Renal Cell CarcinomaPhase 1NCT01472081
Nivolumab (BMS-936558; MDX-1106) in Combination With Sunitinib, Pazopanib, or Ipilimumab in Subjects With Metastatic Renal Cell Carcinoma (RCC) (CheckMate 016)
A Phase 1 study testing Nivolumab, Pazopanib and Sunitinib in people with Renal Cell Carcinoma and Clear-cell Metastatic Renal Cell Carcinoma, run by Bristol-Myers Squibb at 14 sites in 2 countries.
Trial summary
The purpose is to determine the safety, effectiveness and best dose to use when giving Nivolumab in combination with Sunitinib, Pazopanib, or Ipilimumab for the treatment of metastatic renal cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma, Clear-cell Metastatic Renal Cell Carcinoma
- What is being tested?
- Nivolumab, Pazopanib and Sunitinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 9 Feb 2012to 3 Jun 2021
- Phase
- Phase 1
- 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
- Subjects with histological confirmation of RCC
- Advanced or metastatic disease
- Measurable disease as defined by RECIST 1.1 criteria
- Karnofsky Performance Status (KPS) ≥80%
- Available tumor tissue (archival or recent acquisition)
- Subjects enrolled in the I-1, I-3 expansion arms and IN-3 addition arms must not have received any prior systemic therapy for RCC with the following exceptions:
- One prior adjuvant or neoadjuvant therapy for localized or locally advanced RCC is allowed provided recurrence occurred ≥ 6 months after the last dose of the adjuvant or neoadjuvant therapy
- Only prior cytokine based treatment for metastatic RCC [eg, interferon-alpha (IFN-alpha) or interleukin 2 (IL-2)] as prior therapy is allowed
Who cannot join
- Active central nervous system (CNS) metastases
- Active or history of autoimmune disease
- Ongoing symptomatic cardiac dysrhythmias or uncontrolled atrial fibrillation
- History of cerebrovascular accident including transient ischemic attack within the past 12 months
- History of pulmonary embolism or deep vein thrombosis (DVT) within the past 6 months
- Chronic systemic steroids (>10 mg/day Prednisone equivalents) or any other immunosuppressive agents
Show all 16Show fewer
- White blood cell (WBC) <2,000/mm3
- Neutrophiles <1,500/mm3
- Platelets <100,000/mm3
- Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) >3x upper limit of normal (ULN)
- Total Bilirubin >1.5x ULN (except subjects with Gilbert syndrome, total bilirubin <3.0 mg/dL)
- Cardiac ejection fraction <LLN (lower limit of normal)
- Serum creatinine >1.5x ULN or creatinine clearance <40 mL/min (Cockroft-Gault formula)
- For dose escalation cohorts - subjects who received prior Sunitinib or Pazopanib and required permanent discontinuation due to toxicity or required dose reduction or delay during the first 12 weeks of therapy due to toxicity, or received both prior Sunitinib and Pazopanib
- Poorly controlled hypertension
- Active bleeding or bleeding susceptibility
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States10 sites
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland, 21287
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Blumenthal Cancer Center
Charlotte, North Carolina, 28204
Cleveland Clinic
Cleveland, Ohio, 44195
City Of Hope
Duarte, California, 91010-3000
University Of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030-4009
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203
Memorial Sloan Kettering Nassau
New York, New York, 10065
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Canada4 sites
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 1Z5
BC Cancer Agency - Vancouver Centre
Vancouver, British Columbia, V5Z 4E6
About this study
Official title: A Phase 1 Study of Nivolumab (BMS-936558) Plus Sunitinib, Pazopanib or Ipilimumab in Subjects With Metastatic Renal Cell Carcinoma
The purpose is to determine the safety, effectiveness and best dose to use when giving Nivolumab in combination with Sunitinib, Pazopanib, or Ipilimumab for the treatment of metastatic renal cell carcinoma.
