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NCT04985604 · OUTCOME

Overall Response Rate (ORR) by the Investigator

Tovorafenib (DAY101) Monotherapy for Patients With Melanoma and Other Solid Tumors · Source last updated 2025-10-02

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
95% Confidence Interval
Time frame
Up to 23 months

What was measured

ORR was defined as the percentage of participants with the best overall confirmed response of complete response (CR) or partial response (PR) according to the appropriate response assessment criteria including Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) for the disease setting as assessed by the Investigator. CR or PR was confirmed at a subsequent scan (\>=4 weeks) if the criteria for each are met . The exact 95% confidence intervals (CIs) were calculated using Clopper-Pearson method.

Analysis population: Efficacy Analysis Set comprises of all participants who received at least one dose of study drug and have measurable disease as determined by the Investigator at baseline.

Groups in this outcome

Melanoma Cohort

Adult participants (≥ 18 years) were administered Tovorafenib 600 mg orally (PO) once weekly (QW).

Tissue Agnostic Cohort

Adult participants (≥ 18 years) were administered Tovorafenib 600 mg PO QW.

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

Analysis denominator · Participants

GroupSource count
Melanoma Cohort8
Tissue Agnostic Cohort15

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Melanoma Cohort50.0Not reported15.784.3Not reported
Tissue Agnostic Cohort40.0Not reported16.367.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        15.7
        upper Limit
        84.3
        value
        50.0
      2. group Id
        OG001
        lower Limit
        16.3
        upper Limit
        67.7
        value
        40.0
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      15
    units
    Participants
description
ORR was defined as the percentage of participants with the best overall confirmed response of complete response (CR) or partial response (PR) according to the appropriate response assessment criteria including Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) for the disease setting as assessed by the Investigator. CR or PR was confirmed at a subsequent scan (\>=4 weeks) if the criteria for each are met . The exact 95% confidence intervals (CIs) were calculated using Clopper-Pearson method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Adult participants (≥ 18 years) were administered Tovorafenib 600 mg orally (PO) once weekly (QW).
    id
    OG000
    title
    Melanoma Cohort
  2. description
    Adult participants (≥ 18 years) were administered Tovorafenib 600 mg PO QW.
    id
    OG001
    title
    Tissue Agnostic Cohort
param Type
NUMBER
population Description
Efficacy Analysis Set comprises of all participants who received at least one dose of study drug and have measurable disease as determined by the Investigator at baseline.
reporting Status
POSTED
time Frame
Up to 23 months
title
Overall Response Rate (ORR) by the Investigator
type
PRIMARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice