A Phase 2, Randomized, Open-Label, Study of Lorigerlimab with Docetaxel or Docetaxel Alone in Participants with Metastatic Castration-Resistant Prostate Cancer

Conditions

Metastatic Castration-Resistant Prostate Cancer

Brief summary

Median radiographic progression free survival (rPFS) determined by investigator review.

Detailed description

Objective response rate (ORR) per PCWG3 criteria, Duration of response (DoR), Time to response (TTR), PSA50 response rate, PSA90 response rate, Time to PSA progression, Duration of PSA response, Overall survival (OS), Time to First Symptomatic Skeletal Event (SSE), Time to pain progression using the BPI-sf questionnaire, Pain severity using the Brief Pain Index - short form (BPI-sf) questionnaire, Pain interference using the BPI-sf questionnaire, Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire, Comparison of types of adverse events (AEs) between treatment groups, Lorigerlimab maximum concentration or concentration at the end of infusion (Cmax), Lorigerlimab area under the concentration time curve (AUC), Trough drug concentration (Ctrough or Cmin), Clearance (CL), Volume of distribution (Vz), Terminal half-life, Number of participants who develop anti-drug antibodies

Related papers

No related papers found yet.

Interventions

DRUG-

DRUGPrednisona KERN PHARMA 5 mg comprimidos EFG

DRUGMGD019

DRUGDexamethason 4 mg JENAPHARM®

DRUGDocetaxel AqVida 20 mg/ml Konzentrat zur Herstellung einer Infusionslösung

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Median radiographic progression free survival (rPFS) determined by investigator review.	—

Secondary

Measure	Time frame
Objective response rate (ORR) per PCWG3 criteria, Duration of response (DoR), Time to response (TTR), PSA50 response rate, PSA90 response rate, Time to PSA progression, Duration of PSA response, Overall survival (OS), Time to First Symptomatic Skeletal Event (SSE), Time to pain progression using the BPI-sf questionnaire, Pain severity using the Brief Pain Index - short form (BPI-sf) questionnaire, Pain interference using the BPI-sf questionnaire, Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire, Comparison of types of adverse events (AEs) between treatment groups, Lorigerlimab maximum concentration or concentration at the end of infusion (Cmax), Lorigerlimab area under the concentration time curve (AUC), Trough drug concentration (Ctrough or Cmin), Clearance (CL), Volume of distribution (Vz), Terminal half-life, Number of participants who develop anti-drug antibodies	—

Measure

Time frame

Objective response rate (ORR) per PCWG3 criteria, Duration of response (DoR), Time to response (TTR), PSA50 response rate, PSA90 response rate, Time to PSA progression, Duration of PSA response, Overall survival (OS), Time to First Symptomatic Skeletal Event (SSE), Time to pain progression using the BPI-sf questionnaire, Pain severity using the Brief Pain Index - short form (BPI-sf) questionnaire, Pain interference using the BPI-sf questionnaire, Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire, Comparison of types of adverse events (AEs) between treatment groups, Lorigerlimab maximum concentration or concentration at the end of infusion (Cmax), Lorigerlimab area under the concentration time curve (AUC), Trough drug concentration (Ctrough or Cmin), Clearance (CL), Volume of distribution (Vz), Terminal half-life, Number of participants who develop anti-drug antibodies

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Countries

Belgium, Bulgaria, France, Poland, Spain

Outcome results

None listed