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A Study to Evaluate the Safety of Nivolumab and Ipilimumab in Subjects With Previously Untreated Advanced or Metastatic Renal Cell Cancer (CHECKMATE 920)

Primary Purpose

Renal Cell Carcinoma

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Nivolumab

Ipilimumab

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1. 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.

Exclusion Criteria:

Medical Conditions
1. Subjects with any active autoimmune disease or a history of known autoimmune disease
2. Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
3. Known HIV or AIDS-related illness
4. Any positive test for hepatitis B or hepatitis C virus indicating acute or chronic infection.
Prior/Concomitant Therapy
1. Prior systemic treatment in the metastatic setting with Vascular epithelial growth factor(VEGF) or VEGF receptor targeted therapy
2. 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.
3. 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.

Other protocol defined inclusion/exclusion criteria apply

Sites / Locations

Northwest Alabama Cancer Center, Pc
Alaska Urological Institute dba Alaska Clinical Research Center
Ironwood Cancer And Research Centers, Pc
Local Institution - 0028
eCare
Pacific Shores Medical Group
Los Angeles Cancer Network
UCLA Hematology Oncology
Torrance Health Association
Kaiser Permanente Medical Group - Southern California
Sharp Memorial Hospital
Coastal Integrative Cancer Care
Central Coast Med Oncology
Florida Cancer Specialists S.
University Of Miami/Sylvester Cancer Center
UF Health Cancer Center at Orlando Health
Florida Cancer Specialists
Emory University - Winship Cancer Institute
Illinois Cancer Specialists
Local Institution - 0012
Cancer Center Of Kansas
Norton Cancer Institute
Southdale Cancer Clinic
Local Institution - 0009
Park Nicollet Clinic Cancer Center
Hattiesburg Clinic
Jackson Oncology Associates, Pllc
HCA Midwest Division
Comprehensive Cancer Centers of Nevada
Local Institution - 0023
University Of New Mexico
Montefiore Medical Center
Maimonides Medical Center
St. Francis Cancer Treatment Center
Broome Oncology
Local Institution - 0052
Weill Cornell Medical College
SUNY Upstate Medical University
Duke University Medical Center
Southeastern Medical Oncology Center
Oklahoma Cancer Specialists and Research Institute, LLC-Clinical Research
Local Institution - 0071
Charleston Hematology Oncology Associates, Pa
Hollings Cancer Center
Avera Cancer Institute
Tennessee Oncology, PLLC - SCRI - PPDS
Local Institution - 0002
Vanderbilt University Medical Center
Texas Oncology
Texas Oncology
Texas Oncology-Fort Worth 12th Ave
Texas Oncology-Midland Allison Cancer Center
Texas Oncology
University of Virginia Health System
Local Institution - 0042
Bon Secours St Francis Hospital
Virginia Cancer Institute
University of Washington - Seattle Cancer Care Alliance
Medical Oncology Associates
Yakima Valley Memorial Hospital/North Star Lodge
University of Wisconsin Clinical Science Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

ccRCC KPS ≥ 70%

Non-ccRCC, KPS ≥ 70%

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

any RCC with KPS 50%-60%

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

Time to onset is defined as the duration of time in weeks from the first dosing to the immune modulating adverse event onset date. Participants experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death

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

Time to resolution is defined as the longest time from IMAE onset date to complete resolution or improvement to the grade at baseline experienced by the participant (the IMAE end date). Participants experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death

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

The number of participants who received immune modulating medication for participants experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death

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

The number of participants who received Hormone Replacement Therapy for experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death

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

The number of participants who received ≥ 40mg of prednisone for high grade (grades 3-5) IMAEs. Participants experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death

Median Progression Free Survival (PFS)

PFS is defined as the time from first dose to the date of the first documented progressive disease (PD) as determined by the investigator (per RECIST 1.1 criteria or clinical) or death due to any cause whichever occur first. Progressive disease is defined as progression of existing non-target lesions or 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. The appearance of one or more new lesions is also considered progression.

Objective Response Rate (ORR)

ORR is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of response evaluable participants. Best overall response is defined as the best response recorded from the start of the study treatment until the end of treatment. The participant's best overall response assignment will depend on the findings of both target and non-target disease and will also take into consideration the appearance of new lesions. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all lesions and normalization of tumor marker level. All lymph nodes (whether target or non-target) must be non-pathological in size (< 10mm short axis).

