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NCT04637594 · OUTCOME

Rate of Response After Immune Checkpoint Inhibitor (ICI) Rechallenge (Arm B)

Trying to Find the Correct Length of Treatment With Immune Checkpoint Therapy · Source last updated 2026-03-20

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

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Up to 5 years

What was measured

Rate of response is the percentage of patients with response after re-initiation of immune checkpoint inhibitor (ICI) therapy after progression post-registration. Rate of response will be assessed using RECIST 1.1. A chi-square test (or Fisher's exact test) will be used to determine whether there is an association between the best tumor response prior to trial enrollment and that achieved upon ICI re-challenge.

Analysis population: All patients randomized to arm B withdrew from trial before beginning treatment. No data is available to perform analysis.

Groups in this outcome

Arm A (Immune Checkpoint Inhibitor)

CONTINUATION OF ICI TREATMENT: Patients receive either pembrolizumab intravenously (IV) over 30 minutes on day 1, nivolumab IV over 30 minutes on days 1 and 15, atezolizumab IV over 30-60 minutes on day 1, durvalumab IV over 60 minutes on days 1 and 15, or avelumab IV over 60 minutes on days 1 and 15. Cycles repeat every 21 or 42 days for pembrolizumab, every 21 days for atezolizumab, and 28 days for nivolumab, durvalumab, and avelumab in the absence of disease progression or unacceptable toxicity. Pembrolizumab: Given IV Nivolumab: Given IV Atezolizumab: Given IV Durvalumab: Given IV Avelumab: Given IV

Arm B (Immune Checkpoint Inhibitor)

DISCONTINUATION OF ICI TREATMENT: Patients receiving ICI treatment will discontinue ICI treatment within 1 cycle length after randomization. Cycle length is determined by the ICI regimen the patient is receiving at randomization. At disease progression patients may restart the same ICI treatment they were receiving upon randomization at physician discretion. Pembrolizumab: Given IV Nivolumab: Given IV Atezolizumab: Given IV Durvalumab: Given IV Avelumab: Given IV

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

Analysis denominator · Participants

GroupSource count
Arm A (Immune Checkpoint Inhibitor)0
Arm B (Immune Checkpoint Inhibitor)0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    units
    Participants
description
Rate of response is the percentage of patients with response after re-initiation of immune checkpoint inhibitor (ICI) therapy after progression post-registration. Rate of response will be assessed using RECIST 1.1. A chi-square test (or Fisher's exact test) will be used to determine whether there is an association between the best tumor response prior to trial enrollment and that achieved upon ICI re-challenge.
groups
  1. description
    CONTINUATION OF ICI TREATMENT: Patients receive either pembrolizumab intravenously (IV) over 30 minutes on day 1, nivolumab IV over 30 minutes on days 1 and 15, atezolizumab IV over 30-60 minutes on day 1, durvalumab IV over 60 minutes on days 1 and 15, or avelumab IV over 60 minutes on days 1 and 15. Cycles repeat every 21 or 42 days for pembrolizumab, every 21 days for atezolizumab, and 28 days for nivolumab, durvalumab, and avelumab in the absence of disease progression or unacceptable toxicity. Pembrolizumab: Given IV Nivolumab: Given IV Atezolizumab: Given IV Durvalumab: Given IV Avelumab: Given IV
    id
    OG000
    title
    Arm A (Immune Checkpoint Inhibitor)
  2. description
    DISCONTINUATION OF ICI TREATMENT: Patients receiving ICI treatment will discontinue ICI treatment within 1 cycle length after randomization. Cycle length is determined by the ICI regimen the patient is receiving at randomization. At disease progression patients may restart the same ICI treatment they were receiving upon randomization at physician discretion. Pembrolizumab: Given IV Nivolumab: Given IV Atezolizumab: Given IV Durvalumab: Given IV Avelumab: Given IV
    id
    OG001
    title
    Arm B (Immune Checkpoint Inhibitor)
population Description
All patients randomized to arm B withdrew from trial before beginning treatment. No data is available to perform analysis.
reporting Status
POSTED
time Frame
Up to 5 years
title
Rate of Response After Immune Checkpoint Inhibitor (ICI) Rechallenge (Arm B)
type
SECONDARY

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

Preserved source evidence · Not medical advice