A Study of Cabiralzumab Given by Itself or With Nivolumab in Advanced Cancer or Cancer That Has Spread

November 24, 2020 updated by: Bristol-Myers Squibb

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Aichi
      • Nagoya-shi, Aichi, Japan, 4678602
        • Local Institution
    • Chiba
      • Kamogawa-shi, Chiba, Japan, 2968602
        • Local Institution
      • Kashiwa-shi, Chiba, Japan, 2778577
        • Local Institution
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 1040045
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Monotherapy
Cabiralizumab administered as a single agent intravenous formulation
Biological: Cabiralizumab
Specified dose on specified days
Experimental: Combination Therapy
Cabiralizumab will be administered in combination with Nivolumab as an intravenous formulation
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
Biological: Cabiralizumab
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
28 days (from first day of 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.
From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months
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.
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
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.
From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
The number of participants that experienced an AE during the course of the study while participating in cabiralizumab and nivolumab combination therapy.
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
The number of participants that experienced an SAE during the course of the study while participating in cabiralizumab and nivolumab combination therapy.
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
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.
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
The number of participants that died during the course of the study while participating in cabiralizumab and nivolumab combination therapy.
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
The number of participants that experienced a laboratory abnormality during the course of the study while participating in carbiralizumab and nivolumab combination therapy
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)

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
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)

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.
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)

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.
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)

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.
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

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.
Cycles 1, 2, 3, 4, 5, 6, 7, 8, 9
T-HALFeff_Ctrough
Time Frame: Cycle 2 (pre-dose), Cycle 8 (pre-dose)

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.
Cycle 2 (pre-dose), Cycle 8 (pre-dose)
Tmax
Time Frame: Cycle 1 (from Day 1 pre-dose to Day 8, 168 hour)

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.
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

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.
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

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
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

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).
From first dose to end of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ono Pharmaceutical Co. Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 25, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 23, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 23, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 16, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 21, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA025-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Advanced Malignancies

Clinical Trials on Nivolumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings