Advanced Soft-tissue SarcomaPhase 2TRUSTNCT04874311
Bintrafusp Alfa and Doxorubicin Hydrochloride in Treating Patients With Advanced Sarcoma
A Phase 2 study testing Bintrafusp alfa and Doxorubicin in people with Advanced Soft-tissue Sarcoma and Metastatic Soft-tissue Sarcoma, run by Institut Bergonié at 6 sites in France.
Trial summary
This study encompasses two multicenter, prospective, open-labeled, 2-arm, non-comparative randomized phase II trials to assess the antitumor activity of bintrafusp alfa in association with doxorubicin Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Soft-tissue Sarcoma, Metastatic Soft-tissue Sarcoma
- What is being tested?
- Bintrafusp alfa and Doxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 6 sitesFrance
- Study dates
- 1 Mar 2022to Jul 2027
- 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
- Histologically confirmed soft-tissue sarcoma with unknown translocation (including the following histologies but not limited to undifferentiated pleomorphic sarcomas, dedifferentiated liposaromas or leiomyosarcomas). Diagnosis must be reviewed or confirmed by the RRePS Network (Réseau de référence en pathologie des sarcomes et des viscères) as recommended by the French NCI (Institut National du Cancer, Inca).
- Metastatic or unresectable locally advanced disease,
- No previous systemic treatment for advanced/metastatic disease,
- For TLS status: available archived FFPE (Formalin-Fixed Paraffin-Embedded) tumor tissue sample or tumor material newly obtained by biopsy. Except if TLS analysis have been already performed by Biopathological platform at Bergonié Institute, presence or absence of TLS should be confirmed by central review based on FFPE tumor tissue sample (archived or newly obtained by biopsy for research purpose),
- Age ≥ 18 years,
- ECOG ≤ 1,
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- Life expectancy > 3 months,
- Patients must have measurable disease defined as per RECIST v1.1 with at least one lesion that can be measured in at least one dimension as > 10 mm with spiral CT scan.,
- Patient must comply with the collection of tumor biopsies and biomarkers study. Tumors must be accessible for biopsy,
- Adequate hematological, renal, metabolic and hepatic function
- Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization. Serum or urine pregnancy test must be repeated within 72 hours prior to receiving the first dose of study medication,
- Both women and men must agree to use a highly effective method of contraception throughout the treatment period and for at least two months after discontinuation of treatment for women and four months for men.
- No prior or concurrent malignant disease diagnosed or treated in the last 3 years except for superficial/non-invasive bladder cancer, or basal or squamous cell carcinoma in situ treated with curative intent; b. endoscopically resected GI cancers limited to the mucosal layer without recurrence in > 1 year,
- Recovery to grade ≤ 1 from any adverse event derived from previous treatment (excluding alopecia and vitiligo of any grade and non-painful peripheral neuropathy grade ≤ 2) according to to NCI-CTCAE, version 5.0,
- 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 with doxorubicin, daunorubicin, epirubicin, idarubicin and/or any other anthracyclines or anthracediones at the maximum cumulative dose or any approved or investigational treatment targeting PD1, PD-L1 or TGFB1,
- Known central nervous system malignancy (CNS),
- Men or women of childbearing potential who are not using an effective method of contraception as previously described; women who are pregnant or breast feeding,
- Participation to a study involving a medical or therapeutic intervention in the last 30 days,
- Previous enrolment in the present study,
- Patient unable to follow and comply with the study procedures because of any geographical, social or psychological reasons,
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- Known hypersensitivity to any involved study drug or any of its formulation components,
- Any history of anaphylaxis, or recent, within 5 months, history of uncontrollable asthma,
- Individuals deprived of liberty or placed under legal guardianship,
- Any of the following cardiac criteria:
- Mean resting corrected QT interval (QTcF) ≥ 470 msec, obtained from three consecutive ECGs,
- Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG,
- LVEF ≤ 50% per CTCAE v5 by MUGA or echocardiogram
- Any factors increasing the risk of QTc prolongation or arrhythmic events such as heart failure, hypokalaemia, potential for torsades de pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years old or any concomitant medication known to prolong the QT interval,
- Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, unstable angina pectoris, uncontrolled hypertension, congestive heart failure NYHA Grade ≥2, ventricular arrhythmias requiring continuous therapy, supraventricular arrhythmias including atrial fibrillation, which are uncontrolled, haemorrhagic or thrombotic stroke, including transient ischaemic attacks, cerebral vascular accident/stroke or any other central nervous system bleeding
- Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent:
- History of bleeding diathesis or recent major bleeding event ,
- Prior organ transplantation including allogenic stem-cell transplantation, except transplants that do not require immunosuppression,
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection requiring systemic therapy, drug-induced interstitial lung disease or subject has had a history of drug-induced pneumonitis that has required oral or IV steroids, and/or other diseases, which in the opinion of the investigator might impair the subject's tolerance for the study or ability to consistently participate in study procedures,
- Active infection including tuberculosis ,
- Has known active hepatitis B or hepatitis C,
- Has a known history of Human Immunodeficiency Virus infection,
- Receipt of live attenuated vaccine within 30 days prior to the first dose of treatment. Note: Patients, if enrolled, should not receive live vaccine within 30 days prior to the first dose of treatment, whilst receiving study treatments and up to 30 days after the last dose. Seasonal flu vaccines that do not contain a live virus are permitted,
- Patients with current or history of deep vein thrombosis within 6 months prior to randomization,
- Any contraindication to biopsy for the research,
- Any other contraindication to Doxorubicin administration,.
- Patients with oral anticoagulation therapy based on Vitamin K antagonist.
- Prior mediastinal radiation.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Institut Bergonie
Bordeaux, 33000
Centre Georges François Leclerc
Dijon, 21079
Centre Léon Bérard
Lyon, 69000
Institut Paoli Calmette
Marseille, 13000
Institut Curie
Paris, 75000
CHU Poitiers
Poitiers, 86000
About this study
Official title: Bintrafusp Alfa and Doxorubicin Hydrochloride in Treating Patients With Advanced Sarcoma. TRUST Study
This study encompasses two multicenter, prospective, open-labeled, 2-arm, non-comparative randomized phase II trials to assess the antitumor activity of bintrafusp alfa in association with doxorubicin
Read the detailed description
This is a two multicenter, prospective, open-labeled, 2-arm, non-comparative randomized (2:1) phase II trials.
Patients satisfying eligibility criteria will first be stratified into 2 strata / subgroups:
- Soft-tissue sarcoma (STS) patients with an inflamed tumor (i.e. TLS+, defined as presence of mature tertiary lymphoid structures, as per IHC).
- Soft-tissue sarcoma patients with a cold tumor (i.e. TLS-, defined as absence of mature tertiary lymphoid structures, as per IHC).
- Note: TLS+ and TLS- account for 20% and 80% of STS patients, respectively.
STS patients with TLS+ will be randomized between arm A (bintrafusp alfa combined with doxorubicin for 6 cycles, followed by bintrafusp alfa maintenance) and arm B (doxorubicin for 6 cycles) with two patients randomized in arm A for one patient randomized in arm B.
STS patients with TLS- will be randomized between arm C (bintrafusp alfa combined with doxorubicin for 6 cycles, followed by bintrafusp alfa maintenance) and arm D (doxorubicin for 6 cycles) with two patients randomized in arm C for one patient randomized in arm D.
- Being tested
- Bintrafusp alfa, Doxorubicin
- Keywords
- tertiary lymphoid structure, soft-tissue sarcoma, advanced/metastatic, immunotherapy
- Medical subject headings
- Sarcoma, Tertiary Lymphoid Structures, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bintrafusp alfaDrug
Bintrafusp alfa will be administered by intravenous infusion on day 1 every 3 weeks at a fixed dose of 2400 mg.
