A Phase 2 Open-Label, Multi-Center Study of BMS-986504 as Monotherapy and in Combination with Other Agents in Participants with Advanced and/or Metastatic Solid Tumors with Homozygous MTAP Deletion

Conditions

Advanced and/or Metastatic Solid Tumors with Homozygous MTAP Deletion

Brief summary

Achievement of OR- confirmed complete response (CR) or partial response (PR), To check how safe and tolerable different dose levels of BMS‑986504 are when it is given together with other cancer treatments in participants with advanced/metastatic tumor with MTAP gene deletion or MTAP loss.

Detailed description

TTOR- the time from first dose to the date of the first documentation of objective tumor response (CR or PR), DOR (CR or PR)- the time between the date of the first documentation of objective tumor response and the date of disease progression or to death from any cause (whichever occurs first), Achievement of DC- best overall response (BOR) of confirmed CR, confirmed PR, or stable disease (SD), Incidence and severity of adverse events (AEs), serious adverse events (SAEs), treatment related AEs and SAEs, AEs leading to study treatment discontinuation, deaths and laboratory abnormalities, Achievement of CB- BOR of confirmed CR, confirmed PR, or SD for at least 4 months after start of treatment, OR, DC, DOR, TTOR and CBof BMS-986504 in combination with other anti-cancer treatments

Related papers

No related papers found yet.

Interventions

DRUGTEMOZOLOMIDE

DRUGGEMCITABINE

DRUGPACLITAXEL

DRUGBNT327 20 mg ml

DRUGBNT327 50 mg ml

DRUGPACLITAXEL ALBUMIN-BOUND

DRUGCARBOPLATIN

DRUGNavlimetostat

DRUGPEMETREXED

DRUGCISPLATIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Achievement of OR- confirmed complete response (CR) or partial response (PR), To check how safe and tolerable different dose levels of BMS‑986504 are when it is given together with other cancer treatments in participants with advanced/metastatic tumor with MTAP gene deletion or MTAP loss.	—

Secondary

Measure	Time frame
TTOR- the time from first dose to the date of the first documentation of objective tumor response (CR or PR), DOR (CR or PR)- the time between the date of the first documentation of objective tumor response and the date of disease progression or to death from any cause (whichever occurs first), Achievement of DC- best overall response (BOR) of confirmed CR, confirmed PR, or stable disease (SD), Incidence and severity of adverse events (AEs), serious adverse events (SAEs), treatment related AEs and SAEs, AEs leading to study treatment discontinuation, deaths and laboratory abnormalities, Achievement of CB- BOR of confirmed CR, confirmed PR, or SD for at least 4 months after start of treatment, OR, DC, DOR, TTOR and CBof BMS-986504 in combination with other anti-cancer treatments	—

Measure

Time frame

TTOR- the time from first dose to the date of the first documentation of objective tumor response (CR or PR), DOR (CR or PR)- the time between the date of the first documentation of objective tumor response and the date of disease progression or to death from any cause (whichever occurs first), Achievement of DC- best overall response (BOR) of confirmed CR, confirmed PR, or stable disease (SD), Incidence and severity of adverse events (AEs), serious adverse events (SAEs), treatment related AEs and SAEs, AEs leading to study treatment discontinuation, deaths and laboratory abnormalities, Achievement of CB- BOR of confirmed CR, confirmed PR, or SD for at least 4 months after start of treatment, OR, DC, DOR, TTOR and CBof BMS-986504 in combination with other anti-cancer treatments

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Outcome results

None listed