Renal Cell CarcinomaPhase 4CHECKMATE 920NCT02982954
A Study to Evaluate the Safety of Nivolumab and Ipilimumab in Subjects With Previously Untreated Advanced or Metastatic Renal Cell Cancer
A Phase 4 study testing Nivolumab and Ipilimumab in people with Renal Cell Carcinoma, run by Bristol-Myers Squibb at 61 sites in United States.
Trial summary
To investigate the safety of Nivolumab in combination with Ipilimumab in subjects with previously untreated advanced or metastatic Renal Cell Cancer. 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 and Ipilimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 61 sitesUnited States
- Study dates
- 16 Jan 2017to 6 Oct 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
- 1. Type of Participant and Target Disease Characteristics
- Advanced or metastatic RCC
- Histologically confirmed, previously untreated (treatment-naive) RCC
- No prior systemic therapy for RCC except for one prior adjuvant or neoadjuvant therapy for completely resectable RCC
- Measurable disease as per RECIST 1.1. Subject must have extracranial metastasis as measurable disease
- Karnofsky Performance Status (KPS) of at least 70% for Cohort 1, 2, and 3; KPS of 50-60% for Cohort 4
- Tumor tissue need be received by the central vendor (block or unstained slides). Note: Fine Needle Aspiration (FNA)and bone metastases samples are not acceptable for submission.
Who cannot join
- Medical Conditions
- Subjects with any active autoimmune disease or a history of known autoimmune disease
- Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
- Known HIV or AIDS-related illness
- Any positive test for hepatitis B or hepatitis C virus indicating acute or chronic infection.
- Prior/Concomitant Therapy
Show all 10Show fewer
- Prior systemic treatment in the metastatic setting with Vascular epithelial growth factor(VEGF) or VEGF receptor targeted therapy
- Prior treatment with an anti-Programmed Death (PD) -1, anti-PD-L1, anti-PD-L2, anti-cluster of differentiation 137 (CD137), or anti-cytotoxic T-lymphocyte-associated antigen 4(CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. This includes the utilization of these agents in the neo-adjuvant or adjuvant setting.
- Anti-cancer therapy less than 28 days prior to the first dose of study drug or palliative, focal radiation therapy less than 14 days prior to the first dose of study drug.
- Other protocol defined inclusion/exclusion criteria apply
Trial locations and contacts
61 sites in 1 country.
61 sites in 1 country
United States61 sites
University Of New Mexico
Albuquerque, New Mexico, 87106
Alaska Urological Institute dba Alaska Clinical Research Center
Anchorage, Alaska, 99503
Emory University - Winship Cancer Institute
Atlanta, Georgia, 30322
Texas Oncology
Austin, Texas, 78731
Maimonides Medical Center
Brooklyn, New York, 11220
Southdale Cancer Clinic
Burnsville, Minnesota, 55337
Ironwood Cancer And Research Centers, Pc
Chandler, Arizona, 85224
Charleston Hematology Oncology Associates, Pa
Charleston, South Carolina, 29414
Hollings Cancer Center
Charleston, South Carolina, 29425
University of Virginia Health System
Charlottesville, Virginia, 22936
Tennessee Oncology, PLLC - SCRI - PPDS
Chattanooga, Tennessee, 37404
Local Institution - 0009
Coon Rapids, Minnesota, 55433
Texas Oncology
Dallas, Texas, 75246
Duke University Medical Center
Durham, North Carolina, 27710
eCare
Encinitas, California, 92024
Local Institution - 0042
Fairfax, Virginia, 22031
Local Institution - 0028
Fayetteville, Arkansas, 72703
Florida Cancer Specialists S.
