EUCTR2021-001085-37-FR
Active, not recruiting
Phase 1
Randomized phase II study of neoadjuvant chemotherapy plus retifanlimab (INCMGA00012) plus in patients with selected retroperitoneal sarcomas. - TORNADO
Conditionsretroperitoneal sarcomasMedDRA version: 20.0Level: LLTClassification code 10039494Term: Sarcoma NOSSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10077289Term: Retroperitoneal sarcomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- retroperitoneal sarcomas
- Sponsor
- Institut Bergonié
- Enrollment
- 66
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients with retroperitoneal sarcoma histologically confirmed and reviewed by the RRePS Network (Réseau de Référence en Pathologie des Viscères et des tissus mous) as recommended by the French National Cancer Institute(Inca),
- •2\. For TLS status determination: available archived FFPE (Formalin\-Fixed Paraffin\-Embedded) tumor tissue sample. In case of archived material is not available, presence of tumor lesion that can be biopsied for research purpose,
- •3\. Presence of mature tertiary lymphoid structures. Except if presence of TLS have been already confirmed by Biopathological platform at Bergonié Institute, presence of TLS should be confirmed by central review based on FFPE (Formalin\-Fixed Paraffin\-Embedded) tumor tissue sample (archived or newly obtained by biopsy for research purpose). Note that the presence of TLS could be determined by central analysis if not available before,
- •4\. Non\-metastatic and resectable disease,
- •5\. At least one lesion that can be biopsied for research purpose,
- •6\. No prior treatment for the disease under study,
- •7\. Age \= 18 years,
- •8\. Eastern Cooperative Oncology Group (ECOG) performance status (PS) \= 1,
- •9\. Life expectancy \> 3 months,
- •10\. Patients must have measurable disease (lesion in previously irradiated field can be considered as measurable if progressive at inclusion according to RECIST v1\.1\) defined as per RECIST v1\.1 with at least one lesion that can be measured in at least one dimension (longest diameter to be recorded) as \=10 mm with spiral CT scan.
Exclusion Criteria
- •1\. Previous treatment for retroperitoneal sarcoma including surgery, chemotherapy or radiotherapy
- •2\. Previous treatments with doxorubicin, daunorubicin, epirubicin, idarubicin and/or other anthracyclines or anthracenediones at the maximum cumulative dose,
- •3\. Known hypersensitivity to any involved study drug or any of its formulation components,
- •4\. Has an active or ongoing infection requiring systemic therapy,
- •5\. Known central nervous system malignancy (CNS),
- •6\. Women who are pregnant or breast feeding,
- •7\. Has known active hepatitis B or hepatitis C,
- •8\. Has a known history of Human Immunodeficiency Virus (HIV),
- •9\. Previous enrolment in the present study,
- •10\. Patient unable to follow and comply with the study procedures because of any geographical, social or psychological reasons,
Outcomes
Primary Outcomes
Not specified
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