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Resectable SarcomaPhase 2TORNADONCT04968106

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

A Phase 2 study testing Doxorubicin, Ifosfamide and INCMGA00012 in people with Resectable Sarcoma, run by Institut Bergonié at 3 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Resectable Sarcoma
What is being tested?
Doxorubicin, Ifosfamide and INCMGA00012
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
3 sitesFrance
Study dates
7 Dec 2022to Apr 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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,
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  • Age ≥ 18 years,
  • ECOG ≤ 1,
  • Life expectancy > 3 months,
  • Patients must have measurable disease defined as per RECIST v1.1
  • Adequate hematological, renal, metabolic and hepatic function
  • Left ventricular ejection fraction ≥ 50% assessed by ECHO or MUGA within 6 months from study entry,
  • Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to study entry. .
  • Both women and men must agree to use a highly effective method of contraception throughout the treatment period and for one year after discontinuation of treatment for women and 4 months for men.
  • No prior or concurrent malignant disease diagnosed or treated in the last 2 years except for adequately treated in situ carcinoma of the cervix, concomitant endometrial carcinoma stage IA grade 1, basal or squamous skin cell carcinoma, or in situ transitional bladder cell carcinoma,
  • Recovery to grade ≤ 1 from any adverse event (AE) derived from previous treatment (excluding alopecia of any grade and non-painful peripheral neuropathy grade ≤ 2) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, version 5),
  • Voluntarily signed and dated written informed consent prior to any study specific procedure,
  • Patients with a social security in compliance with the French law.

Who cannot join

  • 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,
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  • Has known active hepatitis B or hepatitis C,
  • Has a known history of Human Immunodeficiency Virus (HIV),
  • Previous enrolment in the present study,
  • Patient unable to follow and comply with the study procedures because of any geographical, social or psychological reasons,
  • Has received a live attenuated vaccine or a live vaccine within 30 days prior to the first dose of trial treatment, Note: the killed virus vaccines used for seasonal influenza vaccines for injection are allowed; however intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
  • Uncontrolled or significant cardiovascular disease including, but not limited to, any of the following:
  • Myocardial infarction or stroke/transient ischemic attack within the 6 months prior to study entry.
  • Uncontrolled angina within the 3 months prior to study entry.
  • Any history of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes, or poorly controlled atrial fibrillation).
  • Corrected QT (QTc) prolongation > 480 msec.
  • History of other clinically significant cardiovascular disease (i.e., cardiomyopathy, congestive heart failure with New York Heart Association [NYHA] functional classification III-IV, pericarditis, significant pericardial effusion, significant coronary stent occlusion, poorly controlled venous thrombus).
  • Uncontrolled or significant renal disease including, but not limited to, any of the following:
  • Acute or uncontrolled urinary infection at study entry,
  • Hemorrhagic cystitis at study entry,
  • Presence of blood on dipstick at study entry,
  • Vesical atony,
  • Known urinary tract obstruction.
  • Patients with known history of active inflammatory bowel diseases, including those with small or large intestine inflammation, such as Crohn's disease or ulcerative colitis, will be excluded from the study,
  • Has received systemic antibiotics within 14 days before the first dose of study treatment. Participants receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible.
  • History of organ transplant, including allogeneic stem cell transplantation.
  • Receiving probiotics as of the first dose of study treatment.
  • Has an active autoimmune disease
  • Patients with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible,
  • Patients requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at dose ≤ 10 mg or 10 mg equivalent prednisone day,
  • Administration of steroids through a route known to result in a minimal systemic exposure (topical, intranasal, intra-ocular, intra-articular or inhalation) are acceptable.
  • Evidence of interstitial lung disease, history of interstitial lung disease, or active, noninfectious pneumonitis.
  • Palliative radiation therapy administered within 1 week of first dose of study treatment or radiation therapy in the thoracic region that is > 30 Gy within 6 months of the first dose of study treatment. Note: Participants must have recovered from all radiation-related toxicities (to Grade >1 or baseline), not require corticosteroids for this purpose, and not have had radiation pneumonitis.
  • Person under judicial protection or deprived of liberty.

Trial locations and contacts

3 sites in 1 country.

France3 sites

  • Institut Bergonié

    Bordeaux, 33076

  • Centre Léon Bérard

    Lyon

  • Institut Curie

    Paris

Other trials in France

About this study

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

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

Read the detailed description

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.

Being tested
Doxorubicin, Ifosfamide, INCMGA00012
Keywords
sarcoma, neoadjuvant chemotherapy, mature tertiary lymphoid structures, immune checkpoint inhibitor
Medical subject headings
Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DoxorubicinDrug

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

  • IfosfamideDrug

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

  • INCMGA00012Drug

    Also called Retifanlimab

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

Study groups in NCT04968106
Study groupRoleWhat they receive
Standard Arm A: treatment by neoadjuvant chemotherapyOtherTreatment by doxorubicin and ifosfamide followed by surgery
Receives: Drug: Doxorubicin; Drug: Ifosfamide
Experimental Arm B: treatement by neoadjuvant chemotherapy and retifanlimabExperimentalTreatment by doxorubicin, ifosfamide and retifanlimab followed by surgery
Receives: Drug: Doxorubicin; Drug: Ifosfamide; Drug: INCMGA00012

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 5 months after treatment onset

Secondary outcomes (5)

  1. 1-year progression-free survival

    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)

    Measured: 1 year

  2. 3-year progression-free survival

    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)

    Measured: 3 years

  3. 1-year overall survival

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

    Measured: 1 year

  4. 3-year overall survival

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

    Measured: 3 years

  5. Safety profile independently for each arm: Common Terminology Criteria for Adverse event version 5

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

    Measured: Throughout the treatment period, an expected average of 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2021
  2. Study start7 Dec 2022
  3. Primary completion6 Aug 2025
  4. Study completionApr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
None (open label)
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04968106
Sponsor's protocol ID
IB 2021-01
Other IDs
2023-509498-21-00, 2021-001085-37, 2023
Acronym
TORNADO
Status last verified
Oct 2026
First submitted
13 Jul 2021
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Doxorubicin, Ifosfamide and INCMGA00012 in people with Resectable Sarcoma, run by Institut Bergonié at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of the antitumor activity of retifanlimab when prescribed in association with neoadjuvant chemotherapy (doxorubicin+ifosfamide) (time frame: 5 months after treatment onset). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04968106.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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