A Study of the Safety and Tolerability of BMS-986183 in Patients With Liver Cancer

NCT02828124 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: CA015-003
• Study Type: interventional
• Target: 25
• Locations: 4 countries
• Sites: 4

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of BMS-986183 in patients with liver cancer.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (5)

• Incidence of Adverse Events at Its Worst Grade

  Evaluated by comparing the incidence of Adverse Events (AEs) among subjects using their assigned treatment for at least one day.

  First dose up to approximately 24 months

• Incidence of Serious Adverse Events at Its Worst Grade

  Evaluated by comparing the incidence of Serious Adverse Events (SAEs) among subjects using their assigned treatment for at least one day.

  First dose up to approximately 24 months

• Incidence of Adverse Events Leading to Discontinuation

  Evaluated by comparing the incidence of Adverse Events leading to discontinuation among subjects using their assigned treatment for at least one day.

  First dose up to approximately 24 months

• Incidence of Adverse Events Leading to Death

  Evaluated by comparing the incidence of Adverse Events leading to death among subjects using their assigned treatment for at least one day.

  First dose up to approximately 24 months

• Incidence of Laboratory Test Toxicity Grade Shifting From Baseline

  First dose up to approximately 24 months

Secondary Outcomes (21)

• Best Overall Response (BOR)

  First dose up to approximately 24 months

• Overall Response Rate (ORR)

  First dose up to approximately 24 months

• Duration of Response (DoR)

  First dose up to approximately 24 months

• Progression Free Survival (PFS)

  First dose up to approximately 24 months

• PFS Rate at Week 't'

  First dose up to approximately 24 months

Study Arms (4)

Dose Escalation Monotherapy

EXPERIMENTAL

Biological: BMS-986183

Dose Expansion Monotherapy

EXPERIMENTAL

Biological: BMS-986183

Dose Escalation Combination Therapy

EXPERIMENTAL

Biological: BMS-986183; Biological: Nivolumab

Dose Expansion Combination Therapy

EXPERIMENTAL

Biological: BMS-986183; Biological: Nivolumab

Interventions

BMS-986183 BIOLOGICAL

specified dose on specified days

Dose Escalation Combination Therapy; Dose Escalation Monotherapy; Dose Expansion Combination Therapy; Dose Expansion Monotherapy

Nivolumab BIOLOGICAL

specified dose on specified days

Also known as: BMS-936558, Opdivo

Dose Escalation Combination Therapy; Dose Expansion Combination Therapy

Eligibility Criteria

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

You may qualify if:

• Must have advanced liver cancer that cannot be treated with surgery or other local methods
• Liver cancer is confirmed by a microscopic examination of tissue
• Liver disease is classified as 'A' by a standard method called Child-Pugh score
• Daily living abilities are classified as '0 or 1' by a standard method from the Eastern Cooperative Oncology Group (ECOG)
• Women must use contraception

You may not qualify if:

• Prior liver transplant
• Increase in blood pressure in some of the veins entering the liver
• Cancer that has spread to the brain or the layers of tissue that cover the brain or spinal cord
• Infection with both hepatitis B and C, both hepatitis D and B, infection with HIV, or other infections
• Disease of the heart or blood vessels around the heart
• Active cancers within the last 2 years
• No more than 2 prior systemic treatments or other investigational agents except PD-1/PD-L1 or Ipilimumab (Part 2)
• Currently on anti-platelet or anti-coagulation therapy
• Radiotherapy within 4 weeks of treatment
• Any major allergies

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (4)

Local Institution

Ottawa, Ontario, K1H 8L6, Canada

Location

Local Institution

Singapore, 169610, Singapore

Location

Local Institution

Seoul, 05505, South Korea

Location

Local Institution

Taipei, 10048, Taiwan

Location

Related Links

• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

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: Phase 1/2 Study of BMS-986183 in Subjects with Advanced Hepatocellular Carcinoma
• 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: OTHER
• 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

Study Record Dates

• First Submitted: July 7, 2016
• First Posted: July 11, 2016
• Study Start: August 23, 2016
• Primary Completion: January 8, 2018
• Study Completion: January 8, 2018
• Last Updated: January 30, 2019
• Results First Posted: January 30, 2019

Record last verified: 2019-01

Locations

CA (1); SG (1); TW (1); KR (1)