Advanced CancerPhase 1NCT03203876
A Safety Study of Lirilumab in Combination With Nivolumab or in Combination With Nivolumab and Ipilimumab in Advanced and/or Metastatic Solid Tumors
A Phase 1 study testing Lirilumab, Nivolumab and Ipilimumab in people with Advanced Cancer, run by Bristol-Myers Squibb at 2 sites in Japan.
Trial summary
The purpose of this study is to determine whether lirilumab in combination with nivolumab or in combination with nivolumab and ipilimumab is safe in the treatment of advanced and/or metastatic solid 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?
- Lirilumab, Nivolumab and Ipilimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesJapan
- Study dates
- 14 Jul 2017to 6 Aug 2020
- 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
- For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
- Participants must have histologic or cytologic confirmation of a solid malignancy that is advanced (metastatic and/or unresectable)
- Presence of at least 1 lesion with measurable disease as defined by response evaluation criteria in solid tumors version 1.1 (RECIST v1.1) criteria for response assessment
- The Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Who cannot join
- Participants with untreated central nervous system (CNS) metastases
- Participants with an active, known, or suspected autoimmune disease
- Uncontrolled or significant cardiovascular disease
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Local Institution
Kashiwa-shi, Chiba, 2778577
Local Institution
Kobe, Hyōgo, 6500017
About this study
Official title: A Phase 1 Study of the Safety and Pharmacokinetics of Anti-KIR Monoclonal Antibody (Lirilumab, BMS-986015) in Combination With Anti-PD-1 Monoclonal Antibody (Nivolumab,BMS-936558) or in Combination With Nivolumab and Anti-CTLA-4 Monoclonal Antibody (Ipilimumab, BMS-734016) in Advanced and/or Metastatic Solid Tumors
The purpose of this study is to determine whether lirilumab in combination with nivolumab or in combination with nivolumab and ipilimumab is safe in the treatment of advanced and/or metastatic solid tumors
- Conditions
- Advanced Cancer
- Being tested
- Lirilumab, Nivolumab, Ipilimumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LirilumabBiological
Also called BMS-986015
Specified dose on specified days
NivolumabBiological
Also called BMS-936558, Opdivo
Specified dose on specified days
IpilimumabBiological
Also called BMS-734016, Yervoy
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part One Combination Therapy | Experimental | Lirilumab and Nivolumab Receives: Biological: Lirilumab; Biological: Nivolumab |
| Part 2 Combination Therapy | Experimental | Lirilumab, Nivolumab and Ipilimumab Receives: Biological: Lirilumab; Biological: Nivolumab; Biological: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicity (DLT)
To assess the safety and tolerability of lirilumab in combination with nivolumab
Measured: Up to two years
Incidence of adverse events (AEs)
To assess the safety and tolerability of lirilumab in combination with nivolumab
Measured: Up to two years
Incidence of serious adverse events (SAEs)
To assess the safety and tolerability of lirilumab in combination with nivolumab
Measured: Up to two years
Incidence of death
To assess the safety and tolerability of lirilumab in combination with nivolumab
Measured: Up to two years
Frequency of laboratory test toxicity grade shifting from baseline
To assess the safety and tolerability of lirilumab in combination with nivolumab
Measured: Up to two years
Incidence of AEs leading to discontinuation
To assess the safety and tolerability of lirilumab in combination with nivolumab
Measured: Up to two years
Secondary outcomes (31)
Incidence of dose-limiting toxicity (DLT)
To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab
Measured: Up to two years
Incidence of adverse events (AEs)
To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab
Measured: Up to two years
Incidence of serious adverse events (SAEs)
To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab
Measured: Up to two years
Incidence of death
To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab
Measured: Up to two years
Frequency of laboratory test toxicity grade shifting from baseline
To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab
Measured: Up to two years
Maximum serum observed concentration (Cmax)
To characterize the Pharmacokinetic (PK) of lirilumab given in combination with nivolumab
Measured: Up to two years
Time of maximum observed serum concentration (Tmax)
To characterize the PK of lirilumab given in combination with nivolumab
Measured: Up to two years
Area under the serum concentration-time curve from time zero to the time of last quantifiable concentration [AUC(0-T)]
To characterize the PK of lirilumab given in combination with nivolumab
Measured: Up to two years
Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
To characterize the PK of lirilumab given in combination with nivolumab
Measured: Up to two years
Trough observed serum concentration (Ctrough)
To characterize the PK of lirilumab given in combination with nivolumab
Measured: Up to two years
Area under the serum concentration-time curve in one dosing interval [AUC(TAU)]
To characterize the PK of lirilumab given in combination with nivolumab
Measured: Up to two years
Clearance (CL)
To characterize the PK and immunogenicity of lirilumab given in combination with nivolumab
Measured: Up to two years
Volume of distribution at steady state (Vss)
To characterize the PK of lirilumab given in combination with nivolumab
Measured: Up to two years
Ratio of an exposure measure at steady-state to that after the first dose (AI)
To characterize the PK of lirilumab given in combination with nivolumab
Measured: Up to two years
Half-life (T-HALF)
To characterize the PK of lirilumab given in combination with nivolumab
Measured: Up to two years
Effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure (T-HALF eff)
To characterize the PK of lirilumab given in combination with nivolumab
Measured: Up to two years
Best overall response (BOR)
To assess the preliminary anti-tumor activity
Measured: Up to two years
Duration of response (DOR)
To assess the preliminary anti-tumor activity
Measured: Up to two years
Incidence of anti-drug antibody (ADA)
To characterize immunogenicity
Measured: Up to two years
Incidence of AEs leading to discontinuation
To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab
Measured: Up to two years
Maximum serum observed concentration (Cmax)
To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab
Measured: Up to two years
Time of maximum observed serum concentration (Tmax)
To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab
Measured: Up to two years
Area under the serum concentration-time curve from time zero to the time of last quantifiable concentration [AUC(0-T)]
To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab
Measured: Up to two years
Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab
Measured: Up to two years
Trough observed serum concentration (Ctrough)
To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab
Measured: Up to two years
Area under the serum concentration-time curve in one dosing interval [AUC(TAU)]
To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab
Measured: Up to two years
Clearance (CL)
To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab
Measured: Up to two years
Volume of distribution at steady state (Vss)
To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab
Measured: Up to two years
Ratio of an exposure measure at steady-state to that after the first dose (AI)
To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab
Measured: Up to two years
Half-life (T-HALF)
To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab
Measured: Up to two years
Effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure (T-HALF eff)
To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab
Measured: Up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start14 Jul 2017
- Primary completion6 Aug 2020
- Study completion6 Aug 2020
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT03203876
- Sponsor's protocol ID
- CA223-030
- Status last verified
- Mar 2022
- First submitted
- 28 Jun 2017
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of the Safety and Pharmacokinetics of Anti-KIR Monoclonal Antibody (Lirilumab, BMS-986015) in Combination With Anti-PD-1 Monoclonal Antibody (Nivolumab,BMS-936558) or in Combination With Nivolumab and Anti-CTLA-4 Monoclonal Antibody (Ipilimumab, BMS-734016) in Advanced and/or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT03203876
- Acronym / sponsor ID
- CA223-030
- Conditions
- Advanced Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Ono Pharmaceutical Co., Ltd.
- Study start
- 14 Jul 2017 (actual)
- Primary completion
- 6 Aug 2020 (actual)
- Study completion
- 6 Aug 2020 (actual)
- First posted
- 29 Jun 2017 (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 determine whether lirilumab in combination with nivolumab or in combination with nivolumab and ipilimumab is safe in the treatment of advanced and/or metastatic solid tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part One Combination Therapy | Experimental | Biological: Lirilumab, Biological: NivolumabLirilumab and Nivolumab |
| Part 2 Combination Therapy | Experimental | Biological: Lirilumab, Biological: Nivolumab, Biological: IpilimumabLirilumab, Nivolumab and Ipilimumab |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
- Participants must have histologic or cytologic confirmation of a solid malignancy that is advanced (metastatic and/or unresectable)
- Presence of at least 1 lesion with measurable disease as defined by response evaluation criteria in solid tumors version 1.1 (RECIST v1.1) criteria for response assessment
- The Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Key exclusion criteria (4 listed)
- Participants with untreated central nervous system (CNS) metastases
- Participants with an active, known, or suspected autoimmune disease
- Uncontrolled or significant cardiovascular disease
- 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 |
|---|---|---|
| LirilumabAlso: BMS-986015Specified dose on specified days | Biological | Part 2 Combination Therapy, Part One Combination Therapy |
| NivolumabAlso: BMS-936558, OpdivoSpecified dose on specified days | Biological | Part 2 Combination Therapy, Part One Combination Therapy |
| IpilimumabAlso: BMS-734016, YervoySpecified dose on specified days | Biological | Part 2 Combination Therapy |
Primary outcome
Incidence of dose-limiting toxicity (DLT)
Time frame: Up to two years
To assess the safety and tolerability of lirilumab in combination with nivolumab
Incidence of adverse events (AEs)
Time frame: Up to two years
To assess the safety and tolerability of lirilumab in combination with nivolumab
Incidence of serious adverse events (SAEs)
Time frame: Up to two years
To assess the safety and tolerability of lirilumab in combination with nivolumab
Incidence of death
Time frame: Up to two years
To assess the safety and tolerability of lirilumab in combination with nivolumab
Frequency of laboratory test toxicity grade shifting from baseline
Time frame: Up to two years
To assess the safety and tolerability of lirilumab in combination with nivolumab
Incidence of AEs leading to discontinuation
Time frame: Up to two years
To assess the safety and tolerability of lirilumab in combination with nivolumab
31 secondary outcomes
Incidence of dose-limiting toxicity (DLT)
Time frame: Up to two years
Incidence of adverse events (AEs)
Time frame: Up to two years
Incidence of serious adverse events (SAEs)
Time frame: Up to two years
Incidence of death
Time frame: Up to two years
Frequency of laboratory test toxicity grade shifting from baseline
Time frame: Up to two years
Maximum serum observed concentration (Cmax)
Time frame: Up to two years
Time of maximum observed serum concentration (Tmax)
Time frame: Up to two years
Area under the serum concentration-time curve from time zero to the time of last quantifiable concentration [AUC(0-T)]
Time frame: Up to two years
Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Time frame: Up to two years
Trough observed serum concentration (Ctrough)
Time frame: Up to two years
Area under the serum concentration-time curve in one dosing interval [AUC(TAU)]
Time frame: Up to two years
Clearance (CL)
Time frame: Up to two years
Volume of distribution at steady state (Vss)
Time frame: Up to two years
Ratio of an exposure measure at steady-state to that after the first dose (AI)
Time frame: Up to two years
Half-life (T-HALF)
Time frame: Up to two years
Effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure (T-HALF eff)
Time frame: Up to two years
Best overall response (BOR)
Time frame: Up to two years
Duration of response (DOR)
Time frame: Up to two years
Incidence of anti-drug antibody (ADA)
Time frame: Up to two years
Incidence of AEs leading to discontinuation
Time frame: Up to two years
Maximum serum observed concentration (Cmax)
Time frame: Up to two years
Time of maximum observed serum concentration (Tmax)
Time frame: Up to two years
Area under the serum concentration-time curve from time zero to the time of last quantifiable concentration [AUC(0-T)]
Time frame: Up to two years
Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Time frame: Up to two years
Trough observed serum concentration (Ctrough)
Time frame: Up to two years
Area under the serum concentration-time curve in one dosing interval [AUC(TAU)]
Time frame: Up to two years
Clearance (CL)
Time frame: Up to two years
Volume of distribution at steady state (Vss)
Time frame: Up to two years
Ratio of an exposure measure at steady-state to that after the first dose (AI)
Time frame: Up to two years
Half-life (T-HALF)
Time frame: Up to two years
Effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure (T-HALF eff)
Time frame: Up to two 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 10 Mar 2022.
- 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lirilumab, Nivolumab and Ipilimumab in people with Advanced Cancer, run by Bristol-Myers Squibb at 2 sites 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 4 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 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 dose-limiting toxicity (DLT) (time frame: Up to two 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 10 Mar 2022.