Locally Advanced Cervical Cancer
Conditions
Interventions
investigational material(s)
Generic name etc : Durvalumab
INN of investigational material : -
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational mate
Sponsors
Astrazeneca K.K
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female 2. Aged at least 18 years 3. Documented evidence of cervical adenocarcinoma or squamous carcinoma FIGO (2009) Stages IB2 to IIB node positive or FIGO (2009) IIIA-IVA any node 4. No prior chemotherapy or radiotherapy for cervical cancer 5. WHO/ECOG performance status of 0-1 6. At least 1 lesion, not previously irradiated, that q ualifies as a RECIST 1.1 Target Lesion at baseline
Exclusion criteria
Exclusion criteria: 1. Diagnosis of small cell (neuroendocrine) histology or mucinous adenocarcinoma cervical cancer 2. Intent to administer a fertility-sparing treatment regimen 3. Undergone a previous hysterectomy 4. Evidence of metastatic disease per RECIST 1.1 including lymph nodes 15 mm (short axis) or more above the L1 cephalad body in the inguinal region or outside the planned radiation field 5. History of allogeneic organ transplantati 6. Active or prior documented autoimmune or inflammatory disorders 7. Uncontrolled intercurrent illness 8.History of another primary malignancy and active primary immunodeficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy - | — |
Secondary
| Measure | Time frame |
|---|---|
| safety - | — |
Countries
Brazil, Chile, China, Hungary, India, Korea, Mexico, Peru, Philippines, Poland, Russian Federation, South Africa, Taiwan, United States of America
Outcome results
None listed