recurrent cervical cancer MedDRA version: 21.1 Level: LLT Classification code 10065147 Term: Malignant solid tumor System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Tecentriq
Product Name: Tecentriq
Product Code: MPDL3280A-RO5541267-F-03
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Atezolizumab
Other descriptive name: MPDL3280A
Conc
Sponsors
BGOG-UZLeuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Squamous cell or adenocarcinoma of the cervix(neuroendocrine tumors and other rare variants are excluded). 2.Measurable disease that has progressed since last treatment according to RECIST1.1 3.At least one prior chemotherapy regimen for recurrent or advanced disease with a platinum-taxane combination, but not more than two lines of chemotherapy or targeted therapy in recurrent/advanced setting. 4.ECOG performance scale =2 5.Adequate pretreatment hematologic, renal and hepatic function test 6.Patients are allowed to have had bevacizumab during their prior treatment. 7.Evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on day 1. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (more than 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). 8.Patients of child bearing potential and their partners, who are sexually active, must agree to the use of two highly effective forms of contraception throughout their participation in the study and for 5 months after last dose of study drug(s). 9.Left ventricular ejection fraction measured by MUGA scan or ultrasonography should be 50% or more 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 32 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 16
Exclusion criteria
Exclusion criteria: 1.History of invasive malignancy other than cervical cancer unless there is no recurrence of these other primary tumors the last 3 years. 2.Previous anthracycline-based chemotherapy 3.Central nerve system metastases and leptomeningeal disease, unless stable and asymptomatic the last year 4.Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or to any component of the Atezolizumab formulation 5.Active or history of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with anti-phospholipid syndrome, Wegener’s granulomatosis, Sjögren’s syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis 6.Prior allogenic bone marrow transplantation or prior solid organ transplantation 7.History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan 8.Any other diseases, metabolic dysfunction, physical examination finding or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complication 9.Known positive test for HIV, or active hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C 10.Known active tuberculosis 11.Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia 12.Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study. 13.Administration of a live, attenuated vaccine within 4 weeks prior to Cycle 1, Day 1 or anticipation that such a live attenuated vaccine will be required during the study. 14.Prior immunotherapy: ?-treatment with CD137 agonists or immune checkpoint blockade therapies, anti-PD1, or anti-PDL1 therapeutic antibodies ?-Treatment with systemic immunostimulatory agents (including but not limited to interferon-alpha (IFN-a) and interleukin-2 (IL-2) within 4 weeks or five half-lives of the drug (whichever is shorter) prior to Cycle 1, Day 1 ?-treatment with anti-CTLA-4 may be enrolled, provided at least 5 half-lives (approximately 75 days) have elapsed from the last dose of anti-CTLA-4 to the first dose of Atezolizumab and there was no history of severe immune-mediated adverse effects from anti-CTLA-4 (NCI CTCAE Grade 3 and 4) 15.Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents) within 2 weeks prior to Cycle 1, Day 1, or anticipated requirement for systemic immunosuppressive medications during the trial 16.History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins 17.Sig
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of atezolizumab. To evaluate progression free survival of atezolizumab compared to standard treatment in cervical cancer;Secondary Objective: To evaluate overall survival of atezolizumab compared to standard treatment in cervical cancer To evaluate progression free survival in atezolizumab arm using the imRECIST criteria Evaluate proportion of progression free survival and survival Evaluate response rates of atezolizumab Evaluate disease controle rate Evaluate duration or response;Primary end point(s): Nature frequency and severity of AEs based on physical examinations, vital signs including blood pressure, pulse, electrocardiograms, and laboratory findings including clinical chemistry, hematology and urinalysis.;Timepoint(s) of evaluation of this end point: after 9 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Progression free survival after 9 months in the different arms by RECIST v1.1-criteria (doxorubicin and Atezolizumab in combination doxorubicin) Overall survival in the different arms Progression free survival after 9 months in Atezolizumab arm by imRECIST-criteria Proportion of progression free survival in the different arms at 6, 9, 12 and 18 months and proportion of survival at 6, 9, 12, 18 and 24 months Objective response rate according to RECIST 1.1-criteria and immune-modified RECIST (imRECIST) Percentage of subjects who achieved CR or PR or have demonstrated SD for 24 weeks according to RECIST v1.1 or imRECIST. Time from first response to disease progression in subjects who achieve a PR or better, based on assessments according to RECIST v1.1 and imRECIST.;Timepoint(s) of evaluation of this end point: at 6, 9, 12, 18 and 24 months | — |
Countries
Belgium
Contacts
Public ContactBGOG-UZLeuven
BGOG-UZLeuven
Outcome results
None listed