The target patient population of the protocol includes patients with advanced solid tumors who meet the overall and tumor specific inclusion and exclusion criteria as outlined in each protocol Module. Please refer to the protocol version and the tumor specific protocol Modules for the full list of medical conditions to be investigated. MedDRA version: 21.1 Level: PT Classification code 10061272 Term: Malignant urinary tract neoplasm System Organ Class: 10029104 - Neoplasms benign, malignant and
Conditions
Interventions
Product Name: Durvalumab
Product Code: MEDI4736
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: DURVALUMAB
CAS Number: 1428935-60-7
Current Sponsor code: MEDI4736
Conce
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Must have a life expectancy of at least 12 weeks - Disease not amendable to curative surgery - Eastern Cooperative Oncology Group (ECOG) performance status as defined in the specific module. - Body weight >30 kg. - No prior exposure to anti-PD-1or anti-PD-L1, including on another AstraZeneca study. Exposure to other investigational agents may be permitted after discussion with the Sponsor. - Adequate organ and marrow function as defined in the protocol 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 720 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 480
Exclusion criteria
Exclusion criteria: - Any concurrent chemotherapy, investigational agent, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable. - Local treatment of isolated lesions for palliative intent is acceptable (e.g., local surgery or radiotherapy). - Receipt of any investigational anticancer therapy within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study treatment. - Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug. Note: Local treatment of isolated lesions, excluding target lesions, for palliative intent is acceptable. - Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable. - History of allogenic organ transplantation. - Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, 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 - 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 investigational product (durvalumab + tremelimumab) 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 - History of leptomeningeal carcinomatosis - Has untreated central nervous system (CNS) metastases and/or carcinomatous meningitis identified either on baseline brain imaging (please refer to RECIST for details on the imaging modality) obtained during the screening period or identified prior to signing the ICF. Patients whose brain metastases have been treated may participate provided they show radiographic stability (defined as 2 brain images, both of which are obtained after treatment to the brain metastases. These imaging scans should both be obtained at least 4 weeks apart and show no evidence of intracranial progression). In addition, any neurologic symptoms that developed either as a result of the brain metastases or their treatment must have resolved or be stable either, without the use of steroids, or are stable on a steroid dose of =10mg/day of prednisone or its equivalent and anti-convulsants for at least 14 days prior to the start of treatment. Brain metastases will not be recorded as RECIST Target Lesions at baseline. - History of active primary immunodeficiency. - Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tubercolosis testing in line with local practice), hepatitis B (known positive hepatitis B virus [HBV] surface antigen (HBsAg) result), hepatitis C, 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 hepati
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the incidence, severity, nature, seriousness, intervention/treatment, outcome, and causality, including immune-relatedness, of adverse events of special interest (AESIs) in patients who are treated with durvalumab and tremelimumab combination therapy or durvalumab monotherapy, using fixed dosing. ;Secondary Objective: 1. To assess the incidence, severity, nature, seriousness, intervention/treatment, outcome, and causality of AEs (including SAEs). 2. To assess the incidence and frequency of durvalumab and tremelimumab (as applicable to each tumor Module) interruption and discontinuation due to treatment-emergent AEs (including SAEs). 3. To assess overall survival (OS). Exploratory objective: To assess overall response rate (ORR) and disease control rate (DCR) based on Investigator assessed response to treatment (RECIST 1.1).;Primary end point(s): AESI outcome measures will be assessed, in order to further characterize safety objectives related to AESIs.;Timepoint(s) of evaluation of this end point: - at each visit (every 4 weeks) + safety-follow up visit (90 days after last dose) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): SAE: Number and proportion of patients with SAEs in total and by causality and severity AEs leading to death: Number and proportion of patients with AEs leading to death AEs leading to treatment interruption or discontinuation: Number and proportion of patients with AEs leading to treatment interruption and/or discontinuation Overall Survival: defined as the time from the first date of treatment until death due to any cause. OS (days) = Death date or Censor date – treatment start date + 1. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive. Objective Response Rate (ORR) and Disease Control Rate (DCR): based on investigator assessed response to treatment of CR and PR or CR, PR and SD respectively based on RECIST 1.1.;Timepoint(s) of evaluation of this end point: - at each visit (every 4 weeks) + safety-follow up visit (90 days after last dose) - survival follow up (every 3 month for up to 5 years) | — |
Countries
Austria, Canada, China, Denmark, Finland, France, Germany, Israel, Italy, Japan, Korea, Republic of, Netherlands, Norway, Spain, Sweden, Switzerland, United Kingdom, United States
Contacts
Public ContactClinical Trial Transparency
AstraZeneca
Outcome results
None listed