CTIS2024-514083-31-00Active, not recruitingPhase 1
INTERACT-ION : Ezabenlimab (BI 754091) and mDCF (docetaxel, cisplatin and 5-fluorouracil) followed by chemoradiotherapy in patients with stage III squamous cell anal carcinoma. A phase II study.
Centre Hospitalier Regional Universitaire0 sites55 target enrollmentStarted: July 1, 2024Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 55
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Ages
- 18 to 65+ (—)
- Sex
- All
Inclusion Criteria
- •1.Signed and dated informed consent,, 6.Locally advanced disease defined as: •Stage III (TxN1 or T4N0) Lymph node can be considered positive if one of the following criteria is satisfied: •Enlargement (largest short-axis diameter > 1 cm for mesorectal nodes, and > 1.5 cm for other nodes) OR, •Heterogeneity or necrosis OR, •Irregular contours OR, •Strong enhancement at magnetic resonance imaging (MRI) OR, •Positivity on positron emission tomography (PET) scan,, 7.Patient eligible to the mDCF regimen,, 8.Computed tomography (CT) scan performed within 30 days prior inclusion,, 9.MRI of pelvis performed within 30 days prior inclusion,, 3.Ability to comply with the study protocol in the Investigator’s judgment,, 10.PET scan performed within 30 days prior inclusion,, 11.Adequate hematologic and end-organ function: defined by the following laboratory test results obtained within 7 days prior to initiation of study treatment:, 12.Serum albumin ? 25 g/L (2.5 g/dL),, 13.For patients not receiving therapeutic anticoagulation: International normalized ratio (INR) or activated partial thromboplastin time (PTT) ? 1.5 ? ULN,, 14.Patient affiliated to or beneficiary of French social security health insurance system (PUMA; La protection Universelle Maladie)., 2.Age =18 years,, 4.Performance status ECOG-WHO = 1,, 5.Histologically proved squamous cell anal carcinoma,
Exclusion Criteria
- •1.Previously received chemotherapy or pelvic radiotherapy,, 10.Inadequate organ functions: uncontrolled cardiac condition, known cardiac failure, unstable coronaropathy, respiratory failure, and chronic obstructive pulmonary disease,, 11.Diabetes with vascular or neurovascular complications,, 12.Preexistent peripheral neuropathy or impaired audition,, 13.HIV positive patient with CD4 count under 400/mm3 (HIV test is mandatory before inclusion),, 14.Active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection (chronic or acute), defined as having a positive hepatitis B surface antigen (HBsAg) test at screening. Patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total HBV core antibody (HBcAb) test at screening, are eligible for the study. Active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody test followed by a positive HCV RNA test at screening. The HCV RNA test will be performed only for patients who have a positive HCV antibody test,, 15.Active tuberculosis,, 16.Concomitant treatment with CYP3A4 inhibitor like ritonavir, indinavir, ketoconazole, etc.,, 17.Known hypersensitivity or contraindication to any of the study chemotherapy drugs (taxanes, cisplatin, 5-FU, mitomycin, capecitabine) and dihydro pyrimidine dehydrogenase (DPD) complete deficit,, 18.Uncontrolled infection or another life-risk condition,, 19.Known hearing impairment that contraindicates cisplatin administration,, 2.Previously received anti-tumor immunotherapy (HPV vaccination is allowed),, 20.Administration of a (attenuated) live vaccine within 28 days of planned start of study therapy of known need for this vaccine during treatment,, 21.Administration of prophylactic phenytoin,, 22.Inadequate laboratory values: MDRD CrCl < 60 ml/min, neutrophil count < 1500/mm3, platelets < 100.000/mm3, bilirubin 2.5 x ULN, AST/ALT 2.5 x ULN,, 23.Previous major surgery (requiring general anesthesia) within 28 days of enrollment., 24.Any immunosuppressive therapy (i.e. corticosteroids > 10 mg of hydrocortisone or equivalent dose) within 14 days before the planned start of study therapy,, 25.Active autoimmune disease that has required a systemic treatment in past 2 years (i.e. corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin) is allowed,, 26.Prior allogeneic bone marrow transplantation or prior solid organ transplantation,, 27.Known active central nervous system metastases and/or carcinomatous meningitis. Subject with previously treated brain metastases and with radiological and clinical stability are allowed,, 28.Previously received an anti-PD-1, anti-PD-L1, or anti-CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) agent,, 29.Known hypersensitivity or allergy to Chinese hamster ovary cell products or any component of Ezabenlimab (BI 754091) formulation,, 3.Metastatic disease,, 30.History of colorectal inflammatory disease,, 31.History of idiopathic or secondary pulmonary fibrosis (History of radiation pneumonitis in the radiation field fibrosis is permitted), or evidence of active pneumonitis requiring a systemic treatment with 28 days before the planned start of study therapy., 32.History of severe hypersensitivity reactions to other mAbs, 33.History of Chronic colorectal inflammatory disease (Ulcerative colitis, Crohn's disease),, 34.History of connective disease,, 35.History of autoimmune diseases., 4.Diagnosis of ad
Investigators
Similar Trials
Active, not recruiting
Phase 1
Ezabenlimab (BI 754091) and mDCF (docetaxel, cisplatin, and 5-fluorouracil) followed by hypofractionated radiotherapy in patients with stage III squamous cell anal carcinoma. A phase II study.cancer du canal anal de stade IIIEUCTR2020-006046-40-FRCHU de Besançon55
Unknown
Phase 4
Coadministration of Ezetimibe With Fenofibrate Versus Pravastatin Monotherapy for the Treatment of Hyperlipidaemia in HIV-infected PatientsHIVHyperlipidemiaHIV InfectionsNCT00843661Ospedale di Circolo - Fondazione Macchi60
Completed
Not Applicable
Effect of Fenofibrate and Ezetimibe Combination Treatment on LipidType IIb DyslipidaemiaJPRN-UMIN000001224Comprehensive Support Project for Life-style related disease (CSP-LD)236
Active, not recruiting
Not Applicable
Coadministration of ezetimibe with fenofibrate versus pravastin monotherapy for the treatment of hyperlipidaemia in HIV-infected patients receiving protease inhibitors: a randomized, prospective, controlled pilot study. - NDEUCTR2008-005049-48-ITAZIENDA OSPEDALIERA FONDAZIONE MACCHI (A.O. DI RILIEVO NAZIONALE)
Active, not recruiting
Phase 1
Study of Carfilzomib, Lenalidomide, Dexamethasone and Belantamab Mafodotin in Multiple MyelomaMultiple MyelomaNCT04822337Wake Forest University Health Sciences70