Active — Not RecruitingPhase 2

Neoadjuvant Chemotherapy and Retifanlimab in Patients With Selected Sarcomas (TORNADO)

France66 participantsStarted 2022-12-07

Plain-language summary

Multicenter, prospective, open-labeled, 2-arm, non-comparative randomized phase II trial to assess the antitumor activity of retifanlimab (INCMGA00012) in association with neoadjuvant chemotherapy

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patients with grade 2 or grade 3 soft-tissue sarcoma (limb, trunk wall, retroperitoneum) histologically confirmed and reviewed by the RRePS Network
✓. For TLS status determination: available archived FFPE tumor tissue sample.
✓. 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 tumor tissue sample (archived or newly obtained by biopsy for research purpose).
✓. Non-metastatic and resectable disease,
✓. At least one lesion that can be biopsied for research purpose,
✓. No prior treatment for the disease under study,
✓. Age ≥ 18 years,
✓. ECOG ≤ 1,

Exclusion criteria

✕. Previous treatment for retroperitoneal sarcoma including surgery, chemotherapy or radiotherapy
✕. Previous treatments with doxorubicin, daunorubicin, epirubicin, idarubicin and/or other anthracyclines or anthracenediones at the maximum cumulative dose,
✕. Known hypersensitivity to any involved study drug or any of its formulation components,
✕. Has an active or ongoing infection requiring systemic therapy,
✕. Known central nervous system malignancy (CNS),
✕. Women who are pregnant or breast feeding,
✕. Has known active hepatitis B or hepatitis C,
✕. Has a known history of Human Immunodeficiency Virus (HIV),

What they're measuring

Assessment of the antitumor activity of retifanlimab when prescribed in association with neoadjuvant chemotherapy (doxorubicin+ifosfamide)

Timeframe: 5 months after treatment onset

Trial details

NCT IDNCT04968106

SponsorInstitut Bergonié

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-06

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