Participant flow

DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma · Source last updated 2017-05-25

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   DN24-02 is an autologous cellular immunotherapy product designed to stimulate an immune response against HER2/neu. It consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), which are activated ex vivo with a recombinant fusion protein, BA7072.

   id

   FG000

   title

   DN24-02

2. description

   Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin-containing chemotherapy is beneficial in the adjuvant setting for this patient population.

   id

   FG001

   title

   Standard of Care

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         30

      2. group Id

         FG001

         num Subjects

         30

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         5

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         31

      2. group Id

         FG001

         num Subjects

         37

      type

      Study Terminated

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Site closed research department

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         70

      2. group Id

         FG001

         num Subjects

         72

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         67

      2. group Id

         FG001

         num Subjects

         0

      comment

      Safety population for the DN24-02 arm.

      type

      DN24-02 Arm ≥1 Leukapheresis

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         72

      comment

      Safety population for the Standard of Care arm.

      type

      Standard Care Arm ≥1 Post-baseline Visit

   4. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         70

      2. group Id

         FG001

         num Subjects

         72

      type

      NOT COMPLETED

   title

   Overall Study

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice