None listed
Conditions
Interventions
Placebo +SoC CCRT: patients with FIGO Stage IB2 to IVA cervical cancer. Type of group
Patients will be randomized in a 1: 1 ratio to the following treatment arms: concurrent durvalumab with and after chemotherapy and radiotherapy and concurrent placebo with or after chemotherapy and radiation therapy. They will receive 1500 mg of durvalumab by intravenous infusion or placebo saline every 4 w until the planned therapy of up to 24 cycles is reached or the radiological progression defined by RECIST 1.1 or the histopathological progression in the biopsy, unless toxicity is present un
Sponsors
AstraZeneca AB,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Capability of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol 2. Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses 3. Provision of signed and dated written genetic informed consent prior to collection of sample for genetic analysis The ICF process is described in Appendix A 3. 4. Females age ≥18 years at the time of screening. For patients aged 30 kg 12. Female sex
Exclusion criteria
Exclusion criteria: 1. Diagnosis of small cell (neuroendocrine) histology cervical cancer 2. Intent to administer a fertility-sparing treatment regimen 3. Evidence of metastatic disease per RECIST 1.1 including lymph nodes ≥15 mm (short axis) above the L1 cephalad body or outside the planned radiation field. 4. Patients who have undergone a previous hysterectomy, including a supracervical hysterectomy, or will have a hysterectomy as part of their initial cervical cancer therapy 5. History of allogeneic organ transplantation 6. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn’s disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves’ disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:  Patients with vitiligo or alopecia  Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement  Patients with any chronic skin condition that does not require systemic therapy  Patients without active disease in the last 5 years may be included but only after consultation with the Study Physician  Patients with celiac disease controlled by diet alone 7. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active ILD, serious chronic GI conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent 8. History of another primary malignancy except for  Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence  Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease  Adequately treated carcinoma in situ without evidence of disease 9. History of active primary immunodeficiency 10. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), hepatitis B (known positive HBV HBsAg result), hepatitis C (HCV), or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA. 11. Brain metastases or spinal cord compression. Patients with suspected brain metastases at screening should have an MRI (preferred) or CT each preferably with IV contrast of the brain prior to study entry. Brain metastases will not be recorded as RECIST TLs at baseline. 12. Mean QT interval corrected for heart rate using Fridericia´s formula (QTcF) ≥470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart) 13. Known allergy or hypersensitivity to any of the study drugs or any of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Assessed by investigator tumor assessments and histopathologic confirmation of local tumor progression. PFS (per RECIST 1.1 as assessed by investigator tumor assessments or histopathologic confirmation of local tumor progression) will be defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from therapy or receives another anticancer therapy prior to progression (ie, date of event or censoring – date of randomization + 1). Measure:PFS: Time from the date of randomization to tumor progression or death due to any cause Timepoints:From the date of randomization until the date of objective disease progression or death | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Based on investigator assessments using RECIST 1.1 or histopathologic confirmation of local progression. In addition, the key secondary endpoint (OS) and other secondary endpoints (Incidence of Local Progession, Distant Disease Recurrence, and Secondary Malignancy) will also be analyzed Measure:OS: Time from the randomization date to the date of death from any cause Timepoints:From the date of randomization to death for any reason. Every patient whose death is unknown at the time of analysis will be subject to censorship based on the last recorded date in which it was known that he was still alive. | — |
Countries
Brazil, Chile, China, Hungary, India, Japan, Korea South, Mexico, Peru, Philippines, Poland, Russian Federation, South Africa, Taiwan, United States
Contacts
Public ContactUrsula Isabel Rodriguez Frias
ASTRAZENECA PERU S.A.
Outcome results
None listed