A Study to Evaluate the Safety of Nivolumab and Ipilimumab in Subjects With Previously Untreated Advanced or Metastatic Renal Cell Cancer

NCT02982954 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: CA209-920
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 61

Brief Summary

To investigate the safety of Nivolumab in combination with Ipilimumab in subjects with previously untreated advanced or metastatic Renal Cell Cancer.

Conditions

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• Number of Participants With High Grade (Grade 3-4) Immune Mediated Adverse Events (IMAEs)

  Number of participants with IMAEs in the following categories: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity

  Approximately 39 Months

• Number of Participants With High Grade (Grade 5) Immune Mediated Adverse Events (IMAEs)

  Number of participants with IMAEs in the following categories: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity

  Approximately 39 Months

Secondary Outcomes (9)

• Time to Onset of Grade 3-5 Immune Mediated Adverse Events (IMAEs)

  From first dose to the earliest IMAE (grade 3-5) event onset date (up to approximately 116 weeks)

• Time to Resolution of Grade 3-5 Immune Mediated Adverse Events (IMAEs)

  From the IMAE onset date to the IMAE end date, up to approximately 194 weeks

• Number of Participants Who Received Immune Modulating Medication for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs)

  From first dose up to 100 days post last dose (up to approximately 29 months)

• Number of Participants Who Received Hormone Replacement Therapy for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs)

  From first dose up to 100 days post last dose (up to approximately 29 months)

• Number of Participants Who Received ≥ 40mg of Prednisone for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs)

  From first dose up to 100 days post last dose (up to approximately 29 months)

Study Arms (4)

ccRCC KPS ≥ 70%

EXPERIMENTAL

Clear-Cell Renal Cell Carcinoma (ccRCC) with Karnofsky Performance Status (KPS) ≥ 70%

Drug: Nivolumab; Drug: Ipilimumab

Non-ccRCC, KPS ≥ 70%

EXPERIMENTAL

Non Clear-Cell Renal Cell Carcinoma (nccRCC) with KPS ≥ 70%

Drug: Nivolumab; Drug: Ipilimumab

RCC with non-active Brain Mets, KPS ≥70%

EXPERIMENTAL

Renal Cell Carcinoma (RCC) with non-active Brain Metastases, with KPS ≥70%

Drug: Nivolumab; Drug: Ipilimumab

any RCC with KPS 50%-60%

EXPERIMENTAL

Renal Cell Carcinoma (RCC), regardless of any histology or existing non-active brain metastasis, with KPS 50%-60%

Drug: Nivolumab; Drug: Ipilimumab

Interventions

Nivolumab DRUG

Specified dose on specified day

Also known as: BMS-936558, Opdivo

Non-ccRCC, KPS ≥ 70%; RCC with non-active Brain Mets, KPS ≥70%; any RCC with KPS 50%-60%; ccRCC KPS ≥ 70%

Ipilimumab DRUG

Specified Dose on Specified Day

Also known as: Yervoy, BMS-734016

Non-ccRCC, KPS ≥ 70%; RCC with non-active Brain Mets, KPS ≥70%; any RCC with KPS 50%-60%; ccRCC KPS ≥ 70%

Eligibility Criteria

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

You may qualify if:

• \. Type of Participant and Target Disease Characteristics
• Advanced or metastatic RCC
• Histologically confirmed, previously untreated (treatment-naive) RCC
• No prior systemic therapy for RCC except for one prior adjuvant or neoadjuvant therapy for completely resectable RCC
• Measurable disease as per RECIST 1.1. Subject must have extracranial metastasis as measurable disease
• Karnofsky Performance Status (KPS) of at least 70% for Cohort 1, 2, and 3; KPS of 50-60% for Cohort 4
• Tumor tissue need be received by the central vendor (block or unstained slides). Note: Fine Needle Aspiration (FNA)and bone metastases samples are not acceptable for submission.

You may not qualify if:

• Medical Conditions
• Subjects with any active autoimmune disease or a history of known autoimmune disease
• Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
• Known HIV or AIDS-related illness
• Any positive test for hepatitis B or hepatitis C virus indicating acute or chronic infection.
• Prior/Concomitant Therapy
• Prior systemic treatment in the metastatic setting with Vascular epithelial growth factor(VEGF) or VEGF receptor targeted therapy
• Prior treatment with an anti-Programmed Death (PD) -1, anti-PD-L1, anti-PD-L2, anti-cluster of differentiation 137 (CD137), or anti-cytotoxic T-lymphocyte-associated antigen 4(CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. This includes the utilization of these agents in the neo-adjuvant or adjuvant setting.
• Anti-cancer therapy less than 28 days prior to the first dose of study drug or palliative, focal radiation therapy less than 14 days prior to the first dose of study drug.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (61)

Northwest Alabama Cancer Center, Pc

Muscle Shoals, Alabama, 35661, United States

Location

Alaska Urological Institute dba Alaska Clinical Research Center

Anchorage, Alaska, 99503, United States

Location

Ironwood Cancer And Research Centers, Pc

Chandler, Arizona, 85224, United States

Location

Local Institution - 0028

Fayetteville, Arkansas, 72703, United States

Location

eCare

Encinitas, California, 92024, United States

Location

Pacific Shores Medical Group

Long Beach, California, 90813, United States

Location

Los Angeles Cancer Network

Los Angeles, California, 90017, United States

Location

UCLA Hematology Oncology

Los Angeles, California, 90095, United States

Location

Torrance Health Association

Redondo Beach, California, 90277, United States

Location

Kaiser Permanente Medical Group - Southern California

Riverside, California, 92505, United States

Location

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

Coastal Integrative Cancer Care

San Luis Obispo, California, 93401, United States

Location

Central Coast Med Oncology

Santa Maria, California, 93454, United States

Location

Florida Cancer Specialists S.

