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NCT02280811 · OUTCOME

Objective Tumor Response Rate (Complete or Partial Response)

T Cell Receptor Immunotherapy Targeting HPV-16 E6 for HPV-Associated Cancers · Source last updated 2017-09-06

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
4 years

What was measured

Objective tumor response rate is defined as the number of participants with a complete or partial response per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.

Groups in this outcome

HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin Fludarabine: Patients will receive Fludarabine 25 mg/m\^2/day for 5 days. Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine) Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin Fludarabine: Patients will receive Fludarabine 25 mg/m\^2/day for 5 days. Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine) Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin Fludarabine: Patients will receive Fludarabine 25 mg/m\^2/day for 5 days. Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine) Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin Fludarabine: Patients will receive Fludarabine 25 mg/m\^2/day for 5 days. Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine) Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

HPV-16 E6 mTCR PBL MTD + HD IL-2

patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin Fludarabine: Patients will receive Fludarabine 25 mg/m\^2/day for 5 days. Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine) Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

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

Analysis denominator · Participants

GroupSource count
HPV-16 E6 mTCR PBL 1x10^9 + HD IL-21
HPV-16 E6 mTCR PBL 1x10^10 + HD IL-22
HPV-16 E6 mTCR PBL 1x10^11 + HD IL-21
HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-26
HPV-16 E6 mTCR PBL MTD + HD IL-22

Reported measurements

Complete Response (CR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HPV-16 E6 mTCR PBL 1x10^9 + HD IL-20Not reportedNot reportedNot reportedNot reported
HPV-16 E6 mTCR PBL 1x10^10 + HD IL-20Not reportedNot reportedNot reportedNot reported
HPV-16 E6 mTCR PBL 1x10^11 + HD IL-20Not reportedNot reportedNot reportedNot reported
HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-20Not reportedNot reportedNot reportedNot reported
HPV-16 E6 mTCR PBL MTD + HD IL-20Not reportedNot reportedNot reportedNot reported
Partial Response (PR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HPV-16 E6 mTCR PBL 1x10^9 + HD IL-20Not reportedNot reportedNot reportedNot reported
HPV-16 E6 mTCR PBL 1x10^10 + HD IL-20Not reportedNot reportedNot reportedNot reported
HPV-16 E6 mTCR PBL 1x10^11 + HD IL-20Not reportedNot reportedNot reportedNot reported
HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-22Not reportedNot reportedNot reportedNot reported
HPV-16 E6 mTCR PBL MTD + HD IL-20Not 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
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
    title
    Complete Response (CR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        0
    title
    Partial Response (PR)
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      1
    4. group Id
      OG003
      value
      6
    5. group Id
      OG004
      value
      2
    units
    Participants
description
Objective tumor response rate is defined as the number of participants with a complete or partial response per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
groups
  1. description
    patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin Fludarabine: Patients will receive Fludarabine 25 mg/m\^2/day for 5 days. Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine) Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
    id
    OG000
    title
    HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2
  2. description
    patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin Fludarabine: Patients will receive Fludarabine 25 mg/m\^2/day for 5 days. Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine) Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
    id
    OG001
    title
    HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2
  3. description
    patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin Fludarabine: Patients will receive Fludarabine 25 mg/m\^2/day for 5 days. Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine) Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
    id
    OG002
    title
    HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2
  4. description
    patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin Fludarabine: Patients will receive Fludarabine 25 mg/m\^2/day for 5 days. Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine) Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
    id
    OG003
    title
    HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2
  5. description
    patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin Fludarabine: Patients will receive Fludarabine 25 mg/m\^2/day for 5 days. Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine) Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
    id
    OG004
    title
    HPV-16 E6 mTCR PBL MTD + HD IL-2
param Type
NUMBER
reporting Status
POSTED
time Frame
4 years
title
Objective Tumor Response Rate (Complete or Partial Response)
type
PRIMARY
unit Of Measure
participants

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Preserved source evidence · Not medical advice