Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Investigational Immuno-Therapy Study of Experimental Medication BMS-986253 Given in Combination With Nivolumab in Patients With Advanced Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03400332
Recruitment Status : Recruiting
First Posted : January 17, 2018
Last Update Posted : October 16, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab in patients with advanced cancers.

Condition or disease Intervention/treatment Phase
Cancer Drug: BMS-986253 Biological: Nivolumab Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2a Study of BMS-986253 in Combination With Nivolumab in Advanced Cancers
Actual Study Start Date : January 31, 2018
Estimated Primary Completion Date : November 26, 2023
Estimated Study Completion Date : November 26, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Dose Finding
BMS-986253 administered in combination with Nivolumab
Drug: BMS-986253
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo

Experimental: Dose Expansion
BMS-986253 administered in combination with Nivolumab
Drug: BMS-986253
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo




Primary Outcome Measures :
  1. Incidence of adverse events (AE) [ Time Frame: Approximately 5 years ]
  2. Incidence of serious adverse events (SAE) [ Time Frame: Approximately 5 years ]
  3. Incidence of AEs meeting protocol-defined dose limiting toxicities (DLT) criteria [ Time Frame: Approximately 5 years ]
  4. Incidence of AEs leading to discontinuation [ Time Frame: Approximately 5 years ]
  5. Incidence of deaths [ Time Frame: Approximately 5 years ]
  6. Incidence of labornatory abnormalities [ Time Frame: Approximately 5 years ]

Secondary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: Approximately 5 years ]
  2. Median duration of response (mDOR) [ Time Frame: Approximately 5 years ]
  3. Incidence of anti-drug antibody (ADA) to BMS-986253 [ Time Frame: Approximately 5 years ]
  4. Serum biomarker concentration [ Time Frame: Approximately 5 years ]
  5. Maximum observed serum concentration (Cmax) [ Time Frame: Approximately 5 years ]
  6. Time of maximum observed serum concentration (Tmax) [ Time Frame: Approximately 5 years ]
  7. Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] [ Time Frame: Approximately 5 years ]
  8. Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] [ Time Frame: Approximately 5 years ]
  9. Observed serum concentration at the end of a dosing interval (CTAU) [ Time Frame: Approximately 5 years ]
  10. Trough observed serum concentration at the end of the dosing interval (CTROUGH) [ Time Frame: Approximately 5 years ]


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.


Layout table for eligibility information
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:

  • Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1
  • At least 1 lesion accessible for biopsy
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1

Exclusion Criteria:

  • Participants with CNS metastases as the only site of active disease (Participants with controlled brain metastases; however, will be allowed to enroll)
  • Participants with active, known or suspected autoimmune disease
  • Participants with conditions requiring systemic treatment with either corticosteroids (> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration
  • Participants with a known history of testing positive for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS)
  • Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study 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): NCT03400332


Contacts
Layout table for location contacts
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 #.

  Hide Study Locations
Locations
Layout table for location information
United States, Colorado
Rocky Mountain Cancer Centers Recruiting
Denver, Colorado, United States, 80218
Contact: Allen Cohn, Site 0007         
United States, Florida
Local Institution Not yet recruiting
Miami Beach, Florida, United States, 33140
Contact: Site 0046         
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins Recruiting
Lutherville, Maryland, United States, 21093
Contact: William Sharfman, Site 0003    410-502-5140      
Maryland Oncology Hematology P.A. Recruiting
Rockville, Maryland, United States, 20850
Contact: John Wallmark, Site 0012    240-826-2120      
United States, Michigan
University Of Michigan Health System Terminated
Ann Arbor, Michigan, United States, 48109
United States, Nevada
Comprehensive Cancer Centers of Nevada Recruiting
Las Vegas, Nevada, United States, 89169
Contact: Nicholas Vogelzang, Site 0016    702-952-3406      
United States, New Jersey
John Theurer Cancer Center at Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Martin Gutierrez, Site 0005    551-996-4725      
Rutgers Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Janice Mehnert, Site 0032    732-235-3253      
United States, New York
Icahn School Of Medicine At Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Thomas Marron, Site 0025    212-824-7259      
Columbia University Medical Center (Cumc) Recruiting
New York, New York, United States, 10032
Contact: Charles Drake, Site 0002    212-342-3970      
United States, Oklahoma
Stephenson Cancer Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Susanna Ulahannan, Site 0028    405-271-8778      
United States, Oregon
Willamette Valley Cancer Institute And Research Center Recruiting
Eugene, Oregon, United States, 97401
Contact: Marc Uemura, Site 0017    541-556-1749      
United States, Pennsylvania
Local Institution Not yet recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Site 0031         
Upmc Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Diwakar Davar, Site 0001    412-623-5396      
United States, South Carolina
Greenville Health System Recruiting
Greenville, South Carolina, United States, 29605
Contact: William Edenfield, Site 0009    864-455-3735      
United States, Texas
Texas Oncology Recruiting
Austin, Texas, United States, 78705
Contact: Jason Melear, Site 0011    512-421-4143      
Texas Oncology - Baylor Charles A. Simmons Cancer Center Recruiting
Dallas, Texas, United States, 75246
Contact: Carlos H Roberto Becerra, Site 0010         
Local Institution Not yet recruiting
Fort Worth, Texas, United States, 76104-3927
Contact: Site 0014         
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Sarina Piha-Paul, Site 0018    713-563-1055      
Texas Oncology-San Antonio Medical Center Recruiting
San Antonio, Texas, United States, 78240
Contact: Sridhar Beeram, Site 0006         
Texas Oncology, P.A. Recruiting
Tyler, Texas, United States, 75702
Contact: Donald Richards, Site 0013    903-579-9800      
United States, Virginia
Virginia Cancer Specialists, PC Recruiting
Fairfax, Virginia, United States, 22031
Contact: Alexander Spira, Site 0015    703-208-9268      
Virginia Oncology Associates Recruiting
Norfolk, Virginia, United States, 23502
Contact: Paul Conkling, Site 0008    757-213-5658      
Belgium
Local Institution Recruiting
Bruxelles, Belgium, 1200
Contact: Site 0037         
Local Institution Recruiting
Gent, Belgium, 9000
Contact: Site 0036         
Canada, Alberta
Local Institution Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Site 0030         
Canada, British Columbia
Local Institution Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Site 0029         
Canada, Ontario
Local Institution Recruiting
Toronto, Ontario, Canada, M5G 1Z5
Contact: Site 0020         
Germany
Local Institution Not yet recruiting
Berlin, Germany, 12200
Contact: Site 0034         
Local Institution Not yet recruiting
Hamburg, Germany, 20246
Contact: Site 0035         
Local Institution Not yet recruiting
Mainz, Germany, 55131
Contact: Site 0038         
Local Institution Not yet recruiting
Stuttgart, Germany, 70376
Contact: Site 0048         
Italy
Istituto Nazionale Tumori Fondazione Pascale Recruiting
Napoli, Italy, 80131
Contact: Paolo Ascierto, Site 0027         
Local Institution Recruiting
Rozzano MI, Italy, 20089
Contact: Site 0026         
Spain
Hospital Universitario Ramon Y Cajal Recruiting
Madrid, Spain, 28034
Contact: Teresa Alonso Gordoa, Site 0045    +34913368263      
Fundacion Jimenez Diaz Recruiting
Madrid, Spain, 28040
Contact: Victor Moreno Garcia, Site 0022    +34915504800      
Centro Integral Oncologico Clara Campal Recruiting
Madrid, Spain, 28050
Contact: Emiliano Calvo, Site 0023    +34917567825      
Hospital Universitario Virgen De La Victoria Recruiting
Malaga, Spain, 29010
Contact: Jose Manuel Trigo Perez, Site 0044    +34951032467      
Clinica Universidad de Navarra Recruiting
Pamplona, Spain, 31008
Contact: Ignacio Melero, Site 0021    +34948255400ext2733      
Hospital Clinico Univ. de Santiago-CHUS Recruiting
Santiago Compostela, Spain, 15706
Contact: Carmela Rodriguez, Site 0047    +34981950511      
Switzerland
Chu Vaudois Lausanne Recruiting
Lausanne, Switzerland, 1011
Contact: Angela Orcurto, Site 0040    +41795567517      
Kantonsspital St. Gallen Recruiting
St.Gallen, Switzerland, 9007
Contact: Markus Joerger, Site 0041    +41714941111      
University Hospital Zuerich Recruiting
Zuerich, Switzerland, 8091
Contact: Christian Britschgi, Site 0039         
United Kingdom
Local Institution Recruiting
Manchester, Greater Manchester, United Kingdom, M20 4BX
Contact: Site 0024         
Local Institution Recruiting
Birmingham, WEST Midlands, United Kingdom, B15 2TH
Contact: Site 0019         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Layout table for investigator information
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03400332     History of Changes
Other Study ID Numbers: CA027-002
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents