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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04968106 | Neoadjuvant Chemotherapy and Retifanlimab in Patients With Selected Sarcomas (TORNADO) | PHASE2 | ACTIVE NOT_RECRUITING | 66 | — | — | Dec 7, 2022 | Apr 1, 2028 | Apr 21, 2026 | 3 | France |
Antitumor activity will be assessed in terms of histological response based on surgical sample
| Arm | Type | Description |
|---|---|---|
| Standard Arm A: treatment by neoadjuvant chemotherapy | OTHER | Treatment by doxorubicin and ifosfamide followed by surgery |
| Experimental Arm B: treatement by neoadjuvant chemotherapy and retifanlimab | EXPERIMENTAL | Treatment by doxorubicin, ifosfamide and retifanlimab followed by surgery |
| Name | Type | Description |
|---|---|---|
| Doxorubicin | DRUG | Doxorubicin will administered by intravenous infusion on day 1 every 3 weeks (75 mg/m²) up to 3 cycles |
| Ifosfamide | DRUG | Ifosfamide will be administered by intravenous infusion over 3 days every 3 weeks (9 g/m²) up to 3 cycles |
| INCMGA00012 | DRUG | Retifanlimab will be administered by intravenous infusion on day 1every 3 weeks (375 mg) up to 3 cycles |
Inclusion Criteria: 1. Patients with grade 2 or grade 3 soft-tissue sarcoma (limb, trunk wall, retroperitoneum) histologically confirmed and reviewed by the RRePS Network 2. For TLS status determination: available archived FFPE tumor tissue sample. 3. Presence of mature tertiary lymphoid structures...