A Study of Safety, Tolerability and Pharmacokinetics of Nivolumab in Chinese Subjects With Previously Treated Advanced or Recurrent Solid Tumors

NCT02593786 | Completed Phase 1 Results FDA Drug

• 1 other identifier: CA209-077
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine whether nivolumab is safe and effective in the treatment of advanced or recurrent solid tumors in Chinese subjects.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (4)

• The Number of Participants Experiencing Drug-Related Grade 3-4 Adverse Events (AEs)

  A drug related adverse event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug that has a causal relationship with the treatment. AEs are graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (Version 4.03) (NCI CTCAE) guidelines where Grade 3= Severe and Grade 4= Life-threatening.

  From first dose to 100 days after last dose (up to approximately 28 months)

• The Number of Participants Experiencing Drug-Related Grade 3-4 Serious Adverse Events (SAEs)

  A drug related serious adverse event (SAE) is any untoward medical occurrence that at any dose: results in death; is life-threatening; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is an important medical event that has a casual relationship with the treatment. SAEs are graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (Version 4.03) (NCI CTCAE) guidelines where Grade 3= Severe and Grade 4= Life-threatening.

  From first dose to 100 days after last dose (up to approximately 28 months)

• The Number of Participants Experiencing Abnormal Hepatic Laboratory Test Results

  The number of participants with the following laboratory abnormalities from the following on-treatment evaluations: * ALT or AST \> 3 x ULN, \> 5 x ULN, \> 10 x ULN and \> 20 x ULN * Total bilirubin \> 2 x ULN * Concurrent (within 1 day) ALT or AST \> 3 x ULN and total bilirubin \> 2 x ULN * Concurrent (within 30 days) ALT or AST \> 3 x ULN and total bilirubin \> 2 x ULN

  From first dose to 100 days after last dose (up to approximately 28 months)

• The Number of Participants Experiencing Toxicity Grade 3-4 Laboratory Test Results

  The number of participants with Grade 3-4 laboratory results according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. Note: Grade 4 Toxicities not included in the below table if there were no participants that experienced Grade 4 in that category. Grade 3: prolonged recurrence of symptoms following initial improvement; hospitalization indicated for other clinical sequelae \[e.g., renal impairment, pulmonary infiltrates\]. Grade 4: Life-threatening; pressor or ventilatory support indicated.

  From first dose to 100 days after last dose (up to approximately 28 months)

Secondary Outcomes (18)

• Best Overall Response (BOR)

  From first dose up to approximately 28 months

• Duration of Response (DOR)

  From the date of first response (CR or PR) to the date of the first documented tumor progression or death due to any cause, whichever occurs first. (Up to approximately 28 months)

• Objective Response Rate (ORR)

  From first dose up to approximately 28 months

• Response Rate at 24 Weeks

  Week 24

• Disease Control Rate (DCR) at 24 Weeks

  Week 24

Study Arms (2)

Nivolumab monotherapy

EXPERIMENTAL

Nivolumab specified dose on specified days

Drug: Nivolumab

Cohort Expansion

EXPERIMENTAL

Nivolumab specified dose on specified days

Drug: Nivolumab

Interventions

Nivolumab DRUG

Cohort Expansion; Nivolumab monotherapy

Eligibility Criteria

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

You may qualify if:

• Chinese subjects with advanced or recurrent solid tumors

You may not qualify if:

• Subjects with brain metastases are excluded unless clinically stable for more than 2 weeks at the time of enrollment as determined by the investigator
• Subjects with carcinomatous meningitis are excluded

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (2)

Local Institution - 0001

Guangzhou, Guangdong, 510060, China

Location

Local Institution

Hangzhou, Zhejiang, 310016, China

Location

Related Publications (1)

• Ma Y, Fang W, Zhang Y, Yang Y, Hong S, Zhao Y, Tendolkar A, Chen L, Xu D, Sheng J, Zhao H, Zhang L. A Phase I/II Open-Label Study of Nivolumab in Previously Treated Advanced or Recurrent Nasopharyngeal Carcinoma and Other Solid Tumors. Oncologist. 2019 Jul;24(7):891-e431. doi: 10.1634/theoncologist.2019-0284. Epub 2019 May 2.

  PMID: 31048330 DERIVED

Related Links

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

MeSH Terms

Interventions

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: 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: October 30, 2015
• First Posted: November 2, 2015
• Study Start: January 7, 2016
• Primary Completion: September 27, 2021
• Study Completion: September 27, 2021
• Last Updated: October 24, 2022
• Results First Posted: October 24, 2022

Record last verified: 2022-09

Locations

CN (2)