A phase II single arm clinical trial assessing the efficacy and safety of BIntrafusp alfa (M7824) in previously treated advanced malignant pleural MESothelioma (BIMES). - BIMES

Fundación GECP0 sites47 target enrollmentAugust 26, 2021

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Fundación GECP
Enrollment: 47
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 26, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Fundación GECP

Eligibility Criteria

Inclusion Criteria

•1\. Male or female subjects aged \= 18 years and capable of giving signed informed consent or requirement per local legislation.
•2\. ECOG performance status of 0\-2\.
•3\. Histologically confirmed malignant pleural mesothelioma (all histological subtypes are eligible), unresectable advanced or metastatic.
•4\. 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.
•5\. Evaluable disease or measurable disease as assessed according to the modified RECIST v1\.1 criteria.
•6\. 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.
•7\. Life expectancy of at least 3 months.
•8\. 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.

Exclusion Criteria

•1\. Prior immune checkpoint therapy with an anti\-PD\-1, anti\-PD\-L1, anti\-CD137, or anti\-CTLA\-4 antibody.
•2\. Known severe hypersensitivity \[Grade \= 3 NCI CTCAE 5\.0]) to investigational product or any component in its formulations, any history of anaphylaxis, or recent, within 5 months, history of uncontrollable asthma.
•3\. Previous malignant disease (other than the target malignancy to be investigated in this study) within the last 3 years. Participants with a history of cervical carcinoma in situ, superficial or noninvasive bladder cancer, localized prostate cancer or basal cell or squamous cell carcinoma in situ previously treated with curative intent and endoscopically resected GI cancers limited to the mucosal layer without recurrence in \> 1 year are NOT excluded.
•4\. Active central nervous system (CNS) metastases and/or carcinomatous meningitis that require therapeutic intervention or are causing clinical symptoms. Patients with previously treated brain metastases may participate provided they are stable and are not using steroids for at least 7 days prior to randomization.
•5\. Prior major surgery within 4 weeks prior to the first dose of study intervention.
•6\. Unstable or unresolved surgical or chemotherapy\-related toxicity that would compromise the patient’s capacity to participate in the trial. Persisting Grade \> 1 NCI CTCAE 5\.0 toxicity (except alopecia and vitiligo) related to prior therapy; however, sensory neuropathy Grade \= 2 is acceptable.
•7\. Prior organ transplantation including allogenic stem\-cell transplantation, except transplants that do not require immunosuppression.
•8\. Live vaccines given 30 days prior to first dose of protocol treatment (M7824\). Seasonal flu vaccines that do not contain a live virus are permitted. Also, COVID\-19 vaccines approved by the authorities that do not contain live virus are permitted.
•9\. Drug\-induced interstitial lung disease (ILD) or participant 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 participant’s tolerance for the study or ability to consistently participate in study procedures.
•10\. Active and serious autoimmune disease that might deteriorate upon treatment with immunotherapy. Patients with diabetes type I, vitiligo, psoriasis, or hypo\- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible. Replacement therapy (i.e. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) or topical therapy (e.g., steroids) for psoriasis or eczema is not considered a form of systemic treatment.