Advanced CancerPhase 1NCT03745807
An Investigational Study of NKTR-214 Combined With Nivolumab in Japanese Participants With Advanced Solid Tumors
A Phase 1 study testing NKTR-214 and Nivolumab in people with Advanced Cancer, run by Bristol-Myers Squibb at 1 site in Japan.
Trial summary
The purpose of this study is to assess the safety and tolerability of NTKR-214 in combination with nivolumab in Japanese participants with advanced malignant tumors. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- NKTR-214 and Nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteJapan
- Study dates
- 9 Apr 2019to 18 Dec 2019
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic or cytological confirmation of an advanced (metastatic and/or unresectable) malignant solid tumor with measurable disease per RECIST v1.1.
- Life expectancy >12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Who cannot join
- Active, known or suspected autoimmune disease.
- History of organ transplant that requires use of immune suppressive agents.
- Prior surgery or radiotherapy within 14 days of Cycle 1 Day 1. Participants must have recovered from all radiation-related, toxicities and not requiring corticosteroids.
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study to Evaluate Safety and Tolerability of NKTR-214 (BMS-986321) Administered in Combination With Nivolumab (BMS-936558) in Advanced Malignant Tumors
The purpose of this study is to assess the safety and tolerability of NTKR-214 in combination with nivolumab in Japanese participants with advanced malignant tumors.
- Conditions
- Advanced Cancer
- Being tested
- NKTR-214, Nivolumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NKTR-214Biological
Also called Bempegaldesleukin, BMS-986321
Specified dose on specified days
NivolumabBiological
Also called Opdivo, BMS-936558
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Combination | Experimental | NKTR-214 + nivolumab Receives: Biological: NKTR-214; Biological: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs)
Measured: Approximately 2 years
Incidence of serious adverse events (SAEs)
Measured: Approximately 2 years
Incidence of AEs leading to discontinuation
Measured: Approximately 2 years
Incidence of deaths
Measured: Approximately 2 years
Incidence of AEs meeting protocol-defined dose limiting toxicity (DLT) criteria
Measured: Approximately 2 years
Incidence of laboratory abnormalities
Measured: Approximately 2 years
Secondary outcomes (12)
Maximum observed concentration (Cmax)
Measured: Approximately 2 years
Time of maximum observed concentration (Tmax)
Measured: Approximately 2 years
Area under the concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Measured: Approximately 2 years
Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Measured: Approximately 2 years
Total body clearance (CLT)
Measured: Approximately 2 years
Volume of distribution (Vz)
Measured: Approximately 2 years
Apparent terminal phase half-life (T-HALF)
Measured: Approximately 2 years
Trough observed serum concentration at the end of the dosing interval (Ctrough)
Measured: Approximately 2 years
Incidence of anti-drug antibodies (ADA) to NKTR-214
Measured: Approximately 2 years
Incidence of anti-drug antibodies (ADA) to nivolumab
Measured: Approximately 2 years
Best overall response (BOR)
Measured: Approximately 2 years
Duration of response (DOR)
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start9 Apr 2019
- Primary completion18 Dec 2019
- Study completion18 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nektar Therapeutics, Ono Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03745807
- Sponsor's protocol ID
- CA045-010
- Other IDs
- 18-214-14
- Status last verified
- Sep 2021
- First submitted
- 16 Nov 2018
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual patient level data from this study may be shared with qualified researchers, upon request, following the timelines and process detailed on https://www.bms.com/researchers-and-partners/independent-research/data-sharing-request-process.html
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate Safety and Tolerability of NKTR-214 (BMS-986321) Administered in Combination With Nivolumab (BMS-936558) in Advanced Malignant Tumors
- ClinicalTrials.gov ID
- NCT03745807
- Acronym / sponsor ID
- CA045-010
- Conditions
- Advanced Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Nektar Therapeutics, Ono Pharmaceutical Co., Ltd.
- Study start
- 9 Apr 2019 (actual)
- Primary completion
- 18 Dec 2019 (actual)
- Study completion
- 18 Dec 2019 (actual)
- First posted
- 19 Nov 2018 (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 to assess the safety and tolerability of NTKR-214 in combination with nivolumab in Japanese participants with advanced malignant tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination | Experimental | Biological: NKTR-214, Biological: NivolumabNKTR-214 + nivolumab |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologic or cytological confirmation of an advanced (metastatic and/or unresectable) malignant solid tumor with measurable disease per RECIST v1.1.
- Life expectancy >12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (4 listed)
- Active, known or suspected autoimmune disease.
- History of organ transplant that requires use of immune suppressive agents.
- Prior surgery or radiotherapy within 14 days of Cycle 1 Day 1. Participants must have recovered from all radiation-related, toxicities and not requiring corticosteroids.
- Other protocol defined inclusion/exclusion criteria could 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 |
|---|---|---|
| NKTR-214Also: Bempegaldesleukin, BMS-986321Specified dose on specified days | Biological | Combination |
| NivolumabAlso: Opdivo, BMS-936558Specified dose on specified days | Biological | Combination |
Primary outcome
Incidence of adverse events (AEs)
Time frame: Approximately 2 years
Incidence of serious adverse events (SAEs)
Time frame: Approximately 2 years
Incidence of AEs leading to discontinuation
Time frame: Approximately 2 years
Incidence of deaths
Time frame: Approximately 2 years
Incidence of AEs meeting protocol-defined dose limiting toxicity (DLT) criteria
Time frame: Approximately 2 years
Incidence of laboratory abnormalities
Time frame: Approximately 2 years
12 secondary outcomes
Maximum observed concentration (Cmax)
Time frame: Approximately 2 years
Time of maximum observed concentration (Tmax)
Time frame: Approximately 2 years
Area under the concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Time frame: Approximately 2 years
Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Time frame: Approximately 2 years
Total body clearance (CLT)
Time frame: Approximately 2 years
Volume of distribution (Vz)
Time frame: Approximately 2 years
Apparent terminal phase half-life (T-HALF)
Time frame: Approximately 2 years
Trough observed serum concentration at the end of the dosing interval (Ctrough)
Time frame: Approximately 2 years
Incidence of anti-drug antibodies (ADA) to NKTR-214
Time frame: Approximately 2 years
Incidence of anti-drug antibodies (ADA) to nivolumab
Time frame: Approximately 2 years
Best overall response (BOR)
Time frame: Approximately 2 years
Duration of response (DOR)
Time frame: Approximately 2 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 4 Oct 2021.
- 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.
- Individual participant dataSharing planned: Yes. Individual patient level data from this study may be shared with qualified researchers, upon request, following the timelines and process detailed on https://www.bms.com/researchers-and-partners/independent-research/data-sharing-request-process.html
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NKTR-214 and Nivolumab in people with Advanced Cancer, run by Bristol-Myers Squibb at 1 site in Japan.
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 3 inclusion and 4 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 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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) (time frame: Approximately 2 years). The study lists 6 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 4 Oct 2021.