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An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread

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ClinicalTrials.gov Identifier: NCT03446040
Recruitment Status : Recruiting
First Posted : February 26, 2018
Last Update Posted : May 12, 2021
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to determine whether BMS-986258 both monotherapy and in combination with Nivolumab is safe and tolerable in the treatment of advanced malignant tumors.

Condition or disease Intervention/treatment Phase
Advanced Cancer Biological: BMS-986258 Biological: Nivolumab Drug: rHuPH20 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 248 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 First-in-Human Study of BMS-986258 Alone and in Combination With Nivolumab in Advanced Malignant Tumors
Actual Study Start Date : March 8, 2018
Estimated Primary Completion Date : July 14, 2024
Estimated Study Completion Date : July 15, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Part A Dose Escalation: BMS-986258 Biological: BMS-986258
Specified dose on specified day

Experimental: Part A1: BMS-986258 + Recombinant human hyaluronidase PH20 (rHuPH20) Biological: BMS-986258
Specified dose on specified day

Drug: rHuPH20
Specified dose on specified days
Other Name: Enhanze

Experimental: Part B Dose Escalation: BMS-986258 + nivolumab Biological: BMS-986258
Specified dose on specified day

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

Experimental: Part C Cohort Expansion: BMS-986258 + nivolumab Biological: BMS-986258
Specified dose on specified day

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




Primary Outcome Measures :
  1. Incidence of adverse events (AEs) [ Time Frame: Approximately 2 years ]
  2. Incidence of serious adverse events (SAEs) [ Time Frame: Approximately 2 years ]
  3. Incidence of AEs leading to discontinuation [ Time Frame: Approximately 2 years ]
  4. Incidence of AEs leading to death [ Time Frame: Approximately 2 years ]
  5. Incidence of AEs meeting protocol defined dose-limiting toxicities (DLTs) criteria [ Time Frame: Approximately 2 years ]

Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: up to 12 months ]
  2. Median duration of response (mDOR) [ Time Frame: up to 12 months ]
  3. Progression free survival (PFS) rate [ Time Frame: up to 12 months ]
  4. Maximum observed serum concentration (Cmax) [ Time Frame: Approximately 2 years ]
  5. Time of maximum observed concentration (Tmax) [ Time Frame: Approximately 2 years ]
  6. Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] [ Time Frame: Approximately 2 years ]
  7. Observed concentration at the end of a dosing interval (Ctau) [ Time Frame: Approximately 2 years ]
  8. Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] [ Time Frame: Approximately 2 years ]
  9. Trough observed serum concentration at the end of the dosing interval (Ctrough) [ Time Frame: Approximately 2 years ]
  10. Concentration at the end of infusion (Ceoi) [ Time Frame: Approximately 2 years ]
  11. Incidence of anti-drug antibody (ADA) to BMS-986258 [ Time Frame: Approximately 2 years ]


Information from the National Library of Medicine

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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:

  • Histologic confirmation of one of the 5 tumors [renal cell carcinoma (RCC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), triple negative breast cancer (TNBC)] (metastatic, recurrent, and/or unresectable), with measurable disease per response evaluation criteria in solid tumors v1.1 (RECIST v1.1)
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1
  • Participants must have received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to solid tumor histologies
  • Women must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

  • Active, known or suspected autoimmune disease
  • Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy
  • Other active malignancy requiring concurrent intervention

Other protocol-defined inclusion/exclusion criteria 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): NCT03446040


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, California
Hoag Memorial Hospital Presbyterian Recruiting
Los Angeles, California, United States, 90033
Contact: Anthony El-Khoueiry, Site 0006    213-740-6709      
Usc/Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Anthony El-Khoueiry, Site 0004    213-740-6709      
United States, Colorado
University Of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Elaine Lam, Site 0007    720-848-4604      
United States, Connecticut
Local Institution Not yet recruiting
New Haven, Connecticut, United States, 06520
Contact: Site 0011         
United States, Iowa
Local Institution Not yet recruiting
Iowa City, Iowa, United States, 52242
Contact: Site 0020         
United States, Michigan
Local Institution Not yet recruiting
Ann Arbor, Michigan, United States, 48109-5912
Contact: Site 0018         
START Midwest Recruiting
Grand Rapids, Michigan, United States, 49546
Contact: Manish Sharma, Site 0010    616-954-5559      
United States, New Hampshire
Local Institution Not yet recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Site 0012         
United States, New York
Local Institution Not yet recruiting
Buffalo, New York, United States, 14263
Contact: Site 0017         
United States, Ohio
University of Cincinnati Medical Center Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Davendra Sohal, Site 0016         
United States, Pennsylvania
University Of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Dan Zandberg, Site 0005    412-623-6121      
United States, Tennessee
The West Clinic, P.C. Recruiting
Germantown, Tennessee, United States, 38138
Contact: Daniel Vaena, Site 0002    901-683-0055      
Australia, New South Wales
Local Institution Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Site 0013         
Australia, Victoria
Local Institution Recruiting
Heidelberg, Victoria, Australia, 3084
Contact: Site 0015         
Canada, Alberta
Local Institution Recruiting
Edmonton, Alberta, Canada, T6X 1E8
Contact: Site 0014         
Canada, British Columbia
Local Institution Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Site 0019         
Japan
Local Institution Recruiting
Kobe-shi, Hyogo, Japan, 6500017
Contact: Site 0009         
Local Institution Recruiting
Chuo-ku, Tokyo, Japan, 1040045
Contact: Site 0008         
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: NCT03446040    
Other Study ID Numbers: CA031-002
2019-000442-35 ( EudraCT Number )
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: May 12, 2021
Last Verified: May 2021

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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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Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents