Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03084471 | An Open-Label, Multi-Centre, Study to Assess the Safety of Fixed-Dose Durvalumab + Tremelimumab Combination Therapy or Durvalumab Monotherapy in Advanced Solid Malignancies. | PHASE3 | COMPLETED | 867 | — | — | Jun 5, 2017 | Dec 16, 2022 | Dec 22, 2022 | 79 | United States, Canada +6 |
Incidence, severity, nature, seriousness, intervention/treatment, outcome, and causality of AESIs were assessed. AESIs included events with a potential inflammatory or immune-mediated mechanism that required interventions such as steroids, immunosuppressants, and/or hormone replacement therapy.
| Arm | Type | Description |
|---|---|---|
| Combination therapy | EXPERIMENTAL | Combination therapy (durvalumab + tremelimumab) : Patients will receive the combination therapy followed by monotherapy via intravenous (IV) infusion once Q4W: * Durvalumab 1,500 mg + tremelimumab 75 mg on Week 0, for up to a maximum of 4 doses (or cycles) and * Durvalumab 1,500 mg starting 4 weeks after the last infusion of the combination or discontinuation of tremelimumab. |
| Monotherapy | EXPERIMENTAL | Monotherapy (Durvalumab 1,500 mg): Patients will receive durvalumab 1,500 mg via IV infusion Q4W on Week 0. |
| Name | Type | Description |
|---|---|---|
| MEDI4736 (Durvalumab) | BIOLOGICAL | A human monoclonal antibody (mAb) of the immunoglobulin G (IgG) 1 kappa subclass that blocks the interaction of PD-L1 (but not programmed cell death ligand-2) with PD-1 on T cells and CD80 (B7.1) on immune cells (IC). |
| MEDI4736 (Durvalumab) + Tremelimumab | BIOLOGICAL | Durvalumab: A human mAb of IgG 1 kappa subclass that blocks the interaction of PD-L1 (but not programmed cell death ligand-2) with PD-1 on T cells and CD80 (B7.1) on IC. Tremelimumab: A human Ig G2 mAb that completely blocks the interaction of human CTLA-4 (cluster of differentiation \[CD\]152) with CD80 and CD86 and increase release of cytokines (interleukin \[IL\]-2 and interferon \[IFN\]-γ) from human T cells, peripheral blood mononuclear cells and whole blood. |
Inclusion criteria: 1. Must have a life expectancy of at least 12 weeks. 2. Age ≥18 years at the time of screening. For patients aged \<20 years and enrolled in Japan, a written informed consent should be obtained from the patient and his or her legally acceptable representative 3. Capable of givin...