A Study of Nivolumab Combined With Ipilimumab Versus Nivo... | NCT03873402

ID	Type	Description	Link
2018-004695-35	EudraCT Number

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 21, 2019Actual

Primary Completion Date

Mar 11, 2027Estimated

Completion Date

Mar 11, 2027Estimated

First Submitted Date

Mar 11, 2019

First Submission Date that Met QC Criteria

Mar 12, 2019

First Posted Date

Mar 13, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 20, 2026

Last Update Posted Date

Jan 21, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to test the effectiveness and safety of nivolumab combined with ipilimumab compared to nivolumab monotherapy in participants with previously untreated kidney cancer that has spread.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

437Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nivolumab + ipilimumab	Experimental		Biological: Nivolumab Biological: Ipilimumab
Nivolumab + ipilimumab placebo	Experimental		Other: Ipilimumab placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nivolumab	Biological	Specified dose on specified days	Nivolumab + ipilimumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression free survival (PFS) by blinded independent central review (BICR)		Up to 34 months
Objective response rate (ORR) by BICR		Up to 23 months

Secondary Outcomes

Measure	Description	Time Frame
Overall survival (OS)		Up to 4 years
Overall response rate (ORR) by investigator		Up to 4 years
Disease control rate (DCR) by investigator

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Inclusion Criteria:

Histological confirmation of renal carcinoma with clear cell component including participants who may have sarcomatoid features.
Advanced (not amenable to curative surgery or radiation therapy) renal cell carcinoma (RCC) or metastatic RCC (mRCC).
Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria.
No prior systemic therapy for RCC
Must be intermediate or poor risk as per International Metastatic RCC Database Consortium (IMDC).

Exclusion Criteria:

Any active central nervous system (CNS) metastases.
Active, known, or suspected autoimmune disease.
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or any other agents specifically targeting T-cell co-stimulation or checkpoint pathways

Other protocol-defined inclusion/exclusion criteria apply

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 0013		Washington D.C.	District of Columbia	20007	United States
Local Institution - 0053

Label	URL
BMS Clinical Trial Information	View source
BMS Clinical Trial Patient Recruiting	View source

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Individual patient level data from this study may be shared with qualified researchers, upon request, following the timelines and process detailed on https://www.bms.com/researchers-and-partners/independent-research/data-sharing-request-process.html

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D007680	Kidney Neoplasms
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D007674	Kidney Diseases
D014570	Urologic Diseases
D052801	Male Urogenital Diseases

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins