Phase II study on clear cells sarcoma
- Conditions
- Advanced clear cells sarcomaMedDRA version: 21.1Level: PTClassification code 10073140Term: Clear cell sarcoma of soft tissueSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-004368-21-IT
- Lead Sponsor
- ITALIAN SARCOMA GROUP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 21
1.The patient or legal representative must be able to read and understand the informed consent form (ICF) and must have been willing to give written informed consent for the trial. The subject may also provide an optional consent for the biological/translational sub-study associated. However, the subject may participate in the main trial without participating in biological/translational sub-study
2.Histological centrally and molecularly (ie the presence of translocation t(12;22)(q13;q12) confirmed diagnosis of clear cell sarcoma
3.Confirmed availability of archived FFPE tumor tissue block, or a minimum of 15 slides. If archived FFPE tissue is not available, then a de novo (ie, fresh) tumor sample must be obtained in accordance with local institutional practice for tumor biopsies
4.Locally advanced disease (i.e. surgical resection of local disease unfeasible radically, or unaccepted by the patient, or amenable to become less demolitive, or feasible, or easier, after cytoreduction) and/or metastatic disease
5.Have measurable disease based on RECIST 1.1 as determined by the site. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
6.Patient can be naive or previously treated with 1 or 2 systemic regimens given for recurrent and/or metastatic disease
7.Eastern Cooperative Oncology Group (ECOG) Performance Status = 2
8.Adequate bone marrow function
9.Adequate organ function
10.Cardiac ejection fraction =50% as measured by echocardiogram
11.= 18 years of age on day of signing informed consent.
12.Female participant has a negative serum pregnancy test within 7 days prior to taking study treatment if of childbearing potential and agrees use an adequate method of contraception from screening through 150 days after the last dose of study treatment, or is of non childbearing potential
13.Participant must agree to not breastfeed during the study for 150 days after the last dose of study treatment.
14.Male participant agrees to use an adequate method of contraception (see Section 4.4 for a list of acceptable birth control methods) starting with the first dose of study treatment through 150 days after the last dose of study treatment. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.
15. No history of arterial and/or venous thromboembolic event within the previous 12 months.
16.Participant receiving corticosteroids may continue as long as their dose is stable for least 4 weeks prior to initiating protocol therapy.
17.Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 21
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.Participant must not be simultaneously enrolled in any interventional clinical trial
2.Previous treatment with any non-investigational agents within 14 days of first day of study drug dosing.
3.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
4.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
5.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
6.Has known active central nervous system (CNS) metastases, leptomeningeal metastases, and/or carcinomatous meningitis.
7.Has active, non-infectious pneumonia
8.Has an active infection requiring systemic therapy
9.Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agents
10.Has received a live vaccine within 30 days of planned start of study therapy
11.Major surgery within 3 weeks prior to study entry. Participant must have recovered from any surgical effects.
12.Any one of the following currently or in the previous 6 months:
a.Myocardial infarction,
b.congenital long QT syndrome,
c.Torsades de Pointes,
d.arrhythmias (including sustained ventricular tachyarrhythmia and ventricular fibrillation, bradycardia defined as <50 bpm),
e.right bundle branch block and left anterior hemiblock
f.unstable angina
g.coronary/peripheral artery bypass graft,
h.symptomatic congestive heart failure CHF New York Heart Association Class III or IV), cerebrovascular accident, or transient ischemic attack
i.symptomatic pulmonary embolism.
13.Ongoing cardiac dysrhythmias of NCI CTCAE Grade >=3, atrial fibrillation of any grade,or QTcF interval >470 msec at screening (average of triplicate ECG).
14.Severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, chronic obstructive pulmonary disease, uncontrolled major seizure disorder, unstable spinal cord compression, psychiatric disorder that prohibits obtaining informed consent or active uncontrolled infection).
15.Patient experienced = Grade 3 immune-related AE with prior immunotherapy, with the exception of non-clinically significant lab abnormalities.
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 (eg, hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (eg, hepatitis C virus [HCV] ribonucleic acid [qualitative] is detected)
18.Any known history of human immunodeficiency virus
19.Subjects who have current active hepatic or biliary disease
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 (including TSR-042 components or excipients), any history of anaphylaxis, or uncontrolled asthma
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to evaluate the activity of TSR-042 in patients with advanced CCS according to Response Evaluation Criteria In Solid Tumor (RECIST), version 1.1.<br>Therefore, with reference to a study population of patients with progressive locally advanced or metastatic CCS, primary end point of the study will be to assess: Overall tumor Response Rate, according to RECIST 1.1<br>;Secondary Objective: To assess:<br>•ir-RECIST response rate<br>•CHOI criteria response rate<br>•Overall Survival<br>•Progression Free Survival (PFS)<br>•Clinical Benefit Rate (RECIST CR + PR + SD > 6 months)<br>•Safety<br>•Correlation between response and prior medical treatment<br>•Quality of life reported by patients with Patient-Reported Outcome QoL<br><br>;Primary end point(s): Response rate according Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;Timepoint(s) of evaluation of this end point: Time Frame: At weeks 6, 12, 24, 36, 48, 60, 72, 84, 96
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Response rate according Choi criteria<br>;Timepoint(s) of evaluation of this end point: Time Frame: At weeks 6, 12, 24, 36, 48, 60, 72, 84, 96 <br><br>