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An Investigational Immuno-Therapy Study of Experimental Medication BMS-986277 Given Alone and in Combination With Nivolumab in Epithelial Cancers

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ClinicalTrials.gov Identifier: NCT03363776
Recruitment Status : Active, not recruiting
First Posted : December 6, 2017
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to investigate experimental medication BMS-986277 given alone and in combination with Nivolumab in patients with epithelial cancers.

Condition or disease Intervention/treatment Phase
Cancer Biological: BMS-986277 Biological: Nivolumab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1/2a First in Human Study of BMS-986277 Administered Alone and in Combination With Nivolumab in Advanced Epithelial Tumors
Actual Study Start Date : November 24, 2017
Estimated Primary Completion Date : September 28, 2022
Estimated Study Completion Date : December 29, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Monotherapy
BMS-986277 administered alone
Biological: BMS-986277
Specified dose on specified days

Experimental: Combination Dose Escalation Therapy
BMS-986277 administered in combination with Nivolumab
Biological: BMS-986277
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-963558

Experimental: Combination Expansion Therapy
BMS-986277 monotherapy with option for subsequent Nivolumab therapy
Biological: BMS-986277
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-963558




Primary Outcome Measures :
  1. Number of adverse events (AE) [ Time Frame: Up to 842 days ]
  2. Number of serious adverse events (SAE) [ Time Frame: Up to 842 days ]
  3. Number of AEs meeting dose limiting toxities criteria [ Time Frame: Up to 842 days ]
  4. Number of AEs leading to discontinuation [ Time Frame: Up to 842 days ]
  5. Number of AEs resulting in death [ Time Frame: Up to 842 days ]
  6. Incidence of clinical laboratory test abnormalities [ Time Frame: Up to 842 days ]
  7. Incidence of vital sign abnormalities [ Time Frame: Up to 842 days ]

Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: 24 weeks ]
  2. Disease control rate (DCR) [ Time Frame: 24 weeks ]
  3. Median duration of response (mDOR) [ Time Frame: Up to 2 years ]
  4. Median progression-free survival (mPFS) [ Time Frame: Up to 24 weeks ]
  5. Progression-free survival (PFS) [ Time Frame: Up to 24 weeks ]
  6. Maximum observed blood concentration (Cmax) [ Time Frame: Up to 92 days ]
  7. Time of maximum observed blood concentration (Tmax) [ Time Frame: Up to 92 days ]
  8. Area under the blood concentration-time curve from time zero to time of last quanitifiable concentration [AUC(0-T)] [ Time Frame: Up to 92 days ]
  9. Area under the blood concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] [ Time Frame: Up to 92 days ]
  10. Apparent terminal half-life (T-HALF) [ Time Frame: Up to 92 days ]
  11. Total body clearance (CLT) [ Time Frame: Up to 92 days ]
  12. Volume of distribution at steady-state (Vss) [ Time Frame: Up to 92 days ]
  13. Volume of distribution of the elimination phase (Vz) [ Time Frame: Up to 92 days ]
  14. Average plasma concentration over a dosing interval (AUC[0-48]/48) (Css-avg) [ Time Frame: Up to 92 days ]


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:

  • Histological or cytological confirmation of metastatic and/or unresectable metastatic colorectal, prostate, pancreatic, breast, ovarian, or urothelial carcinoma with measureable disease for solid tumors per RECIST v1.1 and for prostate carcinoma per PCWG3
  • Presence of at least 2 lesions: at least one with measurable disease as defined by RECIST v1.1 for solid tumors and by PCWG3 for prostate carcinoma for response assessment; at least 1 lesion must be 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 in the advanced or metastatic setting, if such a therapy exists, and have been considered for all other potentially efficacious therapies prior to enrollment
  • ECOG performance status less than or equal to 2

Exclusion Criteria:

  • Participants with active central nervous system (CNS) metastases, untreated CNS metastases, or with the CNS as the only site of disease
  • Participants with carcinomatous meningitis
  • Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study treatment
  • Participants with active, known, or suspected autoimmune disease

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): NCT03363776


Locations
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United States, Arizona
Local Institution
Phoenix, Arizona, United States, 85054
United States, California
Local Institution
La Jolla, California, United States, 92093-0987
United States, Massachusetts
Local Institution
Boston, Massachusetts, United States, 02115
United States, New York
Local Institution
New York, New York, United States, 10032
Local Institution
New York, New York, United States, 10065
United States, South Dakota
Sanford Research
Sioux Falls, South Dakota, United States, 57104
Canada, Ontario
Local Institution
Ottawa, Ontario, Canada, K1H 8L6
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 1Z5
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: NCT03363776     History of Changes
Other Study ID Numbers: CA034-001
2017-002199-24 ( EudraCT Number )
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: July 12, 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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Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents