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Sarcoma, Clear CellPhase 2ACCeSsNCT04274023

Study on TSR-042 in Advanced Clear Cell Sarcoma

A Phase 2 study testing TSR-042 in people with Sarcoma, Clear Cell, run by Italian Sarcoma Group at 1 site in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Phase II,single arm study designed to explore the activity of TSR-042, an immunotherapy agent, in patients with a diagnosis of advanced or metastatic clear cell sarcoma (CCS). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sarcoma, Clear Cell
What is being tested?
TSR-042
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteItaly
Study dates
29 Jan 2024to 29 Jan 2024
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Written informed consent
  • Histological centrally confirmed diagnosis of clear cell sarcoma
  • Availability of archived tumor tissue block, or 15 slides.
  • Locally advanced disease
  • Measurable disease based on RECIST 1.1
  • Patient can be naive or previously treated with 1 or 2 systemic regimens given for recurrent and/or metastatic disease
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  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
  • Adequate bone marrow function
  • Adequate organ function
  • Cardiac ejection fraction ≥50%
  • At least 18 years of age on day of signing informed consent.
  • Non-pregnant female patients
  • Non-ot breastfeed during the study for 90 days after the last dose of study treatment.
  • Male participant agrees to use an adequate method of contraception
  • No history of arterial and/or venous thromboembolic event within the previous 12 months.
  • Participant receiving corticosteroids may continue as long as their dose is stable for least 4 weeks prior to initiating protocol therapy.
  • Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Who cannot join

  • Participant must not be simultaneously enrolled in any interventional clinical trial
  • Previous treatment with any non-investigational agents within 14 days of first day of study drug dosing.
  • Must not have received investigational therapy ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior initiating protocol therapy
  • Other primary malignancy with <5 years clinically assessed disease-free interval, except basal cell skin cancer, cervical carcinoma in situ, or other neoplasms judged to entail a low risk of relapse
  • Previous treatment with radiation therapy within 14 days of first day of study drug dosing, or patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Has known active central nervous system (CNS) metastases, leptomeningeal metastases, and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable, have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability
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  • Has active, non-infectious pneumonitis
  • Has an active infection requiring systemic therapy
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agents
  • Has received a live vaccine within 30 days of planned start of study therapy
  • Major surgery within 3 weeks prior to study entry
  • Any one of the following currently or in the previous 6 months:
  • Myocardial infarction, congenital long QT syndrome, Torsades de Pointes, arrhythmias right bundle branch block and left anterior hemiblock unstable angina coronary/peripheral artery bypass graft, symptomatic congestive heart failure New York Heart Association Class III or IV, cerebrovascular accident, or transient ischemic attack symptomatic pulmonary embolism. Ongoing cardiac dysrhythmias of Grade >=3, atrial fibrillation of any grade,or QTcF interval >470 msec 14. Severe and/or uncontrolled medical disease 15. Patient experienced ≥ Grade 3 immune-related AE with prior immunotherapy 16. Participant has a diagnosis of immunodeficiency or has receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to initiating protocol therapy 17. Any known active hepatitis B or hepatitis C 18. Any known history of human immunodeficiency virus 19. Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment) 20. Expected non-compliance to medical regimens 21. Known history of interstitial lung disease 22. Active autoimmune disease that has required systemic treatment in the past 2 years 23. Known severe hypersensitivity reactions to monoclonal antibodies, any history of anaphylaxis, or uncontrolled asthma

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Fondazione IRCSS Istituto Nazionale dei Tumori

    Milan, 20133

Other trials in Italy

About this study

Official title: Phase II Study on TSR-042 in Advanced Clear Cell Sarcoma

Phase II,single arm study designed to explore the activity of TSR-042, an immunotherapy agent, in patients with a diagnosis of advanced or metastatic clear cell sarcoma (CCS).

Read the detailed description

Phase II, single arm, not randomized, European multicentric study designed to explore the activity of TSR-042, a human monoclonal anti-PD-1 inhibitor, in a population of patients with a diagnosis of advanced/metastatic clear cell sarcoma (CCS).

Being tested
TSR-042
Keywords
advanced clear cell sarcoma, anti-PDL1
Medical subject headings
Sarcoma, Clear Cell

What participants receive

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

  • TSR-042Drug

    TSR-042 is an IgG4 humanized monoclonal antibody that binds with high affinity to PD-1, resulting in inhibition of binding to PD-L1 and PD-L2.

Study groups in NCT04274023
Study groupRoleWhat they receive
TSR-042 armExperimentalTSR-042 at a dose of 500 mg in IV infusion (given over t30-minutes) every 21 days for the first 4 doses, followed by 1.000 mg on day 1 of every 42 day.
Receives: Drug: TSR-042

What is being measured

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

  1. Overall Response Rate

    Response rate according Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: At week 12

Secondary outcomes (10)

  1. Immune-related RECIST (ir-RECIST) response rate

    Response rate according ir-RECIST criteria

    Measured: At weeks 6, 12, 24, 36, 48, 60, 72, 84, 96

  2. Choi criteria response rate

    Response rate according Choi criteria

    Measured: At weeks 6, 12, 24, 36, 48, 60, 72, 84, 96

  3. Progression Free Survival (PFS)

    Survival without disease progression

    Measured: At 3 and 5 years

  4. Overall Survival

    Proportion of patients who are still alive at 36 and 60 months after have started the treatment

    Measured: At 3 and 5 years

  5. Clinical Benefit Rate

    Proportion of patients who experienced Complete Response, Progression Response or Stable Disease for over 6 months

    Measured: Month 6

  6. Adverse events related to the treatment

    Safety in term of grading of adverse event is evaluate from the firs treatment dose throughout the study according to CTCAE 5.0

    Measured: Week 3, week 6, week 9, week 12, week 18, week 24, week 36, week 48, week 60, week 72

  7. Growth Modulation Index (GMI)

    Correlation between response and prior disease medical treatment: ratio of time to progression with the nth line of therapy to the those with the n-1th line.

    Measured: At weeks 6, 12, 24, 36, 48, 60, 72, 84, 96

  8. Quality of Life according the 30 questions European Organization for Research and Treatment of Cancer Quality of Life Questionnaire

    Evaluation of the quality of life collected with European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30

    Measured: Day1 Cycle 2, Day 1 Cycle 3, Every 3 cycles (Day1Cyle6, Day1Cycle 9, …) and through study completion, an average of 1 year

  9. Quality of Life according the questionnaire Euro Quality Of Life 5 Domains (EQ-5D)

    Evaluation of the quality of life collected with Euro Quality Of Life 5 Domains (EQ-5D)

    Measured: Day1 Cycle 2, Day 1 Cycle 3, Every 3 cycles (Day1Cyle6, Day1Cycle 9, …) and through study completion, an average of 1 year

  10. Safety according the Patient Reported Outcome according Common Terminology Criteria for Adverse Events (PRO-CTCAE)

    Evaluation of the quality of safety reported by the patient with the PRO-CTCAE

    Measured: Day1 Cycle 2, Day 1 Cycle 3, Every 3 cycles (Day1Cyle6, Day1Cycle 9, …) and through study completion, an average of 1 year

Timeline

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

  1. First posted18 Feb 2020
  2. Study start29 Jan 2024
  3. Primary completion29 Jan 2024
  4. Study completion29 Jan 2024

Why it stopped: Difficulty of enrollment

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
Not applicable
Intervention model
Single group
Model description
Single arm
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04274023
Sponsor's protocol ID
ISG-ACCeSs
Acronym
ACCeSs
Status last verified
Jan 2024
First submitted
13 Feb 2020
Last updated
1 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Granter SR, Weilbaecher KN, Quigley C, Fletcher CD, Fisher DE. Clear cell sarcoma shows immunoreactivity for microphthalmia transcription factor: further evidence for melanocytic differentiation. Mod Pathol. 2001 Jan;14(1):6-9. doi: 10.1038/modpathol.3880249.

    PubMed 11211309

  • Antonescu CR, Tschernyavsky SJ, Woodruff JM, Jungbluth AA, Brennan MF, Ladanyi M. Molecular diagnosis of clear cell sarcoma: detection of EWS-ATF1 and MITF-M transcripts and histopathological and ultrastructural analysis of 12 cases. J Mol Diagn. 2002 Feb;4(1):44-52. doi: 10.1016/S1525-1578(10)60679-4.

    PubMed 11826187

  • Stacchiotti S, Grosso F, Negri T, Palassini E, Morosi C, Pilotti S, Gronchi A, Casali PG. Tumor response to sunitinib malate observed in clear-cell sarcoma. Ann Oncol. 2010 May;21(5):1130-1. doi: 10.1093/annonc/mdp611. Epub 2010 Jan 21. No abstract available.

    PubMed 20093352

  • Tazzari M, Palassini E, Vergani B, Villa A, Rini F, Negri T, Colombo C, Crippa F, Morosi C, Casali PG, Pilotti S, Stacchiotti S, Rivoltini L, Castelli C. Melan-A/MART-1 immunity in a EWS-ATF1 translocated clear cell sarcoma patient treated with sunitinib: a case report. BMC Cancer. 2015 Feb 14;15:58. doi: 10.1186/s12885-015-1044-0.

    PubMed 25880253

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TSR-042 in people with Sarcoma, Clear Cell, run by Italian Sarcoma Group at 1 site in Italy.

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 17 inclusion and 13 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: stopped early, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. 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?

The study was stopped early (reason given: Difficulty of enrollment). Results are not available in the source record.

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?

Overall Response Rate (time frame: At week 12). 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 NCT04274023, which also lists 4 linked publications.

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 1 Feb 2024.

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