Participant flow

MEDI4736 Or MEDI4736 + Tremelimumab In Surgically Resectable Malignant Pleural Mesothelioma · Source last updated 2022-09-29

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

groups

1. description

   8 patients will receive an infusion of MEDI4736 (15 mg/kg intravenously, once), one to six weeks prior to surgical resection. MEDI4736: MEDI4736 is formulated at 50 mg/mL in 26 mM histidine/histidine-HCl, 275 mM trehalose dihydrate, 0.02% (w/v) polysorbate 80, pH 6.0.

   id

   FG000

   title

   MEDI4736

2. description

   8 patients will receive an infusion of MEDI4736 (1500 mg intravenously, once) + tremelimumab (75mg intravenously, once), one to six weeks prior to surgical resection. MEDI4736: MEDI4736 is formulated at 50 mg/mL in 26 mM histidine/histidine-HCl, 275 mM trehalose dihydrate, 0.02% (w/v) polysorbate 80, pH 6.0. Tremelimumab: Tremelimumab Drug Product is formulated at a nominal concentration of 20 mg/mL in 20 mM histidine/histidine hydrochloride, 222 mM trehalose dihydrate, 0.02% (weight/volume \[w/v\]) polysorbate 80, 0.27 mM disodium edetate dihydrate (EDTA), pH 5.5.

   id

   FG001

   title

   MEDI4736 + Tremelimumab

3. description

   4 patients will not receive MEDI4736 or Tremelimumab. no other name: Neither MEDI4736 nor Tremelimumab will be used.

   id

   FG002

   title

   Untreated Arm (Control)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         0

      type

      Not evaluable

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         11

      3. group Id

         FG002

         num Subjects

         4

      type

      STARTED

   2. achievements

      1. comment

         One participant completed all study procedures and got the tumor sample for analysis. However, the sample was too small to analyze in the lab and so that it was not evaluable for primary and secondary analysis.

         group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         8

      3. group Id

         FG002

         num Subjects

         4

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Overall Study

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

Preserved source evidence · Not medical advice