nova Scotia
Local Institution Not yet recruiting
Halifax, Nova Scotia, Canada, B3H 1V7
Contact: Site 0002         
Canada, Ontario
Local Institution Not yet recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Site 0004         
Local Institution Withdrawn
Ottawa, Ontario, Canada, K1H 8L6
Local Institution Not yet recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Site 0010         
Local Institution Not yet recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Site 0003         
Canada, Quebec
Local Institution Not yet recruiting
Montreal, Quebec, Canada, H2X 3E4
Contact: Site 0011         
Local Institution Not yet recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Site 0005         
Local Institution Not yet recruiting
Quebec City, Quebec, Canada, G2L 2Z3
Contact: Site 0007         
Local Institution Not yet recruiting
Sherbrooke, Quebec, Canada, J1E 5N4
Contact: Site 0006         
Sponsors and Collaborators
Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04088500    
Other Study ID Numbers: CA209-73M
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: July 24, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents