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NCT02526017 · OUTCOME

Safety: Number of Participants With Grade 3 or Grade 4 Adverse Events (AEs) and Laboratory Abnormalities Defined as Dose Limiting Toxicities (DLT) (Phase 1a)

Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers · Source last updated 2022-03-09

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
28 days

What was measured

A DLT was defined as a study drug-related ≥ Grade 3 AE (using National Cancer Institute Common Terminology Criteria for Adverse Events v 4.03) occurring during the first 28-days, excluding Grade 3 tumor flare (defined as local pain, irritation, or rash localized at sites of known or suspected tumor), rash, immune-related adverse event (irAE) that resolved to ≤ Grade 1 by 14 days or a transient (resolving within 6 hours of onset) Grade 3 infusion-related AE. Any recurrence of Grade 3 rash, irAE or infusion-related AE was considered a DLT. The protocol was amended such that in the absence of clinical symptoms and other accompanying changes in bilirubin or alanine aminotransferase (ALT), serum elevation of aspartate aminotransferase (AST)/ALT \> 12 × upper limit of normal (ULN) and ≤ 20 × ULN that lasted for \< 7 days and serum elevation of creatine kinase (CK) and/or lactate dehydrogenase (LDH) \> 15 × ULN and ≤ 20 × ULN that lasted for \< 7 days were not considered DLTs.

Analysis population: Participants enrolled in the dose escalation phase who received at least 2 doses of study drug during the 28-day evaluation interval or who discontinued study treatment for drug-related adverse events before receiving 2 doses of study drug were considered evaluable for DLT determination.

Groups in this outcome

Cabiralizumab 2 mg/kg Q2W

Participants received 2 mg/kg cabiralizumab administered intravenously (IV) once every 2 weeks (Q2W).

Cabiralizumab 4 mg/kg Q2W

Participants received 4 mg/kg cabiralizumab IV Q2W

Cabiralizumab 6 mg/kg Q2W

Participants received 6 mg/kg cabiralizumab IV Q2W.

Cabiralizumab 1 mg/kg + Nivolumab 3 mg/kg Q2W

Participants received 1 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W.

Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W

Participants received 2 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W.

Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W

Participants received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W.

Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W

Participants received 6 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W.

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

Analysis denominator · Participants

GroupSource count
Cabiralizumab 2 mg/kg Q2W3
Cabiralizumab 4 mg/kg Q2W10
Cabiralizumab 6 mg/kg Q2W11
Cabiralizumab 1 mg/kg + Nivolumab 3 mg/kg Q2W4
Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W3
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W3
Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W6

Reported measurements

Grade 3 CK increase
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cabiralizumab 2 mg/kg Q2W0Not reportedNot reportedNot reportedNot reported
Cabiralizumab 4 mg/kg Q2W0Not reportedNot reportedNot reportedNot reported
Cabiralizumab 6 mg/kg Q2W1Not reportedNot reportedNot reportedNot reported
Cabiralizumab 1 mg/kg + Nivolumab 3 mg/kg Q2W0Not reportedNot reportedNot reportedNot reported
Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W0Not reportedNot reportedNot reportedNot reported
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W0Not reportedNot reportedNot reportedNot reported
Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W0Not reportedNot reportedNot reportedNot reported
Grade 3 AST increase
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cabiralizumab 2 mg/kg Q2W0Not reportedNot reportedNot reportedNot reported
Cabiralizumab 4 mg/kg Q2W2Not reportedNot reportedNot reportedNot reported
Cabiralizumab 6 mg/kg Q2W1Not reportedNot reportedNot reportedNot reported
Cabiralizumab 1 mg/kg + Nivolumab 3 mg/kg Q2W0Not reportedNot reportedNot reportedNot reported
Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W0Not reportedNot reportedNot reportedNot reported
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W0Not reportedNot reportedNot reportedNot reported
Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
    title
    Grade 3 CK increase
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
    title
    Grade 3 AST increase
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      11
    4. group Id
      OG003
      value
      4
    5. group Id
      OG004
      value
      3
    6. group Id
      OG005
      value
      3
    7. group Id
      OG006
      value
      6
    units
    Participants
description
A DLT was defined as a study drug-related ≥ Grade 3 AE (using National Cancer Institute Common Terminology Criteria for Adverse Events v 4.03) occurring during the first 28-days, excluding Grade 3 tumor flare (defined as local pain, irritation, or rash localized at sites of known or suspected tumor), rash, immune-related adverse event (irAE) that resolved to ≤ Grade 1 by 14 days or a transient (resolving within 6 hours of onset) Grade 3 infusion-related AE. Any recurrence of Grade 3 rash, irAE or infusion-related AE was considered a DLT. The protocol was amended such that in the absence of clinical symptoms and other accompanying changes in bilirubin or alanine aminotransferase (ALT), serum elevation of aspartate aminotransferase (AST)/ALT \> 12 × upper limit of normal (ULN) and ≤ 20 × ULN that lasted for \< 7 days and serum elevation of creatine kinase (CK) and/or lactate dehydrogenase (LDH) \> 15 × ULN and ≤ 20 × ULN that lasted for \< 7 days were not considered DLTs.
groups
  1. description
    Participants received 2 mg/kg cabiralizumab administered intravenously (IV) once every 2 weeks (Q2W).
    id
    OG000
    title
    Cabiralizumab 2 mg/kg Q2W
  2. description
    Participants received 4 mg/kg cabiralizumab IV Q2W
    id
    OG001
    title
    Cabiralizumab 4 mg/kg Q2W
  3. description
    Participants received 6 mg/kg cabiralizumab IV Q2W.
    id
    OG002
    title
    Cabiralizumab 6 mg/kg Q2W
  4. description
    Participants received 1 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W.
    id
    OG003
    title
    Cabiralizumab 1 mg/kg + Nivolumab 3 mg/kg Q2W
  5. description
    Participants received 2 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W.
    id
    OG004
    title
    Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W
  6. description
    Participants received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W.
    id
    OG005
    title
    Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W
  7. description
    Participants received 6 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W.
    id
    OG006
    title
    Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W
param Type
COUNT_OF_PARTICIPANTS
population Description
Participants enrolled in the dose escalation phase who received at least 2 doses of study drug during the 28-day evaluation interval or who discontinued study treatment for drug-related adverse events before receiving 2 doses of study drug were considered evaluable for DLT determination.
reporting Status
POSTED
time Frame
28 days
title
Safety: Number of Participants With Grade 3 or Grade 4 Adverse Events (AEs) and Laboratory Abnormalities Defined as Dose Limiting Toxicities (DLT) (Phase 1a)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice