Solid Tumor
Conditions
Interventions
investigational material(s)
Generic name etc : Durvalumab
INN of investigational material : MEDI4736
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigationa
Sponsors
AstraZeneca
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: General inclusion criteria for all patients 1 Patient must be 18 years or older at the time of signing the ICF. For subjects aged over 20 years and enrolled in Japan a written ICF should be obtained from the subject and his or her legally acceptable representative. 2 Patient received durvalumab monotherapy and or durvalumab containing combination in an AstraZeneca MedImmune sponsored parent clinical study that is approved for enrollment into this study. 3 Patients who received durvalumab in combination with any other approved or investigational anticancer agents in the parent clinical study must have completed or discontinued all other anticancer therapy (beyond durvalumab regimen). 4 Patient must be willing and able to provide written informed consent and to comply with scheduled visits and other study procedures. Additional inclusion criteria for patients entering Cohort 1 5 Currently receiving durvalumab monotherapy (this includes patients enrolled in durvalumab combinations who have completed or discontinued all other anticancer therapy combined with durvalumab in the parent clinical study and are now receiving durvalumab monotherapy) and is currently benefiting from treatment with durvalumab therapy, as determined by the Investigator. Additional inclusion criteria for patients entering Cohort 1 and Cohort 2 6 Adequate organ function as defined 7 Evidence of postmenopausal status or negative urinary or serum pregnancy test for female premenopausal patients. Women will be considered postmenopausal if they have been amenorrheic for 12 months without an alternative medical cause. 8 World Health Organization (WHO)Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2 at enrollment Additional inclusion criteria for retreatment patients in Cohort 2 9 Received durvalumab in a parent clinical study that is approved to enroll into this study. 10 Completed the defined treatment duration with durvalumab monotherapy or durvalumab combination therapy in the parent clinical study 11 At least 1 lesion that can be accurately measured at baseline as below 10 in the longest diameter and that is suitable for accurate repeated measurements as per RECIST v1.1 guidelines.
Exclusion criteria
Exclusion criteria: 1 Involvement in the planning and or conduct of the study . Additional exclusion criteria for Cohort 1 and Cohort 2 2 Currently receiving treatment in another interventional clinical study other than a parent clinical study or received treatment during the followup period before retreatment (Cohort 2 only). 3 Experienced an immune mediated or non immune mediated (hematologic and non hematologic) toxicity that led to permanent discontinuation of durvalumab in the parent clinical study. 4 Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade more than 2 from previousc anticancer therapy with the exception of alopecia vitiligo and the laboratory values defined in the inclusion criteria. 5 Prior treatment with immunotherapy other than durvalumab or any other approved or investigational anticancer agents other than MedImmune AstraZeneca investigational immunotherapy molecules administered in the parent clinical study. 6 Any concurrent chemotherapy, investigational product (IP) biologic or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non cancer related conditions ( hormone replacement therapy) is acceptable. 7 Active or prior documented autoimmune or inflammatory disorders. 8 History of allogenic organ transplantation. 9 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 or 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. 10 Documented active infection including tuberculosis hepatitis B virus (HBV)Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody and absence of HbsAg) are eligible. Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Prior HIV and HBVHCV testing from the parent clinical study is acceptable documentation and patients will not need to undergo an additional testing prior to Cohort 1 enrollment in this study. 11 Receipt of live attenuated vaccine within 30 days prior to the first dose of study drug in the present study. 12 Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy or 180 days after the last dose of durvalumab tremelimumab combination. 13 For patients randomized to receive SoC treatment in parent protocols follow the local prescribing information relating to contraception the time limit for such precautions and any additional restrictions for agents in the SoC treatment regimen. 14 Diagnosis of a new primary malignancy since enrollment into the parent clinical study with the exception of adequately treated non-melanomatous skin cancer and carcinoma in situ with no evidence of disease. 15 Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE Grade 1 have not experienced recurrence of an AE if re-challenged and not currently require maintenance doses. 16 Known allergy or hypersensitivity to any of the stud
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety All SAEs Non-serious AEs that lead to dose modification, drug discontinuation, or withdrawal from the study All Grade 3 and Grade 4 AEs Grade 2 AEs that affect vital organs Immune-mediated AEs Laboratory findings qualifying as an SAE/AE (endpoints defined above) up until 90 days after the last dose of durvalumab in all patients | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy ORR Number percent of patients with a confirmed response of CR or PR. DOR Time from first documented CR or PR to time of first documented disease progression or death in the absence of disease progression | — |
Countries
Africa, Asia except Japan, Japan, North America, Oceania, South America
Contacts
Public ContactTomoyasu Muro
Tomoyasu Muro
Outcome results
None listed