Renal Cell CarcinomaPhase 1PIVOT IO 011NCT04540705
A Study to Compare Bempegaldesleukin (BEMPEG: NKTR-214) Combined With Nivolumab and Tyrosine Kinase Inhibitor (TKI) to Nivolumab and TKI Alone in Participants With Previously Untreated Kidney Cancer That is Advanced or Has Spread
A Phase 1 study testing Nivolumab, Axitinib and Cabozantinib in people with Renal Cell Carcinoma, run by Bristol-Myers Squibb at 39 sites in 8 countries.
Trial summary
The purpose of this study is in Part 1, to determine the safety of nivolumab, bempegaldesleukin (BEMPEG: NKTR-214), and Tyrosine Kinase Inhibitor (TKI) combination. 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, Axitinib and Cabozantinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 39 sitesin 8 countries
- Study dates
- 11 Sep 2020to 18 Jan 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Histological confirmation of renal cell carcinoma (RCC) with clear cell component including participants who may also have sarcomatoid features
- Advanced (not amenable to curative surgery or radiation therapy) or metastatic (American Joint Committee on Cancer (AJCC) Stage 4) RCC
- No prior systemic therapy, including prior PD-L1 therapy, for RCC is allowed with the following exception:
- One prior adjuvant or neoadjuvant therapy for completely resectable RCC is allowed. Therapy must have included an agent that targets vascular endothelial growth factor (VEGF) pathway or VEGF receptors and recurrence must have occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy
- Life Expectancy ≥ 12 weeks
- Karnofsky Performance Status (KPS) of at least 70%
- Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1 criteria
- Males and females must agree to follow specific methods of contraception, if applicable
Who cannot join
- Active CNS brain metastases or leptomeningeal metastases
- Active, known or suspected autoimmune disease
- Inadequately treated adrenal insufficiency
- History of pulmonary embolism (PE), deep vein thrombosis (DVT), or prior clinically significant venous or non-CVA/TIA arterial thromboembolic event (eg, internal jugular vein thrombosis) within 3 months prior to treatment assignment (Part 1) and randomization (Part 2)
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
39 sites in 8 countries.
39 sites in 8 countries
United States8 sites
Local Institution - 0014
Houston, Texas, 77030-3721
Local Institution
Louisville, Kentucky, 40202
Local Institution
Nashville, Tennessee, 37232
Local Institution - 0009
New York, New York, 10065
Local Institution
Portland, Oregon, 97213
Local Institution - 0007
Seattle, Washington, 98109
Local Institution - 0005
Springdale, Arkansas, 72762
Local Institution - 0001
St Louis, Missouri, 63110
Brazil6 sites
Local Institution - 0032
Barretos, São Paulo, 14784400
Local Institution - 0030
Belo Horizonte, Minas Gerais, 30130-090
Local Institution - 0035
Curitiba, Paraná, 80730-150
Local Institution - 0028
Porto Alegre, Rio Grande do Sul, 91350-200
Local Institution - 0036
Santa Cruz do Sul, Rio Grande do Sul, 96830-180
Local Institution - 0029
São José do Rio Preto, São Paulo, 15090-000
Germany6 sites
Local Institution - 0042
Essen, 45147
Local Institution - 0045
Hanover, 30625
Local Institution - 0040
Jena, 07747
Local Institution - 0044
Munich, 81675
Local Institution - 0041
Nuremberg, 90419
Local Institution - 0046
Würzburg, 97080
Russia6 sites
Local Institution - 0059
Moscow, 115478
Local Institution - 0052
Moscow, 121205
Local Institution - 0087
Moscow, 121359
Local Institution - 0051
Novosibirsk, 630099
Local Institution - 0085
Omsk, 644013
Local Institution - 0058
Saint Petersburg, 197758
Argentina4 sites
Local Institution - 0026
Buenos Aires, 1419
Local Institution - 0025
Mar del Plata, Buenos Aires, 7600
Local Institution - 0075
Río Cuarto, Córdoba Province, X5800ALB
Local Institution - 0024
San Juan, 5400
Canada4 sites
Local Institution - 0056
Edmonton, Alberta, T6G 1Z2
Local Institution - 0022
St. John's, Newfoundland and Labrador, A1B 3V6
Local Institution - 0008
Toronto, Ontario, M5G 1Z5
Local Institution - 0015
Vancouver, British Columbia, V5Z 4E6
Mexico4 sites
Local Institution - 0048
Mexico City, Mexico City, 14080
Local Institution - 0049
Monterrey, Nuevo León, 66460
Local Institution - 0055
Querétaro, 76000
Local Institution - 0050
Zapopan, Jalisco, 45070
About this study
Official title: A Phase 1 Study to Compare Bempegaldesleukin Combined With Nivolumab and Tyrosine Kinase Inhibitor (TKI) to Nivolumab and TKI Alone in Participants With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (mRCC) (PIVOT IO 011)
The purpose of this study is in Part 1, to determine the safety of nivolumab, bempegaldesleukin (BEMPEG: NKTR-214), and Tyrosine Kinase Inhibitor (TKI) combination.
- Conditions
- Renal Cell Carcinoma
- Being tested
- Nivolumab, Axitinib, Cabozantinib
- Keywords
- NKTR-214, nivolumab, bempeg
- 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.