Fort Myers, Florida, 33901
Local Institution - 0012
Fort Wayne, Indiana, 46845
Texas Oncology-Fort Worth 12th Ave
Fort Worth, Texas, 76104
Southeastern Medical Oncology Center
Goldsboro, North Carolina, 27534
St. Francis Cancer Treatment Center
Grand Island, New York, 68803
Local Institution - 0023
Hackensack, New Jersey, 07601
Hattiesburg Clinic
Hattiesburg, Mississippi, 39401
Jackson Oncology Associates, Pllc
Jackson, Mississippi, 39202
Broome Oncology
Johnson City, New York, 13790
HCA Midwest Division
Kansas City, Missouri, 64132
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148
Pacific Shores Medical Group
Long Beach, California, 90813
Los Angeles Cancer Network
Los Angeles, California, 90017
UCLA Hematology Oncology
Los Angeles, California, 90095
Norton Cancer Institute
Louisville, Kentucky, 40202
University of Wisconsin Clinical Science Center
Madison, Wisconsin, 53705
University Of Miami/Sylvester Cancer Center
Miami, Florida, 33136
Texas Oncology-Midland Allison Cancer Center
Midland, Texas, 79701
Bon Secours St Francis Hospital
Midlothian, Virginia, 23114
Park Nicollet Clinic Cancer Center
Minneapolis, Minnesota, 55416
Northwest Alabama Cancer Center, Pc
Muscle Shoals, Alabama, 35661
Local Institution - 0002
Nashville, Tennessee, 37203-1624
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-6307
Local Institution - 0052
New York, New York, 10016
Weill Cornell Medical College
New York, New York, 10021
Illinois Cancer Specialists
Niles, Illinois, 60714
UF Health Cancer Center at Orlando Health
Orlando, Florida, 32806
Local Institution - 0071
Pittsburgh, Pennsylvania, 15240
Torrance Health Association
Redondo Beach, California, 90277
Virginia Cancer Institute
Richmond, Virginia, 23226
Kaiser Permanente Medical Group - Southern California
Riverside, California, 92505
Texas Oncology
San Antonio, Texas, 78217
Sharp Memorial Hospital
San Diego, California, 92123
Coastal Integrative Cancer Care
San Luis Obispo, California, 93401
Central Coast Med Oncology
Santa Maria, California, 93454
University of Washington - Seattle Cancer Care Alliance
Seattle, Washington, 98109
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
Medical Oncology Associates
Spokane, Washington, 99208
Florida Cancer Specialists
St. Petersburg, Florida, 33705
SUNY Upstate Medical University
Syracuse, New York, 13210
Montefiore Medical Center
The Bronx, New York, 10461
Oklahoma Cancer Specialists and Research Institute, LLC-Clinical Research
Tulsa, Oklahoma, 74146
Cancer Center Of Kansas
Wichita, Kansas, 67214
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, 98902
About this study
Official title: Phase 3b/4 Safety Trial of Nivolumab Combined With Ipilimumab in Subjects With Previously Untreated, Advanced or Metastatic RCC (CheckMate 920: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 920)
To investigate the safety of Nivolumab in combination with Ipilimumab in subjects with previously untreated advanced or metastatic Renal Cell Cancer.
- Conditions
- Renal Cell Carcinoma
- Being tested
- Nivolumab, Ipilimumab
- 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 BMS-936558, Opdivo
Specified dose on specified day
IpilimumabDrug
Also called Yervoy, BMS-734016
Specified Dose on Specified Day
| Study group | Role | What they receive |
|---|---|---|
| ccRCC KPS ≥ 70% | Experimental | Clear-Cell Renal Cell Carcinoma (ccRCC) with Karnofsky Performance Status (KPS) ≥ 70% Receives: Drug: Nivolumab; Drug: Ipilimumab |
| Non-ccRCC, KPS ≥ 70% | Experimental | Non Clear-Cell Renal Cell Carcinoma (nccRCC) with KPS ≥ 70% Receives: Drug: Nivolumab; Drug: Ipilimumab |
| RCC with non-active Brain Mets, KPS ≥70% | Experimental | Renal Cell Carcinoma (RCC) with non-active Brain Metastases, with KPS ≥70% Receives: Drug: Nivolumab; Drug: Ipilimumab |
| any RCC with KPS 50%-60% | Experimental | Renal Cell Carcinoma (RCC), regardless of any histology or existing non-active brain metastasis, with KPS 50%-60% Receives: Drug: Nivolumab; Drug: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With High Grade (Grade 3-4) Immune Mediated Adverse Events (IMAEs)
Number of participants with IMAEs in the following categories: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity
Measured: Approximately 39 Months
Number of Participants With High Grade (Grade 5) Immune Mediated Adverse Events (IMAEs)
Number of participants with IMAEs in the following categories: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity
Measured: Approximately 39 Months
Secondary outcomes (9)
Time to Onset of Grade 3-5 Immune Mediated Adverse Events (IMAEs)
Time to onset is defined as the duration of time in weeks from the first dosing to the immune modulating adverse event onset date. Participants experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death
Measured: From first dose to the earliest IMAE (grade 3-5) event onset date (up to approximately 116 weeks)
Time to Resolution of Grade 3-5 Immune Mediated Adverse Events (IMAEs)
Time to resolution is defined as the longest time from IMAE onset date to complete resolution or improvement to the grade at baseline experienced by the participant (the IMAE end date). Participants experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death
Measured: From the IMAE onset date to the IMAE end date, up to approximately 194 weeks
Number of Participants Who Received Immune Modulating Medication for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs)
The number of participants who received immune modulating medication for participants experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death
Measured: From first dose up to 100 days post last dose (up to approximately 29 months)
Number of Participants Who Received Hormone Replacement Therapy for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs)
The number of participants who received Hormone Replacement Therapy for experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death
Measured: From first dose up to 100 days post last dose (up to approximately 29 months)
Number of Participants Who Received ≥ 40mg of Prednisone for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs)
The number of participants who received ≥ 40mg of prednisone for high grade (grades 3-5) IMAEs. Participants experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death
Measured: From first dose up to 100 days post last dose (up to approximately 29 months)
Median Progression Free Survival (PFS)
PFS is defined as the time from first dose to the date of the first documented progressive disease (PD) as determined by the investigator (per RECIST 1.1 criteria or clinical) or death due to any cause whichever occur first. Progressive disease is defined as progression of existing non-target lesions or at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Measured: From first dose to the date of the first documented progressive disease, up to approximately 12 months
Objective Response Rate (ORR)
ORR is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of response evaluable participants. Best overall response is defined as the best response recorded from the start of the study treatment until the end of treatment. The participant's best overall response assignment will depend on the findings of both target and non-target disease and will also take into consideration the appearance of new lesions. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all lesions and normalization of tumor marker level. All lymph nodes (whether target or non-target) must be non-pathological in size (< 10mm short axis).
Measured: From first dose up to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (up to approximately 26 months)
Time to Response Rate (TRR)
TTR is defined as the median percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of response evaluable participants. Best overall response is defined as the best response recorded from the start of the study treatment until the end of treatment. The participant's best overall response assignment will depend on the findings of both target and non-target disease and will also take into consideration the appearance of new lesions. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all lesions and normalization of tumor marker level. All lymph nodes (whether target or non-target) must be non-pathological in size (< 10mm short axis).
Measured: From the date of first dose to first documented CR or PR, up to approximately 15 months
Duration of Response (DOR)
DOR is defined as the time between the date of first confirmed response to the date of the first documented tumor progression per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, or death due to any cause, whichever occurs first. DOR will be computed for participants who achieve partial response (PR) or complete response (CR) only. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all lesions and normalization of tumor marker level. All lymph nodes (whether target or non-target) must be non-pathological in size (< 10mm short axis).
Measured: From first confirmed response to the date of the first documented tumor progression or death, up to approximately 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study start16 Jan 2017
- Primary completion11 May 2020
- Study completion6 Oct 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.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 211 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
- NCT02982954
- Sponsor's protocol ID
- CA209-920
- Acronym
- CHECKMATE 920
- Status last verified
- Oct 2022
- First submitted
- 2 Dec 2016
- Last updated
- 1 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
George DJ, Spigel DR, Gordan LN, Kochuparambil ST, Molina AM, Yorio J, Rezazadeh Kalebasty A, McKean H, Tchekmedyian N, Tykodi SS, Zhang J, Askelson M, Johansen JL, Hutson TE. Safety and efficacy of first-line nivolumab plus ipilimumab alternating with nivolumab monotherapy in patients with advanced renal cell carcinoma: the non-randomised, open-label, phase IIIb/IV CheckMate 920 trial. BMJ Open. 2022 Sep 14;12(9):e058396. doi: 10.1136/bmjopen-2021-058396.
PubMed 36104138Tykodi SS, Gordan LN, Alter RS, Arrowsmith E, Harrison MR, Percent I, Singal R, Van Veldhuizen P, George DJ, Hutson T, Zhang J, Zoco J, Johansen JL, Rezazadeh Kalebasty A. Safety and efficacy of nivolumab plus ipilimumab in patients with advanced non-clear cell renal cell carcinoma: results from the phase 3b/4 CheckMate 920 trial. J Immunother Cancer. 2022 Feb;10(2):e003844. doi: 10.1136/jitc-2021-003844.
PubMed 35210307
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3b/4 Safety Trial of Nivolumab Combined With Ipilimumab in Subjects With Previously Untreated, Advanced or Metastatic RCC (CheckMate 920: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 920)
- ClinicalTrials.gov ID
- NCT02982954
- Acronym / sponsor ID
- CHECKMATE 920 / CA209-920
- Conditions
- Renal Cell Carcinoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2017 (actual)
- Primary completion
- 11 May 2020 (actual)
- Study completion
- 6 Oct 2021 (actual)
- First posted
- 6 Dec 2016 (estimated)
- Results
- Posted 14 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the safety of Nivolumab in combination with Ipilimumab in subjects with previously untreated advanced or metastatic Renal Cell Cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ccRCC KPS ≥ 70% | Experimental | Drug: Nivolumab, Drug: IpilimumabClear-Cell Renal Cell Carcinoma (ccRCC) with Karnofsky Performance Status (KPS) ≥ 70% |
| Non-ccRCC, KPS ≥ 70% | Experimental | Drug: Nivolumab, Drug: IpilimumabNon Clear-Cell Renal Cell Carcinoma (nccRCC) with KPS ≥ 70% |
| RCC with non-active Brain Mets, KPS ≥70% | Experimental | Drug: Nivolumab, Drug: IpilimumabRenal Cell Carcinoma (RCC) with non-active Brain Metastases, with KPS ≥70% |
| any RCC with KPS 50%-60% | Experimental | Drug: Nivolumab, Drug: IpilimumabRenal Cell Carcinoma (RCC), regardless of any histology or existing non-active brain metastasis, with KPS 50%-60% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1. Type of Participant and Target Disease Characteristics
- Advanced or metastatic RCC
- Histologically confirmed, previously untreated (treatment-naive) RCC
- No prior systemic therapy for RCC except for one prior adjuvant or neoadjuvant therapy for completely resectable RCC
- Measurable disease as per RECIST 1.1. Subject must have extracranial metastasis as measurable disease
Key exclusion criteria (10 listed)
- Medical Conditions
- Prior/Concomitant Therapy
- Other protocol defined inclusion/exclusion criteria apply
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: BMS-936558, OpdivoSpecified dose on specified day | Drug | Non-ccRCC, KPS ≥ 70%, RCC with non-active Brain Mets, KPS ≥70%, any RCC with KPS 50%-60%, ccRCC KPS ≥ 70% |
| IpilimumabAlso: Yervoy, BMS-734016Specified Dose on Specified Day | Drug | Non-ccRCC, KPS ≥ 70%, RCC with non-active Brain Mets, KPS ≥70%, any RCC with KPS 50%-60%, ccRCC KPS ≥ 70% |
Primary outcome
Number of Participants With High Grade (Grade 3-4) Immune Mediated Adverse Events (IMAEs)
Time frame: Approximately 39 Months
Number of participants with IMAEs in the following categories: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity
Number of Participants With High Grade (Grade 5) Immune Mediated Adverse Events (IMAEs)
Time frame: Approximately 39 Months
Number of participants with IMAEs in the following categories: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity
9 secondary outcomes
Time to Onset of Grade 3-5 Immune Mediated Adverse Events (IMAEs)
Time frame: From first dose to the earliest IMAE (grade 3-5) event onset date (up to approximately 116 weeks)
Time to Resolution of Grade 3-5 Immune Mediated Adverse Events (IMAEs)
Time frame: From the IMAE onset date to the IMAE end date, up to approximately 194 weeks
Number of Participants Who Received Immune Modulating Medication for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs)
Time frame: From first dose up to 100 days post last dose (up to approximately 29 months)
Number of Participants Who Received Hormone Replacement Therapy for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs)
Time frame: From first dose up to 100 days post last dose (up to approximately 29 months)
Number of Participants Who Received ≥ 40mg of Prednisone for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs)
Time frame: From first dose up to 100 days post last dose (up to approximately 29 months)
Median Progression Free Survival (PFS)
Time frame: From first dose to the date of the first documented progressive disease, up to approximately 12 months
Objective Response Rate (ORR)
Time frame: From first dose up to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (up to approximately 26 months)
Time to Response Rate (TRR)
Time frame: From the date of first dose to first documented CR or PR, up to approximately 15 months
Duration of Response (DOR)
Time frame: From first confirmed response to the date of the first documented tumor progression or death, up to approximately 48 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36104138George DJ, Spigel DR, Gordan LN, Kochuparambil ST, Molina AM, Yorio J, Rezazadeh Kalebasty A, McKean H, Tchekmedyian N, Tykodi SS, Zhang J, Askelson M, Johansen JL, Hutson TE. Safety and efficacy of first-line nivolumab plus ipilimumab alternating with nivolumab monotherapy in patients with advanced renal cell carcinoma: the non-randomised, open-label, phase IIIb/IV CheckMate 920 trial. BMJ Open. 2022 Sep 14;12(9):e058396. doi: 10.1136/bmjopen-2021-058396.
- Derived from this study: PubMed 35210307Tykodi SS, Gordan LN, Alter RS, Arrowsmith E, Harrison MR, Percent I, Singal R, Van Veldhuizen P, George DJ, Hutson T, Zhang J, Zoco J, Johansen JL, Rezazadeh Kalebasty A. Safety and efficacy of nivolumab plus ipilimumab in patients with advanced non-clear cell renal cell carcinoma: results from the phase 3b/4 CheckMate 920 trial. J Immunother Cancer. 2022 Feb;10(2):e003844. doi: 10.1136/jitc-2021-003844.
- 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.
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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
61 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 and Ipilimumab in people with Renal Cell Carcinoma, run by Bristol-Myers Squibb at 61 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 7 inclusion and 10 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 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 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 14 Oct 2021). 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?
Number of Participants With High Grade (Grade 3-4) Immune Mediated Adverse Events (IMAEs) (time frame: Approximately 39 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02982954, which also lists 2 linked publications.
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 1 Nov 2022.