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Nivolumab Combined With Ipilimumab Versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 214)

Primary Purpose

Advanced Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Nivolumab

Ipilimumab

Sunitinib

About this trial

This is an interventional treatment trial for Advanced Renal Cell Carcinoma

Eligibility Criteria

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

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

Histological confirmation of renal cell carcinoma (RCC) with a clear-cell component
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:
1. One prior adjuvant or neoadjuvant therapy for completely resectable RCC if such therapy did not include an agent that targets vascular endothelial growth factor (VEGF) or VEGF receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy
  - Karnofsky Performance Status (KPS) of at least 70%
  - Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  - Tumor tissue [formalin-fixed paraffin-embedded (FFPE) archival or recent acquisition] must be received by the central vendor (block or unstained slides) in order to randomize a subject to study treatment. (Note: Fine Needle Aspiration [FNA] and bone metastases samples are not acceptable for submission)

Exclusion Criteria:

Any history of or current central nervous system (CNS) metastases. Baseline imaging of the brain is required within 28 days prior to randomization
Prior systemic treatment with VEGF or VEGF receptor targeted therapy (including, but not limited to, Sunitinib, Pazopanib, Axitinib, Tivozanib, and Bevacizumab)
Prior treatment with an anti-programmed death (PD)-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Any active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids (>10 mg daily Prednisone equivalent) or immunosuppressive medications except for syndromes which would not be expected to recur in the absence of an external trigger. Subjects with vitiligo or type I diabetes mellitus or residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement are permitted to enroll
Any condition requiring systemic treatment with corticosteroids (>10 mg daily Prednisone equivalents) or other immunosuppressive medications within 14 days prior to first dose of study drug. Inhaled steroids and adrenal replacement steroid doses >10 mg daily Prednisone equivalents are permitted in the absence of active autoimmune disease

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg

Arm B: Sunitinib 50 mg

Arm Description

Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks

Outcomes

Primary Outcome Measures

Investigator-assessed Objective Response Rate(ORR) in Intermediate/Poor Risk Participants Per IRRC Using RECIST v1.1

ORR was defined as the proportion of randomized subjects who achieved a best response of complete response (CR) or partial response (PR) using the RECIST v1.1 criteria based on IRRC assessment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), greater than or equal to 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Overall Survival (OS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)

OS was defined as the time from randomization to the date of death from any cause. Survival time was censored at the date of last contact ("last known alive date") for subjects who were alive.

Progression-Free Survival (PFS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)

PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the IRRC (as per RECIST 1.1 criteria), or death due to any cause, whichever occurred first. Subsequent therapy included anticancer therapy, tumor directed radiotherapy, or tumor directed surgery. Subjects who died without a reported progression were considered to have progressed on the date of their death.

Secondary Outcome Measures

Investigator-assessed Objective Response Rate(ORR) in Any Risk Participants Per IRRC Using RECIST v1.1

Overall Survival (OS) in Any Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)

Overall survival is defined as the time from randomization to the date of death from any cause. For subjects that are alive, their survival time will be censored at the date of last contact ("last known alive date"). Overall survival will be censored for subjects at the date of randomization if they were randomized but had no follow-up. Survival follow-up will be conducted every 3 months after subject's off-treatment date.

Progression-Free Survival (PFS) in Any Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)

Full Information

NCT ID

NCT02231749

First Posted

September 1, 2014

Last Updated

September 5, 2023

Sponsor

Bristol-Myers Squibb

Collaborators

Ono Pharmaceutical Co. Ltd

1. Study Identification

Unique Protocol Identification Number

NCT02231749

Brief Title

Nivolumab Combined With Ipilimumab Versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 214)

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 16, 2014 (Actual)

Primary Completion Date

June 26, 2017 (Actual)

Study Completion Date

August 7, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

Collaborators

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 compare the objective response rate, progression free survival and the overall survival of Nivolumab combined with Ipilimumab to Sunitinib monotherapy in patients with previously untreated Renal Cell Cancer.

6. Conditions and Keywords

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

Advanced Renal Cell Carcinoma, Metastatic 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

1390 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg

Arm Type

Experimental

Arm Description

Arm Title

Arm B: Sunitinib 50 mg

Arm Type

Active Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

Nivolumab

Other Intervention Name(s)

BMS-936558, Opdivo

Intervention Type

Biological

Intervention Name(s)

Ipilimumab

Other Intervention Name(s)

Yervoy

Intervention Type

Drug

Intervention Name(s)

Sunitinib

Other Intervention Name(s)

Sutent

Primary Outcome Measure Information:

Title

Investigator-assessed Objective Response Rate(ORR) in Intermediate/Poor Risk Participants Per IRRC Using RECIST v1.1

Description

Time Frame

From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to June 2017, approximately 31 months)

Title

Overall Survival (OS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)

Description

OS was defined as the time from randomization to the date of death from any cause. Survival time was censored at the date of last contact ("last known alive date") for subjects who were alive.

Time Frame

From the date of randomization to the date of death (assessed up to June 2017, approximately 31 months)

Title

Progression-Free Survival (PFS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)

Description

Time Frame

From date of first dose to date of documented disease progression or death due to any cause, whichever occurs first (assessed up to June 2017, approximately 31 months)

Secondary Outcome Measure Information:

Title

Investigator-assessed Objective Response Rate(ORR) in Any Risk Participants Per IRRC Using RECIST v1.1

Description

Time Frame

From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to June 2017, approximately 31 months)

Title

Overall Survival (OS) in Any Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)

Description

Time Frame

From the date of randomization to the date of death (assessed up to June 2017, approximately 31 months)

Title

Progression-Free Survival (PFS) in Any Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)

Description

Time Frame

From date of first dose to date of documented disease progression or death due to any cause, whichever occurs first (assessed up to June 2017, approximately 31 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Histological confirmation of renal cell carcinoma (RCC) with a clear-cell component 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: One prior adjuvant or neoadjuvant therapy for completely resectable RCC if such therapy did not include an agent that targets vascular endothelial growth factor (VEGF) or VEGF receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy Karnofsky Performance Status (KPS) of at least 70% Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Tumor tissue [formalin-fixed paraffin-embedded (FFPE) archival or recent acquisition] must be received by the central vendor (block or unstained slides) in order to randomize a subject to study treatment. (Note: Fine Needle Aspiration [FNA] and bone metastases samples are not acceptable for submission) Exclusion Criteria: Any history of or current central nervous system (CNS) metastases. Baseline imaging of the brain is required within 28 days prior to randomization Prior systemic treatment with VEGF or VEGF receptor targeted therapy (including, but not limited to, Sunitinib, Pazopanib, Axitinib, Tivozanib, and Bevacizumab) Prior treatment with an anti-programmed death (PD)-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways Any active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids (>10 mg daily Prednisone equivalent) or immunosuppressive medications except for syndromes which would not be expected to recur in the absence of an external trigger. Subjects with vitiligo or type I diabetes mellitus or residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement are permitted to enroll Any condition requiring systemic treatment with corticosteroids (>10 mg daily Prednisone equivalents) or other immunosuppressive medications within 14 days prior to first dose of study drug. Inhaled steroids and adrenal replacement steroid doses >10 mg daily Prednisone equivalents are permitted in the absence of active autoimmune disease

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:

