Neoplasms

All Conditions

Symptoms and General Pathology

Rare Diseases

Sarcoma

Tertiary Lymphoid Structures

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Doxorubicin

Liposomal doxorubicin

Immune Checkpoint Inhibitors

Ifosfamide

Isophosphamide mustard

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Antineoplastic Agents, Alkylating

Alkylating Agents

Treatment by doxorubicin and ifosfamide followed by surgery

Treatment by doxorubicin, ifosfamide and retifanlimab followed by surgery

Doxorubicin will administered by intravenous infusion on day 1 every 3 weeks (75 mg/m²) up to 3 cycles

Ifosfamide will be administered by intravenous infusion over 3 days every 3 weeks (9 g/m²) up to 3 cycles

Retifanlimab will be administered by intravenous infusion on day 1every 3 weeks (375 mg) up to 3 cycles

INCMGA00012

Antoine ITALIANO, MD, PhD

Simone MATHOULIN-PELISSIER, MD, PhD

Mehdi BRAHMI, MD

Sarah WATSON, MD

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

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

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

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

Antitumor activity will be assessed in terms of histological response based on surgical sample

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)

Overall Survival (OS) is defined as the time from study treatment initiation to death (of any cause).

Toxicity will be grade using the Common Terminology Criteria for adverse events version 5 and coded according to the standardized medical terminology MedDRA

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Neoadjuvant Chemotherapy and Retifanlimab in Patients With Selected Sarcomas (TORNADO)	NCT04968106	Resectable Sarc...	Doxorubicin Ifosfamide INCMGA00012	18 Years -	Institut Bergonié
Neoadjuvant Chemotherapy and Retifanlimab in Patients With Selected Sarcomas (TORNADO)	NCT04968106	Resectable Sarc...	Doxorubicin Ifosfamide INCMGA00012	18 Years -	Institut Bergonié

Spots Global Cancer Trial Database for mature tertiary lymphoid structures