Study of the Efficacy and Safety of the Bintrafusp Alfa in Previously Treated Advanced Malignant … (NCT05005429) | Clinical Trial Compass
CompletedPhase 2
Study of the Efficacy and Safety of the Bintrafusp Alfa in Previously Treated Advanced Malignant Pleural Mesothelioma
Spain47 participantsStarted 2021-09-20
Plain-language summary
This is an open-label, non-randomized, phase II, single arm, multi-center controlled clinical trial.
47 patients will be enrolled in this trial to determine the efficacy and safety of Bintrafusp alfa (M7824) in advanced malignant pleural mesothelioma patients previously treated with platinum-based chemotherapy.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Male or female subjects aged ≥ 18 years and capable of giving signed informed consent or requirement per local legislation.
* ECOG performance status of 0-2.
* Histologically confirmed malignant pleural mesothelioma (all histological subtypes are eligible), unresectable advanced or metastatic.
* Patients that progressed or be intolerant to ≤ 2 regimens of chemotherapy, including platinum-based chemotherapy with pemetrexed. Prior bevacizumab treatment given during chemotherapy are allowed.
* Evaluable disease or measurable disease as assessed according to the modified RECIST v1.1 criteria.
* Availability of tumor tissue for translational research (at least 10 slides); Archival tumor tissue at diagnosis can be sent if it was obtained less than 18 months ago.
* Life expectancy of at least 3 months.
* Adequate hematologic and organ function defined by the following laboratory results obtained within 14 days prior to enrollment:
Hematologic: Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, and hemoglobin ≥ 9 g/dL Hepatic: Total bilirubin level ≤ the upper limit of normal (UNL) range, AST and ALT levels ≤ 1.5 x ULN and ALP ≤ 2.5 x ULN. For participants with liver involvement in their tumor, AST ≤5 x ULN, ALT ≤ 5 x ULN, and bilirubin ≤ 3.0 x ULN.
Renal: Creatinine level ≤1.5 x ULN or estimated creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method) For participants with Cr…
What they're measuring
1
To Evaluate the Efficacy of the Treatment
Timeframe: From administration of first dose of bintrafusp alfa until objective tumor progression or death, up to 2 years.