Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03061539 | Nivolumab and Ipilimumab Treatment in Prostate Cancer With an Immunogenic Signature | PHASE2 | ACTIVE NOT_RECRUITING | 380 | — | — | Feb 6, 2018 | Jun 1, 2027 | Sep 28, 2022 | 1 | United Kingdom |
Patients will be considered as having had a treatment response if any one of the following criteria are satisfied: * Radiological response (RECIST 1.1) * PSA response ≥50% confirmed by a second PSA test at least 4 weeks later (PCWG3 2016) * Conversion of CTC count from ≥5 cells/7.5ml at baseline to \<5 cells/7.5ml confirmed by a second CTC test at least 4 weeks later (PCWG3 2016)
| Arm | Type | Description |
|---|---|---|
| Nivolumab & Ipilimumab - Cohort 1 | EXPERIMENTAL | Patients will receive Nivolumab 1 mg/kg + ipilimumab 3 mg/kg every three weeks for a maximum of 4 doses followed by a 6 week gap after last combination dose. The patients will then receive 480 mg flat dose of nivolumab every 4 weeks for up to one year, or until progression, unacceptable toxicity or withdrawal of consent. |
| Nivolumab & Ipilimumab - Cohort 2 | EXPERIMENTAL | Patients will receive Nivolumab 3 mg/kg + ipilimumab 1 mg/kg every three weeks for a maximum of 4 doses followed by a 3 week gap after last combination dose. The patients will then receive 480 mg flat dose of nivolumab every 4 weeks for up to one year, or until progression, unacceptable toxicity or withdrawal of consent. |
| Name | Type | Description |
|---|---|---|
| Nivolumab & Ipilimumab | DRUG | Combination Therapy: Cohort 1: Nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks for a maximum of 4 cycles . Cohort 2 : Nivolumab 3mg/kg + ipilimumab 1mg/kg every 3 weeks for a maximum of 4 cycles. Treatment free gap after last combination dose : Cohort 1: 6 weeks; Cohort 2: 3 weeks Monotherapy: 480 mg flat dose of nivolumab every 4 weeks for up to 10 cycles, or until progression, unacceptable toxicity or withdrawal of consent |
Inclusion Criteria: * Metastatic castrate resistant prostate cancer. * Histologically confirmed prostate adenocarcinoma. * Patient has archival prostate cancer tissue available or is willing to undergo a new biopsy. * Immunogenic biomarker positive disease - see Appendix 1 NB patients will be inclu...