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A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 9ER)

Primary Purpose

Renal Cell Carcinoma

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Nivolumab

Cabozantinib

Sunitinib

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

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

Histological confirmation of RCC with a clear-cell component, including participants who may also have sarcomatoid features
Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC
No prior systemic therapy for RCC with the following exception:
i) One prior adjuvant or neoadjuvant therapy for completely resectable RCC if such therapy did not include an agent that targets VEGF or VEGF receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy

Exclusion Criteria:

Any active CNS metastases
Any active, known or suspected autoimmune disease
Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization
Participants who have received a live/attenuated vaccine within 30 days of first treatment

Other protocol defined inclusion/exclusion criteria could apply

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Doublet

Monotherapy

Triplet

Arm Description

Nivolumab and Cabozantinib

Sunitinib

Nivolumab, Ipilimumab, Cabozantinib *Enrollment to the triplet arm was discontinued by protocol amendment

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)

PFS is defined as the time from date of randomization to the first documented tumor progression date or death due to any cause, whichever occurs first based on BICR assessment using RECIST v1.1. Participants who die without a reported progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment on or prior to initiation of subsequent anti-cancer therapy. Progressive disease (PD); 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study

Secondary Outcome Measures

Overall Survival (OS)

Overall Survival is defined as the time between the date of randomization and the date of death due to any cause. For participants that are alive, their survival time will be censored at the date of last contact date (or "last known alive date").

Objective Response Rate (ORR)

Objective Response Rate (ORR) is defined as the percentage of randomized participants who achieve a best response of confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments (using RECIST v1.1 criteria) divided by the number of all randomized participants. Complete response (CR): Disappearance of all target lesions. Partial response (PR): 30% decrease in the sum of diameters of target lesions.

Number of Participants Experiencing Adverse Events (AEs)

Number of participants experiencing various types of any grade adverse events (AEs) during the specified time frame.

Number of Participants Experiencing Serious Adverse Events (SAEs)

Number of participants experiencing various types of any grade serious adverse events (SAEs) during the specified time frame.

Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation

Number of participants experiencing various types of any grade adverse events (AEs) leading to discontinuation during the specified time frame.

Number of Deaths

Number of deaths due to any cause during the specified time frame.

Number of Participants With Laboratory Abnormalities

Number of participants experiencing laboratory abnormalities in hematology, serum chemistry and electrolytes with grade 3 or higher during the specified time frame.

Number of Participants With Laboratory Values Grade Shifting From Baseline

Number of participants experiencing worsening shift from baseline in any grade and grade 3-4 of laboratory values during the specified time frame.

Full Information

NCT ID

NCT03141177

First Posted

May 3, 2017

Last Updated

October 11, 2023

Sponsor

Bristol-Myers Squibb

Collaborators

Exelixis, Ono Pharmaceutical Co. Ltd

1. Study Identification

Unique Protocol Identification Number

NCT03141177

Brief Title

A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

Acronym

CheckMate 9ER

Official Title

A Phase 3, Randomized, Open-Label Study of Nivolumab Combined With Cabozantinib Versus Sunitinib in Participants With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

August 22, 2017 (Actual)

Primary Completion Date

February 12, 2020 (Actual)

Study Completion Date

April 17, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

Collaborators

Exelixis, Ono Pharmaceutical Co. Ltd

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

The purpose of this study is to determine whether Nivolumab Combined with Cabozantinib is safe and effective compared to Sunitinib in previously untreated advanced or metastatic renal cell carcinoma

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 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

701 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Doublet

Arm Type

Experimental

Arm Description

Nivolumab and Cabozantinib

Arm Title

Monotherapy

Arm Type

Active Comparator

Arm Description

Sunitinib

Arm Title

Triplet

Arm Type

Experimental

Arm Description

Nivolumab, Ipilimumab, Cabozantinib *Enrollment to the triplet arm was discontinued by protocol amendment

Intervention Type

Biological

Intervention Name(s)

Nivolumab

Other Intervention Name(s)

Opdivo, BMS-936558

Intervention Description

Specified dose on specified day

Intervention Type

Drug

Intervention Name(s)

Cabozantinib

Other Intervention Name(s)

Cabometyx

Intervention Description

Specified dose on specified days

Intervention Type

Drug

Intervention Name(s)

Sunitinib

Other Intervention Name(s)

Sutent

Intervention Description

Specified dose on specified days.

Intervention Type

Biological

Intervention Name(s)

Ipilimumab

Other Intervention Name(s)

Yervoy, BMS-734016

Intervention Description

Specified dose on specified days

Primary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Description

Time Frame

From randomization date to date of first documented tumor progression or death, whichever occurs first (Up to 31 months)

Secondary Outcome Measure Information:

Title

Overall Survival (OS)

Description

Time Frame

From randomization date to death date (Up to 31 months)

Title

Objective Response Rate (ORR)

Description

Time Frame

Up to 31 Months

Title

Number of Participants Experiencing Adverse Events (AEs)

Description

Number of participants experiencing various types of any grade adverse events (AEs) during the specified time frame.

Time Frame

From first dose to 100 days following last dose (Up to 32 Months)

Title

Number of Participants Experiencing Serious Adverse Events (SAEs)

Description

Number of participants experiencing various types of any grade serious adverse events (SAEs) during the specified time frame.

Time Frame

From first to dose to 100 days following last dose (Up to 32 months)

Title

Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation

Description

Number of participants experiencing various types of any grade adverse events (AEs) leading to discontinuation during the specified time frame.

Time Frame

From first dose to 30 days following last dose (Up to 30 months)

Title

Number of Deaths

Description

Number of deaths due to any cause during the specified time frame.

Time Frame

From first dose to (up to 31 months) following first dose

Title

Number of Participants With Laboratory Abnormalities

Description

Number of participants experiencing laboratory abnormalities in hematology, serum chemistry and electrolytes with grade 3 or higher during the specified time frame.

Time Frame

From first dose to 30 days following last dose (Up to 30 Months)

Title

Number of Participants With Laboratory Values Grade Shifting From Baseline

Description

Number of participants experiencing worsening shift from baseline in any grade and grade 3-4 of laboratory values during the specified time frame.

Time Frame

From first dose to 30 days following last dose (Up to 30 Months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Histological confirmation of RCC with a clear-cell component, including participants who may also have sarcomatoid features Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC No prior systemic therapy for RCC with the following exception: i) One prior adjuvant or neoadjuvant therapy for completely resectable RCC if such therapy did not include an agent that targets VEGF or VEGF receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy Exclusion Criteria: Any active CNS metastases Any active, known or suspected autoimmune disease Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization Participants who have received a live/attenuated vaccine within 30 days of first treatment Other protocol defined inclusion/exclusion criteria could 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

Local Institution - 0077

City

Daphne

State/Province

Alabama

ZIP/Postal Code

36526

Country

United States

Facility Name

Local Institution - 0044

City

Goodyear

State/Province

Arizona

ZIP/Postal Code

85338

Country

United States

Facility Name

Local Institution - 0132

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85724-5024

Country

United States

Facility Name

Local Institution - 0133

City

Bakersfield

State/Province

California

ZIP/Postal Code

93309

Country

United States

Facility Name

Local Institution - 0093

City

Los Angeles

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

Local Institution - 0090

City

Redondo Beach

State/Province

California

ZIP/Postal Code

90277

Country

United States

Facility Name

Local Institution - 0088

City

San Luis Obispo

State/Province

California

ZIP/Postal Code

93401

Country

United States

Facility Name

Central Coast Medical Oncology Corporation

City

Santa Maria

State/Province

California

ZIP/Postal Code

93454

Country

United States

Facility Name

Local Institution - 0103

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Local Institution - 0127

City

Athens

State/Province

Georgia

ZIP/Postal Code

30607

Country

United States

Facility Name

Local Institution - 0086

City

Newnan

State/Province

Georgia

ZIP/Postal Code

30265

Country

United States

Facility Name

Local Institution - 0036

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

Local Institution - 0042

City

Zion

State/Province

Illinois

ZIP/Postal Code

60099

Country

United States

Facility Name

Local Institution - 0091

City

Fort Wayne

State/Province

Indiana

ZIP/Postal Code

46804

Country

United States

Facility Name

Local Institution - 0087

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67214

Country

United States

Facility Name

Local Institution - 0113

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Local Institution - 0037

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Local Institution - 0106

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64132

Country

United States

Facility Name

Local Institution - 0035

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Local Institution - 0102

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89169

Country

United States

Facility Name

Local Institution - 0040

City

Buffalo

State/Province

New York

ZIP/Postal Code

14263

Country

United States

Facility Name

Local Institution - 0017

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Local Institution - 0067

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Local Institution - 0135

City

Allentown

State/Province

Pennsylvania

ZIP/Postal Code

18105

Country

United States

Facility Name

Local Institution - 0105

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Local Institution - 0080

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

Local Institution - 0075

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

Local Institution - 0068

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Local Institution - 0078

City

Sherman

State/Province

Texas

ZIP/Postal Code

75090

Country

United States

Facility Name

Local Institution - 0131

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23502

Country

United States

Facility Name

Local Institution - 0046

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1120AAT

Country

Argentina

Facility Name

Local Institution - 0048

City

Ciudad Autonoma De Buenos Aire

State/Province

Buenos Aires

ZIP/Postal Code

1181

Country

Argentina

Facility Name

Local Institution - 0114

City

Viedma

State/Province

RIO Negro

ZIP/Postal Code

8500

Country

Argentina

Facility Name

Local Institution - 0138

City

Caba

ZIP/Postal Code

1426

Country

Argentina

Facility Name

Local Institution - 0050

City

Cordoba

ZIP/Postal Code

5000

Country

Argentina

Facility Name

Local Institution - 0049

City

Cordoba

ZIP/Postal Code

X5004FHP

Country

Argentina

Facility Name

Local Institution - 0047

City

Tucuman

ZIP/Postal Code

4000

Country

Argentina

Facility Name

Local Institution - 0002

City

North Ryde

State/Province

New South Wales

ZIP/Postal Code

Country

Australia

Facility Name

Local Institution - 0008

City

Sydney

State/Province

New South Wales

ZIP/Postal Code

2010

Country

Australia

Facility Name

Local Institution - 0009

City

Sydney

State/Province

New South Wales

ZIP/Postal Code

2139

Country

Australia

Facility Name

Local Institution - 0073

City

Westmead

State/Province

New South Wales

ZIP/Postal Code

2145

Country

Australia

Facility Name

Local Institution - 0006

City

Herston

State/Province

Queensland

ZIP/Postal Code

4006

Country

Australia

Facility Name

Local Institution - 0001

City

Southport

State/Province

Queensland

ZIP/Postal Code

4215

Country

Australia

Facility Name

Local Institution - 0004

City

Elizabeth Vale

State/Province

South Australia

ZIP/Postal Code

5112

Country

Australia

Facility Name

Local Institution - 0005

City

Malvern

State/Province

Victoria

ZIP/Postal Code

3144

Country

Australia

Facility Name

Local Institution - 0007

City

Doubleview

State/Province

Western Australia

ZIP/Postal Code

6018

Country

Australia

Facility Name

Local Institution - 0129

City

South Brisbane

ZIP/Postal Code

4101

Country

Australia

Facility Name

Local Institution - 0057

City

Belo Horizonte

State/Province

Minas Gerais

ZIP/Postal Code

30130-090

Country

Brazil

Facility Name

Local Institution - 0119

City

Ijui

State/Province

RIO Grande DO SUL

ZIP/Postal Code

98700-000

Country

Brazil

Facility Name

Local Institution - 0056

City

Porto Alegre

State/Province

RIO Grande DO SUL

ZIP/Postal Code

90610-000

Country

Brazil

Facility Name

Local Institution - 0060

City

Porto Alegre

State/Province

RIO Grande DO SUL

ZIP/Postal Code

91350-200

Country

Brazil

Facility Name

Local Institution - 0058

City

Barretos

State/Province

Sao Paulo

ZIP/Postal Code

14784-400

Country

Brazil

Facility Name

Local Institution - 0066

City

Rio De Janeiro

ZIP/Postal Code

20231-050

Country

Brazil

Facility Name

Local Institution - 0074

City

Sao Paulo

ZIP/Postal Code

01323-020

Country

Brazil

Facility Name

Local Institution - 0061

City

Sao Paulo

ZIP/Postal Code

05651901

Country

Brazil

Facility Name

Local Institution - 0045

City

Santiago

State/Province

Metropolitana

ZIP/Postal Code

8420383

Country

Chile

Facility Name

Local Institution - 0034

City

Hradec Kralove

ZIP/Postal Code

500 05

Country

Czechia

Facility Name

Local Institution - 0033

City

Olomouc

ZIP/Postal Code

779 00

Country

Czechia

Facility Name

Local Institution - 0013

City

Aachen

ZIP/Postal Code

52074

Country

Germany

Facility Name

Local Institution - 0016

City

Bonn

ZIP/Postal Code

53127

Country

Germany

Facility Name

Local Institution - 0117

City

Essen

ZIP/Postal Code

45136

Country

Germany

Facility Name

Local Institution - 0023

City

Jena

ZIP/Postal Code

07747

Country

Germany

Facility Name

Local Institution - 0010

City

Muenchen

ZIP/Postal Code

81675

Country

Germany

Facility Name

Local Institution - 0014

City

Nuernberg

ZIP/Postal Code

90419

Country

Germany

Facility Name

Local Institution - 0011

City

Tuebingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Local Institution - 0082