Fort Myers, Florida, 33901, United States

Location

University Of Miami/Sylvester Cancer Center

Miami, Florida, 33136, United States

Location

UF Health Cancer Center at Orlando Health

Orlando, Florida, 32806, United States

Location

Florida Cancer Specialists

St. Petersburg, Florida, 33705, United States

Location

Emory University - Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Illinois Cancer Specialists

Niles, Illinois, 60714, United States

Location

Local Institution - 0012

Fort Wayne, Indiana, 46845, United States

Location

Cancer Center Of Kansas

Wichita, Kansas, 67214, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40202, United States

Location

Southdale Cancer Clinic

Burnsville, Minnesota, 55337, United States

Location

Local Institution - 0009

Coon Rapids, Minnesota, 55433, United States

Location

Park Nicollet Clinic Cancer Center

Minneapolis, Minnesota, 55416, United States

Location

Hattiesburg Clinic

Hattiesburg, Mississippi, 39401, United States

Location

Jackson Oncology Associates, Pllc

Jackson, Mississippi, 39202, United States

Location

HCA Midwest Division

Kansas City, Missouri, 64132, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89148, United States

Location

Local Institution - 0023

Hackensack, New Jersey, 07601, United States

Location

University Of New Mexico

Albuquerque, New Mexico, 87106, United States

Location

Maimonides Medical Center

Brooklyn, New York, 11220, United States

Location

St. Francis Cancer Treatment Center

Grand Island, New York, 68803, United States

Location

Broome Oncology

Johnson City, New York, 13790, United States

Location

Local Institution - 0052

New York, New York, 10016, United States

Location

Weill Cornell Medical College

New York, New York, 10021, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Southeastern Medical Oncology Center

Goldsboro, North Carolina, 27534, United States

Location

Oklahoma Cancer Specialists and Research Institute, LLC-Clinical Research

Tulsa, Oklahoma, 74146, United States

Location

Local Institution - 0071

Pittsburgh, Pennsylvania, 15240, United States

Location

Charleston Hematology Oncology Associates, Pa

Charleston, South Carolina, 29414, United States

Location

Hollings Cancer Center

Charleston, South Carolina, 29425, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

Tennessee Oncology, PLLC - SCRI - PPDS

Chattanooga, Tennessee, 37404, United States

Location

Local Institution - 0002

Nashville, Tennessee, 37203-1624, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-6307, United States

Location

Texas Oncology

Austin, Texas, 78731, United States

Location

Texas Oncology

Dallas, Texas, 75246, United States

Location

Texas Oncology-Fort Worth 12th Ave

Fort Worth, Texas, 76104, United States

Location

Texas Oncology-Midland Allison Cancer Center

Midland, Texas, 79701, United States

Location

Texas Oncology

San Antonio, Texas, 78217, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22936, United States

Location

Local Institution - 0042

Fairfax, Virginia, 22031, United States

Location

Bon Secours St Francis Hospital

Midlothian, Virginia, 23114, United States

Location

Virginia Cancer Institute

Richmond, Virginia, 23226, United States

Location

University of Washington - Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

Medical Oncology Associates

Spokane, Washington, 99208, United States

Location

Yakima Valley Memorial Hospital/North Star Lodge

Yakima, Washington, 98902, United States

Location

University of Wisconsin Clinical Science Center

Madison, Wisconsin, 53705, United States

Location

Related Publications (2)

• George DJ, Spigel DR, Gordan LN, Kochuparambil ST, Molina AM, Yorio J, Rezazadeh Kalebasty A, McKean H, Tchekmedyian N, Tykodi SS, Zhang J, Askelson M, Johansen JL, Hutson TE. Safety and efficacy of first-line nivolumab plus ipilimumab alternating with nivolumab monotherapy in patients with advanced renal cell carcinoma: the non-randomised, open-label, phase IIIb/IV CheckMate 920 trial. BMJ Open. 2022 Sep 14;12(9):e058396. doi: 10.1136/bmjopen-2021-058396.

  PMID: 36104138 DERIVED

• Tykodi SS, Gordan LN, Alter RS, Arrowsmith E, Harrison MR, Percent I, Singal R, Van Veldhuizen P, George DJ, Hutson T, Zhang J, Zoco J, Johansen JL, Rezazadeh Kalebasty A. Safety and efficacy of nivolumab plus ipilimumab in patients with advanced non-clear cell renal cell carcinoma: results from the phase 3b/4 CheckMate 920 trial. J Immunother Cancer. 2022 Feb;10(2):e003844. doi: 10.1136/jitc-2021-003844.

  PMID: 35210307 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• 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

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 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2016
• First Posted: December 6, 2016
• Study Start: January 16, 2017
• Primary Completion: May 11, 2020
• Study Completion: October 6, 2021
• Last Updated: November 1, 2022
• Results First Posted: October 14, 2021

Record last verified: 2022-10

Locations

US (61)