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NCT02988817 · OUTCOME

Number of Participants With Best Cancer Antigen 125 (CA-125) Response

Enapotamab Vedotin (HuMax-AXL-ADC) Safety Study in Patients With Solid Tumors · Source last updated 2023-08-01

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
From Screening (within 2 weeks before starting of the study treatment) through Day 1130 (maximum observed duration)

What was measured

The best CA-125 response was evaluated in participants with ovarian cancer. A CA-125 partial response was defined as at least a 50% reduction in CA-125 levels in blood from a pretreatment sample. Participants who had a CA-125 partial response and had CA-125 level falls to within the reference range (0-35 units/mL) were classified as CA-125 complete responders. The response was confirmed and maintained for at least 28 days. The best overall response (CA-125 partial response and CA-125 complete response) is reported.

Analysis population: Participants from the full analysis set with ovarian cancer who had an initial CA-125 level of at least twice the upper limit of the reference range within 2 weeks before starting the study treatment were evaluated for this outcome measure.

Groups in this outcome

Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.

Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.

Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.

Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.

Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.

Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.

Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.

Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.

Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.

Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.

Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.

Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W

Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.

Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W

Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.

Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W

Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.

Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W

Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.

Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W

Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.

Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W

Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.

Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W

Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.

Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W

Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.

Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W

Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.

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

Analysis denominator · Participants

GroupSource count
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W0
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W1
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W0
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W1
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W3
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W3
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W1
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W1
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W0
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W2
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W2
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W0
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W0
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W0
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W0
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W0
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W19
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W0
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W0
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W0

Reported measurements

CA-125 partial response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W0Not reportedNot reportedNot reportedNot reported
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W0Not reportedNot reportedNot reportedNot reported
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W0Not reportedNot reportedNot reportedNot reported
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W0Not reportedNot reportedNot reportedNot reported
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W1Not reportedNot reportedNot reportedNot reported
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W0Not reportedNot reportedNot reportedNot reported
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W0Not reportedNot reportedNot reportedNot reported
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W0Not reportedNot reportedNot reportedNot reported
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W2Not reportedNot reportedNot reportedNot reported
CA-125 complete response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W0Not reportedNot reportedNot reportedNot reported
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W0Not reportedNot reportedNot reportedNot reported
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W0Not reportedNot reportedNot reportedNot reported
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W0Not reportedNot reportedNot reportedNot reported
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W0Not reportedNot reportedNot reportedNot reported
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W0Not reportedNot reportedNot reportedNot reported
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W0Not reportedNot reportedNot reportedNot reported
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W0Not reportedNot reportedNot reportedNot reported
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG001
        value
        0
      2. group Id
        OG003
        value
        0
      3. group Id
        OG004
        value
        0
      4. group Id
        OG005
        value
        0
      5. group Id
        OG006
        value
        1
      6. group Id
        OG007
        value
        0
      7. group Id
        OG009
        value
        0
      8. group Id
        OG010
        value
        0
      9. group Id
        OG016
        value
        2
    title
    CA-125 partial response
  2. categories
    1. measurements
      1. group Id
        OG001
        value
        0
      2. group Id
        OG003
        value
        0
      3. group Id
        OG004
        value
        0
      4. group Id
        OG005
        value
        0
      5. group Id
        OG006
        value
        0
      6. group Id
        OG007
        value
        0
      7. group Id
        OG009
        value
        0
      8. group Id
        OG010
        value
        0
      9. group Id
        OG016
        value
        0
    title
    CA-125 complete response
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      1
    5. group Id
      OG004
      value
      3
    6. group Id
      OG005
      value
      3
    7. group Id
      OG006
      value
      1
    8. group Id
      OG007
      value
      1
    9. group Id
      OG008
      value
      0
    10. group Id
      OG009
      value
      2
    11. group Id
      OG010
      value
      2
    12. group Id
      OG011
      value
      0
    units
    Participants
description
The best CA-125 response was evaluated in participants with ovarian cancer. A CA-125 partial response was defined as at least a 50% reduction in CA-125 levels in blood from a pretreatment sample. Participants who had a CA-125 partial response and had CA-125 level falls to within the reference range (0-35 units/mL) were classified as CA-125 complete responders. The response was confirmed and maintained for at least 28 days. The best overall response (CA-125 partial response and CA-125 complete response) is reported.
groups
  1. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
    id
    OG000
    title
    Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
  2. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
    id
    OG001
    title
    Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
  3. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
    id
    OG002
    title
    Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
  4. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
    id
    OG003
    title
    Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
  5. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
    id
    OG004
    title
    Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
  6. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
    id
    OG005
    title
    Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
  7. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
    id
    OG006
    title
    Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
  8. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
    id
    OG007
    title
    Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W
  9. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
    id
    OG008
    title
    Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W
  10. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
    id
    OG009
    title
    Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W
  11. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
    id
    OG010
    title
    Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W
  12. description
    Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
    id
    OG011
    title
    Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
param Type
COUNT_OF_PARTICIPANTS
population Description
Participants from the full analysis set with ovarian cancer who had an initial CA-125 level of at least twice the upper limit of the reference range within 2 weeks before starting the study treatment were evaluated for this outcome measure.
reporting Status
POSTED
time Frame
From Screening (within 2 weeks before starting of the study treatment) through Day 1130 (maximum observed duration)
title
Number of Participants With Best Cancer Antigen 125 (CA-125) Response
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice