Skip to content
Triangle logo TriangleGet started
← Full study record

NCT05490771 · OUTCOME

Overall Response Rate (ORR)

Testing Copanlisib as a Potential Targeted Treatment in Cancers With PIK3CA Mutations (MATCH-Subprotocol Z1F) · Source last updated 2026-05-05

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
90% Confidence Interval
Time frame
Tumor assessments occurred at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 30 months post registration

What was measured

ORR is defined as the percentage of patients whose tumors have a complete or partial response to treatment among analyzable (ie, eligible, treated and PIK3CA mutation status confirmed) patients. Objective response is defined consistent with Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Details about how to define complete response and partial response can be found in the master protocol. 90% two-sided binomial exact confidence interval is calculated for ORR.

Analysis population: Eligible, treated and PIK3CA mutation status confirmed

Groups in this outcome

Treatment (Copanlisib)

Patients receive copanlisib IV over 1 hour on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Treatment (Copanlisib)25

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment (Copanlisib)16Not reported633Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Description
    The ORR was compared against a null benchmark value of 5%. If the observed ORR were ≥5 of 31 (16%), it would then be concluded that the agent is promising and worthy of further investigation. When the number of analyzable cases (who were eligible and treated, and with outside assay results confirmed by the central MATCH assay) was \<31, the one-sided exact binomial test would be used for significance test with one-side type I error rate of 5%.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0341
    statistical Method
    one-sided exact binomial test
Complete source fields
analyses
  1. group Description
    The ORR was compared against a null benchmark value of 5%. If the observed ORR were ≥5 of 31 (16%), it would then be concluded that the agent is promising and worthy of further investigation. When the number of analyzable cases (who were eligible and treated, and with outside assay results confirmed by the central MATCH assay) was \<31, the one-sided exact binomial test would be used for significance test with one-side type I error rate of 5%.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0341
    statistical Method
    one-sided exact binomial test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6
        upper Limit
        33
        value
        16
denoms
  1. counts
    1. group Id
      OG000
      value
      25
    units
    Participants
description
ORR is defined as the percentage of patients whose tumors have a complete or partial response to treatment among analyzable (ie, eligible, treated and PIK3CA mutation status confirmed) patients. Objective response is defined consistent with Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Details about how to define complete response and partial response can be found in the master protocol. 90% two-sided binomial exact confidence interval is calculated for ORR.
dispersion Type
90% Confidence Interval
groups
  1. description
    Patients receive copanlisib IV over 1 hour on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
    id
    OG000
    title
    Treatment (Copanlisib)
param Type
NUMBER
population Description
Eligible, treated and PIK3CA mutation status confirmed
reporting Status
POSTED
time Frame
Tumor assessments occurred at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 30 months post registration
title
Overall Response Rate (ORR)
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice