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

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ClinicalTrials.gov Identifier: NCT03195478
Recruitment Status : Recruiting
First Posted : June 22, 2017
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
A Study to Evaluate Safety and Effectiveness of Nivolumab in Combination With Ipilimumab in Chinese Patients With Previously Treated Late-Stage Cancer

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: Nivolumab Drug: Ipilimumab Phase 1 Phase 2

Detailed Description:
A Phase 1/2 study evaluating safety and pharmacokinetic profile in solid tumor participants and preliminary efficacy in metastatic colorectal cancer participants.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of Nivolumab (BMS-936558) in Combination With Ipilimumab (BMS-734016) in Chinese Subjects With Previously Treated Metastatic or Recurrent Solid Tumors
Actual Study Start Date : July 27, 2017
Estimated Primary Completion Date : November 12, 2024
Estimated Study Completion Date : November 12, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nivo/Ipi Combination Therapy A
Specified Dose of Nivolumab and Ipilimumab on specified days
Drug: Nivolumab
Specified dose of Nivolumab on specified days.
Other Names:
  • BMS-936558
  • Opdivo

Drug: Ipilimumab
Specified Dose of Ipilimumab on specified days
Other Names:
  • BMS-734016
  • Yervoy

Experimental: Nivo/Ipi Combination Therapy B
Specified Dose of Nivolumab and Ipilimumab Combination Therapy on specified days followed by specified dose of Nivolumab Monotherapy on specified days
Drug: Nivolumab
Specified dose of Nivolumab on specified days.
Other Names:
  • BMS-936558
  • Opdivo

Drug: Ipilimumab
Specified Dose of Ipilimumab on specified days
Other Names:
  • BMS-734016
  • Yervoy

Experimental: Nivo/Ipi Combination Therapy C
Specified Dose of Nivolumab and Ipilimumab Combination Therapy on specified days followed by specified dose of Nivolumab Monotherapy on specified days
Drug: Nivolumab
Specified dose of Nivolumab on specified days.
Other Names:
  • BMS-936558
  • Opdivo

Drug: Ipilimumab
Specified Dose of Ipilimumab on specified days
Other Names:
  • BMS-734016
  • Yervoy

Experimental: Nivo/Ipi Combination Arm D
Specified dose of Nivolumab and Ipilimumab Combination Therapy on specified days followed by specified dose of Nivolumab Monotherapy on specified days
Drug: Nivolumab
Specified dose of Nivolumab on specified days.
Other Names:
  • BMS-936558
  • Opdivo

Drug: Ipilimumab
Specified Dose of Ipilimumab on specified days
Other Names:
  • BMS-734016
  • Yervoy




Primary Outcome Measures :
  1. Composite of Number and percent of all treated participants that experience Adverse Events (AEs) [ Time Frame: Up to 3.2 years ]
    Measured by number of patients

  2. Composite of Number and percent of all treated participants that experience serious adverse events (SAEs) [ Time Frame: Up to 3.2 years ]
    Measured by number of patients

  3. Composite of Number and percent of all treated participants that experience AEs leading to discontinuation [ Time Frame: Up to 3.2 years ]
    Measured by number of patients

  4. Composite of Number and percent of all treated subjects that experience AEs leading to death [ Time Frame: Up to 3.2 years ]
    Measured by number of patients

  5. Composite of Number and percent of participants with clinical laboratory abnormalities [ Time Frame: Up to 3.2 years ]
    Measured by number of patients

  6. Blinded independent central review (BICR) assessed Objective Response Rate (ORR) [ Time Frame: Up to 3.2 years ]
    Applies to Part 2


Secondary Outcome Measures :
  1. Maximum observed serum concentration (Cmax) [ Time Frame: Up to 3.2 years ]
    Measured using serum concentration versus time data. Applies to Part 1

  2. Time of maximum observed serum concentration (Tmax) [ Time Frame: Up to 3.2 years ]
    Measured using serum concentration versus time data. Applies to Part 1

  3. Area under the plasma concentration-time curve from time zero to the last time of the last quantifiable concentration (AUC[0-T]) [ Time Frame: Up to 3.2 years ]
    Measured using serum concentration versus time data. Applies to Part 1

  4. Area under the concentration-time curve in one dosing interval (AUC[TAU]) [ Time Frame: Up to 3.2 years ]
    Measured using serum concentration versus time data. Applies to Part 1

  5. Serum concentration achieved at the end of study drug infusion (Ceoinf) [ Time Frame: Up to 3.2 years ]
    Measured using serum concentration data. Applies to Part 1

  6. Trough observed serum concentration at the end of dosing interval (Ctrough) [ Time Frame: Up to 3.2 years ]
    Measured using serum concentration data. Applies to Part 1

  7. Concentration at the end of dosing interval (Ctau) [ Time Frame: Up to 3.2 years ]
    Measured using serum concentration data. Applies to Part 1

  8. Anti-drug Antibody (ADA) [ Time Frame: Up to 3.2 years ]
    Measured by immunoassay Applies to Part 1

  9. Investigator-assessed ORR [ Time Frame: Up to 3.2 years ]
    Applies to Part 2

  10. Investigator-assessed and BICR-assessed disease control rate (DCR), [ Time Frame: Up to 3.2 years ]
    Applies to Part 2

  11. Investigator-assessed and BICR-assessed duration of response (DOR), [ Time Frame: Up to 3.2 years ]
    Applies to Part 2

  12. Investigator-assessed and BICR-assessed progression-free survival (PFS), [ Time Frame: Up to 3.2 years ]
    Applies to Part 2

  13. Overall Survival (OS) [ Time Frame: Up to 4.2 years ]
    Applies to Part 2



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  1. Mainland Chinese subjects with advanced or recurrent solid tumors.
  2. One prior anti-cancer therapy that did not work or documented refusal to receive chemotherapy or biological therapy.

Exclusion Criteria:

  1. 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).
  2. Subjects with carcinomatous meningitis
  3. Active, known or suspected autoimmune disease or infection
  4. Positive blood screen for chronic infection of hepatitis B or hepatitis C (HCV antibody positive unless HCV RNA is negative)
  5. Prior immuno-oncology therapy

Other protocol defined inclusion/exclusion criteria could apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195478


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
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China, Beijing
Local Institution Not yet recruiting
Beijing, Beijing, China, 100021
Contact: Site 0015         
Local Institution Not yet recruiting
Beijing, Beijing, China, 100032
Contact: Site 0003         
China, Guangdong
Local Institution Not yet recruiting
Guangzhou, Guangdong, China, 510080
Contact: Site 0014         
Local Institution Not yet recruiting
Guangzhou, Guangdong, China, 510655
Contact: Site 0012         
China, Heilongjiang
Local Institution Not yet recruiting
Harbin, Heilongjiang, China, 155040
Contact: Site 0011         
China, Henan
Local Institution Not yet recruiting
Zhengzhou, Henan, China, 450052
Contact: Site 0017         
China, Shanghai
Local Institution Not yet recruiting
Shanghai, Shanghai, China, 200020
Contact: Site 0016         
China, Tianjin
Local Institution Not yet recruiting
Tianjin, Tianjin, China, 300222
Contact: Site 0004         
China, Zhejiang
Local Institution Not yet recruiting
Hangzhou, Zhejiang, China, 310009
Contact: Site 0013         
China
Local Institution Recruiting
Beijing, China, 100142
Contact: Site 0001         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03195478     History of Changes
Other Study ID Numbers: CA209-672
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Neoplasms
Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents