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

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: NCT03661632
Recruitment Status : Completed
First Posted : September 7, 2018
Last Update Posted : November 8, 2021
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 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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 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 : September 11, 2018
Actual Primary Completion Date : November 11, 2019
Actual Study Completion Date : December 29, 2020

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: 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


Outcome Measures
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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 ]

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:

  • 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
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): NCT03661632


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, Pennsylvania
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Belgium
Local Institution
Bruxelles, Belgium, 1200
Local Institution
Gent, Belgium, 9000
Canada, Ontario
Local Institution
Toronto, Ontario, Canada, M5G 1Z5
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:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03661632    
Other Study ID Numbers: CA044-001
2018-002108-15 ( EudraCT Number )
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: November 8, 2021
Last Verified: October 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
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action