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

NCT03158272 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: CA025-001
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Advanced Malignancies

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  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

  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

  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

  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

  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

  From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months

Study Arms (2)

Monotherapy

EXPERIMENTAL

Cabiralizumab administered as a single agent intravenous formulation

Biological: Cabiralizumab

Combination Therapy

EXPERIMENTAL

Cabiralizumab will be administered in combination with Nivolumab as an intravenous formulation

Biological: Cabiralizumab; Biological: Nivolumab

Interventions

Cabiralizumab BIOLOGICAL

Specified dose on specified days

Combination Therapy; Monotherapy

Nivolumab BIOLOGICAL

Specified dose on specified days

Also known as: Opdivo

Combination Therapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Ono Pharmaceutical Co. Ltd: collaborator

Study Sites (4)

Local Institution

Nagoya, Aichi-ken, 4678602, Japan

Location

Local Institution

Kamogawa-shi, Chiba, 2968602, Japan

Location

Local Institution

Kashiwa-shi, Chiba, 2778577, Japan

Location

Local Institution

Chuo-ku, Tokyo, 1040045, Japan

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Interventions

cabiralizumab; Nivolumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email:

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel assignment will only in combination therapy arm.

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 18, 2017
• Study Start: May 25, 2017
• Primary Completion: October 23, 2019
• Study Completion: October 23, 2019
• Last Updated: December 21, 2020
• Results First Posted: December 21, 2020

Record last verified: 2020-11

Locations

JP (4)