RecruitingPhase 2NCT04968106

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


Sponsor

Institut Bergonié

Enrollment

66 participants

Start Date

Dec 7, 2022

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (called TORNADO) is testing whether adding an immunotherapy drug called retifanlimab to standard chemotherapy before surgery improves outcomes for people with certain types of soft-tissue sarcoma (cancerous tumours of the muscles, fat, tendons, or other connective tissue). **You may be eligible if...** - You have a grade 2 or grade 3 soft-tissue sarcoma in the arm, leg, torso, or abdomen, confirmed by biopsy and reviewed by a specialist network - Your tumour shows a feature called tertiary lymphoid structures (TLS), which are clusters of immune cells that may predict better response to immunotherapy - Your cancer has not spread to other parts of the body and can be surgically removed - You have at least one tumour that can be biopsied - You have not previously received treatment for this cancer - You are 18 or older and in adequate health (ECOG 0–1) **You may NOT be eligible if...** - Your sarcoma has spread (metastatic) - Your tumour lacks TLS features on testing - You have already received treatment for this sarcoma - You have serious organ problems or active infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGDoxorubicin

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

DRUGIfosfamide

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

DRUGINCMGA00012

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


Locations(4)

Institut Bergonié

Bordeaux, France

Centre Léon Bérard

Lyon, France

Institut Curie

Paris, France

Institut Gustave Roussy

Villejuif, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04968106


Related Trials