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NCT01769222 · OUTCOME

Dose-limiting Toxicity

Ipilimumab and Local Radiation for Selected Solid Tumors · Source last updated 2024-01-24

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
Not reported
Time frame
4 weeks

What was measured

Safety as the percentage of patients in Phase 1 (ipilimumab monotherapy) of the study, who experienced dose-limiting toxicities (DLTs) or serious adverse events (SAEs), using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Analysis population: This study did not proceed to Phase 2 (ipilimumab plus radiation combination therapy).

Groups in this outcome

Ipilimumab 25 mg

Participants receive ipilimumab intratumorally on Day 1 Ipilimumab: Given intratumorally

Ipilimumab 25 mg and Radiation Therapy

Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions Ipilimumab: Given intratumorally Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions

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

Analysis denominator · Participants

GroupSource count
Ipilimumab 25 mg3
Ipilimumab 25 mg and Radiation Therapy0

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ipilimumab 25 mg0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      0
    units
    Participants
description
Safety as the percentage of patients in Phase 1 (ipilimumab monotherapy) of the study, who experienced dose-limiting toxicities (DLTs) or serious adverse events (SAEs), using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
groups
  1. description
    Participants receive ipilimumab intratumorally on Day 1 Ipilimumab: Given intratumorally
    id
    OG000
    title
    Ipilimumab 25 mg
  2. description
    Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions Ipilimumab: Given intratumorally Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions
    id
    OG001
    title
    Ipilimumab 25 mg and Radiation Therapy
param Type
NUMBER
population Description
This study did not proceed to Phase 2 (ipilimumab plus radiation combination therapy).
reporting Status
POSTED
time Frame
4 weeks
title
Dose-limiting Toxicity
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice