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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05678673 | Study of XL092 + Nivolumab vs Sunitinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma | PHASE3 | ACTIVE NOT_RECRUITING | 317 | — | — | Jan 1, 2023 | Jun 1, 2028 | Jul 14, 2025 | 163 | United States, Argentina +23 |
Defined as the time from randomization to the earlier of either radiographic PD per RECIST 1.1 as determined by the BIRC or death from any cause
Defined as the proportion of subjects with the best overall response of complete response (CR) or partial response (PR) per RECIST 1.1 as determined by the BIRC that is confirmed at a follow-up assessment ≥ 28 days later
| Arm | Type | Description |
|---|---|---|
| XL092 + Nivolumab | EXPERIMENTAL | Subjects with advanced or metastatic nccRCC will receive XL092 + nivolumab |
| Sunitinib Malate | ACTIVE_COMPARATOR | Subjects with advanced or metastatic nccRCC will receive an active comparator of sunitinib |
| Name | Type | Description |
|---|---|---|
| XL092 | DRUG | Specified doses on specified days |
| Nivolumab | DRUG | Specified doses on specified days |
| Sunitinib Malate | DRUG | Specified doses on specified days |
Inclusion Criteria: * Histologically confirmed nccRCC that is unresectable, advanced or metastatic. Histologic subtypes including papillary, unclassified, and translocation-associated are allowed. Among the eligible histologic subtypes, sarcomatoid features are allowed. * Measurable disease accordi...