- Being tested
- Nivolumab, Pazopanib, Sunitinib, Ipilimumab
- Medical subject headings
- Carcinoma, Renal Cell, Clear-cell metastatic renal cell carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabBiological
Also called BMS-936558 (MDX-1106)
PazopanibBiological
Also called Votrient (Pazopanib hydrochloride)
SunitinibDrug
Also called Sutent®, Sunitinib Malate
IpilimumabBiological
Also called YERVOY™
| Study group | Role | What they receive |
|---|---|---|
| Arm S: Nivolumab + Sunitinib | Experimental | Nivolumab 0.3, 2.0 (starting dose), 5.0 mg/kg solution intravenously every 21 days until Progressive disease (PD), toxicity or discontinue for other reasons
Sunitinib 50 mg capsule by mouth on Days 1-28 of 42 day cycle until Progressive disease (PD), toxicity or discontinue for other reasons Receives: Biological: Nivolumab; Drug: Sunitinib |
| Arm P: Nivolumab + Pazopanib | Experimental | Nivolumab 0.3, 2.0 (starting dose), 5.0 mg/kg solution intravenously every 21 days until Progressive disease (PD), toxicity or discontinue for other reasons
Pazopanib 800 mg tablet by mouth daily until Progressive disease (PD), toxicity or discontinue for other reasons Receives: Biological: Nivolumab; Biological: Pazopanib |
| Arm I-1: Nivolumab + Ipilimumab | Experimental | Nivolumab 3 mg/kg solution intravenously (IV) every 21 days during Induction phase and every 14 days during Maintenance phase until Progressive disease (PD), toxicity or discontinue for other reasons
Ipilimumab 1mg/kg solution intravenously (IV) every 21 days during Induction phase (Ipilimumab will not be administered during Maintenance phase) until Progressive disease (PD), toxicity or discontinue for other reasons Receives: Biological: Nivolumab; Biological: Ipilimumab |
| Arm I-3: Nivolumab + Ipilimumab | Experimental | Nivolumab 1mg/kg solution intravenously (IV) every 21 days during Induction phase and 3mg/kg solution intravenously (IV) every 14 days during Maintenance phase
Ipilimumab 3mg/kg solution intravenously (IV) every 21 days during Induction phase. Ipilimumab will not be administered during Maintenance phase Receives: Biological: Nivolumab; Biological: Ipilimumab |
| Arm IN-3: Nivolumab+Ipilimumab | Experimental | Nivolumab 3mg/kg solution intravenously (IV) every 21 days during Induction phase and 3mg/kg solution intravenously (IV) every 14 days during Maintenance phase
Ipilimumab 3mg/kg solution intravenously (IV) every 21 days during Induction phase. Ipilimumab will not be administered during Maintenance phase Receives: Biological: Nivolumab; Biological: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation
Safety assessments by treatment arm and dose level were based on incidence of AEs, and the incidence of serious adverse events (SAEs). AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling.
Measured: From date of first dose to date of last dose plus 100 days (assessed up to March 2016, approximately 49 months)
Secondary outcomes (5)
Best Overall Response Rate (BOR)
BOR was defined as the best response designation over the study as a whole, recorded between the date of first dose of study medication and the date of objectively documented progression per RECIST 1.1 criteria or the date of subsequent anti-cancer therapy, whichever occurred first.
CR = Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD = At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum 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. SD = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Measured: From date of first dose to date of disease progression or subsequent anti-cancer therapy, whichever occurred first (assessed up to March 2016, approximately 49 months)
Objective Response Rate (ORR)
ORR was defined as the proportion of participants who achieved a BOR of either complete response (CR) or partial response (PR) in the population of interest.
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 a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: From date of first dose to interim analysis (Assessed up to March 2016, approximately 49 months)
Duration of Response (DOR)
DOR was computed for participants with BOR of CR or PR only, and defined as the time between the date of first documented objective response and the date of the first subsequent disease progression or death. Participants who remained alive and had not progressed were censored on the last tumor assessment date (prior to subsequent cancer therapy).
Measured: From date of first dose to date of disease progression or death, whichever occurred first (assessed up to March 2016, approximately 49 months)
Rate of Progression-free Survival (PFS) at Week 24
Rate of PFS at week 24 was defined as the proportion of participants remaining progression free or surviving at 24 weeks, calculated by the product-limit method (Kaplan-Meier estimate) which took into account censored data. Participants who did not have any on-study tumor assessment and did not die were censored on the date of first dose of study medication.
Measured: 24 weeks
Progression-free Survival (PFS)
PFS was defined as the time from the date of first dose of study medication to the date of first disease progression or death. Participants who did not have any on-study tumor assessment and did not die were censored on the date of first dose of study medication.
Measured: From date of first dose to date of disease progression or death, whichever occurred first (assessed up to March 2016, approximately 49 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study start9 Feb 2012
- Primary completion2 Feb 2016
- Study completion3 Jun 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ono Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01472081
- Sponsor's protocol ID
- CA209-016
- Status last verified
- Nov 2021
- First submitted
- 26 Oct 2011
- Last updated
- 2 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Amin A, Plimack ER, Ernstoff MS, Lewis LD, Bauer TM, McDermott DF, Carducci M, Kollmannsberger C, Rini BI, Heng DYC, Knox J, Voss MH, Spratlin J, Berghorn E, Yang L, Hammers HJ. Safety and efficacy of nivolumab in combination with sunitinib or pazopanib in advanced or metastatic renal cell carcinoma: the CheckMate 016 study. J Immunother Cancer. 2018 Oct 22;6(1):109. doi: 10.1186/s40425-018-0420-0.
PubMed 30348216Dorff TB, Pal SK, Quinn DI. Novel tyrosine kinase inhibitors for renal cell carcinoma. Expert Rev Clin Pharmacol. 2014 Jan;7(1):67-73. doi: 10.1586/17512433.2014.862496. Epub 2013 Dec 2.
PubMed 24308791
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Nivolumab (BMS-936558) Plus Sunitinib, Pazopanib or Ipilimumab in Subjects With Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT01472081
- Acronym / sponsor ID
- CA209-016
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Ono Pharmaceutical Co., Ltd.
- Study start
- 9 Feb 2012 (actual)
- Primary completion
- 2 Feb 2016 (actual)
- Study completion
- 3 Jun 2021 (actual)
- First posted
- 16 Nov 2011 (estimated)
- Results
- Posted 2 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose is to determine the safety, effectiveness and best dose to use when giving Nivolumab in combination with Sunitinib, Pazopanib, or Ipilimumab for the treatment of metastatic renal cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm S: Nivolumab + Sunitinib | Experimental | Biological: Nivolumab, Drug: SunitinibNivolumab 0.3, 2.0 (starting dose), 5.0 mg/kg solution intravenously every 21 days until Progressive disease (PD), toxicity or discontinue for other reasons Sunitinib 50 mg capsule by mouth on Days 1-28 of 42 day cycle until Progressive disease (PD), toxicity or discontinue for other reasons |
| Arm P: Nivolumab + Pazopanib | Experimental | Biological: Nivolumab, Biological: PazopanibNivolumab 0.3, 2.0 (starting dose), 5.0 mg/kg solution intravenously every 21 days until Progressive disease (PD), toxicity or discontinue for other reasons Pazopanib 800 mg tablet by mouth daily until Progressive disease (PD), toxicity or discontinue for other reasons |
| Arm I-1: Nivolumab + Ipilimumab | Experimental | Biological: Nivolumab, Biological: IpilimumabNivolumab 3 mg/kg solution intravenously (IV) every 21 days during Induction phase and every 14 days during Maintenance phase until Progressive disease (PD), toxicity or discontinue for other reasons Ipilimumab 1mg/kg solution intravenously (IV) every 21 days during Induction phase (Ipilimumab will not be administered during Maintenance phase) until Progressive disease (PD), toxicity or discontinue for other reasons |
| Arm I-3: Nivolumab + Ipilimumab | Experimental | Biological: Nivolumab, Biological: IpilimumabNivolumab 1mg/kg solution intravenously (IV) every 21 days during Induction phase and 3mg/kg solution intravenously (IV) every 14 days during Maintenance phase Ipilimumab 3mg/kg solution intravenously (IV) every 21 days during Induction phase. Ipilimumab will not be administered during Maintenance phase |
| Arm IN-3: Nivolumab+Ipilimumab | Experimental | Biological: Nivolumab, Biological: IpilimumabNivolumab 3mg/kg solution intravenously (IV) every 21 days during Induction phase and 3mg/kg solution intravenously (IV) every 14 days during Maintenance phase Ipilimumab 3mg/kg solution intravenously (IV) every 21 days during Induction phase. Ipilimumab will not be administered during Maintenance phase |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects with histological confirmation of RCC
