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NCT03621982 · OUTCOME

Overall Survival (OS)

Study of ADCT-301 in Patients With Selected Advanced Solid Tumors · Source last updated 2024-06-13

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Up to 3 years

What was measured

OS defined as the time between the start of treatment and death from any cause for participants treated with ADCT-301 as monotherapy and for participants treated with ADCT-301 in combination with pembrolizumab.

Analysis population: Efficacy Analysis Set: The Efficacy analysis set consisted of all participants who received at least 1 dose of study drug, had valid Baseline disease assessment(s), and at least one valid post-Baseline disease assessment. The monotherapy arms and combination arms were pooled as pre-specified in protocol section 3.

Groups in this outcome

ADCT-301 Monotherapy

Participants received 20, 30, 45, 60, 80, 100, 125 and 150 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.

ADCT-301 Combination Therapy

Participants received 20, 30, 45, 60, 80, 100, 125 and 150 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).

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

Analysis denominator · Participants

GroupSource count
ADCT-301 Monotherapy44
ADCT-301 Combination Therapy33

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
ADCT-301 Monotherapy4.37Not reported2.996.74Not reported
ADCT-301 Combination Therapy7.59Not reported4.1110.61Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.99
        upper Limit
        6.74
        value
        4.37
      2. group Id
        OG001
        lower Limit
        4.11
        upper Limit
        10.61
        value
        7.59
denoms
  1. counts
    1. group Id
      OG000
      value
      44
    2. group Id
      OG001
      value
      33
    units
    Participants
description
OS defined as the time between the start of treatment and death from any cause for participants treated with ADCT-301 as monotherapy and for participants treated with ADCT-301 in combination with pembrolizumab.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received 20, 30, 45, 60, 80, 100, 125 and 150 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
    id
    OG000
    title
    ADCT-301 Monotherapy
  2. description
    Participants received 20, 30, 45, 60, 80, 100, 125 and 150 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
    id
    OG001
    title
    ADCT-301 Combination Therapy
param Type
MEDIAN
population Description
Efficacy Analysis Set: The Efficacy analysis set consisted of all participants who received at least 1 dose of study drug, had valid Baseline disease assessment(s), and at least one valid post-Baseline disease assessment. The monotherapy arms and combination arms were pooled as pre-specified in protocol section 3.
reporting Status
POSTED
time Frame
Up to 3 years
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice