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Active Not Recruiting INTERVENTIONAL NCT04968106

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

Randomized Phase II Study of Neoadjuvant Chemotherapy Plus Retifanlimab (INCMGA00012) in Patients With Selected Sarcomas

Sponsor: Incyte Biosciences International Sàrl

Updated 11 times since 2021 Last updated: Apr 20, 2026 Started: Dec 7, 2022 Primary completion: Aug 6, 2025 Completion: Apr 1, 2028
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Resectable Sarcoma, this trial is ongoing. The trial is conducted by Incyte Biosciences International Sàrl and has accumulated 11 data snapshots since 2022. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Study Description(click to expand)

This is a multicenter, prospective, open-labeled, 2-arm, non-comparative randomized (1:1) phase II trial. Patients will be randomized between arm A (neodjuvant chemotherapy by doxorubicin + ifosfamide) and arm B (neodjuvant chemotherapy by doxorubicin + ifosfamide and retifanlimab) with one patient randomized in arm A for one patient randomized in arm B.

This is a multicenter, prospective, open-labeled, 2-arm, non-comparative randomized (1:1) phase II trial. Patients will be randomized between arm A (neodjuvant chemotherapy by doxorubicin + ifosfamide) and arm B (neodjuvant chemotherapy by doxorubicin + ifosfamide and retifanlimab) with one patient randomized in arm A for one patient randomized in arm B.

Status Flow

~Sep 2021 – ~Dec 2021 · 3 months · monthly snapshotNot Yet Recruiting~Dec 2021 – ~Jan 2022 · 31 days · monthly snapshotNot Yet Recruiting~Jan 2022 – ~Apr 2022 · 3 months · monthly snapshotNot Yet Recruiting~Apr 2022 – ~Jun 2022 · 2 months · monthly snapshotNot Yet Recruiting~Jun 2022 – ~Nov 2022 · 5 months · monthly snapshotNot Yet Recruiting~Nov 2022 – ~Apr 2023 · 5 months · monthly snapshotRecruiting~Apr 2023 – ~Jul 2024 · 15 months · monthly snapshotRecruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotRecruiting~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotRecruiting~Sep 2025 – ~Apr 2026 · 8 months · monthly snapshotRecruitingApr 21, 2026 – present · 4 months · daily APIActive Not Recruiting

Change History

11 versions recorded
  1. Apr 21, 2026 — Present [daily]

    Active Not Recruiting

    Status: RecruitingActive Not Recruiting · Phase: PHASE2None

  2. Sep 2025 — Apr 2026 [monthly]

    Recruiting PHASE2

  3. Sep 2024 — Sep 2025 [monthly]

    Recruiting PHASE2

  4. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE2

  5. Apr 2023 — Jul 2024 [monthly]

    Recruiting PHASE2

Show 6 earlier versions
  1. Nov 2022 — Apr 2023 [monthly]

    Recruiting PHASE2

    Status: Not Yet RecruitingRecruiting

  2. Jun 2022 — Nov 2022 [monthly]

    Not Yet Recruiting PHASE2

  3. Apr 2022 — Jun 2022 [monthly]

    Not Yet Recruiting PHASE2

  4. Jan 2022 — Apr 2022 [monthly]

    Not Yet Recruiting PHASE2

  5. Dec 2021 — Jan 2022 [monthly]

    Not Yet Recruiting PHASE2

  6. Sep 2021 — Dec 2021 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility 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

Contact Information

Sponsor contact:
  • Incyte Biosciences International Sàrl
  • Institut Bergonié
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .