A phase 2 trial of BMS-986365 in mCSPC patients with suboptimal PSA-response after 7 months of Androgen Deprivation Therapy (ADT) plus Androgen Receptor Pathway Inhibition (ARPI).

Conditions

Metastatic Castrate Sensitive Prostate Cancer - mCSPC

Brief summary

Confirmed PSA 50% response rate

Detailed description

Confirmed PSA 30 % and 90% response rate, Confirmed absolute PSA response rates (PSA ≤0.02, >0.02 – <0.2, ≥0.2-4.0 and >4.0 ng/ml), Time to PSA progression, Time to mCRPC, rPFS, Time to pain progression (TTPP), Time to symptomatic skeletal related event (TTSSE), Time to initiation of the first subsequent systemic therapy (TFST), The incidence of treatment emergent AEs (according to NCI-CTC AE 5.0), SAEs, AEs leading to dose modifications, interruptions, and discontinuation, ECG findings, and laboratory abnormalities and changes from baseline (including clinical chemistry and hematology parameters), Overall Survival, Change from baseline in NCCN FACT FPSI-17 total and subscale scores, Change from baseline in EQ-5D-5L, Change from baseline in BPI-SF, Analysis of AR copy number, splice variants and mutations at baseline, ctDNA detection rate at baseline, Changes in ctDNA from baseline during treatment

Related papers

No related papers found yet.

Interventions

DRUGBMS-986365

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Confirmed PSA 50% response rate	—

Secondary

Measure	Time frame
Confirmed PSA 30 % and 90% response rate, Confirmed absolute PSA response rates (PSA ≤0.02, >0.02 – <0.2, ≥0.2-4.0 and >4.0 ng/ml), Time to PSA progression, Time to mCRPC, rPFS, Time to pain progression (TTPP), Time to symptomatic skeletal related event (TTSSE), Time to initiation of the first subsequent systemic therapy (TFST), The incidence of treatment emergent AEs (according to NCI-CTC AE 5.0), SAEs, AEs leading to dose modifications, interruptions, and discontinuation, ECG findings, and laboratory abnormalities and changes from baseline (including clinical chemistry and hematology parameters), Overall Survival, Change from baseline in NCCN FACT FPSI-17 total and subscale scores, Change from baseline in EQ-5D-5L, Change from baseline in BPI-SF, Analysis of AR copy number, splice variants and mutations at baseline, ctDNA detection rate at baseline, Changes in ctDNA from baseline during treatment	—

Measure

Time frame

Confirmed PSA 30 % and 90% response rate, Confirmed absolute PSA response rates (PSA ≤0.02, >0.02 – <0.2, ≥0.2-4.0 and >4.0 ng/ml), Time to PSA progression, Time to mCRPC, rPFS, Time to pain progression (TTPP), Time to symptomatic skeletal related event (TTSSE), Time to initiation of the first subsequent systemic therapy (TFST), The incidence of treatment emergent AEs (according to NCI-CTC AE 5.0), SAEs, AEs leading to dose modifications, interruptions, and discontinuation, ECG findings, and laboratory abnormalities and changes from baseline (including clinical chemistry and hematology parameters), Overall Survival, Change from baseline in NCCN FACT FPSI-17 total and subscale scores, Change from baseline in EQ-5D-5L, Change from baseline in BPI-SF, Analysis of AR copy number, splice variants and mutations at baseline, ctDNA detection rate at baseline, Changes in ctDNA from baseline during treatment

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Outcome results

None listed