City

Athens

ZIP/Postal Code

11528

Country

Greece

Facility Name

Local Institution - 0083

City

Thessaloniki

ZIP/Postal Code

546 45

Country

Greece

Facility Name

Local Institution - 0072

City

Haifa

ZIP/Postal Code

3109601

Country

Israel

Facility Name

Local Institution - 0070

City

Kfar Saba

ZIP/Postal Code

44281

Country

Israel

Facility Name

Local Institution - 0071

City

Petah Tikva

ZIP/Postal Code

49414

Country

Israel

Facility Name

Local Institution - 0069

City

Ramat Gan

ZIP/Postal Code

52621

Country

Israel

Facility Name

Local Institution - 0054

City

Arezzo

ZIP/Postal Code

52100

Country

Italy

Facility Name

Local Institution - 0052

City

Milano

ZIP/Postal Code

20132

Country

Italy

Facility Name

Local Institution - 0055

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Local Institution - 0053

City

Padova

ZIP/Postal Code

Padova

Country

Italy

Facility Name

Local Institution - 0051

City

Pavia

ZIP/Postal Code

27100

Country

Italy

Facility Name

Local Institution - 0147

City

Pavia

ZIP/Postal Code

27100

Country

Italy

Facility Name

Local Institution - 0172

City

Terni

ZIP/Postal Code

05100

Country

Italy

Facility Name

Local Institution - 0148

City

Akita-shi

State/Province

Akita

ZIP/Postal Code

010-8543

Country

Japan

Facility Name

Local Institution - 0157

City

Sapporo-shi

State/Province

Hokkaido

ZIP/Postal Code

0608648

Country

Japan

Facility Name

Local Institution - 0164

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

0608543

Country

Japan

Facility Name

Local Institution - 0168

City

Kobe

State/Province

Hyogo

ZIP/Postal Code

6500017

Country

Japan

Facility Name

Local Institution - 0159

City

Morioka

State/Province

Iwate

ZIP/Postal Code

0208505

Country

Japan

Facility Name

Local Institution - 0171

City

Yokohama

State/Province

Kanagawa

ZIP/Postal Code

236-0004

Country

Japan

Facility Name

Local Institution - 0166

City

Yokohama

State/Province

Kanagawa

ZIP/Postal Code

241-8515

Country

Japan

Facility Name

Local Institution - 0150

City

Niigata-shi

State/Province

Niigata

ZIP/Postal Code

9518520

Country

Japan

Facility Name

Local Institution - 0169

City

Okayama-shi

State/Province

Okayama

ZIP/Postal Code

7008558

Country

Japan

Facility Name

Local Institution - 0154

City

Osaka

State/Province

Osaka-shi

ZIP/Postal Code

545-8586

Country

Japan

Facility Name

Local Institution - 0160

City

Osaka-sayama

State/Province

Osaka

ZIP/Postal Code

589-8511

Country

Japan

Facility Name

Local Institution - 0170

City

Osaka-shi

State/Province

Osaka

ZIP/Postal Code

5418567

Country

Japan

Facility Name

Local Institution - 0163

City

Suita-shi

State/Province

Osaka

ZIP/Postal Code

565-0871

Country

Japan

Facility Name

Local Institution - 0155

City

Hidaka-shi

State/Province

Saitama

ZIP/Postal Code

3501298

Country

Japan

Facility Name

Local Institution - 0153

City

Tokushima-shi

State/Province

Tokushima

ZIP/Postal Code

7708503

Country

Japan

Facility Name

Local Institution - 0152

City

Adachi-ku

State/Province

Tokyo

ZIP/Postal Code

123-8558

Country

Japan

Facility Name

Local Institution - 0158

City

Bunkyo-ku

State/Province

Tokyo

ZIP/Postal Code

1138519

Country

Japan

Facility Name

Local Institution - 0151

City

Bunkyo-ku

State/Province

Tokyo

ZIP/Postal Code

1138603

Country

Japan

Facility Name

Local Institution - 0173

City

Minato-ku

State/Province

Tokyo

ZIP/Postal Code

1058470

Country

Japan

Facility Name

Local Institution - 0156

City

Aomori