- Advanced or metastatic disease
- Measurable disease as defined by RECIST 1.1 criteria
- Karnofsky Performance Status (KPS) ≥80%
- Available tumor tissue (archival or recent acquisition)
Key exclusion criteria (16 listed)
- Active central nervous system (CNS) metastases
- Active or history of autoimmune disease
- Ongoing symptomatic cardiac dysrhythmias or uncontrolled atrial fibrillation
- History of cerebrovascular accident including transient ischemic attack within the past 12 months
- History of pulmonary embolism or deep vein thrombosis (DVT) within the past 6 months
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 (MDX-1106) | Biological | Arm I-1: Nivolumab + Ipilimumab, Arm I-3: Nivolumab + Ipilimumab, Arm IN-3: Nivolumab+Ipilimumab, Arm P: Nivolumab + Pazopanib, Arm S: Nivolumab + Sunitinib |
| PazopanibAlso: Votrient (Pazopanib hydrochloride) | Biological | Arm P: Nivolumab + Pazopanib |
| SunitinibAlso: Sutent®, Sunitinib Malate | Drug | Arm S: Nivolumab + Sunitinib |
| IpilimumabAlso: YERVOY™ | Biological | Arm I-1: Nivolumab + Ipilimumab, Arm I-3: Nivolumab + Ipilimumab, Arm IN-3: Nivolumab+Ipilimumab |
Primary outcome
Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation
Time frame: From date of first dose to date of last dose plus 100 days (assessed up to March 2016, approximately 49 months)
Safety assessments by treatment arm and dose level were based on incidence of AEs, and the incidence of serious adverse events (SAEs). AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling.
5 secondary outcomes
Best Overall Response Rate (BOR)
Time frame: From date of first dose to date of disease progression or subsequent anti-cancer therapy, whichever occurred first (assessed up to March 2016, approximately 49 months)
Objective Response Rate (ORR)
Time frame: From date of first dose to interim analysis (Assessed up to March 2016, approximately 49 months)
Duration of Response (DOR)
Time frame: From date of first dose to date of disease progression or death, whichever occurred first (assessed up to March 2016, approximately 49 months)
Rate of Progression-free Survival (PFS) at Week 24
Time frame: 24 weeks
Progression-free Survival (PFS)
Time frame: From date of first dose to date of disease progression or death, whichever occurred first (assessed up to March 2016, approximately 49 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30348216Amin A, Plimack ER, Ernstoff MS, Lewis LD, Bauer TM, McDermott DF, Carducci M, Kollmannsberger C, Rini BI, Heng DYC, Knox J, Voss MH, Spratlin J, Berghorn E, Yang L, Hammers HJ. Safety and efficacy of nivolumab in combination with sunitinib or pazopanib in advanced or metastatic renal cell carcinoma: the CheckMate 016 study. J Immunother Cancer. 2018 Oct 22;6(1):109. doi: 10.1186/s40425-018-0420-0.
- Derived from this study: PubMed 24308791Dorff TB, Pal SK, Quinn DI. Novel tyrosine kinase inhibitors for renal cell carcinoma. Expert Rev Clin Pharmacol. 2014 Jan;7(1):67-73. doi: 10.1586/17512433.2014.862496. Epub 2013 Dec 2.
- 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.
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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
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nivolumab, Pazopanib and Sunitinib in people with Renal Cell Carcinoma and Clear-cell Metastatic Renal Cell Carcinoma, run by Bristol-Myers Squibb at 14 sites in 2 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 8 inclusion and 16 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 2 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Canada. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 2 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?
Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation (time frame: From date of first dose to date of last dose plus 100 days (assessed up to March 2016, approximately 49 months)). 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 NCT01472081, 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 2 Dec 2021.