| General information |
| Database: | DB00547 |
| Objective: | They examined the antiPDL1 antibody MPDL3280A, a systemic cancer immunotherapy, for the treatment of metastatic UBC(metastatic bladder cancer). |
| Authors: | Powles T, et al |
| Title: | MPDL3280A (antiPDL1) treatment leads to clinical activity in metastatic bladder cancer. |
| Journal: | Nature. |
| Year: | 2014 |
| PMID: | 25428503 |
| Trial Design |
| Clinical Trial Id: | NCT01375842 |
| Agent: | MPDL3280A
|
| Target: | Programmed cell death ligand 1 (PDL1)
|
| Cancer Type: | bladder cancer |
| Cancer Subtype: | advanced urothelial bladder cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | phase I escalation and expansion study |
| Key Patients Feature: | metastaticurothelial bladder cancer (UBC) |
| Biomarker: | PDL1 expression on tumour and tumourinfiltratingimmunecells |
| Biomark Analysis: | This phase I expansion study, with an adaptive design thatallowed for biomarkerpositive enriched cohorts, demonstrated thattumour sexpressing PDL1positive tumourinfiltrating immune cells had particularly high response rates. |
| Control Group Info: | NA |
| Treatment Info: | This UBC cohort was initially selected by PDL1 immunohistochemistry (IHC) on tumourinfiltrating immune cells to test the hypothesis that PDL1positive patients might specifically respond to MPDL3280A. The cohort was subsequently expanded to include patients regardless of PDL1 status to determine whether PDL1negative patients could also respond. |
| Primary End Point: | the singleagent safety and tolerability |
| Secondary End Point: | antitumour activity. |
| Patients Number: | 205 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | NA |
| Conclusions: | These results suggest that MPDL3280A may have an important role in treating UBCthe drug received breakthrough designation status by the US Food and Drug Administration (FDA) in June 2014. |