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Local Institution - 0006

City

Duarte

State/Province

California

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91010

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United States

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Local Institution - 0057

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La Jolla

State/Province

California

ZIP/Postal Code

92093-0698

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United States

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Los Angeles

State/Province

California

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90033

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United States

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Los Angeles

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California

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United States

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Stanford

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California

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United States

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New Haven

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Connecticut

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United States

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Washington

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District of Columbia

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United States

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Tampa

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Florida

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United States

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Atlanta

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Georgia

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United States

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Indianapolis

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Indiana

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Iowa City

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Fairway

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Kansas

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United States

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Baltimore

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United States

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Baltimore

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Boston

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United States

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Boston

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Boston

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Boston

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Detroit

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Charleston

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Chattanooga

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Dallas

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Texas

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Houston

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Texas

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United States

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Seattle

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Washington

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Berazategui

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1880

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Argentina

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Capital Federal

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Buenos Aires

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Argentina

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City

Ciudad Autonoma De Buenos Aire

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Buenos Aires

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Argentina

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San Miguel De Tucuman

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Tucuman

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Argentina

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San Miguel de Tucuman

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Tucuman

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Argentina

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Caba

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Argentina

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Cordoba

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Argentina

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Kogarah

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Australia

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Westmead

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Herston

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Australia

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Southport

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Australia

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Australia

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Linz

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Wels

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Austria

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Wien

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Austria

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Gent

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Leuven

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Belgium

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Porto Alegre

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Brazil

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Porto Alegre

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Brazil

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Sao Paulo

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São Paulo

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Brazil

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Rio de Janeiro

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Brazil

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Sao Paulo

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01406-100

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Brazil

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Sao Paulo

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Brazil

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Calgary

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Alberta

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Canada

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Edmonton

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Alberta

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Canada

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Kelowna

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Canada

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Vancouver

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British Columbia

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Canada

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Moncton

State/Province

New Brunswick

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Canada

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Toronto

State/Province

Ontario

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Canada

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Toronto

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Ontario

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Canada

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Montreal

State/Province

Quebec

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Canada

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Santiago

State/Province

Metropolitana

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Chile

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Santiago

State/Province

Metropolitana

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Chile

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Santiago

State/Province

Metropolitana

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Chile

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Vina del Mar

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Chile

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Bogota

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Colombia

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Medellin

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Colombia

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Medellin

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MEDELLIN

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Colombia

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Liberec

State/Province

Liberecký Kraj

ZIP/Postal Code

460 63

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Czechia

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Brno

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656 53

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Czechia

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Hradec Kralove

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Czechia

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Olomouc

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Czechia

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Aarhus N

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8200

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Denmark

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Herlev

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2730

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Denmark

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Odense

ZIP/Postal Code

5000

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Denmark

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Helsinki

ZIP/Postal Code

00290

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Finland

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Local Institution - 0028

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Tampere

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33521

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Finland

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Besancon

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25030

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France

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Local Institution - 0062

City

Bordeaux

ZIP/Postal Code

33075

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France

Facility Name

Local Institution - 0169

City

La Roche-Sur-Yon Cedex 9

ZIP/Postal Code

85925

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France

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Local Institution - 0060

City

Marseille Cedex 9

ZIP/Postal Code

13273

Country

France

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Local Institution - 0063

City

Saint Herblain

ZIP/Postal Code

44805

Country

France

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Local Institution - 0065

City

Strasbourg

ZIP/Postal Code

67091

Country

France

Facility Name

Local Institution - 0059

City

Toulouse Cedex 9

ZIP/Postal Code

31059

Country

France

Facility Name

Local Institution - 0058

City

Villejuif

ZIP/Postal Code

94805

Country

France

Facility Name

Local Institution - 0061

City

Paris

State/Province

Île-de-France

ZIP/Postal Code

75015

Country

France

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Local Institution - 0125

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Aachen

ZIP/Postal Code

52074

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Germany

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Local Institution - 0126

City

Erlangen

ZIP/Postal Code

91054

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Germany

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Local Institution - 0141

City

Frankfurt

ZIP/Postal Code

60590

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Germany

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Local Institution - 0147

City

Hamburg

ZIP/Postal Code

20246

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Germany

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Local Institution - 0142

City

Hannover

ZIP/Postal Code

30625

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Germany

Facility Name

Local Institution - 0123

City

Heidelberg

ZIP/Postal Code

69126

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Germany

Facility Name

Local Institution - 0127

City

Homburg

ZIP/Postal Code

66424

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Germany

Facility Name

Local Institution - 0129

City

Jena

ZIP/Postal Code

07747

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Germany

Facility Name

Local Institution - 0143

City

Magdeburg

ZIP/Postal Code

39120

Country

Germany

Facility Name

Local Institution - 0124

City

Muenchen

ZIP/Postal Code

81675

Country

Germany

Facility Name

Local Institution - 0146

City

Muenster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Local Institution - 0130

City

Ulm

ZIP/Postal Code

89075

Country

Germany

Facility Name

Local Institution - 0184

City

Gyula

State/Province

Békés

ZIP/Postal Code

5700

Country

Hungary

Facility Name

Local Institution - 0083

City

Budapest

ZIP/Postal Code

1122

Country

Hungary

Facility Name

Local Institution - 0082

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Local Institution - 0084

City

Pecs

ZIP/Postal Code

7624

Country

Hungary

Facility Name

Local Institution - 0015

City

Wilton

State/Province

Cork

ZIP/Postal Code

Country

Ireland

Facility Name

Local Institution - 0017

City

Dublin 7

State/Province

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Local Institution - 0018

City

Dublin 7

State/Province

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Local Institution - 0016

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Local Institution - 0120

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

Local Institution - 0117

City

Kfar Saba

ZIP/Postal Code

44281

Country

Israel

Facility Name

Local Institution - 0121

City

Petach Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Local Institution - 0118

City

Ramat-gan

ZIP/Postal Code

52621

Country

Israel

Facility Name

Local Institution - 0119

City

Zerifin

ZIP/Postal Code

70300

Country

Israel

Facility Name

Local Institution - 0022

City

Arezzo

ZIP/Postal Code

52100

Country

Italy

Facility Name

Local Institution - 0024

City

Meldola (fc)

ZIP/Postal Code

47014

Country

Italy

Facility Name

Local Institution - 0023

City

Milano

ZIP/Postal Code

20133

Country

Italy

Facility Name

Local Institution - 0064

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Local Institution - 0079

City

Padova

ZIP/Postal Code

35128

Country

Italy

Facility Name

Local Institution - 0025

City

Pavia

ZIP/Postal Code

27100

Country

Italy

Facility Name

Local Institution - 0026

City

Roma

ZIP/Postal Code

00149

Country

Italy

Facility Name

Local Institution - 0192

City

Akita-shi

State/Province

Akita

ZIP/Postal Code

010-8542

Country

Japan

Facility Name

Local Institution - 0209

City

Hirosaki-shi

State/Province

Aomori

ZIP/Postal Code

036-8563

Country

Japan

Facility Name

Local Institution - 0187

City

Chiba-shi

State/Province

Chiba

ZIP/Postal Code

260-8717

Country

Japan

Facility Name

Local Institution - 0196

City

Fukuoka-shi

State/Province

Fukuoka

ZIP/Postal Code

8128582

Country

Japan

Facility Name

Local Institution - 0188

City

Sapporo-shi

State/Province

Hokai-do

ZIP/Postal Code

060-8543

Country

Japan

Facility Name

Local Institution

City

Sapporo-shi

State/Province

Hokkaido

ZIP/Postal Code

0608648

Country

Japan

Facility Name

Local Institution - 0206

City

Kobe

State/Province

Hyogo

ZIP/Postal Code

6500017

Country

Japan

Facility Name

Local Institution - 0205

City

Tsukuba-shi

State/Province

Ibaraki

ZIP/Postal Code

3058576

Country

Japan

Facility Name

Local Institution - 0200

City

Morioka-shi

State/Province

Iwate

ZIP/Postal Code

0208505

Country

Japan

Facility Name

Local Institution - 0186

City

Yokohama-shi

State/Province

Kanagawa

ZIP/Postal Code

2360004

Country

Japan

Facility Name

Local Institution - 0189

City

Kumamoto-shi

State/Province

Kumamoto

ZIP/Postal Code

8608556

Country

Japan

Facility Name

Local Institution - 0191

City

Kyoto-shi

State/Province

Kyoto

ZIP/Postal Code

6028566

Country

Japan

Facility Name

Local Institution - 0199

City

Niigata-shi

State/Province

Niigata

ZIP/Postal Code

9518520

Country

Japan

Facility Name

Local Institution - 0204

City

Okayama-shi

State/Province

Okayama

ZIP/Postal Code

7008558

Country

Japan

Facility Name

Local Institution - 0190

City

Osaka-sayama

State/Province

Osaka

ZIP/Postal Code

589-8511

Country

Japan

Facility Name

Local Institution - 0201

City

Suita-shi

State/Province

Osaka

ZIP/Postal Code

565-0871

Country

Japan

Facility Name

Local Institution - 0208

City

Hamamatsu-shi

State/Province

Shizuoka

ZIP/Postal Code

4313192

Country

Japan

Facility Name

Local Institution - 0194

City

Tokushima-shi

State/Province

Tokushima

ZIP/Postal Code

770-8503

Country

Japan

Facility Name

Local Institution - 0202

City

Bunkyo-ku

State/Province

Tokyo

ZIP/Postal Code

113-8603

Country

Japan

Facility Name

Local Institution - 0197

City

Bunkyo-ku

State/Province

Tokyo

ZIP/Postal Code

1138431

Country

Japan

Facility Name

Local Institution - 0195

City

Bunkyo-ku

State/Province

Tokyo

ZIP/Postal Code

1138655

Country

Japan

Facility Name

Local Institution - 0207

City

Koto-ku

State/Province

Tokyo

ZIP/Postal Code

1358550

Country

Japan

Facility Name

Local Institution - 0185

City

Shinjuku-Ku

State/Province

Tokyo

ZIP/Postal Code

1608582

Country

Japan

Facility Name

Local Institution - 0193

City

Shinjuku-ku

State/Province

Tokyo

ZIP/Postal Code

1628666

Country

Japan

Facility Name

Local Institution - 0198

City

Tokyo

ZIP/Postal Code

113-8519

Country

Japan

Facility Name

Local Institution - 0203

City

Yamagata

ZIP/Postal Code

9909585

Country

Japan

Facility Name

Local Institution - 0178

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Local Institution - 0177

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Local Institution - 0176

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Facility Name

Local Institution - 0168

City

Mexico D.f.

State/Province

Distrito Federal

ZIP/Postal Code

14050

Country

Mexico

Facility Name

Local Institution - 0171

City

Monterrey

State/Province

Nuevo Leon

ZIP/Postal Code

64460

Country

Mexico

Facility Name

Local Institution - 0175

City

Queretaro

State/Province

Querétaro

ZIP/Postal Code

76090

Country

Mexico

Facility Name

Local Institution - 0167

City

Oaxaca

ZIP/Postal Code

68000

Country

Mexico

Facility Name

Local Institution - 0029

City

Amsterdam

ZIP/Postal Code

1066 CX

Country

Netherlands

Facility Name

Local Institution - 0040

City

Groningen

ZIP/Postal Code

9713 GZ

Country

Netherlands

Facility Name

Local Institution - 0030

City

Nijmegen

ZIP/Postal Code

6525 GA

Country

Netherlands

Facility Name

Local Institution - 0093

City

Krakow

ZIP/Postal Code

31-115

Country

Poland

Facility Name

Local Institution - 0112

City

Poznan

ZIP/Postal Code

60-569

Country

Poland

Facility Name

Local Institution - 0106

City

Wroclaw

ZIP/Postal Code

50-556

Country

Poland

Facility Name

Local Institution - 0089

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

Local Institution - 0088

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Local Institution - 0086

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Local Institution - 0085

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Local Institution - 0087

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Local Institution - 0111

City

Oviedo

ZIP/Postal Code

33011

Country

Spain

Facility Name

Local Institution - 0090

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Local Institution - 0134

City

Solna

ZIP/Postal Code

171 64

Country

Sweden

Facility Name

Local Institution - 0179

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Facility Name

Local Institution - 0180

City

Taipei

ZIP/Postal Code

112

Country

Taiwan

Facility Name

Local Institution - 0181

City

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

Facility Name

Local Institution - 0115

City

Altindağ

State/Province

Ankara

ZIP/Postal Code

06230

Country

Turkey

Facility Name

Local Institution - 0114

City

Antalya

ZIP/Postal Code

07070

Country

Turkey

Facility Name

Local Institution - 0122

City

Istanbul

ZIP/Postal Code

34890

Country

Turkey

Facility Name

Local Institution - 0010

City

London

State/Province

Greater London

ZIP/Postal Code

SW3 6JJ

Country

United Kingdom

Facility Name

Local Institution - 0009

City

Glasgow

State/Province

Lanarkshire

ZIP/Postal Code

G12 0YN

Country

United Kingdom

Facility Name

Local Institution - 0077

City

London

ZIP/Postal Code

EC1A 7BE

Country

United Kingdom

Facility Name

Local Institution - 0021

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

Facility Name

Local Institution - 0011

City

Northwood

ZIP/Postal Code

HA6 2RN

Country

United Kingdom

Facility Name

Local Institution - 0012

City

Swansea

ZIP/Postal Code

SA2 8QA

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

35383908

Citation

Motzer RJ, McDermott DF, Escudier B, Burotto M, Choueiri TK, Hammers HJ, Barthelemy P, Plimack ER, Porta C, George S, Powles T, Donskov F, Gurney H, Kollmannsberger CK, Grimm MO, Barrios C, Tomita Y, Castellano D, Grunwald V, Rini BI, McHenry MB, Lee CW, McCarthy J, Ejzykowicz F, Tannir NM. Conditional survival and long-term efficacy with nivolumab plus ipilimumab versus sunitinib in patients with advanced renal cell carcinoma. Cancer. 2022 Jun 1;128(11):2085-2097. doi: 10.1002/cncr.34180. Epub 2022 Apr 5.

Results Reference

derived

PubMed Identifier

35383907

Citation

Labriola MK, George DJ. Setting a new standard for long-term survival in metastatic kidney cancer. Cancer. 2022 Jun 1;128(11):2058-2060. doi: 10.1002/cncr.34177. Epub 2022 Apr 5. No abstract available.

Results Reference

derived

PubMed Identifier

34750035

Citation

Albiges L, Tannir NM, Burotto M, McDermott D, Plimack ER, Barthelemy P, Porta C, Powles T, Donskov F, George S, Kollmannsberger CK, Gurney H, Grimm MO, Tomita Y, Castellano D, Rini BI, Choueiri TK, Leung D, Saggi SS, Lee CW, McHenry MB, Motzer RJ. First-line Nivolumab plus Ipilimumab Versus Sunitinib in Patients Without Nephrectomy and With an Evaluable Primary Renal Tumor in the CheckMate 214 Trial. Eur Urol. 2022 Mar;81(3):266-271. doi: 10.1016/j.eururo.2021.10.001. Epub 2021 Nov 5.

Results Reference

derived

PubMed Identifier

33246931

Citation

Albiges L, Tannir NM, Burotto M, McDermott D, Plimack ER, Barthelemy P, Porta C, Powles T, Donskov F, George S, Kollmannsberger CK, Gurney H, Grimm MO, Tomita Y, Castellano D, Rini BI, Choueiri TK, Saggi SS, McHenry MB, Motzer RJ. Nivolumab plus ipilimumab versus sunitinib for first-line treatment of advanced renal cell carcinoma: extended 4-year follow-up of the phase III CheckMate 214 trial. ESMO Open. 2020 Nov;5(6):e001079. doi: 10.1136/esmoopen-2020-001079.

Results Reference

derived

PubMed Identifier

32661118

Citation

Motzer RJ, Escudier B, McDermott DF, Aren Frontera O, Melichar B, Powles T, Donskov F, Plimack ER, Barthelemy P, Hammers HJ, George S, Grunwald V, Porta C, Neiman V, Ravaud A, Choueiri TK, Rini BI, Salman P, Kollmannsberger CK, Tykodi SS, Grimm MO, Gurney H, Leibowitz-Amit R, Geertsen PF, Amin A, Tomita Y, McHenry MB, Saggi SS, Tannir NM. Survival outcomes and independent response assessment with nivolumab plus ipilimumab versus sunitinib in patients with advanced renal cell carcinoma: 42-month follow-up of a randomized phase 3 clinical trial. J Immunother Cancer. 2020 Jul;8(2):e000891. doi: 10.1136/jitc-2020-000891. Erratum In: J Immunother Cancer. 2021 May;9(5):

Results Reference

derived

PubMed Identifier

31992108

Citation

Ambavane A, Yang S, Atkins MB, Rao S, Shah A, Regan MM, McDermott DF, Michaelson MD. Clinical and economic outcomes of treatment sequences for intermediate- to poor-risk advanced renal cell carcinoma. Immunotherapy. 2020 Jan;12(1):37-51. doi: 10.2217/imt-2019-0199. Epub 2020 Jan 29.

Results Reference

derived

PubMed Identifier

31633185

Citation

Tomita Y, Kondo T, Kimura G, Inoue T, Wakumoto Y, Yao M, Sugiyama T, Oya M, Fujii Y, Obara W, Motzer RJ, Uemura H. Nivolumab plus ipilimumab versus sunitinib in previously untreated advanced renal-cell carcinoma: analysis of Japanese patients in CheckMate 214 with extended follow-up. Jpn J Clin Oncol. 2020 Jan 24;50(1):12-19. doi: 10.1093/jjco/hyz132.

Results Reference

derived

PubMed Identifier

31427204

Citation

Motzer RJ, Rini BI, McDermott DF, Aren Frontera O, Hammers HJ, Carducci MA, Salman P, Escudier B, Beuselinck B, Amin A, Porta C, George S, Neiman V, Bracarda S, Tykodi SS, Barthelemy P, Leibowitz-Amit R, Plimack ER, Oosting SF, Redman B, Melichar B, Powles T, Nathan P, Oudard S, Pook D, Choueiri TK, Donskov F, Grimm MO, Gurney H, Heng DYC, Kollmannsberger CK, Harrison MR, Tomita Y, Duran I, Grunwald V, McHenry MB, Mekan S, Tannir NM; CheckMate 214 investigators. Nivolumab plus ipilimumab versus sunitinib in first-line treatment for advanced renal cell carcinoma: extended follow-up of efficacy and safety results from a randomised, controlled, phase 3 trial. Lancet Oncol. 2019 Oct;20(10):1370-1385. doi: 10.1016/S1470-2045(19)30413-9. Epub 2019 Aug 16. Erratum In: Lancet Oncol. 2019 Aug 21;: Lancet Oncol. 2020 Jun;21(6):e304. Lancet Oncol. 2020 Nov;21(11):e518.

Results Reference

derived

PubMed Identifier

30658932

Citation

Cella D, Grunwald V, Escudier B, Hammers HJ, George S, Nathan P, Grimm MO, Rini BI, Doan J, Ivanescu C, Paty J, Mekan S, Motzer RJ. Patient-reported outcomes of patients with advanced renal cell carcinoma treated with nivolumab plus ipilimumab versus sunitinib (CheckMate 214): a randomised, phase 3 trial. Lancet Oncol. 2019 Feb;20(2):297-310. doi: 10.1016/S1470-2045(18)30778-2. Epub 2019 Jan 15. Erratum In: Lancet Oncol. 2019 Jun;20(6):e293.

Results Reference

derived

PubMed Identifier

29562145

Citation

Motzer RJ, Tannir NM, McDermott DF, Aren Frontera O, Melichar B, Choueiri TK, Plimack ER, Barthelemy P, Porta C, George S, Powles T, Donskov F, Neiman V, Kollmannsberger CK, Salman P, Gurney H, Hawkins R, Ravaud A, Grimm MO, Bracarda S, Barrios CH, Tomita Y, Castellano D, Rini BI, Chen AC, Mekan S, McHenry MB, Wind-Rotolo M, Doan J, Sharma P, Hammers HJ, Escudier B; CheckMate 214 Investigators. Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma. N Engl J Med. 2018 Apr 5;378(14):1277-1290. doi: 10.1056/NEJMoa1712126. Epub 2018 Mar 21.

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/s/US/English/USenHome

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

Nivolumab Combined With Ipilimumab Versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 214)

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Nivolumab Combined With Ipilimumab Versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 214)

Advanced Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

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