Advanced MalignanciesPhase 1NCT03158272
A Study of Cabiralzumab Given by Itself or With Nivolumab in Advanced Cancer or Cancer That Has Spread
A Phase 1 study testing Cabiralizumab and Nivolumab in people with Advanced Malignancies, run by Bristol-Myers Squibb at 4 sites in Japan.
Trial summary
The purpose of this study is to determine whether an investigational immuno-therapy, cabiralizumab in combination with nivolumab, is safe and tolerable in the treatment of advanced malignancies. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Advanced Malignancies
- What is being tested?
- Cabiralizumab and Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 4 sitesJapan
- Study dates
- 25 May 2017to 23 Oct 2019
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Performance status 0-1
- Adequate organ function
- Cohort M1, 2 and C1: Measurable disease
- Cohort M1, M2 and C1: Subjects must have histologic or cytologic confirmation of an advanced (metastatic and/or unresectable) malignant solid tumor
- Cohort C2: Documented refractory or relapsed multiple myeloma
- Subjects must be refractory to or have relapsed after standard therapies, or have no known effective treatment
Who cannot join
- Cohort M1, M2, and C1: Untreated or active central nervous system (CNS) or leptomeningeal metastases
- Cohort M1, M2, and C1: Subjects with hepatocellular carcinoma (HCC)
- Cohort C2: Subjects with solitary bone or extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Local Institution
Chuo-ku, Tokyo, 1040045
Local Institution
Kamogawa-shi, Chiba, 2968602
Local Institution
Kashiwa-shi, Chiba, 2778577
Local Institution
Nagoya, Aichi-ken, 4678602
About this study
Official title: A Phase 1 Study of Cabiralizumab (BMS-986227, FPA008) Administered Alone or in Combination With Nivolumab (BMS-936558) in Advanced Malignancies
The purpose of this study is to determine whether an investigational immuno-therapy, cabiralizumab in combination with nivolumab, is safe and tolerable in the treatment of advanced malignancies.
- Conditions
- Advanced Malignancies
- Being tested
- Cabiralizumab, Nivolumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabiralizumabBiological
Specified dose on specified days
NivolumabBiological
Also called Opdivo
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy | Experimental | Cabiralizumab administered as a single agent intravenous formulation Receives: Biological: Cabiralizumab |
| Combination Therapy | Experimental | Cabiralizumab will be administered in combination with Nivolumab as an intravenous formulation Receives: Biological: Cabiralizumab; Biological: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs) - Carbiralizumab Monotherapy
The number of participants that experienced an AE during the course of the study while participating in cabiralizumab monotherapy treatment.
Measured: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months
Number of Participants With Serious Adverse Events (SAEs) - Carbiralizumab Monotherapy
The number of participants that experienced a SAE during the course of the study while participating in cabiralizumab monotherapy treatment.
Measured: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months
Number of Participants With AEs Meeting Protocol-defined Dose-Limiting Toxicity (DLT) Criteria - Carbiralizumab Monotherapy
The number of participants that experienced an AE meeting protocol-defined DLT criteria during the course of the study while participating in cabiralizumab monotherapy treatment.
Measured: 28 days (from first day of treatment)
Number of Participants With AEs Leading to Discontinuation - Carbiralizumab Monotherapy
The number of participants that experienced an AE leading to discontinuation during the course of the study while participating in cabiralizumab monotherapy treatment.
Measured: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months
Number of Participants Who Died - Carbiralizumab Monotherapy
The number of participants that died during the course of the study while participating in cabiralizumab monotherapy treatment.
Measured: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months
Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy
The number of participants that experienced a laboratory abnormality during the course of the study while participating in cabiralizumab monotherapy treatment.
Measured: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months
Secondary outcomes (15)
Number of Participants With Adverse Events (AEs) - Carbiralizumab and Nivolumab Combo Therapy
The number of participants that experienced an AE during the course of the study while participating in cabiralizumab and nivolumab combination therapy.
Measured: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months
Number of Participants With Serious Adverse Events (SAEs) - Carbiralizumab and Nivolumab Combo Therapy
The number of participants that experienced an SAE during the course of the study while participating in cabiralizumab and nivolumab combination therapy.
Measured: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months
Number of Participants With AEs Leading to Discontinuation - Carbiralizumab and Nivolumab Combo Therapy
The number of participants that experienced an AE leading to discontinuation during the course of the study while participating in cabiralizumab and nivolumab combination therapy.
Measured: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months
Number of Participants Who Died - Carbiralizumab and Nivolumab Combo Therapy
The number of participants that died during the course of the study while participating in cabiralizumab and nivolumab combination therapy.
Measured: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
The number of participants that experienced a laboratory abnormality during the course of the study while participating in carbiralizumab and nivolumab combination therapy
Measured: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months
AI_Ctrough
Pharmacokinetics of cabiralizumab and nivolumab were derived from serum concentration versus time data.
