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Sarcoma,Soft TissuePhase 2RT-ImmuneNCT03474094

Clinical and Biological Activity of an Anti-PD-L1 (Atezolizumab) in Operable Localised Soft Tissue Sarcomas Patients to be Treated With Radiotherapy

A Phase 2 study testing Pre-operative radiotherapy followed by 2 cycles of atezolizumab then surgery, 2 cycles of atezolizumab followed by surgery then post-operative radiotherapy and Pre-operative radiotherapy followed by surgery then 2 cycles of atezolizumab. in people with Sarcoma,Soft Tissue, run by Centre Leon Berard at 6 sites in 2 countries.

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

This multicentric, randomised, Phase II trial will use a pick-the-winner design in order to evaluate the clinical and biological activity of atezolizumab when combined with pre-operative or post-operative radiotherapy in STS patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sarcoma,Soft Tissue
What is being tested?
Pre-operative radiotherapy followed by 2 cycles of atezolizumab then surgery, 2 cycles of atezolizumab followed by surgery then post-operative radiotherapy and Pre-operative radiotherapy followed by surgery then 2 cycles of atezolizumab.
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
6 sitesin 2 countries
Study dates
1 Aug 2018to 30 Dec 2026
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

  • Male or female patients aged ≥ 18 years at time of inform consent signature.
  • Histologically confirmed soft tissue sarcoma including liposarcoma, leiomyosarcoma, myxofibrosarcoma, UPS, angiosarcoma, all translocation sarcoma except Ewing, rhabdomyosarcoma (RMS), and myxoid liposarcoma (LPS).
  • Soft tissue sarcoma suitable for neoadjuvant RT and amenable to surgery with curative intent (high-grade non-metastatic tumors, intermediate and low-grade tumors greater than 5 cm).
  • Note: Patients with local relapsing disease amenable to surgery are eligible.
  • Presence of at least one tumor lesion with a diameter ≥10 mm, visible by medical imaging and accessible to percutaneous or endoscopic sampling that permit core needle biopsy without unacceptable risk and suitable for retrieval of a minimum of three, but ideally 4, cores using a biopsy needle of at least 16-gauge.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 (Appendix 4).
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  • Adequate end organs and bone marrow functions as defined below according to lab tests performed within 7 days before W1D1:
  • Bone marrow (without transfusion within 2 weeks before W1D1):
  • Hemoglobin ≥ 9.0 g/dL,
  • Absolute neutrophil count ≥ 1.5 x 109/L,
  • Platelets ≥ 100 x 109/L,
  • Lymphocyte count ≥ 0.5 x 109/L.
  • Renal function:
  • Serum creatinine clearance ≥ 30 mL/min/1.73m2 (MDRD or CKD-EPI formula - Appendix 3)
  • Hepatic function
  • Serum bilirubin < 1.5 × Upper Limit of Normal (ULN), with the following exception: Patients with known Gilbert disease who have serum bilirubin level ≤ 3 ULN may be enrolled.
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase ≤ 2.5 ULN.
  • Coagulation
  • INR and aPTT ≤ 1.5 ULN Note: This is applicable only for patients not receiving an anticoagulant treatment: patients receiving therapeutic anticoagulation must be on stable dose.
  • Minimal wash-out period for prior treatments (minimal time required from the end date of prior treatment to W1D1):
  • Immunosuppressive medication > 28 days, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid,
  • Live attenuated vaccines > 30 days, Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
  • Major surgical procedure, open biopsy (excluding skin cancer resection and screening tumor biopsy), or significant traumatic injury > 14 days (the wound must have healed),
  • Any approved or investigational anti-cancer therapy, including chemotherapy, hormonal therapy or targeted therapy > 21 days,
  • Systemic immunostimulatory agents > 28 days or five half-lives of the drug, whichever is longer,
  • Oral or IV antibiotics > 14 days.
  • Women of child-bearing potential must have a negative serum pregnancy test within 7 days before randomisation and must agree to use an effective form of contraception from the time of the negative pregnancy test up to 5 months after the last dose of atezolizumab (See Appendix 5).
  • Fertile men must agree to use an effective method of birth control during the study and for up to 5 months after the last dose of atezolizumab.
  • Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.
  • Patients must be covered by a medical insurance in country where applicable.

Who cannot join

  • Patients with evidence of metastatic disease, defined by the presence of any of the followings:
  • Lesions that are discontinuous from the primary tumor,
  • Lesions that are not regional lymph nodes,
  • Lesions that do not share a body cavity with the primary tumor,
  • Evidence by medical imagining (eg CT-scan) of metastatic disease.
  • Patients with history of severe allergic or other hypersensitivity reactions to:
Show all 38Show fewer
  • Chimeric or humanized antibodies or fusion proteins,
  • Biopharmaceuticals produced in Chinese hamster ovary cells, or
  • Any component of the atezolizumab formulation.
  • Patients using or requirement to use while on the study of any not permitted concomitant medications :
  • Any approved anti-cancer systemic treatment including chemotherapy, hormonotherapy, biological therapy, immunotherapy other than atezolizumab,
  • Any investigational agents,
  • Live vaccines. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, BCG, and typhoid (oral) vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however intranasal influenza vaccines (e.g. Flu-Mist®) are live attenuated vaccines, and are not allowed during the study active period,
  • Traditional herbal medicines since the ingredients of many herbal medicines are not fully studied and their use may result in unanticipated drug-drug interactions that may cause or confound assessment of toxicity,
  • Immunostimulatory agents, including but not limited to IFN-α, IFN-γ, or IL-2, during the entire study. These agents, in combination with atezolizumab, could potentially increase the risk for autoimmune conditions. In addition, all patients (including those who discontinue the study early) should not receive other immunostimulatory agents for 10 weeks after the last dose of atezolizumab,
  • Immunosuppressive medications, including but not limited to cyclophosphamide, azathioprine, methotrexate, and thalidomide. These agents could potentially alter the activity and the safety of atezolizumab. Systemic corticosteroids and anti-TNF-α agents may attenuate potential beneficial immunologic effects of treatment with atezolizumab but may be administered to manage irAE (See Safety Plan). If feasible, alternatives to these agents should be considered.
  • Patients with a malignancy other than STS within 5 years prior to randomisation with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome (such as adequately treated in situ carcinoma of the cervix, basal or squamous cell skin cancer, localised prostate cancer or ductal in situ carcinoma treated surgically with curative intent).
  • Patients with severe infections within 4 weeks prior to randomisation including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia.
  • Patients with history of autoimmune disease including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.
  • Note: Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:
  • Rash must cover less than 10% of body surface area (BSA).
  • Disease is well controlled at baseline and only requiring low potency topical steroids.
  • No acute exacerbations of underlying condition within the previous 12 months (not requiring PUVA [psoralen plus ultraviolet A radiation], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, high-potency or oral steroids)" Note: Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible.
  • Note: Patients with a type I diabetes well controlled by a stable dose of insulin are eligible.
  • Patients with active B or C hepatitis infection. Note: Patients with past Hepatitis B Virus (HBV) infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test) are eligible. Patients positive for Hepatitis C Virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
  • Patients with active tuberculosis.
  • Patients with ongoing toxicities (Grade ≥1 according to CTCAE V5.0) from previous therapies, except for alopecia (any grades) and lab values defined in inclusion criteria.
  • Note: Some Grade 2 may be permitted following discussion with the Sponsor.
  • Patients with evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including significant liver disease (such as cirrhosis, uncontrolled major seizure disorder, or superior vena cava syndrome).
  • Patients with significant cardiovascular disease, such as New York Heart Association cardiac disease Class II or greater, myocardial infarction within 3 months prior to W1D1, unstable arrhythmias or unstable angina.
  • Notes:
  • Patients with a known Left Ventricular Ejection Fraction (LVEF) < 40% will be excluded
  • Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or LVEF < 50% must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate.
  • Patients with history of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e. bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on imaging.
  • Pregnant or lactating women.
  • Prior organ transplantation including allogeneic stem cell transplantation.
  • Patients who are known to be serologically positive for human immunodeficiency virus (HIV).
  • E16. Patient with prior treatment with anti-PD-1, or anti-PD-L1 immune checkpoint blockade therapies.

