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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03841201 | Immunotherapy With Nivolumab in Combination With Lenvatinib for Advanced Stage Hepatocellular Carcinoma | PHASE2 | COMPLETED | 50 | — | — | Jun 12, 2019 | May 2, 2023 | May 12, 2023 | 1 | Germany |
Number and percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) according to RECIST 1.1
Type, incidence and severity of AEs, SAEs according to NCI-CTCAE V 4.03
| Arm | Type | Description |
|---|---|---|
| Treatment | EXPERIMENTAL | * Lenvatinib peroral qd (8 mg for patients with body weight \<60kg and 12 mg for patients with body weight ≥ 60kg) * Nivolumab i.v. q2w (240mg fixed dose IV) max. 36 cycles |
| Name | Type | Description |
|---|---|---|
| Lenvatinib | DRUG | oral |
| Nivolumab | DRUG | iv infusion |
Inclusion Criteria: 1. Fully-informed written consent. 2. Males and females ≥ 18 years of age \*There are no data that indicate special gender distribution. Therefore patients will be enrolled in the study gender-independently. 3. Unresectable, multinodular tumour, not eligible for resection or...