Time to Response Rate (TRR)

TTR is defined as the median percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of response evaluable participants. Best overall response is defined as the best response recorded from the start of the study treatment until the end of treatment. The participant's best overall response assignment will depend on the findings of both target and non-target disease and will also take into consideration the appearance of new lesions. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all lesions and normalization of tumor marker level. All lymph nodes (whether target or non-target) must be non-pathological in size (< 10mm short axis).

Duration of Response (DOR)

DOR is defined as the time between the date of first confirmed response to the date of the first documented tumor progression per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, or death due to any cause, whichever occurs first. DOR will be computed for participants who achieve partial response (PR) or complete response (CR) only. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all lesions and normalization of tumor marker level. All lymph nodes (whether target or non-target) must be non-pathological in size (< 10mm short axis).

Full Information

NCT ID

NCT02982954

First Posted

December 2, 2016

Last Updated

October 6, 2022

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT02982954

Brief Title

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

Acronym

CHECKMATE 920

Official Title

Phase 3b/4 Safety Trial of Nivolumab Combined With Ipilimumab in Subjects With Previously Untreated, Advanced or Metastatic RCC (CheckMate 920: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 920)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

January 16, 2017 (Actual)

Primary Completion Date

May 11, 2020 (Actual)

Study Completion Date

October 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Cell Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

211 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ccRCC KPS ≥ 70%

Arm Type

Experimental

Arm Description

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

Arm Title

Non-ccRCC, KPS ≥ 70%

Arm Type

Experimental

Arm Description

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

Arm Title

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

Arm Type

Experimental

Arm Description

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

Arm Title

any RCC with KPS 50%-60%

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Nivolumab

Other Intervention Name(s)

BMS-936558, Opdivo

Intervention Description

Specified dose on specified day

Intervention Type

Drug

Intervention Name(s)

Ipilimumab

Other Intervention Name(s)

Yervoy, BMS-734016

Intervention Description

Specified Dose on Specified Day

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Approximately 39 Months

Title

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

Description

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

Time Frame

Approximately 39 Months

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

Median Progression Free Survival (PFS)

Description

Time Frame

From first dose to the date of the first documented progressive disease, up to approximately 12 months

Title

Objective Response Rate (ORR)

Description

Time Frame

From first dose up to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (up to approximately 26 months)

Title

Time to Response Rate (TRR)

Description

Time Frame

From the date of first dose to first documented CR or PR, up to approximately 15 months

Title

Duration of Response (DOR)

Description

Time Frame

From first confirmed response to the date of the first documented tumor progression or death, up to approximately 48 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 1. 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. Exclusion Criteria: 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. Other protocol defined inclusion/exclusion criteria apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Northwest Alabama Cancer Center, Pc

City

Muscle Shoals

State/Province

Alabama

ZIP/Postal Code

35661

Country

United States

Facility Name

Alaska Urological Institute dba Alaska Clinical Research Center

City

Anchorage

State/Province

Alaska

ZIP/Postal Code

99503

Country

United States

Facility Name

Ironwood Cancer And Research Centers, Pc

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85224

Country

United States

Facility Name

Local Institution - 0028

City

Fayetteville

State/Province

Arkansas

ZIP/Postal Code

72703

Country

United States

Facility Name

eCare

City

Encinitas

State/Province

California

ZIP/Postal Code

92024

Country

United States

Facility Name

Pacific Shores Medical Group

City

Long Beach

State/Province

California

ZIP/Postal Code

90813

Country

United States

Facility Name

Los Angeles Cancer Network

City

Los Angeles

State/Province

California

ZIP/Postal Code

90017

Country

United States

Facility Name

UCLA Hematology Oncology

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

Torrance Health Association

City

Redondo Beach

State/Province

California

ZIP/Postal Code

90277

Country

United States

Facility Name

Kaiser Permanente Medical Group - Southern California

City

Riverside

State/Province

California

ZIP/Postal Code

92505

Country

United States

Facility Name

Sharp Memorial Hospital

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Coastal Integrative Cancer Care

City

San Luis Obispo

State/Province

California

ZIP/Postal Code

93401

Country

United States

Facility Name

Central Coast Med Oncology

City

Santa Maria

State/Province

California

ZIP/Postal Code

93454

Country

United States

Facility Name

Florida Cancer Specialists S.

