A Study of Nivolumab in Combination With Ipilimumab in Chinese Participants With Previously Treated Advanced or Recurrent Solid Tumors

NCT ID: NCT03195478

Last Updated: 2025-09-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-02

Study Completion Date

2024-01-05

Brief Summary

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The purpose of this study is to evaluate the safety and effectiveness of Nivolumab in combination with Ipilimumab in Chinese participants with previously treated late stage cancer.

Detailed Description

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Conditions

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Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nivo/Ipi Combination Therapy A

Group Type EXPERIMENTAL

Nivolumab

Intervention Type DRUG

Specified dose on specified days

Ipilimumab

Intervention Type DRUG

Specified dose on specified days

Nivo/Ipi Combination Therapy B

Group Type EXPERIMENTAL

Nivolumab

Intervention Type DRUG

Specified dose on specified days

Ipilimumab

Intervention Type DRUG

Specified dose on specified days

Nivo/Ipi Combination Therapy C

Group Type EXPERIMENTAL

Nivolumab

Intervention Type DRUG

Specified dose on specified days

Ipilimumab

Intervention Type DRUG

Specified dose on specified days

Nivo/Ipi Combination Arm D

Group Type EXPERIMENTAL

Nivolumab

Intervention Type DRUG

Specified dose on specified days

Ipilimumab

Intervention Type DRUG

Specified dose on specified days

Interventions

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Nivolumab

Specified dose on specified days

Intervention Type DRUG

Ipilimumab

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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BMS-936558 Opdivo BMS-734016 Yervoy

Eligibility Criteria

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Inclusion Criteria

* Mainland Chinese participants with advanced or recurrent solid tumors
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* One prior anti-cancer therapy that did not work or documented refusal to receive chemotherapy or biological therapy

Exclusion Criteria

* Cancer that has spread to the brain or central nervous system unless it has been adequately treated . In addition, either no longer receiving corticosteroids, or on a stable or decreasing dose of no more than 10 mg daily prednisone (or equivalent)
* Active, known or suspected autoimmune disease or infection
* Positive blood screen for chronic infection of hepatitis B or hepatitis C (HCV antibody positive unless HCV RNA is negative)
* Prior immuno-oncology therapy
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 - 0015

Beijing, Beijing Municipality, China

Site Status

Local Institution - 0001

Beijing, Beijing Municipality, China

Site Status

Local Institution

Guangzhou, Guangdong, China

Site Status

Local Institution - 0012

Guangzhou, Guangdong, China

Site Status

Local Institution - 0011

Harbin, Heilongjiang, China

Site Status

Local Institution

Zhengzhou, Henan, China

Site Status

Local Institution - 0021

Wuhan, Hubei, China

Site Status

Local Institution - 0020

Xi'an, Shan1xi, China

Site Status

Local Institution - 0016

Shanghai, Shanghai Municipality, China

Site Status

Local Institution - 0018

Chengdu, Sichuan, China

Site Status

Local Institution - 0004

Tianjin, Tianjin Municipality, China

Site Status

Local Institution - 0013

Hangzhou, Zhejiang, China

Site Status

Countries

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China

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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CA209-672

Identifier Type: -

Identifier Source: org_study_id

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