Patient with FIGO Stages IB2 to IIB Node+ and IIIA to IVA with any node. Patients must not have previously received any definitive surgical, radiation, or systemic therapy for cervical cancer and must be immunotherapy-naïve.
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: 1. Female 2. Aged at least 18 years 3. Documented evidence of cervical adenocarcinoma or squamous carcinoma FIGO Stage IB2-IIB Node positive or 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 qualifies as a RECIST 1.1 Target Lesion at baseline. 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 571 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 143
Exclusion criteria
Exclusion criteria: 1. Diagnosis of small cell (neuroendocrine) histology 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) above the L1 cephalad body or outside the planned radiation field. 5. History of allogeneic organ transplantation 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 |
|---|---|
| Main Objective: To assess the efficacy of durvalumab + SoC CCRT compared with placebo + SoC CCRT in terms of Progression-Free Survival (PFS);Secondary Objective: 1. To further assess the efficacy of durvalumab + SoC CCRT compared with placebo + SoC CCRT in terms of overall survival(OS), PFS in PD-L1 positive patients, objective response rate(ORR), complete response (CR) rate, and DoR in Patients with CR. 2. To assess the effect of durvalumab + SoC CCRT compared with placebo + SoC CCRT on the incidence of local progression, distant disease progression, and secondary malignancy as the first documented progression event. 3. To assess disease-related symptoms and health-related quality of life (HRQoL) in patients with cervical cancer treated with durvalumab + SoC CCRT compared with placebo + SoC CCRT using the core quality of life questionnaire (EORTC QLQ-C30) and core quality of life questionnaire cervical cancer module (CX24). 4. To assess the PK of durvalumab when in combination with CCRT. 5. To investigate the immunogenicity of durvalumab when in combination with CCRT.;Primary end point(s): Progression-free survival (PFS) per RECIST 1.1 or histopathologic confirmation of local tumor progression;Timepoint(s) of evaluation of this end point: Estimated to be from the time of randomization up to 4.5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Overall Survival (OS) 2. Objective Response Rate (ORR) 3. Complete Response (CR) rate 4. Duration of Response (DoR) in patients with a Complete Response (CR) 5. Health-related quality of life (HRQoL) measured by EORTC QLQ-C30 and core quality of life questionnaire cervical cancer module (CX24). 6. PK and ADA of durvalumab when in combination with CCRT 7. Progression-free Survival(PFS) in PD-L1 high patients;Timepoint(s) of evaluation of this end point: 1. During treatment and through to study completion, up to approximately 5 years. 2. During treatment and through to database lock, up to approximately 4.5 years. 3. During treatment and through to database lock, up to approximately 5 months. 4. During treatment and through to database lock, up to approximately 4.5 years. 5. During treatment and through to database lock, up to approximately 4.5 years. 6. During treatment and through to 180 days after last dose of investigational product. 7. During treatment and through to database lock, up to approximately 4.5 years. | — |
Countries
Brazil, Chile, China, Hungary, India, Japan, Korea, Republic of, Mexico, Peru, Philippines, Poland, Russian Federation, South Africa, Taiwan, United States
Contacts
Public ContactClinical Trial Transparency
AstraZeneca AB
Outcome results
None listed