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33901

Country

United States

Facility Name

University Of Miami/Sylvester Cancer Center

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

UF Health Cancer Center at Orlando Health

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Florida Cancer Specialists

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33705

Country

United States

Facility Name

Emory University - Winship Cancer Institute

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Illinois Cancer Specialists

City

Niles

State/Province

Illinois

ZIP/Postal Code

60714

Country

United States

Facility Name

Local Institution - 0012

City

Fort Wayne

State/Province

Indiana

ZIP/Postal Code

46845

Country

United States

Facility Name

Cancer Center Of Kansas

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67214

Country

United States

Facility Name

Norton Cancer Institute

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

Southdale Cancer Clinic

City

Burnsville

State/Province

Minnesota

ZIP/Postal Code

55337

Country

United States

Facility Name

Local Institution - 0009

City

Coon Rapids

State/Province

Minnesota

ZIP/Postal Code

55433

Country

United States

Facility Name

Park Nicollet Clinic Cancer Center

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55416

Country

United States

Facility Name

Hattiesburg Clinic

City

Hattiesburg

State/Province

Mississippi

ZIP/Postal Code

39401

Country

United States

Facility Name

Jackson Oncology Associates, Pllc

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39202

Country

United States

Facility Name

HCA Midwest Division

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64132

Country

United States

Facility Name

Comprehensive Cancer Centers of Nevada

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89148

Country

United States

Facility Name

Local Institution - 0023

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601

Country

United States

Facility Name

University Of New Mexico

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87106

Country

United States

Facility Name

Montefiore Medical Center

City

Bronx

State/Province

New York

ZIP/Postal Code

10461

Country

United States

Facility Name

Maimonides Medical Center

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11220

Country

United States

Facility Name

St. Francis Cancer Treatment Center

City

Grand Island

State/Province

New York

ZIP/Postal Code

68803

Country

United States

Facility Name

Broome Oncology

City

Johnson City

State/Province

New York

ZIP/Postal Code

13790

Country

United States

Facility Name

Local Institution - 0052

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

Weill Cornell Medical College

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Facility Name

SUNY Upstate Medical University

City

Syracuse

State/Province

New York

ZIP/Postal Code

13210

Country

United States

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Southeastern Medical Oncology Center

City

Goldsboro

State/Province

North Carolina

ZIP/Postal Code

27534

Country

United States

Facility Name

Oklahoma Cancer Specialists and Research Institute, LLC-Clinical Research

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74146

Country

United States

Facility Name

Local Institution - 0071

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15240

Country

United States

Facility Name

Charleston Hematology Oncology Associates, Pa

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29414

Country

United States

Facility Name

Hollings Cancer Center

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Avera Cancer Institute

City

Sioux Falls

State/Province

South Dakota

ZIP/Postal Code

57105

Country

United States

Facility Name

Tennessee Oncology, PLLC - SCRI - PPDS

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37404

Country

United States

Facility Name

Local Institution - 0002

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203-1624

Country

United States

Facility Name

Vanderbilt University Medical Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232-6307

Country

United States

Facility Name

Texas Oncology

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

Texas Oncology

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

Texas Oncology-Fort Worth 12th Ave

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

Texas Oncology-Midland Allison Cancer Center

City

Midland

State/Province

Texas

ZIP/Postal Code

79701

Country

United States

Facility Name

Texas Oncology

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78217

Country

United States

Facility Name

University of Virginia Health System

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22936

Country

United States

Facility Name

Local Institution - 0042

City

Fairfax

State/Province

Virginia

ZIP/Postal Code

22031

Country

United States

Facility Name

Bon Secours St Francis Hospital

City

Midlothian

State/Province

Virginia

ZIP/Postal Code

23114

Country

United States

Facility Name

Virginia Cancer Institute

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23226

Country

United States

Facility Name

University of Washington - Seattle Cancer Care Alliance

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

Facility Name

Medical Oncology Associates

City

Spokane

State/Province

Washington

ZIP/Postal Code

99208

Country

United States

Facility Name

Yakima Valley Memorial Hospital/North Star Lodge

City

Yakima

State/Province

Washington

ZIP/Postal Code

98902

Country

United States

Facility Name

University of Wisconsin Clinical Science Center

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53705

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

36104138

Citation

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.

Results Reference

derived

PubMed Identifier

35210307

Citation

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.

Results Reference

derived

Links:

URL

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Description

BMS Clinical Trial Information

URL

http://www.BMSStudyConnect.com

Description

BMS Clinical Trial Patient Recruiting

URL

http://www.fda.gov/safety/medwatch/safetyinformation/default.htm

Description

FDA Safety Alerts and Recalls

Learn more about this trial

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

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