DoxorubicinDrug
Doxorubicin will be administered by intravenous infusion on day 1 every 3 weeks at a fixed dose of 75 mg/m² for a maximum of 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm A: treatment by bintrafusp alfa combined with doxorubicin | Experimental | Soft-tissue sarcoma patients with an inflammed tumor will be treated with bintrafusp alfa combined with doxorubicin for 6 cycles, followed by bintrafusp alfa maintenance Receives: Drug: Bintrafusp alfa; Drug: Doxorubicin |
| Standard Arm B: treatment by doxorubicin | Other | Soft-tissue sarcoma patients with an inflammed tumor will be treated with doxorubicin for 6 cycles Receives: Drug: Doxorubicin |
| Experimental Arm C: treatment by bintrafusp alfa combined with doxorubicin | Experimental | Soft-tissue sarcoma patients with a cold tumor will be treated with bintrafusp alfa combined with doxorubicin for 6 cycles, followed by bintrafusp alfa maintenance Receives: Drug: Bintrafusp alfa; Drug: Doxorubicin |
| Standard Arm D: treatment by doxorubicin | Other | Soft-tissue sarcoma patients with a cold tumor will be treated with doxorubicin for 6 cycles Receives: Drug: Doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the antitumor activity of combined administration of standard doxorubicin and double immune modulation with Bintrafusp alfa in terms of 6-month progression-free rate, in STS patients with an inflammed tumor
Antitumor activity will be assessed in terms of 6-month progression-free rate and is defined as the rate of complete or partial response (CR, PR) or stable disease (SD), as per RECIST v1.1.
Measured: 6 months
Assessment of the antitumor activity of combined administration of standard doxorubicin and double immune modulation with Bintrafusp alfa in terms of 6-month progression-free rate, in STS patients with a cold tumor
Antitumor activity will be assessed in terms of 6-month progression-free rate and is defined as the rate of complete or partial response (CR, PR) or stable disease (SD), as per RECIST v1.1.
Measured: 6 months
Secondary outcomes (11)
6-month objective response rate (ORR) independently for patients with an inflammed tumor
Objective response is defined as complete response (CR) or partial response (PR) as per adapted RECIST v1.1.
Measured: 6 months
6-month objective response rate (ORR) independently for patients with a cold tumor
Objective response is defined as complete response (CR) or partial response (PR) as per adapted RECIST v1.1.
Measured: 6 months
Best overall response for patients with an inflammed tumor
Best overall response is defined as the best reponse across all time points (RECIST v1.1). The best overall response rate is determined once all the data for the patient is known
Measured: throughout the treatment period, an expected average of 6 months
Best overall response for patients with a cold tumor
Best overall response is defined as the best reponse across all time points (RECIST v1.1). The best overall response rate is determined once all the data for the patient is known
Measured: throughout the treatment period, an expected average of 6 months
1-year progression-free survival for patients with an inflammed tumor
Progression-free survival is defined as the delay between the date of randomization and the date of progression (as per RECIST v1.1) or death (from any cause), whichever occurs first
Measured: 1 year
1-year progression-free survival for patients with a cold tumor
Progression-free survival is defined as the delay between the date of randomization and the date of progression (as per RECIST v1.1) or death (from any cause), whichever occurs first
Measured: 1 year
1-year overall survival for patients with an inflammed tumor
Overall survival is defined as the delay between the date of randomization and the date of death (from any cause)
Measured: 1 year
1-year overall survival for patients with a cold tumor
Overall survival is defined as the delay between the date of randomization and the date of death (from any cause)
Measured: 1 year
Assessment of the antitumor activity of combined administration of standard doxorubicin and double immune modulation with Bintrafusp alfa in terms of immune response, in STS patients with an inflammed tumor
Immune response is defined following (iRECIST - Seymour et al. 2017).
Measured: Throughout the treatment period, an expected average of 6 months
Assessment of the antitumor activity of combined administration of standard doxorubicin and double immune modulation with Bintrafusp alfa in terms of immune response, in STS patients with a cold tumor
Immune response is defined following (iRECIST - Seymour et al. 2017).
