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

NCT ID: NCT02593786

Last Updated: 2022-10-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-07

Study Completion Date

2021-09-27

Brief Summary

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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.

Detailed Description

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Conditions

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Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nivolumab monotherapy

Nivolumab specified dose on specified days

Group Type EXPERIMENTAL

Nivolumab

Intervention Type DRUG

Cohort Expansion

Nivolumab specified dose on specified days

Group Type EXPERIMENTAL

Nivolumab

Intervention Type DRUG

Interventions

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Nivolumab

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Chinese subjects with advanced or recurrent solid tumors

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0001

Guangzhou, Guangdong, China

Site Status

Local Institution

Hangzhou, Zhejiang, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 31048330 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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CA209-077

Identifier Type: -

Identifier Source: org_study_id

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