An Investigational Immunotherapy Study of BMS-986310 Administered Alone and in Combination With Nivolumab in Patients With Advanced Solid Tumors



Status:Recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/3/2019
Start Date:August 30, 2018
End Date:March 31, 2023
Contact:Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Email:Clinical.Trials@bms.com
Phone:please email:

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Phase 1/2 Study of BMS-986310 Administered Alone and in Combination With Nivolumab in Participants With Advanced Solid Tumors

The purpose of this study is to determine if BMS-986310 administered in combination with
nivolumab, will demonstrate adequate safety and tolerability, as well as a favorable
risk/benefit profile, to support further clinical testing.


Inclusion Criteria:

- Patients with measurable disease per RECIST v1.1 and have at least one lesion
accessible for biopsy.

- ECOG performance status less than or equal to 1

Part 1 and Sub-study B:

i) Part 1 participants must have advanced or metastatic disease where no other standard of
care treatment option is possible.

ii) Sub-study B participants must have advanced or metastatic disease where no other
standard of care treatment is possible, and they must have had disease progression on an
anti-PD-(L)1 based regimen as their most recent prior therapy

Sub-study A:

i) Males and females with histologically confirmed TNBC as defined by ASCO/CAP guidelines.

ii) Participants must be newly diagnosed, no prior history of treatment for TNBC.

iii) Tumor size greater than or equal to 1cm3 iv) Participants must not meet criteria for
standard of care neoadjuvant therapy and must be candidates for SOC surgical resection of
primary tumor.

Part 2 i) Patients with NSCLC ii) Patients with Pancreatic Cancer iii) Patients with TNBC
iiii) Patients with CRC

Exclusion Criteria:

- History of severe adverse drug reactions to nonsteroidal anti-inflammatory drugs
(NSAIDs), or those with adverse reactions to an NSAID that is currently prescribed

- Participants with an active, known or suspected autoimmune disease.
We found this trial at
5
sites
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Phone: 314-362-4349
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, MO
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99-101 Belliardstraat
Bruxelles, 1040
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Bruxelles,
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Phone: 551-996-4725
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Hackensack, NJ
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Houston, Texas 77030
Phone: 713-745-4452
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Houston, TX
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Pittsburgh, Pennsylvania 15232
Phone: 412-623-4881
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Pittsburgh, PA
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