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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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03446040
Recruitment Status : Active, not recruiting
First Posted : February 26, 2018
Last Update Posted : December 1, 2022
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 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 : March 20, 2023
Estimated Study Completion Date : March 20, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Part A Dose Escalation: BMS-986258 Biological: BMS-986258
Specified dose on specified days
Experimental: Part A1: BMS-986258 + Recombinant human hyaluronidase PH20 (rHuPH20) Biological: BMS-986258
Specified dose on specified days

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 days

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558
Experimental: Part C Cohort Expansion: BMS-986258 + nivolumab Biological: BMS-986258
Specified dose on specified days

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


Outcome Measures
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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 ]

Eligibility Criteria
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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

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

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): NCT03446040


Locations
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United States, California
Local Institution - 0004
Los Angeles, California, United States, 90033
Local Institution - 0006
Los Angeles, California, United States, 90033
United States, Colorado
Local Institution - 0007
Aurora, Colorado, United States, 80045
United States, Connecticut
Local Institution
New Haven, Connecticut, United States, 06520
United States, Iowa
Local Institution
Iowa City, Iowa, United States, 52242
United States, Michigan
Local Institution - 0018
Ann Arbor, Michigan, United States, 48109-5912
Local Institution - 0010
Grand Rapids, Michigan, United States, 49546
United States, New Hampshire
Local Institution - 0012
Lebanon, New Hampshire, United States, 03756
United States, Ohio
Local Institution - 0016
Cincinnati, Ohio, United States, 45267
United States, Pennsylvania
University Of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
Local Institution - 0002
Germantown, Tennessee, United States, 38138
Australia, New South Wales
Local Institution - 0013
Westmead, New South Wales, Australia, 2145
Australia, Victoria
Local Institution - 0015
Melbourne, Victoria, Australia, 3084
Canada, British Columbia
Local Institution - 0019
Vancouver, British Columbia, Canada, V5Z 4E6
Canada
Local Institution - 0014
Edmonton, Canada, T6X 1E8
Japan
Local Institution
Kobe-shi, Hyogo, Japan, 6500017
Local Institution - 0008
Chuo-ku, Tokyo, Japan, 1040045
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:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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: December 1, 2022
Last Verified: November 2022

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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
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action