A Phase 2 Trial of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men with Metastatic Castration-Resistant Prostate Cancer

Conditions

Metastatic Castration-Resistant Prostate Cancer

Brief summary

Objective Response Rate (ORR) in Cohort B, C, and Cohort D, Radiographic Progression-Free Survival (rPFS)

Detailed description

Radiographic/Clinical Progression-Free Survival (rcPFS) in Cohort B, C, Radiographic/Clinical Progression-Free Survival (rcPFS) in Cohort D, Overall Survival (OS) in Cohort B, C, Overall Survival (OS) in Cohort D, Incidence of Adverse Events (AEs), Incidence of Serious Adverse Events (SAEs), Incidence of Adverse Events (AEs) leading to discontinuation, Incidence of Immune-mediated Adverse Events (IMAEs), Incidence of deaths, Incidence of laboratory abnormalities: Hematology, Clinical Chemistry, Coagulation, Liver function, Thyroid function, Adrenal function, Renal function, Number of participants with changes in pain as measured by Brief Pain Inventory-Short Form (BPI-SF), Estimated changes in health status and health utility as measured by the 3-level EuroQol Five Dimensions (EQ-5D-3L), Changes in cancer related symptoms and quality of life using the Functional Assessment Of Cancer Therapy - Prostate (FACT-P) questionnaire, Prostate Specfic Antigen (PSA) Response Rate

Related papers

No related papers found yet.

Interventions

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

DRUGMDX1106 ONO-4538

DRUGIpilimumab

DRUGPREDNISONE

DRUGJEVTANA 60 mg concentrate and solvent for solution for infusion

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Objective Response Rate (ORR) in Cohort B, C, and Cohort D, Radiographic Progression-Free Survival (rPFS)	—

Secondary

Measure	Time frame
Radiographic/Clinical Progression-Free Survival (rcPFS) in Cohort B, C, Radiographic/Clinical Progression-Free Survival (rcPFS) in Cohort D, Overall Survival (OS) in Cohort B, C, Overall Survival (OS) in Cohort D, Incidence of Adverse Events (AEs), Incidence of Serious Adverse Events (SAEs), Incidence of Adverse Events (AEs) leading to discontinuation, Incidence of Immune-mediated Adverse Events (IMAEs), Incidence of deaths, Incidence of laboratory abnormalities: Hematology, Clinical Chemistry, Coagulation, Liver function, Thyroid function, Adrenal function, Renal function, Number of participants with changes in pain as measured by Brief Pain Inventory-Short Form (BPI-SF), Estimated changes in health status and health utility as measured by the 3-level EuroQol Five Dimensions (EQ-5D-3L), Changes in cancer related symptoms and quality of life using the Functional Assessment Of Cancer Therapy - Prostate (FACT-P) questionnaire, Prostate Specfic Antigen (PSA) Response Rate	—

Measure

Time frame

Radiographic/Clinical Progression-Free Survival (rcPFS) in Cohort B, C, Radiographic/Clinical Progression-Free Survival (rcPFS) in Cohort D, Overall Survival (OS) in Cohort B, C, Overall Survival (OS) in Cohort D, Incidence of Adverse Events (AEs), Incidence of Serious Adverse Events (SAEs), Incidence of Adverse Events (AEs) leading to discontinuation, Incidence of Immune-mediated Adverse Events (IMAEs), Incidence of deaths, Incidence of laboratory abnormalities: Hematology, Clinical Chemistry, Coagulation, Liver function, Thyroid function, Adrenal function, Renal function, Number of participants with changes in pain as measured by Brief Pain Inventory-Short Form (BPI-SF), Estimated changes in health status and health utility as measured by the 3-level EuroQol Five Dimensions (EQ-5D-3L), Changes in cancer related symptoms and quality of life using the Functional Assessment Of Cancer Therapy - Prostate (FACT-P) questionnaire, Prostate Specfic Antigen (PSA) Response Rate

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Countries

Germany

Outcome results

None listed