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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05492123 | Nivolumab-ipilimumab and Chemoradiation for Cervical Cancer | PHASE2 | RECRUITING | 112 | — | — | Aug 30, 2022 | Mar 31, 2028 | Jan 5, 2024 | 14 | Brazil |
No evidence of disease recurrence/regrowth after 3 years of follow-up
| Arm | Type | Description |
|---|---|---|
| Standard Chemoradiation | ACTIVE_COMPARATOR | Traditional radiation therapy with a target of 45 Gy in 25 1.8Gy fractions with concurrent weekly cisplatin 40mg/m2/week or carboplatin AUC 2/week |
| Immunotherapy | EXPERIMENTAL | 4 cycles of induction therapy with nivolumab 1mg/kg and ipilimumab 3mg/kg every 3 weeks followed by traditional radiation therapy with a target of 45 Gy in 25 1.8Gy fractions with concurrent weekly cisplatin 40mg/m2/week (or carboplatin AUC 2/week) with concurrent nivolumab 240mg every 2 weeks. |
| Name | Type | Description |
|---|---|---|
| Nivolumab 40 mg in 4 ml Injection | DRUG | Nivolumab 1mg/kg every 3 weeks for 4 cycles prior to radiation and 240mg every 2 weeks with concurrent radiation |
| Ipilimumab 200 MG in 40 ML Injection | DRUG | Ipilimumab 3mg/kg every 3 weeks for 4 cycles prior to radiation |
| Chemoradiation | RADIATION | Radiation to a dose of 45Gy over 25 1.8Gyfractions and brachytherapy with concurrent weekly cisplatin 40mg/m2/w or carboplatin AUC 2/w |
Inclusion Criteria: * Female participants older than 18 years * Documented evidence of cervical adenocarcinoma or squamous carcinoma FIGO Stage IB2-IB3 node positive or Stage IIB-IVA * No prior chemotherapy, immune checkpoint inhibitors or radiotherapy for cervical cancer * WHO/ECOG performance sta...