Ctrough Accumulation Index; ratio of Ctrough at steady-state (i.e. Cycle 8) to Ctrough after the first dose
Data collected from participants participating in cabiralizumab monotherapy, as well as cabiralizumab and nivolumab combination therapy.
AI = Ctrough on cycle 8 / Ctrough on Cycle 2
Measured: Cycle 2 (pre-dose), Cycle 8 (pre-dose)
AUC(0-T)
Pharmacokinetics of cabiralizumab and nivolumab were derived from serum concentration versus time data.
AUC(0-T) is defined as the area under the serum concentration-time curve from time zero to time of last quantifiable concentration after the first dose.
Data collected from participants participating in cabiralizumab monotherapy, as well as cabiralizumab and nivolumab combination therapy.
Measured: Cycle 1 (from Day 1 pre-dose to Day 8, 168 hour)
AUC(TAU)
Pharmacokinetics of cabiralizumab and nivolumab were derived from serum concentration versus time data.
AUC(TAU) is defined as the area under the serum concentration-time curve in one dosing interval.
Data collected from participants participating in cabiralizumab monotherapy, as well as cabiralizumab and nivolumab combination therapy.
Measured: Cycle 1 (from Day 1 pre-dose to Day 8, 168 hour)
Cmax
Pharmacokinetics of cabiralizumab and nivolumab were derived from serum concentration versus time data.
Cmax is defined as the maximum observed serum concentration.
Data collected from participants participating in cabiralizumab monotherapy, as well as cabiralizumab and nivolumab combination therapy.
Measured: Cycle 1 (from Day 1 pre-dose to Day 8, 168 hour)
Ctrough
Pharmacokinetics of cabiralizumab and nivolumab were derived from serum concentration versus time data.
Ctrough is defined as the Trough observed serum concentration (predose at each cycle).
Data collected from participants participating in cabiralizumab monotherapy, as well as cabiralizumab and nivolumab combination therapy.
Measured: Cycles 1, 2, 3, 4, 5, 6, 7, 8, 9
T-HALFeff_Ctrough
Pharmacokinetics of cabiralizumab and nivolumab were derived from serum concentration versus time data.
T-HALFeff_Ctrough is defined as the effective elimination half-life that explains the degree of Ctrough accumulation observed.
Data collected from participants participating in cabiralizumab monotherapy, as well as cabiralizumab and nivolumab combination therapy.
Measured: Cycle 2 (pre-dose), Cycle 8 (pre-dose)
Tmax
Pharmacokinetics of cabiralizumab and nivolumab were derived from serum concentration versus time data.
Tmax is defined as the time of maximum observed serum concentration.
Data collected from participants participating in cabiralizumab monotherapy, as well as cabiralizumab and nivolumab combination therapy.
Measured: Cycle 1 (from Day 1 pre-dose to Day 8, 168 hour)
Incidence of Anti-drug Antibodies (ADA)
To characterize the immunogenicity of cabiralizumab and nivolumab.
Baseline ADA-positive participant is defined as a participant who has a ADA detected sample at baseline. ADA-positive participant is a participant with at least 1 ADA-positive sample relative to baseline after initiation of the treatment.
Data collected from participants participating in cabiralizumab monotherapy, as well as cabiralizumab and nivolumab combination therapy.
Measured: Day 1 pre-dose for cycles 2, 3, 5, 9, 13, 21
Best Overall Response (BOR)
To assess the preliminary anti-tumor activity of cabiralizumab administered alone and in combination with nivolumab per RECIST 1.1 (M1, M2, C1 cohorts: participants with advanced solid tumors) and per IMWG criteria (Cohort C2: participants with hematologic malignancies).
IMWG: International Myeloma Working Group
RECIST: Response Evaluation Criteria in Solid Tumors
Measured: From first dose to end of follow-up, assessed up to July 2019, approximately 24 months
Duration of Response (DOR)
To assess the preliminary anti-tumor activity of cabiralizumab administered alone and in combination with nivolumab per RECIST 1.1 (M1, M2, C1 cohorts: participants with advanced solid tumors) and per IMWG criteria (Cohort C2: participants with hematologic malignancies).
IMWG: International Myeloma Working Group
RECIST: Response Evaluation Criteria in Solid Tumors
Duration of response (DOR) was listed for participants with a BOR of complete response (CR) or partial response (PR).
Measured: From first dose to end of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start25 May 2017
- Primary completion23 Oct 2019
- Study completion23 Oct 2019
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.
- Other trials for Advanced MalignanciesStudies 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
- Model description
- Parallel assignment will only in combination therapy arm.
- Masking
- None (open label)
- Enrolment
- 19 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
- NCT03158272
- Sponsor's protocol ID
- CA025-001
- Status last verified
- Nov 2020
- First submitted
- 16 May 2017
- Last updated
- 21 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- 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 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Cabiralizumab (BMS-986227, FPA008) Administered Alone or in Combination With Nivolumab (BMS-936558) in Advanced Malignancies
- ClinicalTrials.gov ID
- NCT03158272
- Acronym / sponsor ID
- CA025-001
- Conditions
- Advanced Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Ono Pharmaceutical Co., Ltd.
- Study start
- 25 May 2017 (actual)
- Primary completion
- 23 Oct 2019 (actual)
- Study completion
- 23 Oct 2019 (actual)
- First posted
- 18 May 2017 (actual)
- Results
- Posted 21 Dec 2020
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 an investigational immuno-therapy, cabiralizumab in combination with nivolumab, is safe and tolerable in the treatment of advanced malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel assignment will only in combination therapy arm.
| Arm | Type | Receives |
|---|---|---|
| Monotherapy | Experimental | Biological: CabiralizumabCabiralizumab administered as a single agent intravenous formulation |
| Combination Therapy | Experimental | Biological: Cabiralizumab, Biological: NivolumabCabiralizumab will be administered in combination with Nivolumab as an intravenous formulation |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Performance status 0-1
- Adequate organ function
- Cohort M1, 2 and C1: Measurable disease
- Cohort M1, M2 and C1: Subjects must have histologic or cytologic confirmation of an advanced (metastatic and/or unresectable) malignant solid tumor
- Cohort C2: Documented refractory or relapsed multiple myeloma
Key exclusion criteria (4 listed)
- Cohort M1, M2, and C1: Untreated or active central nervous system (CNS) or leptomeningeal metastases
- Cohort M1, M2, and C1: Subjects with hepatocellular carcinoma (HCC)
- Cohort C2: Subjects with solitary bone or extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia
- 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 |
|---|---|---|
| CabiralizumabSpecified dose on specified days | Biological | Combination Therapy, Monotherapy |
| NivolumabAlso: OpdivoSpecified dose on specified days | Biological | Combination Therapy |
Primary outcome
Number of Participants With Adverse Events (AEs) - Carbiralizumab Monotherapy
Time frame: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months
The number of participants that experienced an AE during the course of the study while participating in cabiralizumab monotherapy treatment.
Number of Participants With Serious Adverse Events (SAEs) - Carbiralizumab Monotherapy
Time frame: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months
The number of participants that experienced a SAE during the course of the study while participating in cabiralizumab monotherapy treatment.
Number of Participants With AEs Meeting Protocol-defined Dose-Limiting Toxicity (DLT) Criteria - Carbiralizumab Monotherapy
Time frame: 28 days (from first day of treatment)
The number of participants that experienced an AE meeting protocol-defined DLT criteria during the course of the study while participating in cabiralizumab monotherapy treatment.
Number of Participants With AEs Leading to Discontinuation - Carbiralizumab Monotherapy
Time frame: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months
The number of participants that experienced an AE leading to discontinuation during the course of the study while participating in cabiralizumab monotherapy treatment.
Number of Participants Who Died - Carbiralizumab Monotherapy
Time frame: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months
The number of participants that died during the course of the study while participating in cabiralizumab monotherapy treatment.
Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy
Time frame: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months
The number of participants that experienced a laboratory abnormality during the course of the study while participating in cabiralizumab monotherapy treatment.
15 secondary outcomes
Number of Participants With Adverse Events (AEs) - Carbiralizumab and Nivolumab Combo Therapy
Time frame: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months
Number of Participants With Serious Adverse Events (SAEs) - Carbiralizumab and Nivolumab Combo Therapy
Time frame: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months
Number of Participants With AEs Leading to Discontinuation - Carbiralizumab and Nivolumab Combo Therapy
Time frame: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months
Number of Participants Who Died - Carbiralizumab and Nivolumab Combo Therapy
Time frame: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
Time frame: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months
AI_Ctrough
Time frame: Cycle 2 (pre-dose), Cycle 8 (pre-dose)
AUC(0-T)
Time frame: Cycle 1 (from Day 1 pre-dose to Day 8, 168 hour)
AUC(TAU)
Time frame: Cycle 1 (from Day 1 pre-dose to Day 8, 168 hour)
Cmax
Time frame: Cycle 1 (from Day 1 pre-dose to Day 8, 168 hour)
Ctrough
Time frame: Cycles 1, 2, 3, 4, 5, 6, 7, 8, 9
T-HALFeff_Ctrough
Time frame: Cycle 2 (pre-dose), Cycle 8 (pre-dose)
Tmax
Time frame: Cycle 1 (from Day 1 pre-dose to Day 8, 168 hour)
Incidence of Anti-drug Antibodies (ADA)
Time frame: Day 1 pre-dose for cycles 2, 3, 5, 9, 13, 21
Best Overall Response (BOR)
Time frame: From first dose to end of follow-up, assessed up to July 2019, approximately 24 months
Duration of Response (DOR)
Time frame: From first dose to end of follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
4 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 Cabiralizumab and Nivolumab in people with Advanced Malignancies, run by Bristol-Myers Squibb at 4 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 6 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 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Yes. Results are posted in the registry (first posted 21 Dec 2020). 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 Adverse Events (AEs) - Carbiralizumab Monotherapy (time frame: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months). 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 21 Dec 2020.