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

France5 sites

  • Institut Bergonie

    Bordeaux

  • Centre Oscar Lambret

    Lille

  • Centre Léon Bérard

    Lyon, 69008

  • Institut Claudius Regaud

    Toulouse, 31059

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

United Kingdom1 site

  • Royal Marsden Hospital

    London

Other trials in United Kingdom

About this study

Official title: A European, Multicenter, Randomized, Open-label, Phase II Trial Aiming to Assess the Clinical and Biological Activity of an Anti-PD-L1 (Atezolizumab) in Operable Localised Soft Tissue Sarcomas Patients to be Treated With Radiotherapy

This multicentric, randomised, Phase II trial will use a pick-the-winner design in order to evaluate the clinical and biological activity of atezolizumab when combined with pre-operative or post-operative radiotherapy in STS patients.

Following Inform Consent Form (ICF) signature, eligible patients will be randomised (1:1:1) to receive:

Read more
  • Arm A: Radiotherapy followed by atezolizumab then surgery.
  • Arm B: Atezolizumab followed by surgery then radiotherapy.
  • Arm C: Radiotherapy then surgery followed by atezolizumab.

The sequence of the study treatments is different among the 3 study arms. However, the dose regimens will be the same:

  • Atezolizumab will be administered to all patients at the dose of 1200mg, by IV injection, for 2 cycles (Q3W).
  • Radiotherapy will be administered to all patients at the dose of 2Gy/day, 5 days per week, for a total of 5 weeks and 50Gy.
  • Surgery will be performed as per institutional practice.

Randomisation will be stratified according to histological subtypes as follows:

Group 1: Liposarcoma (LPS), Undifferentiated Pleomorphic Sarcoma (UPS), Leiomyosarcoma (LMS), myxofibrosarcoma, angiosarcoma versus Group 2: all translocation sarcoma except Ewing, rhabdomyosarcoma (RMS) and myxoid LPS.

Read the detailed description

This trial is a European, multicenter, open-label, randomized, Phase II trial using a pick-the-winner design aiming to the clinical and biological activity of anti-PD-L1 (atezolizumab) in a population of operable localised soft tissue sarcomas (STS) patients to be treated with radiotherapy.

Following inform consent signature and validation of eligibility criteria, patients will be randomized (1:1:1) into one of the 3 study arms:

  • Arm A: Pre-operative radiotherapy followed by 2 cycles of atezolizumab then surgery
  • Arm B: 2 cycles of atezolizumab followed by surgery then post-operative radiotherapy
  • Arm C: Pre-operative radiotherapy followed by surgery then 2 cycles of atezolizumab.

The sequence of treatment is different between the study arms, but the regimen of study treatments are the same. All randomized patients will received:

  • The conventionally fractionated radiotherapy regimen of 2 Gy, 5 days a week up to a total dose of 50 Gy over 5 weeks. Radiotherapy will be either pre-(Arms A and C) or post-(Arm B) operative.
  • Two cycles of atezolizumab (1200mg, IV, Q3W)
  • Surgery will be performed as per institutional practice.

Randomisation will be stratified according to histological subtypes as follows

  • Group 1: Leiomyosarcoma [LMS], Undifferentiated Pleomorphic Sarcoma [UPS], Liposarcoma [LPS], myxofibrosarcoma, angiosarcoma versus
  • Group 2: all translocation sarcoma except Ewing, rhabdomyosarcoma RMS and myxoid LPS.

Following this sequence of treatment, all patients will be followed-up 2 weeks after the end of the treatment period then W18, W24 (=M6) then every 3 months until disease relapse, death, loss to follow-up. The minimal follow-up will be 1 year for the last randomized patient.

During the study period, the following tumor samples will be also collected for all randomized patients:

  • A de novo tumor biopsy before study treatment start (pre-treatment tumor sample)
  • A fragment of the surgery specimen.
Being tested
Pre-operative radiotherapy followed by 2 cycles of atezolizumab then surgery, 2 cycles of atezolizumab followed by surgery then post-operative radiotherapy, Pre-operative radiotherapy followed by surgery then 2 cycles of atezolizumab.
Keywords
Clinical Trial, randomized, phase II, atezolizumab, PD-L1
Medical subject headings
Sarcoma

What participants receive

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

  • Pre-operative radiotherapy followed by 2 cycles of atezolizumab then surgeryCombination product

    W1,W2, W3, W4 \& W5: RADIOTHERAPY. A 3-dimensional conformal RT (3D-CRT) with photons ≥ 6MV will be realized based on the acquisition of a CT-scan performed in treatment position. Intensity modulated RT (IMRT), volumetric modulated arc therapy (VMAT) and tomotherapy are authorized.

    W6 and W9: ATEZOLIZUMAB IV INJECTION. 2 injections of 1200 mg of atezolizumab with a 3-week interval

    W11: SURGERY. Surgery should be performed as per Institutional practice by a surgeon with appropriate training in the treatment of sarcoma. The primary aim of surgery is to completely excise the tumor with a margin of normal tissue commonly accepted as 1 cm soft tissue, or equivalent

  • 2 cycles of atezolizumab followed by surgery then post-operative radiotherapyCombination product

    W1 and W4: ATEZOLIZUMAB IV INJECTION. 2 injections of 1200 mg of atezolizumab with a 3-week interval

    W6: SURGERY Surgery should be performed as per Institutional practice by a surgeon with appropriate training in the treatment of sarcoma. The primary aim of surgery is to completely excise the tumor with a margin of normal tissue commonly accepted as 1 cm soft tissue, or equivalent

    W7, W8, W9, W10 \& W11: RADIOTHERAPY A 3-dimensional conformal RT (3D-CRT) with photons ≥ 6MV will be realized based on the acquisition of a CT-scan performed in treatment position. Intensity modulated RT (IMRT), volumetric modulated arc therapy (VMAT) and tomotherapy are authorized.

  • Pre-operative radiotherapy followed by surgery then 2 cycles of atezolizumab.Combination product

    W1,W2, W3, W4 \& W5: RADIOTHERAPY A 3-dimensional conformal RT (3D-CRT) with photons ≥ 6MV will be realized based on the acquisition of a CT-scan performed in treatment position. Intensity modulated RT (IMRT), volumetric modulated arc therapy (VMAT) and tomotherapy are authorized.

    W6: SURGERY Surgery should be performed as per Institutional practice by a surgeon with appropriate training in the treatment of sarcoma. The primary aim of surgery is to completely excise the tumor with a margin of normal tissue commonly accepted as 1 cm soft tissue, or equivalent

    W11 and W14: ATEZOLIZUMAB IV INJECTION. 2 injections of 1200 mg of atezolizumab with a 3-week interval

Study groups in NCT03474094
Study groupRoleWhat they receive
pre-operative radiotherapy and atezolizumabExperimentalPre-operative radiotherapy followed by 2 cycles of atezolizumab then surgery
Receives: Combination Product: Pre-operative radiotherapy followed by 2 cycles of atezolizumab then surgery
pre-operative atezolizumab and post-operative radiotherapyExperimental2 cycles of atezolizumab followed by surgery then post-operative radiotherapy
Receives: Combination Product: 2 cycles of atezolizumab followed by surgery then post-operative radiotherapy
pre-operative radiotherapy and post-operative atezolizumabActive comparatorPre-operative radiotherapy then surgery followed by 2 cycles of atezolizumab
Receives: Combination Product: Pre-operative radiotherapy followed by surgery then 2 cycles of atezolizumab.

What is being measured

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

  1. Pathological impact of PD-L1 neutralisation (by atezolizumab) with or without radiotherapy versus radiotherapy alone in operable localised STS

    Rate of pathological response (defined by at least 80°% of necrosis on surgery specimens) following PDL1 neutralisation with atezolizumab +/- radiotherapy versus RT alone

    Measured: 11 weeks

Secondary outcomes (14)

  1. Rate of patients with complete or near-complete pathologic response

    Rate of patients with complete or near-complete pathologic response defined as ≥ 95% of necrosis. All pathology slides will be subjected to local central review by a subspecialty sarcoma pathologist. Surgery specimens will be examined for determination of tumor necrosis percentage.

    Measured: 11 weeks

  2. Rate of patients with at least 50% of necrosis

    Rate of patients with at least 50% of necrosis on the surgery specimen

    Measured: 11 weeks

  3. Percentage of residual viable cells

    Percentage of residual viable cells will be calculated for all surgery specimens.

    Measured: 11 weeks

  4. Objective Response Rate (ORR)

    Rate of patients with Complete Response (CR) and Partial Response (PR) as per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Measured: 11 weeks

  5. Tumor volume change

    Tumor volume change (before versus after pre-operative treatment)

    Measured: 11 weeks

  6. Quality of resection

    Quality of resection will be described per study arms

    Measured: 11 weeks

  7. Local Recurrence Rate (LRR) at 1 year post-surgery:

    Rate of local recurrence 1 year after surgery.

    Measured: as long as 1 year from date of surgery

  8. Time To Relapse (TTR)

    Time from inclusion to relapse of the disease.

    Measured: from date of inclusion to relapse, for a maximum of 36 months from first randomized patient

  9. Disease Free Survival (DFS)

    time alive without disease.

    Measured: Time after treatment ends that the patient survives without disease, for a maximum of 36 months from first randomized patient

  10. the impact of study treatments on immune cell infiltration

    Number of T cells (including but not limited to GmzB+/CD8+ T-cell, CD3+ T-cell), B cells (CD20, IgG), and Treg (FOXP3) on pre (tumor biopsy at inclusion) and post-treatment (surgery specimen) by immunofluorescence (IF)

    Measured: 11 weeks

  11. Number of patients with a significant change (at least a 2-fold change) in number of immune cell infiltration

    Number of patients with a significant change (at least a 2-fold change) in number of T cells and other immune subsets under study treatments

    Measured: 11 weeks

  12. Frequency of adverse events

    Frequency of Adverse Event (AE), Serious Adverse Event (SAE), AE of special interest (AESI) and SUSAR graded using Common Terminology Criteria for Adverse Events (CTCAE) V4.03.

    Measured: a maximum of 36 months from date of first randomized patient

  13. Amputation rate

    Amputation rate will be measured per study arms

    Measured: 11 weeks

  14. Severity of adverse events

    Severity of Adverse Event (AE), Serious Adverse Event (SAE), AE of special interest (AESI) and SUSAR graded using Common Terminology Criteria for Adverse Events (CTCAE) V4.03.

    Measured: a maximum of 36 months from date of first randomized patient

Timeline

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

  1. First posted22 Mar 2018
  2. Study start1 Aug 2018
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2026 (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
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03474094
Sponsor's protocol ID
RT-Immune (ET16-132)
Acronym
RT-Immune
Status last verified
Feb 2026
First submitted
6 Mar 2018
Last updated
10 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pre-operative radiotherapy followed by 2 cycles of atezolizumab then surgery, 2 cycles of atezolizumab followed by surgery then post-operative radiotherapy and Pre-operative radiotherapy followed by surgery then 2 cycles of atezolizumab. in people with Sarcoma,Soft Tissue, run by Centre Leon Berard at 6 sites in 2 countries.

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 30 inclusion and 38 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 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in France, United Kingdom. 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?

Pathological impact of PD-L1 neutralisation (by atezolizumab) with or without radiotherapy versus radiotherapy alone in operable localised STS (time frame: 11 weeks). 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 NCT03474094.

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 10 Feb 2026.

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