Approval Probability
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Adjusted LOA
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NBTXR3 · 3 trials · 12 indications
To compare antitumor activity in terms of Pathological complete response rate (pCRR) of intratumor injection of NBTXR3 activated by external beam radiation therapy (EBRT), versus EBRT alone
Determination of DLTs, the MTD (if possible), and RP2Ds for each cohort
Incidence of Grade 3 and higher treatment-related AEs
\- To evaluate the feasibility of NBTXR3 given as intratumor implantation (by injection) and activated by external beam radiation in patients with soft tissue sarcoma of the extremity and trunk wall
\- To assess the safety profile and determine the early dose limiting toxicity (DLT) of NBTXR3 intratumor implantation (by injection) and activated by external beam radiation
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | NBTXR3 + Radiotherapy |
| Arm B | ACTIVE_COMPARATOR | Radiotherapy alone |
| NBTXR3 activated by SABR followed by anti-PD-1 monotherapy | EXPERIMENTAL | Intratumoral injection of NBTXR3 followed by SABR followed by monotherapy with nivolumab or pembrolizumab |
| NBTXR3 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| NBTXR3 | DEVICE | One intratumor implantation by injection |
| Radiation therapy | DEVICE | 5 weeks/50 Gy (5 x 2 Gy by week) |
| SABR | RADIATION | Radiotherapy given as a definite number of fractions at the dose defined for each radiation field |
| Nivolumab | DRUG | Anti-PD-1 monotherapy |
| Pembrolizumab | DRUG | Anti-PD-1 monotherapy |
Inclusion Criteria: * Age: 18 years and older * Locally Advanced Soft Tissue Sarcoma of the Extremity and Trunk Wall * All grades * Candidate to radiotherapy + surgery (ESMO guideline 2014) i.e. tumor must not have involvement of bone and / or vessel and or nerve : * Primary tumor or, * Relaps...