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NCT04148937 · OUTCOME

Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR)

A Study of the CD73 Inhibitor LY3475070 Alone or in Combination With Pembrolizumab in Participants With Advanced Cancer · Source last updated 2024-04-05

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
Baseline through Disease Progression or Death (Estimated at up to 10.4 Months)

What was measured

ORR is the best overall tumor response of complete response (CR) or partial response (PR) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.

Analysis population: All enrolled participants in phase1a who received at least one dose of LY3475070.

Groups in this outcome

Cohort A - 150mg QD LY3475070

Participants received 150mg LY3475070 orally once daily on a 21-day cycle until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.

Cohort A - 300mg QD LY3475070

Participants received 300mg LY3475070 orally once daily on a 21-day cycle until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.

Cohort A - 300mg BID LY3475070

Participants received 300mg LY3475070 orally twice daily on a 21-day cycle until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.

Cohort A - 600mg QD LY3475070

Participants received 600mg LY3475070 orally once daily on a 21-day cycle until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.

Cohort B - 150mg QD LY3475070 + Pembrolizumab

Participants received 150mg LY3475070 orally once daily on a 21-day cycle in combination with an intravenous infusion of 200mg pembrolizumab on day 1 until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.

Cohort B - 150mg BID LY3475070 + Pembrolizumab

Participants received 150mg LY3475070 orally twice daily on a 21-day cycle in combination with an intravenous infusion of 200mg pembrolizumab on day 1 until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.

Cohort B - 300mg QD LY3475070 + Pembrolizumab

Participants received 300mg LY3475070 orally once daily on a 21-day cycle in combination with an intravenous infusion of 200mg pembrolizumab on day 1 until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.

Cohort B - 300mg BID LY3475070 + Pembrolizumab

Participants received 300mg LY3475070 orally twice daily on a 21-day cycle in combination with an intravenous infusion of 200mg pembrolizumab on day 1 until progressive disease, unacceptable toxicity or other criterion for study

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

Analysis denominator · Participants

GroupSource count
Cohort A - 150mg QD LY34750704
Cohort A - 300mg QD LY34750706
Cohort A - 300mg BID LY34750706
Cohort A - 600mg QD LY34750704
Cohort B - 150mg QD LY3475070 + Pembrolizumab3
Cohort B - 150mg BID LY3475070 + Pembrolizumab11
Cohort B - 300mg QD LY3475070 + Pembrolizumab1
Cohort B - 300mg BID LY3475070 + Pembrolizumab17

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A - 150mg QD LY34750700Not reportedNot reportedNot reportedNot reported
Cohort A - 300mg QD LY34750700Not reportedNot reportedNot reportedNot reported
Cohort A - 300mg BID LY34750700Not reportedNot reportedNot reportedNot reported
Cohort A - 600mg QD LY34750700Not reportedNot reportedNot reportedNot reported
Cohort B - 150mg QD LY3475070 + Pembrolizumab0Not reportedNot reportedNot reportedNot reported
Cohort B - 150mg BID LY3475070 + Pembrolizumab0Not reportedNot reportedNot reportedNot reported
Cohort B - 300mg QD LY3475070 + Pembrolizumab0Not reportedNot reportedNot reportedNot reported
Cohort B - 300mg BID LY3475070 + Pembrolizumab0Not 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
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      4
    5. group Id
      OG004
      value
      3
    6. group Id
      OG005
      value
      11
    7. group Id
      OG006
      value
      1
    8. group Id
      OG007
      value
      17
    units
    Participants
description
ORR is the best overall tumor response of complete response (CR) or partial response (PR) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.
groups
  1. description
    Participants received 150mg LY3475070 orally once daily on a 21-day cycle until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.
    id
    OG000
    title
    Cohort A - 150mg QD LY3475070
  2. description
    Participants received 300mg LY3475070 orally once daily on a 21-day cycle until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.
    id
    OG001
    title
    Cohort A - 300mg QD LY3475070
  3. description
    Participants received 300mg LY3475070 orally twice daily on a 21-day cycle until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.
    id
    OG002
    title
    Cohort A - 300mg BID LY3475070
  4. description
    Participants received 600mg LY3475070 orally once daily on a 21-day cycle until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.
    id
    OG003
    title
    Cohort A - 600mg QD LY3475070
  5. description
    Participants received 150mg LY3475070 orally once daily on a 21-day cycle in combination with an intravenous infusion of 200mg pembrolizumab on day 1 until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.
    id
    OG004
    title
    Cohort B - 150mg QD LY3475070 + Pembrolizumab
  6. description
    Participants received 150mg LY3475070 orally twice daily on a 21-day cycle in combination with an intravenous infusion of 200mg pembrolizumab on day 1 until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.
    id
    OG005
    title
    Cohort B - 150mg BID LY3475070 + Pembrolizumab
  7. description
    Participants received 300mg LY3475070 orally once daily on a 21-day cycle in combination with an intravenous infusion of 200mg pembrolizumab on day 1 until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.
    id
    OG006
    title
    Cohort B - 300mg QD LY3475070 + Pembrolizumab
  8. description
    Participants received 300mg LY3475070 orally twice daily on a 21-day cycle in combination with an intravenous infusion of 200mg pembrolizumab on day 1 until progressive disease, unacceptable toxicity or other criterion for study
    id
    OG007
    title
    Cohort B - 300mg BID LY3475070 + Pembrolizumab
param Type
NUMBER
population Description
All enrolled participants in phase1a who received at least one dose of LY3475070.
reporting Status
POSTED
time Frame
Baseline through Disease Progression or Death (Estimated at up to 10.4 Months)
title
Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR)
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice