Renal Cell CarcinomaPhase 4CheckMate 374NCT02596035
An Investigational Immuno-therapy Safety Trial of Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma
A Phase 4 study testing Nivolumab in people with Renal Cell Carcinoma, run by Bristol-Myers Squibb at 39 sites in United States.
Trial summary
This study will generate safety data on Nivolumab given by itself in treatment of advanced Renal Cell Carcinoma (RCC). The primary objective of this study is to assess immune related side effects, also known as immune-mediated adverse events (IMAEs), in patients treated with Nivolumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- Nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 39 sitesUnited States
- Study dates
- 8 Jan 2016to 24 May 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced or Metastatic renal cell carcinoma (RCC)
- Predominant clear cell histology:
- At least 1 but no more than 2 prior systemic anti vascular endothelial growth factor (anti-VEGF) treatments
- No more than 3 total prior systemic treatment regimens in the advanced or metastatic setting
- Subjects with prior treatment with a mechanistic target of rapamycin (mTOR) are eligible
- Non-clear cell histology: 0-3 prior systemic therapies and may include mTOR inhibitor
Show all 9Show fewer
- Brain metastases allowed if asymptomatic, without edema, and not receiving corticosteroids or radiation
- Performance Status (PS): ≥ 70% Karnofsky Performance Scale (KPS)
- All Memorial Sloan-Kettering Cancer Center (MSKCC) prognostic scores allowed
Who cannot join
- Subjects with any active autoimmune disease or a history of known autoimmune disease
- History of severe hypersensitivity reaction to other monoclonal antibodies
- Prior malignancy, active within the last 3 years, except for locally curable cancers which have been apparently cured
- Known HIV or AIDS-related illness
- Any positive tests for Hepatitis B or Hepatitis C virus indicating acute or chronic infection
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United States39 sites
University Of Colorado
Aurora, Colorado, 80045
Comprehensive Blood And Cancer Center
Bakersfield, California, 93309
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland, 21231
Local Institution - 0053
Buffalo, New York, 14263
Local Institution - 0020
Charleston, South Carolina, 29414
Local Institution - 0005
Chattanooga, Tennessee, 37404
Local Institution - 0015
Dallas, Texas, 75246
Local Institution - 0008
Fort Myers, Florida, 33901
Local Institution - 0052
Fort Wayne, Indiana, 46845
The Center For Cancer And Blood Disorders
Fort Worth, Texas, 76104
St. Jude Hospital Yorba Linda
Fullerton, California, 92835
Local Institution - 0012
Germantown, Tennessee, 38138
Local Institution - 0028
Grand Junction, Colorado, 81501
Local Institution - 0034
Houston, Texas, 77024
Broome Oncology
Johnson City, New York, 13790
HCA Midwest Division
Kansas City, Missouri, 64132
Local Institution - 0018
Lakewood, Colorado, 80228
Local Institution - 0014
Las Vegas, Nevada, 89169
Southeast Nebraska Hematology & Oncology Consultants, P.C.
Lincoln, Nebraska, 68510
Norton Cancer Institute
Louisville, Kentucky, 40202
Baptist Health Medical Group Oncology
Miami, Florida, 33176
Local Institution - 0004
Nashville, Tennessee, 37203
Local Institution - 0055
New York, New York, 10065
Illinois Cancer Specialists
Niles, Illinois, 60714
Local Institution - 0032
Norfolk, Virginia, 23502
Local Institution - 0011
Omaha, Nebraska, 68130
Urology Cancer Center Laboratory
Omaha, Nebraska, 68130
Local Institution - 0030
Phoenix, Arizona, 85016
Local Institution - 0016
Portland, Oregon, 97213-2982
Cancer Care Associates Medical Group, Inc.
Redondo Beach, California, 90277
Local Institution - 0047
Richmond, Virginia, 23230
Local Institution - 0017
Roanoke, Virginia, 24014
Local Institution - 0021
San Antonio, Texas, 78217
Sansum Santa Barbara Medical Foundation Clinic
Santa Barbara, California, 93105
Local Institution - 0039
Seattle, Washington, 98109
Texas Cancer Center - Sherman
Sherman, Texas, 75090-0504
Local Institution - 0007
St. Petersburg, Florida, 33705
Local Institution - 0054
Tampa, Florida, 33612-9497
Local Institution - 0001
Tulsa, Oklahoma, 74146
About this study
Official title: A Phase 3b/4 Safety Trial of Nivolumab (BMS-936558) in Subjects With Advanced or Metastatic Renal Cell Carcinoma (CheckMate 374: CHECKpoint Pathway and Nivolumab Clinical Trial Evaluation 374)
This study will generate safety data on Nivolumab given by itself in treatment of advanced Renal Cell Carcinoma (RCC). The primary objective of this study is to assess immune related side effects, also known as immune-mediated adverse events (IMAEs), in patients treated with Nivolumab.
- Conditions
- Renal Cell Carcinoma
- Being tested
- Nivolumab
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Also called Opdivo
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab | Experimental | Nivolumab dose as specified Receives: Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs)
IMAEs were tabulated using worst grade per Common Terminology Criteria for Adverse Events, National Cancer Institute (NCI CTCAE) Version 4.0 criteria by system organ class and MedDRA version 20.1 preferred term.
Measured: Up to 100 days of the last dose of study drug (Approximately 2 years)
Secondary outcomes (6)
Median Time to Onset of High Grade (Grade 3-5) Immune Mediated Adverse Events
Time to onset was calculated from first dosing date to the event onset date. If a participant never experienced the given AE, the participant will be censored at the last contact date.
Measured: Up to 100 days of the last dose of study drug (Approximately 10 months up to 26 months)
Median Time to Resolution of High Grade (Grade 3-5) Immune Mediated Adverse Events
Time-to resolution of grade 3-5 AE was defined as the longest time from onset to complete resolution or improvement to the grade at baseline among all clustered select AEs in the category experienced by the participant. Events which worsened into grade 5 events (death) or have a resolution date equal to the date of death are considered unresolved. If a clustered AE is considered as unresolved, the resolution date will be censored to the last known date alive.
Measured: From onset of grade 3-5 IMAEs to resolution of IMAEs (Approximately 4 years and 7 months)
Percentage of Participants Who Receive Immune Modulating Medication for the Immune-Mediated Event (Any Grade)
Immune modulating medication includes corticosteroids, infliximab, cyclophosphamide, Intravenous immunoglobulin (IVIG), and mycophenolate mofetil
Measured: Up to 100 days of the last dose of study drug (Approximately 3 years and 2 months)
Percentage of Participants Who Receive More Than Equal to (>=) 40 mg Prednisone Equivalents for the Immune-Mediated Event
Immune modulating medication includes corticosteroids, infliximab, cyclophosphamide, Intravenous immunoglobulin (IVIG), and mycophenolate mofetil
Measured: Up to 100 days of the last dose of study drug (Approximately 3 years and 2 months)
Total Duration of All Immune Modulating Medications Given for the Immune-Mediated Event
Immune modulating medication includes corticosteroids, infliximab, cyclophosphamide, Intravenous immunoglobulin (IVIG), and mycophenolate mofetil.
Measured: From the initiation of Immune modulating medication to discontinuation (approximately 4 years and 9 months).)
Percentage of Participants With a Resolution of IMAEs After Initiating Immune Modulating Medication
Percentage of participants with a resolution of IMAEs after initiating immune modulating medication.
Measured: Up to 100 days of the last dose of study drug (Approximately 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study start8 Jan 2016
- Primary completion19 Mar 2018
- Study completion24 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02596035
- Sponsor's protocol ID
- CA209-374
- Other IDs
- 2015-003286-28, 2015
- Acronym
- CheckMate 374
- Status last verified
- Oct 2022
- First submitted
- 2 Nov 2015
- Last updated
- 27 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b/4 Safety Trial of Nivolumab (BMS-936558) in Subjects With Advanced or Metastatic Renal Cell Carcinoma (CheckMate 374: CHECKpoint Pathway and Nivolumab Clinical Trial Evaluation 374)
- ClinicalTrials.gov ID
- NCT02596035
- Acronym / sponsor ID
- CheckMate 374 / CA209-374
- Conditions
- Renal Cell Carcinoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 8 Jan 2016 (actual)
- Primary completion
- 19 Mar 2018 (actual)
- Study completion
- 24 May 2021 (actual)
- First posted
- 4 Nov 2015 (estimated)
- Results
- Posted 28 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will generate safety data on Nivolumab given by itself in treatment of advanced Renal Cell Carcinoma (RCC). The primary objective of this study is to assess immune related side effects, also known as immune-mediated adverse events (IMAEs), in patients treated with Nivolumab.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nivolumab | Experimental | Drug: NivolumabNivolumab dose as specified |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Advanced or Metastatic renal cell carcinoma (RCC)
- Predominant clear cell histology:
- Non-clear cell histology: 0-3 prior systemic therapies and may include mTOR inhibitor
- Brain metastases allowed if asymptomatic, without edema, and not receiving corticosteroids or radiation
- Performance Status (PS): ≥ 70% Karnofsky Performance Scale (KPS)
Key exclusion criteria (6 listed)
- Subjects with any active autoimmune disease or a history of known autoimmune disease
- History of severe hypersensitivity reaction to other monoclonal antibodies
- Prior malignancy, active within the last 3 years, except for locally curable cancers which have been apparently cured
- Known HIV or AIDS-related illness
- Any positive tests for Hepatitis B or Hepatitis C virus indicating acute or chronic infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabAlso: Opdivo | Drug | Nivolumab |
Primary outcome
Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs)
Time frame: Up to 100 days of the last dose of study drug (Approximately 2 years)
IMAEs were tabulated using worst grade per Common Terminology Criteria for Adverse Events, National Cancer Institute (NCI CTCAE) Version 4.0 criteria by system organ class and MedDRA version 20.1 preferred term.
6 secondary outcomes
Median Time to Onset of High Grade (Grade 3-5) Immune Mediated Adverse Events
Time frame: Up to 100 days of the last dose of study drug (Approximately 10 months up to 26 months)
Median Time to Resolution of High Grade (Grade 3-5) Immune Mediated Adverse Events
Time frame: From onset of grade 3-5 IMAEs to resolution of IMAEs (Approximately 4 years and 7 months)
Percentage of Participants Who Receive Immune Modulating Medication for the Immune-Mediated Event (Any Grade)
Time frame: Up to 100 days of the last dose of study drug (Approximately 3 years and 2 months)
Percentage of Participants Who Receive More Than Equal to (>=) 40 mg Prednisone Equivalents for the Immune-Mediated Event
Time frame: Up to 100 days of the last dose of study drug (Approximately 3 years and 2 months)
Total Duration of All Immune Modulating Medications Given for the Immune-Mediated Event
Time frame: From the initiation of Immune modulating medication to discontinuation (approximately 4 years and 9 months).)
Percentage of Participants With a Resolution of IMAEs After Initiating Immune Modulating Medication
Time frame: Up to 100 days of the last dose of study drug (Approximately 2 years)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
Related trials for Renal Cell Carcinoma
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Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nivolumab in people with Renal Cell Carcinoma, run by Bristol-Myers Squibb at 39 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) (time frame: Up to 100 days of the last dose of study drug (Approximately 2 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2022.