Renal Cell CarcinomaPhase 2NCT01354431

BMS-936558 (MDX-1106) In Subjects With Advanced/Metastatic Clear-Cell Renal Cell Carcinoma (RCC)

A Phase 2 study testing nivolumab in people with Renal Cell Carcinoma, run by Bristol-Myers Squibb at 41 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to measure how active BMS-936558 (nivolumab) is against Renal Cell Carcinoma (RCC) as measured by the disease not progressing and whether a dose response relationship exists. 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
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 168 participants
Where: 41 sitesin 4 countries
Study dates: 31 May 2011to 15 Apr 2021
Phase: Phase 2
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

Histologic confirmation of Renal cell carcinoma (RCC) with a clear cell component
Previous treatment with at least one anti-angiogenic agent
Progressed within 6 months of study enrollment
Subjects should not have had more than 3 prior treatments for locally advanced or metastatic disease
Must have available tumor tissue for submission
Subjects must also meet various laboratory parameters for inclusion

Who cannot join

Subjects with any active autoimmune disease or a history of known autoimmune disease
Other protocol-defined inclusion/exclusion criteria apply

Trial locations and contacts

41 sites in 4 countries.

Country

City, postcode or hospital

41 sites in 4 countries

United States34 sites

University Of Michigan Medical Center
Ann Arbor, Michigan, 48109
University Of Colorado
Aurora, Colorado, 80045
University Of Maryland
Baltimore, Maryland, 21201
The Bunting-Blaustein Cancer Research Building
Baltimore, Maryland, 21287
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Beth Israel Deaconess Medical Ctr.
Boston, Massachusetts, 02215
Roswell Park Cancer Institute
Buffalo, New York, 14263
Medical University Of South Carolina
Charleston, South Carolina, 29425
Blumenthal Cancer Center
Charlotte, North Carolina, 28204
Northwestern University Feinberg School Of Medicine
Chicago, Illinois, 60611
Cleveland Clinic
Cleveland, Ohio, 44195
Wayne State University
Detroit, Michigan, 48201
Duke University Medical Center
Durham, North Carolina, 27710
Indiana University Health Melvin And Bren Simon Cancer Center
Indianapolis, Indiana, 46202
University Of Kansas Medical Center
Kansas City, Kansas, 66160
UCSD Moores Cancer Center
La Jolla, California, 92093
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Ucla
Los Angeles, California, 90024
Samuel Oschin Comprehensive Cancer Inst.
Los Angeles, California, 90048
Loyola University Medical Center
Maywood, Illinois, 60153
Masonic Cancer Ctr, University Of Minnesota
Minneapolis, Minnesota, 55455
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203
Vanderbilt-Ingram Cancer Ctr
Nashville, Tennessee, 37232
St. Luke'S Roosevelt Hospital Center
New York, New York, 10019
Mount Sinai Medical Center
New York, New York, 10029
Memorial Sloan Kettering Nassau
New York, New York, 10065
Weill Cornell Medical College
New York, New York, 10065
University Of Pennsylvania
Philadelphia, Pennsylvania, 19104
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
University of Washington - Seattle Cancer Care Alliance
Seattle, Washington, 98109
Stanford Cancer Center
Stanford, California, 94305
North Mississippi Hematology And Oncology Associates, Ltd
Tupelo, Mississippi, 38801
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Wheaton Franciscan Health Care
Wauwatosa, Wisconsin, 53226

Other trials in United States

Canada5 sites

Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
Local Institution
Halifax, Nova Scotia, B3H 2Y9
London Regional Cancer Program
London, Ontario, N6A 4L6
Centre D'Oncologie Dr-Leon-Richard
Moncton, New Brunswick, E1C 8X3
Centre Hospitalier Universitaire De Montreal-Notre-Dame Hosp
Montreal, Quebec, H2L 4M1

Other trials in Canada

Finland1 site

Local Institution
Helsinki, 00029

Other trials in Finland

Italy1 site

Local Institution
Siena, 53100

Other trials in Italy

About this study

Official title: A Randomized, Blinded, Phase 2 Dose-Ranging Study Of BMS-936558 (MDX-1106) In Subjects With Progressive, Advanced/Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy

Conditions: Renal Cell Carcinoma
Being tested: nivolumab
Keywords: Advanced/Metastatic, clear cell component
Medical subject headings: Carcinoma, Renal Cell, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

nivolumabBiological
Also called BMS-936558
Solution, Intravenous (IV), 0.3 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons
nivolumabBiological
Also called BMS-936558
Solution, Intravenous (IV), 2.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons
nivolumabBiological
Also called BMS-936558
Solution, Intravenous (IV), 10.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons

Study groups in NCT01354431
Study group	Role	What they receive
Arm 1: nivolumab - 0.3 mg/kg	Experimental	Not described Receives: Biological: nivolumab
Arm 2: nivolumab - 2.0 mg/kg	Experimental	Not described Receives: Biological: nivolumab
Arm 3: nivolumab - 10.0 mg/kg	Experimental	Not described Receives: Biological: nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression Free Survival (PFS)
PFS is defined as the time from randomization to date of first disease progression (either clinical or radiographic progression, as assessed by the investigator). Tumor assessments (radiographic scans) were done every 6 weeks from randomization for the first 12 months, then every 12 weeks until progression. Survival was assessed every 3 months. The analysis of PFS was conducted after approximately 116 events (progression or death), approximately 2 years. PFS was calculated based on investigator's assessment of first date of progression (either clinical or radiographic progression) or date of death if progression did not occur. Progression was at least a 20% increase in the sum of diameters of the longest target lesions since screening (the sum must be an absolute increase of at least 5 mm), or measurable increase in non-target lesion or appearance of one or more new lesions.
Measured: From randomization to disease progression or death (up to approximately 2 years)

Secondary outcomes (3)

Best Overall Response Rate (BORR)
BORR is defined as the percentage of participants whose best response is either partial response (PR) or complete response (CR). Tumor response was evaluated by investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
PR: at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
80% confidence interval is based on the Clopper and Pearson method
Measured: From randomization until disease progression or discontinuation of study therapy (up to approximately 2 years)
Overall Survival (OS)
OS is defined as the time from date of randomization until date of death. If the participant did not die, overall survival will be censored on the last date the participant was known to be alive. Survival status is collected at each visit during treatment and every 3 months during follow-up.
OS is based on Kaplan-Meier estimates.
Measured: From randomization to to date of death (up to approximately 8 years)
Number of Participants Experiencing Adverse Events
Number of participants experiencing different types of events, including Adverse Events (AEs), Drug-related AEs, AEs leading to discontinuation, Drug-related AEs leading to discontinuation, Serious Adverse Events (SAEs), Drug-related SAEs.
Events are classified based on the NCI Common Terminology Criteria (CTC) version 4.0
Measured: From first dose to 30 days following last dose (up to approximately 6 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 May 201115 Apr 2021

First posted16 May 2011 (estimated)
Study start31 May 2011
Primary completion15 May 2013
Study completion15 Apr 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 (3)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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 168 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01354431
Sponsor's protocol ID: CA209-010
Status last verified: May 2022
First submitted: 10 May 2011
Last updated: 12 May 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Expanded access: Available

Publications

George S, Motzer RJ, Hammers HJ, Redman BG, Kuzel TM, Tykodi SS, Plimack ER, Jiang J, Waxman IM, Rini BI. Safety and Efficacy of Nivolumab in Patients With Metastatic Renal Cell Carcinoma Treated Beyond Progression: A Subgroup Analysis of a Randomized Clinical Trial. JAMA Oncol. 2016 Sep 1;2(9):1179-86. doi: 10.1001/jamaoncol.2016.0775.
PubMed 27243803
Motzer RJ, Rini BI, McDermott DF, Redman BG, Kuzel TM, Harrison MR, Vaishampayan UN, Drabkin HA, George S, Logan TF, Margolin KA, Plimack ER, Lambert AM, Waxman IM, Hammers HJ. Nivolumab for Metastatic Renal Cell Carcinoma: Results of a Randomized Phase II Trial. J Clin Oncol. 2015 May 1;33(13):1430-7. doi: 10.1200/JCO.2014.59.0703. Epub 2014 Dec 1.
PubMed 25452452
George S, Pili R, Carducci MA, Kim JJ. Role of immunotherapy for renal cell cancer in 2011. J Natl Compr Canc Netw. 2011 Sep 1;9(9):1011-8. doi: 10.6004/jnccn.2011.0085.
PubMed 21917625

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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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

All Renal Cell Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Blinded, Phase 2 Dose-Ranging Study Of BMS-936558 (MDX-1106) In Subjects With Progressive, Advanced/Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy
ClinicalTrials.gov ID: NCT01354431
Acronym / sponsor ID: CA209-010
Conditions: Renal Cell Carcinoma
Keywords: Advanced/Metastatic, clear cell component
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 168 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Collaborators: Ono Pharma USA Inc
Study start: 31 May 2011 (actual)
Primary completion: 15 May 2013 (actual)
Study completion: 15 Apr 2021 (actual)
First posted: 16 May 2011 (estimated)
Results: Posted 20 Oct 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Arm 1: nivolumab - 0.3 mg/kg	Experimental	Biological: nivolumab
Arm 2: nivolumab - 2.0 mg/kg	Experimental	Biological: nivolumab
Arm 3: nivolumab - 10.0 mg/kg	Experimental	Biological: nivolumab

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Histologic confirmation of Renal cell carcinoma (RCC) with a clear cell component
Previous treatment with at least one anti-angiogenic agent
Progressed within 6 months of study enrollment
Subjects should not have had more than 3 prior treatments for locally advanced or metastatic disease
Must have available tumor tissue for submission

Key exclusion criteria (2 listed)

Subjects with any active autoimmune disease or a history of known autoimmune disease
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-936558Solution, Intravenous (IV), 0.3 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons	Biological	Arm 1: nivolumab - 0.3 mg/kg
nivolumabAlso: BMS-936558Solution, Intravenous (IV), 2.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons	Biological	Arm 2: nivolumab - 2.0 mg/kg
nivolumabAlso: BMS-936558Solution, Intravenous (IV), 10.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons	Biological	Arm 3: nivolumab - 10.0 mg/kg

Primary outcome

Progression Free Survival (PFS)
Time frame: From randomization to disease progression or death (up to approximately 2 years)
PFS is defined as the time from randomization to date of first disease progression (either clinical or radiographic progression, as assessed by the investigator). Tumor assessments (radiographic scans) were done every 6 weeks from randomization for the first 12 months, then every 12 weeks until progression. Survival was assessed every 3 months. The analysis of PFS was conducted after approximately 116 events (progression or death), approximately 2 years. PFS was calculated based on investigator's assessment of first date of progression (either clinical or radiographic progression) or date of death if progression did not occur. Progression was at least a 20% increase in the sum of diameters of the longest target lesions since screening (the sum must be an absolute increase of at least 5 mm), or measurable increase in non-target lesion or appearance of one or more new lesions.

3 secondary outcomes

Best Overall Response Rate (BORR)
Time frame: From randomization until disease progression or discontinuation of study therapy (up to approximately 2 years)
Overall Survival (OS)
Time frame: From randomization to to date of death (up to approximately 8 years)
Number of Participants Experiencing Adverse Events
Time frame: From first dose to 30 days following last dose (up to approximately 6 years)

Results and safety

Results posted to the registry on 20 Oct 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nivolumab 0.3 mg/kg	60	59
Nivolumab 2 mg/kg	54	54
Nivolumab 10 mg/kg	54	54

Primary outcome: Progression Free Survival (PFS)

Time frame: From randomization to disease progression or death (up to approximately 2 years). Median (80% Confidence Interval). Unit: Months

Measure	Nivolumab 0.3 mg/kg n = 60	Nivolumab 2 mg/kg n = 54	Nivolumab 10 mg/kg n = 54
Value	2.63 (1.81 to 3.02)	4.11 (2.86 to 5.39)	4.17 (2.79 to 5.49)

Population analysed: All randomized participants

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-cause mortality was assessed from first dose to study completion date (up to approximately 118 months). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 79 months).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NIVOLUMAB 0.3 mg/kg	30 of 59 (50.8%)	55 of 59 (93.2%)	51 of 60
NIVOLUMAB 2 mg/kg	35 of 54 (64.8%)	54 of 54 (100%)	46 of 54
NIVOLUMAB 10 mg/kg	24 of 54 (44.4%)	52 of 54 (96.3%)	47 of 54

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27243803George S, Motzer RJ, Hammers HJ, Redman BG, Kuzel TM, Tykodi SS, Plimack ER, Jiang J, Waxman IM, Rini BI. Safety and Efficacy of Nivolumab in Patients With Metastatic Renal Cell Carcinoma Treated Beyond Progression: A Subgroup Analysis of a Randomized Clinical Trial. JAMA Oncol. 2016 Sep 1;2(9):1179-86. doi: 10.1001/jamaoncol.2016.0775.
Derived from this study: PubMed 25452452Motzer RJ, Rini BI, McDermott DF, Redman BG, Kuzel TM, Harrison MR, Vaishampayan UN, Drabkin HA, George S, Logan TF, Margolin KA, Plimack ER, Lambert AM, Waxman IM, Hammers HJ. Nivolumab for Metastatic Renal Cell Carcinoma: Results of a Randomized Phase II Trial. J Clin Oncol. 2015 May 1;33(13):1430-7. doi: 10.1200/JCO.2014.59.0703. Epub 2014 Dec 1.
Derived from this study: PubMed 21917625George S, Pili R, Carducci MA, Kim JJ. Role of immunotherapy for renal cell cancer in 2011. J Natl Compr Canc Netw. 2011 Sep 1;9(9):1011-8. doi: 10.6004/jnccn.2011.0085.
BMS Clinical Trial InformationLink provided by the sponsor.
BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
Investigator Inquiry FormLink provided by the sponsor.
FDA Safety Alerts and RecallsLink provided by the sponsor.

Related trials for Renal Cell Carcinoma

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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)
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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

41 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing nivolumab in people with Renal Cell Carcinoma, run by Bristol-Myers Squibb at 41 sites in 4 countries.

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 6 inclusion and 2 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 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States, Canada, Finland, Italy. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 20 Oct 2015). 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?

Progression Free Survival (PFS) (time frame: From randomization to disease progression or death (up to approximately 2 years)). 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 NCT01354431, which also lists 3 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 12 May 2022.