A Phase I/II Study of BMS-986253 in Combination with Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers.

Study Identifier:
CA027-002
CT.gov Identifier:
NCT03400332
EudraCT Identifier:
2023-509061-20
EU Trial (CTIS) Number:
2023-509061-20-00
Study Contact Information:
N/A
Study Complete

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Study Summary

To investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.

To explore various peripheral and intra-tumor pharmacodynamic effects of blocking IL-8 in a target selected patient population.

Outcomes include safety, tolerability, efficacy, pharmacokinetics, immunogenicity of BMS-986253 plus nivolumab, and measurement of serum IL-8 levels at baseline and during treatment.

To evaluate the safety and therapeutic benefit of BMS-986253, an anti–IL-8 mAb, plus nivolumab, in a biomarker-enriched (high baseline serum IL-8) patient population with advanced solid tumors

To Characterize safety, tolerability and TLD, and determine the DRF2 of BMS-986253 administered in combination with nivolumab in participants with advanced solid tumors.

Safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity were evaluated (investigator-assessed, RECIST v1.1).

To present updated results from part 1 of the phase 1/2 trial of BMS-986253 + NIVO + r - IPI in pts with advanced cancer.

To report the final analysis from part 2 of CA027-002, a randomized phase 2 study of anti–IL-8 + NIVO + IPI vs placebo (PBO) + NIVO + IPI in pts with advanced melanoma resistant to PD-(L)1 blockade.

To find out if BMS-986253 is safe and determine the best dose of BMS-986253 to give patients in future studies when used with other anti-cancer drugs in advanced solid tumors. 2.To find out how well the treatment of other anti-cancer drugs in combination with BMS-986253 work at treating advanced solid tumors, as compared to when paired with a placebo

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Bladder
  • Non-Small Cell Lung Cancer
  • Melanoma
  • Renal
  • Head & Neck
  • Solid Tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Part 1A: BMS-986253 + nivolumabDrug: BMS-986253
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  • Drug: Biological: Nivolumab
  • Drug: Experimental: Part 1B: BMS-986253 + nivolumabDrug: BMS-986253
  • Drug: Experimental: Part 1C: BMS-986253 + nivolumab + ipilimumabDrug: BMS-986253
  • Drug: Biological: Ipilimumab
  • Drug: Experimental: Part 2A: BMS-986253 + nivolumab + ipilimumabDrug: BMS-986253
  • Drug: Placebo Comparator: Part 2B: Placebo + nivolumab + ipilimumabBiological: Nivolumab
  • Drug: Other: Placebo
  • Drug: Patients will be randomized 1: 1 to receive BMS-986253 + NIVO + IPI or placebo + NIVO + IPI and stratified by serum IL-8 level, BRAFV600E status, and lactate dehydrogenase level. The dose and frequency of BMS-986253, NIVO, and IPI will be determined by part 1 data
  • Drug: EIOC 2022:
  • Drug: EIOC 2024:
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Study Complete

    Requirements information
    Inclusion criteria
    • Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1
    • At least 1 lesion accessible for biopsy
    • Eastern Cooperative Oncology Group Performance Status of 0 or 1
    • Pts with unresectable, stage III/IV melanoma who had progressed on/after anti–PD-(L)1 agents as their most recent therapy enrolled. No prior anti–cytotoxic T lymphocyte antigen-4 therapy was allowed.
    Exclusion criteria
    • Participants with CNS metastases as the only site of active disease (Participants with controlled brain metastases; however, will be allowed to enroll)
    • Participants with active, known or suspected autoimmune disease
    • Participants with conditions requiring systemic treatment with either corticosteroids (> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration
    • Participants with a known history of testing positive for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS)
    • Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy
    • Other protocol defined inclusion/exclusion criteria could apply

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (CIOCC)
    Madrid, Spain, 28050
    Investigator
    Emiliano Calvo
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Bladder
    Non-Small Cell Lung Cancer
    Melanoma
    Renal
    Head & Neck
    Solid Tumor