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Testing Nivolumab as a Potential Targeted Treatment in Cancers With Mismatch Repair Deficiency (MATCH-Subprotocol Z1D) · Source last updated 2021-04-06

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

groups

1. description

   Patients receive nivolumab IV over 30-60 minutes on days 1 and 15 of cycles 1-4 and on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Nivolumab: Given IV

   id

   FG000

   title

   Treatment (Nivolumab)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         13

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         16

      type

      Disease progression

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Death

   4. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Declining health

   6. reasons

      1. group Id

         FG000

         num Subjects

         9

      type

      Still receiving treatment at the time of the analysis

   7. reasons

      1. group Id

         FG000

         num Subjects

         5

      type

      Ineligible

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         47

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         42

      type

      Eligible

   3. achievements

      1. group Id

         FG000

         num Subjects

         47

      type

      Treated

   4. achievements

      1. comment

         One patient experienced disease progression in cycle 1 and an AE form was not submitted.

         group Id

         FG000

         num Subjects

         46

      type

      Treated and Reported Adverse Event Data

   5. achievements

      1. group Id

         FG000

         num Subjects

         42

      type

      Eligible and Treated

   6. achievements

      1. group Id

         FG000

         num Subjects

         0

      comment

      Treatment continued until progression or intolerability. At the time of the final analysis of the data, 9 patients were still receiving protocol treatment.

      type

      COMPLETED

   7. achievements

      1. group Id

         FG000

         num Subjects

         47

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

To be assigned to a specific MATCH subprotocol, patients needed to submit a tumor biopsy for molecular characterization and those with molecular variants addressed by treatments included in the trial entered corresponding MATCH subprotocol. For the subprotocol Z1D, patients had to have complete loss of nuclear expression of MLH1 or MSH2 MMR gene products by IHC.

recruitment Details

Subprotocol Z1D was activated in NCI-MATCH on May 31, 2016. Patients enrolled for screening by the MATCH assay between this date and the end of screening enrollment in May 2017, were evaluated for MSH2 and MLH1 expression by immunohistochemistry (IHC). In the end, 47 patients were enrolled to the subprotocol.

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Preserved source evidence · Not medical advice