ZIP/Postal Code

0368563

Country

Japan

Facility Name

Local Institution - 0167

City

Chiba

ZIP/Postal Code

260-8717

Country

Japan

Facility Name

Local Institution - 0161

City

Fukuoka

ZIP/Postal Code

812-8582

Country

Japan

Facility Name

Local Institution - 0162

City

Nagasaki

ZIP/Postal Code

8528501

Country

Japan

Facility Name

Local Institution - 0149

City

Tokyo

ZIP/Postal Code

160-8582

Country

Japan

Facility Name

Local Institution - 0165

City

Yamagata

ZIP/Postal Code

9909585

Country

Japan

Facility Name

Local Institution - 0062

City

Ciudad de Mexico

State/Province

Distrito Federal

ZIP/Postal Code

06100

Country

Mexico

Facility Name

Local Institution - 0116

City

Mexico

State/Province

Distrito Federal

ZIP/Postal Code

14080

Country

Mexico

Facility Name

Local Institution - 0115

City

Tlalpan

State/Province

Distrito Federal

ZIP/Postal Code

14080

Country

Mexico

Facility Name

Local Institution - 0108

City

Zapopan

State/Province

Jalisco

ZIP/Postal Code

45070

Country

Mexico

Facility Name

Local Institution - 0065

City

Monterrey

State/Province

Nuevo Leon

ZIP/Postal Code

64000

Country

Mexico

Facility Name

Local Institution - 0143

City

Monterrey

State/Province

Nuevo LEON

ZIP/Postal Code

64060

Country

Mexico

Facility Name

Local Institution - 0064

City

Monterrey

State/Province

Nuevo Leon

ZIP/Postal Code

64460

Country

Mexico

Facility Name

Local Institution - 0136

City

Merida

State/Province

Yucatan

ZIP/Postal Code

97125

Country

Mexico

Facility Name

Local Institution - 0063

City

Queretaro

ZIP/Postal Code

76000

Country

Mexico

Facility Name

Local Institution - 0084

City

Biala Podlaska

ZIP/Postal Code

21-500

Country

Poland

Facility Name

Local Institution - 0130

City

Bydgoszcz

ZIP/Postal Code

85796

Country

Poland

Facility Name

Local Institution - 0085

City

Gdansk

ZIP/Postal Code

80-219

Country

Poland

Facility Name

Local Institution - 0021

City

Cluj-Napoca

ZIP/Postal Code

400015

Country

Romania

Facility Name

Local Institution - 0022

City

Craiova

ZIP/Postal Code

200542

Country

Romania

Facility Name

Local Institution - 0020

City

Moscow

ZIP/Postal Code

125284

Country

Russian Federation

Facility Name

Local Institution - 0099

City

Saint-Petersburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

Local Institution - 0125

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Local Institution - 0121

City

Madrid

ZIP/Postal Code

28009

Country

Spain

Facility Name

Local Institution - 0120

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Local Institution - 0144

City

Santander

ZIP/Postal Code

39008

Country

Spain

Facility Name

Local Institution - 0124

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Local Institution - 0123

City

Valencia

ZIP/Postal Code

46014

Country

Spain

Facility Name

Local Institution - 0107

City

Ankara

ZIP/Postal Code

06018

Country

Turkey

Facility Name

Local Institution - 0139

City

Ankara

ZIP/Postal Code

06590

Country

Turkey

Facility Name

Local Institution - 0094

City

Ankara

ZIP/Postal Code

06800

Country

Turkey

Facility Name

Local Institution - 0096

City

Antalya

ZIP/Postal Code

07070

Country

Turkey

Facility Name

Local Institution - 0097

City

Denizli

ZIP/Postal Code

20070

Country

Turkey

Facility Name

Local Institution - 0095

City

Edirne

ZIP/Postal Code

22030

Country

Turkey

Facility Name

Local Institution - 0146

City

Istanbul

ZIP/Postal Code

34300

Country

Turkey

Facility Name

Local Institution - 0111

City

