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

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ClinicalTrials.gov Identifier: NCT03661632
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced Cancer Drug: BMS-986310 Biological: Nivolumab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 308 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1/2 Study of BMS-986310 Administered Alone and in Combination With Nivolumab in Participants With Advanced Solid Tumors
Actual Study Start Date : August 30, 2018
Estimated Primary Completion Date : September 12, 2023
Estimated Study Completion Date : September 12, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Dose Escalation

Part 1: BMS-986310 + Nivolumab Combination Dose Escalation

Sub-Study A: A cohort of Cisplatin Ineligible Muscle Invasive Bladder Cancer patients will receive either monotherapy BMS-986310, or BMS-986310 + Nivolumab, or Nivolumab monotherapy.

Sub-Study B: A cohort of PD[L]1 relapsed / refractory tumor cancer patients will be treated with monotherapy BMS-986310 followed by BMS-986310 + nivolumab

Drug: BMS-986310
Specified dose on specified days

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

Experimental: Cohort Expansion

Part 2: Cohort Expansion will initiate upon consideration of the totality of data from Part 1.

BMS-986310 + Nivolumab combination will be administered in specific patient populations.

Drug: BMS-986310
Specified dose on specified days

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




Primary Outcome Measures :
  1. Incidence of Adverse Events (AE) [ Time Frame: up to 3 years ]
  2. Incidence of Serious Adverse Events (SAE) [ Time Frame: up to 3 years ]
  3. Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria [ Time Frame: up to 3 years ]
  4. Incidence of AEs leading to dose delays and discontinuation or delay in radical cystectomy (RC) [ Time Frame: up to 3 years ]
  5. Incidence of Laboratory abnormalities [ Time Frame: up to 3 years ]
  6. Incidence of death [ Time Frame: up to 3 years ]

Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: up to 3 years ]
  2. Median duration of response (mDOR) [ Time Frame: up to 3 years ]
  3. Progression free survival rate (PFSR) [ Time Frame: up to 24 months ]
  4. Maximum observed serum concentration (Cmax) [ Time Frame: up to 3 years ]
  5. Observed serum concentration at the end of a dosing interval (Ctau) [ Time Frame: up to 3 years ]
  6. Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] [ Time Frame: up to 3 years ]
  7. Apparent total body clearance (CLT/F) [ Time Frame: up to 3 years ]
  8. Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] [ Time Frame: up to 3 years ]
  9. AUC accumulation index (AI_AUC) [ Time Frame: up to 3 years ]
  10. Cmax accumulation index (AI_Cmax) [ Time Frame: up to 3 years ]
  11. Summary changes of prostaglandin E metabolite (PGEM) in urine [ Time Frame: up to 3 years ]
  12. Summary changes of tumor necrosis factor (TNFa) in blood [ Time Frame: up to 3 years ]
  13. Summary of PK parameters at T-HALF [ Time Frame: up to 3 years ]
  14. Summary of PK parameter AUC(INF) after single dose [ Time Frame: up to 3 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

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, in one of the following tumor types: Renal cell carcinoma, Melanoma, colorectal cancer (CRC) microsatellite instability (MSI)-High (determined by Clinical Laboratory Improvement Amendments (CLIA) validated assay, testing methodology must be provided), Bladder cancer, Squamous Cell Carcinoma of the Head and Neck (SCCHN), 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) Participants must be newly diagnosed, no prior history of treatment for bladder cancer ii) Participants must not meet criteria for standard of care neoadjuvant therapy and must be candidates for SOC surgical resection of primary tumor.

iii) Histologically confirmed muscle-Invasive bladder cancer (MIBC) pure or mixed histology urothelial carcinoma Part 2 - Patients with relapsed / refractory solid tumors where no other standard of care treatment option is available.

Exclusion Criteria:

  • History of severe adverse drug reactions to nonsteroidal anti-inflammatory drugs (NSAIDs) or Cyclooxygenase-2 (COX-2) inhibitors.
  • Participants with an active, known or suspected autoimmune disease.
  • Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population

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): NCT03661632


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, Illinois
Local Institution Not yet recruiting
Chicago, Illinois, United States, 60637
Contact: Site 0015         
United States, Minnesota
Local Institution Not yet recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Site 0016         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Haeseong Park, Site 0008    314-362-4140      
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Martin Gutierrez, Site 0003    551-996-4725      
United States, New York
Local Institution Not yet recruiting
New York, New York, United States, 10016
Contact: Site 0013         
United States, Ohio
Local Institution Not yet recruiting
Cleveland, Ohio, United States, 44106-5055
Contact: Site 0017         
United States, Pennsylvania
UPMC Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Diwakar Davar, Site 0007    412-623-8962      
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Filip Janku, Site 0005    713-745-4297      
United States, Wisconsin
Local Institution Not yet recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Site 0014         
Belgium
Local Institution Recruiting
Bruxelles, Belgium, 1200
Contact: Site 0002         
Local Institution Recruiting
Gent, Belgium, 9000
Contact: Site 0001         
Canada, Alberta
Local Institution Not yet recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Site 0006         
Canada, Ontario
Local Institution Recruiting
Toronto, Ontario, Canada, M5G 1Z5
Contact: Site 0004         
Israel
Local Institution Not yet recruiting
Haifa, Israel, 3109601
Contact: Site 0010         
Local Institution Not yet recruiting
Tel Aviv, Israel, 64239
Contact: Site 0009         
Italy
Local Institution Not yet recruiting
Milano, Italy, 20133
Contact: Site 0011         
Local Institution Not yet recruiting
Rozzano MI, Italy, 20089
Contact: Site 0012         
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: NCT03661632     History of Changes
Other Study ID Numbers: CA044-001
2018-002108-15 ( EudraCT Number )
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 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