Adult patients with treatment-naïve surgically non-metastatic and resectable primary retroperitoneal, limbs and trunk wall undifferentiated pleomorphic sarcomas.
Conditions
Brief summary
The antitumor activity of retifanlimab (INCMGA00012) when prescribed in association with neoadjuvant chemotherapy (Doxorubicin + Ifosfamide) will be assessed based on histological response defined as less than 10% of viable tumor cells on surgical sample.
Detailed description
Progression-free survival (PFS) is defined as the time from study treatment initiation to the first occurrence of disease progression or death (of any cause), whichever occurs first. 1- and 3-year PFS rates and median PFS will be reported., Overall Survival (OS) is defined as the time from study treatment initiation to death (of any cause). 1- and 3-year OS rates and median OS will be reported., Safety will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) from the NCI v5.0. Toxicity will be graded using the CTCAE v5.0. Adverse events, serious and non-serious, will be coded as per the MedDRA dictionary.
Interventions
DRUGHOLOXAN 2000 mg
DRUGsolution pour perfusion
Sponsors
Institut Bergonie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The antitumor activity of retifanlimab (INCMGA00012) when prescribed in association with neoadjuvant chemotherapy (Doxorubicin + Ifosfamide) will be assessed based on histological response defined as less than 10% of viable tumor cells on surgical sample. | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) is defined as the time from study treatment initiation to the first occurrence of disease progression or death (of any cause), whichever occurs first. 1- and 3-year PFS rates and median PFS will be reported., Overall Survival (OS) is defined as the time from study treatment initiation to death (of any cause). 1- and 3-year OS rates and median OS will be reported., Safety will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) from the NCI v5.0. Toxicity will be graded using the CTCAE v5.0. Adverse events, serious and non-serious, will be coded as per the MedDRA dictionary. | — |
Countries
France
Outcome results
None listed