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A Dose Escalation and Combination Immunotherapy Study to Evaluate BMS-986226 Alone or in Combination With Nivolumab or Ipilimumab in Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT03251924
Recruitment Status : Recruiting
First Posted : August 16, 2017
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
The purpose of this study is to investigate BMS-986226 administered alone or in combination with nivolumab or ipilimumab.

Condition or disease Intervention/treatment Phase
Cancer Tumors Neoplasm Malignancy Drug: BMS-986226 Biological: Nivolumab Biological: Ipilimumab Biological: Tetanus Vaccine Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 234 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Dose Escalation and Combination Cohort Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Efficacy of BMS-986226 Alone or in Combination With Nivolumab or Ipilimumab in Patients With Advanced Solid Tumors
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : October 4, 2022
Estimated Study Completion Date : May 15, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: BMS-986226
administered intravenously
 Drug: BMS-986226
specified dose on specified days

Biological: Tetanus Vaccine
specified dose on specified days
Experimental: BMS-986226 and Nivolumab
administered intravenously
 Drug: BMS-986226
specified dose on specified days

Biological: Nivolumab
specified dose on specified days
Other Names:
  • BMS-936558
  • PD-1 receptor blocking monoclonal antibody [mAb]
  • Opdivo

Biological: Tetanus Vaccine
specified dose on specified days
Experimental: BMS-986226 and Ipilimumab
administered intravenously
 Drug: BMS-986226
specified dose on specified days

Biological: Ipilimumab
specified dose on specified days
Other Names:
  • BMS-734016
  • MDX010
  • Checkpoint blocking antibody that recognizes CTLA-4
  • Yervoy

Biological: Tetanus Vaccine
specified dose on specified days


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of adverse events (AE) [ Time Frame: Approximately 2 years ]
  2. Incidence of serious adverse events (SAE) [ Time Frame: Approximately 2 years ]
  3. Incidence of AE due to discontinuation [ Time Frame: Approximately 2 years ]
  4. Incidence of AE resulting in death [ Time Frame: Approximately 2 years ]
  5. Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria [ Time Frame: Approximately 2 years ]
  6. Incidence of clinical laboratory test abnormalities graded according to common terminology criteria for adverse events (CTCAE) [ Time Frame: Approximately 2 years ]

Secondary Outcome Measures :
  1. Objective response rate (ORR) measure by Clopper-Pearson method [ Time Frame: Approximately 2 years ]
  2. Median Duration of Response (mDOR) measured by Kaplan-Meier method [ Time Frame: Approximately 2 years ]
  3. Progression Free Survival (PFS) measured by Kaplan-Meier method [ Time Frame: At 24 weeks ]
  4. Maximum observed plasma concentration (Cmax) [ Time Frame: Approximately 2 years ]
  5. Time of maximum observed plasma concentration (Tmax) [ Time Frame: Approximately 2 years ]
  6. Area under the concentration-time curve from time 0 to the time of the last [AUC (0-T)] [ Time Frame: Approximately 2 years ]
  7. Area under the concentration-time curve in 1 dosing interval [AUC(TAU)] [ Time Frame: Approximately 2 years ]
  8. Incidence of anti-drug antibodies to BMS-986226 assessed by immunoassay [ Time Frame: Approximately 2 years ]
  9. Change from baseline in immunoassay for BMS-986226 [ Time Frame: Approximately 2 years ]

Eligibility Criteria
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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:

  • Advanced solid tumors
  • Histological or cytological confirmation of a malignancy that is advanced (metastatic and/or unresectable) with measureable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or PCWG3 (prostate only).
  • At least 1 lesion accessible for biopsy in addition to the target lesion
  • Participants must have received, and then progressed or been intolerant to, at least 1 standard treatment regimen
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2

Exclusion Criteria:

  • Participants with active central nervous system (CNS) metastases, untreated CNS metastases, or with the CNS as the only site of disease are excluded (controlled brain metastases will be allowed to enroll)
  • Participants with carcinomatous meningitis
  • Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast
  • Active, known, or suspected autoimmune disease
  • Uncontrolled or significant cardiovascular disease
  • Participants with known allergies to egg products, neomycin and tetanus toxoid.
  • Prior adverse reaction to tetanus toxoid- containing vaccines.

Other protocol defined inclusion/exclusion criteria could apply

Contacts and Locations
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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): NCT03251924


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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United States, District of Columbia
Local Institution Not yet recruiting
Washington, District of Columbia, United States, 20007
Contact: Site 0013         
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: F Stephen Hodi, Site 0005         
United States, Missouri
Washington University School OF Medicine-Siteman Cancer Center Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Tanner Johanns, Site 0012         
United States, New Jersey
John Theurer Cancer Center at Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Martin Gutierrez, Site 0002         
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Jessica Bauman, Site 0001    215-728-5682      
United States, Tennessee
Tennessee Oncology, PLLC Recruiting
Nashville, Tennessee, United States, 37203
Contact: Todd Bauer, Site 0004         
Canada, Alberta
Local Institution Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Site 0014         
Canada, Ontario
Juravinski Cancer Centre Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Sebastien Hotte, Site 0006    9053879495      
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 1Z5
Contact: Aaron Hansen, Site 0003    41694645015606      
Spain
Local Institution Recruiting
Madrid, Spain, 28040
Contact: Site 0007         
Local Institution Recruiting
Madrid, Spain, 28050
Contact: Site 0008         
Switzerland
Kantonsspital Graubuenden Recruiting
Chur, Switzerland, 7000
Contact: Richard Cathomas, Site 0009    +41812567177      
Chu Vaudois Lausanne Recruiting
Lausanne, Switzerland, 1011
Contact: Stefan Zimmermann, Site 0010    +41213146891      
University Hospital Zuerich Recruiting
Schlieren, Switzerland, 8952
Contact: Tamara Rordorf, Site 0011    +41432585412      
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site BMS Clinical Trial Patient Recruiting  This link exits the ClinicalTrials.gov site Investigator Inquiry Form  This link exits the ClinicalTrials.gov site FDA Safety Alerts and Recalls  This link exits the ClinicalTrials.gov site

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03251924    
Other Study ID Numbers: CA021-002
2017-000238-73 ( EudraCT Number )
First Posted: August 16, 2017    Key Record Dates
Last Update Posted: August 8, 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
Additional relevant MeSH terms:
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Neoplasms
Nivolumab
Ipilimumab
Antibodies
Immunoglobulins
 Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Antineoplastic Agents