Measured: Throughout the treatment period, an expected average of 6 months
Safety profile independently for each population: Common Terminology Criteria for Adverse Event version 5
Toxicity graded using the Common Terminology Criteria for Adverse Events version 5
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.
- First posted5 May 2021
- Study start1 Mar 2022
- Primary completionJan 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Soft-tissue SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04874311
- Sponsor's protocol ID
- IB 2020-05
- Other IDs
- 2020-005703-39
- Acronym
- TRUST
- Status last verified
- Jul 2026
- First submitted
- 4 May 2021
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bintrafusp Alfa and Doxorubicin Hydrochloride in Treating Patients With Advanced Sarcoma. TRUST Study
- ClinicalTrials.gov ID
- NCT04874311
- Acronym / sponsor ID
- TRUST / IB 2020-05
- Keywords
- tertiary lymphoid structure, soft-tissue sarcoma, advanced/metastatic, immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Collaborators
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 5 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study encompasses two multicenter, prospective, open-labeled, 2-arm, non-comparative randomized phase II trials to assess the antitumor activity of bintrafusp alfa in association with doxorubicin
Detailed description
This is a two multicenter, prospective, open-labeled, 2-arm, non-comparative randomized (2:1) phase II trials.
Patients satisfying eligibility criteria will first be stratified into 2 strata / subgroups:
- Soft-tissue sarcoma (STS) patients with an inflamed tumor (i.e. TLS+, defined as presence of mature tertiary lymphoid structures, as per IHC).
- Soft-tissue sarcoma patients with a cold tumor (i.e. TLS-, defined as absence of mature tertiary lymphoid structures, as per IHC).
- Note: TLS+ and TLS- account for 20% and 80% of STS patients, respectively.
STS patients with TLS+ will be randomized between arm A (bintrafusp alfa combined with doxorubicin for 6 cycles, followed by bintrafusp alfa maintenance) and arm B (doxorubicin for 6 cycles) with two patients randomized in arm A for one patient randomized in arm B.
STS patients with TLS- will be randomized between arm C (bintrafusp alfa combined with doxorubicin for 6 cycles, followed by bintrafusp alfa maintenance) and arm D (doxorubicin for 6 cycles) with two patients randomized in arm C for one patient randomized in arm D.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm A: treatment by bintrafusp alfa combined with doxorubicin | Experimental | Drug: Bintrafusp alfa, Drug: DoxorubicinSoft-tissue sarcoma patients with an inflammed tumor will be treated with bintrafusp alfa combined with doxorubicin for 6 cycles, followed by bintrafusp alfa maintenance |
| Standard Arm B: treatment by doxorubicin | Other | Drug: DoxorubicinSoft-tissue sarcoma patients with an inflammed tumor will be treated with doxorubicin for 6 cycles |
| Experimental Arm C: treatment by bintrafusp alfa combined with doxorubicin | Experimental | Drug: Bintrafusp alfa, Drug: DoxorubicinSoft-tissue sarcoma patients with a cold tumor will be treated with bintrafusp alfa combined with doxorubicin for 6 cycles, followed by bintrafusp alfa maintenance |
| Standard Arm D: treatment by doxorubicin | Other | Drug: DoxorubicinSoft-tissue sarcoma patients with a cold tumor will be treated with doxorubicin for 6 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically confirmed soft-tissue sarcoma with unknown translocation (including the following histologies but not limited to undifferentiated pleomorphic sarcomas, dedifferentiated liposaromas or leiomyosarcomas). Diagnosis must be reviewed or confirmed by the RRePS Network (Réseau de référence en pathologie des sarcomes et des viscères) as recommended by the French NCI (Institut National du Cancer, Inca).
- Metastatic or unresectable locally advanced disease,
- No previous systemic treatment for advanced/metastatic disease,
- For TLS status: available archived FFPE (Formalin-Fixed Paraffin-Embedded) tumor tissue sample or tumor material newly obtained by biopsy. Except if TLS analysis have been already performed by Biopathological platform at Bergonié Institute, presence or absence of TLS should be confirmed by central review based on FFPE tumor tissue sample (archived or newly obtained by biopsy for research purpose),
- Age ≥ 18 years,
Key exclusion criteria (28 listed)
- Previous treatment with doxorubicin, daunorubicin, epirubicin, idarubicin and/or any other anthracyclines or anthracediones at the maximum cumulative dose or any approved or investigational treatment targeting PD1, PD-L1 or TGFB1,
- Known central nervous system malignancy (CNS),
- Men or women of childbearing potential who are not using an effective method of contraception as previously described; women who are pregnant or breast feeding,
- Participation to a study involving a medical or therapeutic intervention in the last 30 days,
- Previous enrolment in the present study,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bintrafusp alfaBintrafusp alfa will be administered by intravenous infusion on day 1 every 3 weeks at a fixed dose of 2400 mg. | Drug | Experimental Arm A: treatment by bintrafusp alfa combined with doxorubicin, Experimental Arm C: treatment by bintrafusp alfa combined with doxorubicin |
| DoxorubicinDoxorubicin will be administered by intravenous infusion on day 1 every 3 weeks at a fixed dose of 75 mg/m² for a maximum of 6 cycles | Drug | Experimental Arm A: treatment by bintrafusp alfa combined with doxorubicin, Experimental Arm C: treatment by bintrafusp alfa combined with doxorubicin, Standard Arm B: treatment by doxorubicin, Standard Arm D: treatment by doxorubicin |
Primary outcome
Assessment of the antitumor activity of combined administration of standard doxorubicin and double immune modulation with Bintrafusp alfa in terms of 6-month progression-free rate, in STS patients with an inflammed tumor
Time frame: 6 months
Antitumor activity will be assessed in terms of 6-month progression-free rate and is defined as the rate of complete or partial response (CR, PR) or stable disease (SD), as per RECIST v1.1.
Assessment of the antitumor activity of combined administration of standard doxorubicin and double immune modulation with Bintrafusp alfa in terms of 6-month progression-free rate, in STS patients with a cold tumor
Time frame: 6 months
Antitumor activity will be assessed in terms of 6-month progression-free rate and is defined as the rate of complete or partial response (CR, PR) or stable disease (SD), as per RECIST v1.1.
11 secondary outcomes
6-month objective response rate (ORR) independently for patients with an inflammed tumor
Time frame: 6 months
6-month objective response rate (ORR) independently for patients with a cold tumor
Time frame: 6 months
Best overall response for patients with an inflammed tumor
Time frame: throughout the treatment period, an expected average of 6 months
Best overall response for patients with a cold tumor
Time frame: throughout the treatment period, an expected average of 6 months
1-year progression-free survival for patients with an inflammed tumor
Time frame: 1 year
1-year progression-free survival for patients with a cold tumor
Time frame: 1 year
1-year overall survival for patients with an inflammed tumor
Time frame: 1 year
1-year overall survival for patients with a cold tumor
Time frame: 1 year
Assessment of the antitumor activity of combined administration of standard doxorubicin and double immune modulation with Bintrafusp alfa in terms of immune response, in STS patients with an inflammed tumor
Time frame: Throughout the treatment period, an expected average of 6 months
Assessment of the antitumor activity of combined administration of standard doxorubicin and double immune modulation with Bintrafusp alfa in terms of immune response, in STS patients with a cold tumor
Time frame: Throughout the treatment period, an expected average of 6 months
Safety profile independently for each population: Common Terminology Criteria for Adverse Event version 5
Time frame: Throughout the treatment period, an expected average of 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bintrafusp alfa and Doxorubicin in people with Advanced Soft-tissue Sarcoma and Metastatic Soft-tissue Sarcoma, run by Institut Bergonié at 6 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 16 inclusion and 28 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 24 Jul 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. 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 combined administration of standard doxorubicin and double immune modulation with Bintrafusp alfa in terms of 6-month progression-free rate, in STS patients with an inflammed tumor (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2026.