NivolumabBiological
Also called OPDIVO
Specified dose on specified days
AxitinibDrug
Also called INLYTA
Specified dose on specified days
CabozantinibDrug
Also called Cabometyx
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part 1A (Part 1): Nivolumab + Axitinib | Experimental | Not described Receives: Biological: Nivolumab; Drug: Axitinib |
| Part 1B (Part 1): Nivolumab + Cabozantinib | Experimental | Not described Receives: Biological: Nivolumab; Drug: Cabozantinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs) by severity (Part 1)
Measured: Up to 2.5 years
Incidence of serious adverse events (SAEs) (Part 1)
Measured: Up to 2.5 years
Incidence of dose-limiting toxicities (DLTs) (Part 1)
Measured: Up to 2.5 years
Incidence of AEs leading to discontinuation (Part 1)
Measured: Up to 5 years
Incidence of immune-mediated adverse events (imAEs) (Part 1)
Measured: Up to 5 years
Incidence of changes in clinical laboratory results by severity: Hematology tests (Part 1)
Measured: Up to 2.5 years
Incidence of changes in clinical laboratory results by severity: Clinical Chemistry tests (Part 1)
Measured: Up to 2.5 years
Incidence of changes in clinical laboratory results by severity: Urinalysis tests (Part 1)
Measured: Up to 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start11 Sep 2020
- Primary completion18 Jan 2024
- Study completion18 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nektar Therapeutics
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04540705
- Sponsor's protocol ID
- CA045-011
- Other IDs
- 2018-003200-39, 18-214-15, 2018
- Acronym
- PIVOT IO 011
- Status last verified
- Feb 2024
- First submitted
- 3 Sep 2020
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Compare Bempegaldesleukin Combined With Nivolumab and Tyrosine Kinase Inhibitor (TKI) to Nivolumab and TKI Alone in Participants With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (mRCC) (PIVOT IO 011)
- ClinicalTrials.gov ID
- NCT04540705
- Acronym / sponsor ID
- PIVOT IO 011 / CA045-011
- Conditions
- Renal Cell Carcinoma
- Keywords
- NKTR-214, nivolumab, bempeg
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Nektar Therapeutics
- Study start
- 11 Sep 2020 (actual)
- Primary completion
- 18 Jan 2024 (actual)
- Study completion
- 18 Jan 2024 (actual)
- First posted
- 7 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is in Part 1, to determine the safety of nivolumab, bempegaldesleukin (BEMPEG: NKTR-214), and Tyrosine Kinase Inhibitor (TKI) combination.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1A (Part 1): Nivolumab + Axitinib | Experimental | Biological: Nivolumab, Drug: Axitinib |
| Part 1B (Part 1): Nivolumab + Cabozantinib | Experimental | Biological: Nivolumab, Drug: Cabozantinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histological confirmation of renal cell carcinoma (RCC) with clear cell component including participants who may also have sarcomatoid features
- Advanced (not amenable to curative surgery or radiation therapy) or metastatic (American Joint Committee on Cancer (AJCC) Stage 4) RCC
- No prior systemic therapy, including prior PD-L1 therapy, for RCC is allowed with the following exception:
- Life Expectancy ≥ 12 weeks
- Karnofsky Performance Status (KPS) of at least 70%
Key exclusion criteria (5 listed)
- Active CNS brain metastases or leptomeningeal metastases
- Active, known or suspected autoimmune disease
- Inadequately treated adrenal insufficiency
- History of pulmonary embolism (PE), deep vein thrombosis (DVT), or prior clinically significant venous or non-CVA/TIA arterial thromboembolic event (eg, internal jugular vein thrombosis) within 3 months prior to treatment assignment (Part 1) and randomization (Part 2)
- 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: OPDIVOSpecified dose on specified days | Biological | Part 1A (Part 1): Nivolumab + Axitinib, Part 1B (Part 1): Nivolumab + Cabozantinib |
| AxitinibAlso: INLYTASpecified dose on specified days | Drug | Part 1A (Part 1): Nivolumab + Axitinib |
| CabozantinibAlso: CabometyxSpecified dose on specified days | Drug | Part 1B (Part 1): Nivolumab + Cabozantinib |
Primary outcome
Incidence of adverse events (AEs) by severity (Part 1)
Time frame: Up to 2.5 years
Incidence of serious adverse events (SAEs) (Part 1)
Time frame: Up to 2.5 years
Incidence of dose-limiting toxicities (DLTs) (Part 1)
Time frame: Up to 2.5 years
Incidence of AEs leading to discontinuation (Part 1)
Time frame: Up to 5 years
Incidence of immune-mediated adverse events (imAEs) (Part 1)
Time frame: Up to 5 years
Incidence of changes in clinical laboratory results by severity: Hematology tests (Part 1)
Time frame: Up to 2.5 years
Incidence of changes in clinical laboratory results by severity: Clinical Chemistry tests (Part 1)
Time frame: Up to 2.5 years
Incidence of changes in clinical laboratory results by severity: Urinalysis tests (Part 1)
Time frame: Up to 2.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink 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
39 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nivolumab, Axitinib and Cabozantinib in people with Renal Cell Carcinoma, run by Bristol-Myers Squibb at 39 sites in 8 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 5 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 28 Feb 2024. 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, Brazil, Germany, Russia, Argentina and 3 more countries. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of adverse events (AEs) by severity (Part 1) (time frame: Up to 2.5 years). The study lists 8 primary outcomes in all. 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 28 Feb 2024; AzTrials last refreshed its copy on 2 Nov 2026.