Phase 4
N=163
Durvalumab Long-Term Safety and Efficacy Study
Solid Tumor
Bottom Line
View on ClinicalTrials.gov: NCT04078152 ↗Enrolled (actual)
163
Serious AEs
21.1%
Results posted
Sep 2024
Primary outcome: Primary: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — 85; 1; 0; 23 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Durvalumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
85; 1; 0; 23; 0; 0 | — |
| SECONDARY Cohort 2: Overall Response Rate (ORR) |
— | — |
| SECONDARY Cohort 2: Duration of Response (DOR) |
NA | — |
| SECONDARY Number of Participants Who Were Alive |
90; 23; 26 | — |
Summary
The aims of the study are to monitor the long-term safety of durvalumab, to provide continued treatment or retreatment with durvalumab to eligible patients, and to collect overall survival (OS) information.
Eligibility Criteria
Inclusion Criteria
- Patient must be 18 years or older, at the time of signing the ICF. For subjects aged < 20 years and enrolled in Japan, a written ICF should be obtained from the subject and his or her legally acceptable representative.
- 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.
- 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).
- Patient must be willing and able to provide written informed consent and to comply with scheduled visits and other study procedures.
Exclusion Criteria
The following exclusion criteria apply only to patients receiving treatment or retreatment:
- Currently receiving treatment in another interventional study other than the parent clinical study or, for retreatment patients, received treatment during the follow up period with an agent other than durvalumab
- Any concurrent chemotherapy, IP, biologic or hormonal therapy for cancer treatment
- Experienced an immune-mediated or non-immune-mediated toxicity that led to permanent discontinuation of durvalumab in parent clinical study
- Diagnosis of a new primary malignancy since enrollment into the parent clinical study
Data sourced from ClinicalTrials.gov (NCT04078152). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.