London

ZIP/Postal Code

EC1A 7BE

Country

United Kingdom

Facility Name

Local Institution - 0109

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

Facility Name

Local Institution - 0140

City

Truro

ZIP/Postal Code

TR1 3LJ

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

36327527

Citation

Apolo AB, Powles T, Escudier B, Burotto M, Zhang J, Simsek B, Scheffold C, Motzer RJ, Choueiri TK. Nivolumab plus ipilimumab plus cabozantinib triplet combination for patients with previously untreated advanced renal cell carcinoma: Results from a discontinued arm of the phase III CheckMate 9ER trial. Eur J Cancer. 2022 Dec;177:63-71. doi: 10.1016/j.ejca.2022.09.020. Epub 2022 Oct 4.

Results Reference

derived

PubMed Identifier

35688173

Citation

Motzer RJ, Powles T, Burotto M, Escudier B, Bourlon MT, Shah AY, Suarez C, Hamzaj A, Porta C, Hocking CM, Kessler ER, Gurney H, Tomita Y, Bedke J, Zhang J, Simsek B, Scheffold C, Apolo AB, Choueiri TK. Nivolumab plus cabozantinib versus sunitinib in first-line treatment for advanced renal cell carcinoma (CheckMate 9ER): long-term follow-up results from an open-label, randomised, phase 3 trial. Lancet Oncol. 2022 Jul;23(7):888-898. doi: 10.1016/S1470-2045(22)00290-X. Epub 2022 Jun 7. Erratum In: Lancet Oncol. 2022 Jul;23(7):e319. Lancet Oncol. 2022 Sep;23(9):e404.

Results Reference

derived

PubMed Identifier

35032437

Citation

Cella D, Motzer RJ, Suarez C, Blum SI, Ejzykowicz F, Hamilton M, Wallace JF, Simsek B, Zhang J, Ivanescu C, Apolo AB, Choueiri TK. Patient-reported outcomes with first-line nivolumab plus cabozantinib versus sunitinib in patients with advanced renal cell carcinoma treated in CheckMate 9ER: an open-label, randomised, phase 3 trial. Lancet Oncol. 2022 Feb;23(2):292-303. doi: 10.1016/S1470-2045(21)00693-8. Epub 2022 Jan 12.

Results Reference

derived

PubMed Identifier

34980597

Citation

Hamuro L, Hu Z, Passarell J, Barcomb H, Zhang J, Goldstein S, Bello A, Roy A, Zhu L. Exposure-Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma. Clin Cancer Res. 2022 Apr 14;28(8):1603-1613. doi: 10.1158/1078-0432.CCR-21-3149.

Results Reference

derived

PubMed Identifier

33657295

Citation

Choueiri TK, Powles T, Burotto M, Escudier B, Bourlon MT, Zurawski B, Oyervides Juarez VM, Hsieh JJ, Basso U, Shah AY, Suarez C, Hamzaj A, Goh JC, Barrios C, Richardet M, Porta C, Kowalyszyn R, Feregrino JP, Zolnierek J, Pook D, Kessler ER, Tomita Y, Mizuno R, Bedke J, Zhang J, Maurer MA, Simsek B, Ejzykowicz F, Schwab GM, Apolo AB, Motzer RJ; CheckMate 9ER Investigators. Nivolumab plus Cabozantinib versus Sunitinib for Advanced Renal-Cell Carcinoma. N Engl J Med. 2021 Mar 4;384(9):829-841. doi: 10.1056/NEJMoa2026982.

Results Reference

derived

PubMed Identifier

33058158

Citation

Hofmann F, Hwang EC, Lam TB, Bex A, Yuan Y, Marconi LS, Ljungberg B. Targeted therapy for metastatic renal cell carcinoma. Cochrane Database Syst Rev. 2020 Oct 14;10(10):CD012796. doi: 10.1002/14651858.CD012796.pub2.

Results Reference

derived

Links:

URL

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

Description

BMS Clinical Trial Information

URL

https://www.BMSStudyConnect.com

Description

BMS Clinical Trial Patient Recruiting

URL

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

Description

FDA Safety Alerts and Recalls

Learn more about this trial

A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

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A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 9ER)

Renal Cell Carcinoma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial