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Completed

NCT Number: NCT03661632

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-986310

Drug

Specified dose on specified days

Nivolumab

Biological

Specified dose on specified days

Other names: Opdivo, BMS-936558

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Sep 7, 2018
Registry last updated
Nov 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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