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NCT03989115 · OUTCOME

Overall Response Rate (ORR)

Dose-Esc/Exp RMC4630 & Cobi in Relapsed/Refractory Solid Tumors & RMC4630& Osi in EGFR+ Locally Adv/Meta NSCLC · Source last updated 2023-06-26

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

Measure
NUMBER
Unit
% of participants
Interval / dispersion
95% Confidence Interval
Time frame
Response assessment occurs from the start of intervention until the date of documented disease progression per RECIST 1.1 or the date of subsequent therapy, whichever occurs first.

What was measured

ORR is defined as the proportion of participants who achieve a CR or PR per RECIST v1.1. ORR and the corresponding 95% two-sided confidence interval were derived.

Groups in this outcome

Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 20mg QD (21/7)

Participants who received intermittent dose of RMC-4630 80 mg on D1 and D4 of a 28-day cycle and Cobimetinib 20 mg QD 21days on and 7 days off of a 28-day cycle.

Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 40mg QD (21/7)

Participants who received intermittent dose of RMC-4630 80mg on D1 and D4 of a 28-day cycle and Cobimetinib 40mg QD 21days on and 7 days off of a 28-day cycle.

Intermittent RMC-4630 140mg (D1D4) + Cobimetinib 20mg QD (21/7)

Participants who received intermittent dose of RMC-4630 140 mg on D1 and D4 of a 28-day cycle and Cobimetinib 20mg QD 21days on and 7 days off of a 28-day cycle.

Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 20mg QD (21/7)

Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and Cobimetinib 20mg QD 21days on and 7 days off of a 28-day cycle.

Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 40mg (D1D2)

Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and Cobimetinib 40mg D1 and D2 of a 28-day cycle.

Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 60mg D1D2

Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and Cobimetinib 60mg D1 and D2 of a 28-day cycle.

Intermittent RMC-4630 100mg (D1D2) + Osimertinib 80mg (QD)

Participants who received intermittent dose of RMC-4630 100 mg on D1 and D2 of a 28-day cycle and daily dose of Osimertinib 80 mg from D1 through D28 of a 28-day cycle.

Intermittent RMC-4630 140mg (D1D2) + Osimertinib 80mg (QD)

Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and daily dose of Osimertinib 80 mg from D1 through D28 of a 28-day cycle.

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

Analysis denominator · Participants

GroupSource count
Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 20mg QD (21/7)6
Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 40mg QD (21/7)6
Intermittent RMC-4630 140mg (D1D4) + Cobimetinib 20mg QD (21/7)8
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 20mg QD (21/7)6
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 40mg (D1D2)55
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 60mg D1D26
Intermittent RMC-4630 100mg (D1D2) + Osimertinib 80mg (QD)3
Intermittent RMC-4630 140mg (D1D2) + Osimertinib 80mg (QD)3

Reported measurements

Source class 1
Values in % of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 20mg QD (21/7)0Not reported0.045.9Not reported
Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 40mg QD (21/7)0Not reported0.045.9Not reported
Intermittent RMC-4630 140mg (D1D4) + Cobimetinib 20mg QD (21/7)0Not reported0.036.9Not reported
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 20mg QD (21/7)0Not reported0.045.9Not reported
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 40mg (D1D2)1.82Not reported0.09.7Not reported
Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 60mg D1D20Not reported0.045.9Not reported
Intermittent RMC-4630 100mg (D1D2) + Osimertinib 80mg (QD)0Not reported0.07.1Not reported
Intermittent RMC-4630 140mg (D1D2) + Osimertinib 80mg (QD)0Not reported0.07.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        45.9
        value
        0
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        45.9
        value
        0
      3. group Id
        OG002
        lower Limit
        0.0
        upper Limit
        36.9
        value
        0
      4. group Id
        OG003
        lower Limit
        0.0
        upper Limit
        45.9
        value
        0
      5. group Id
        OG004
        lower Limit
        0.0
        upper Limit
        9.7
        value
        1.82
      6. group Id
        OG005
        lower Limit
        0.0
        upper Limit
        45.9
        value
        0
      7. group Id
        OG006
        lower Limit
        0.0
        upper Limit
        7.1
        value
        0
      8. group Id
        OG007
        lower Limit
        0.0
        upper Limit
        7.1
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      8
    4. group Id
      OG003
      value
      6
    5. group Id
      OG004
      value
      55
    6. group Id
      OG005
      value
      6
    7. group Id
      OG006
      value
      3
    8. group Id
      OG007
      value
      3
    units
    Participants
description
ORR is defined as the proportion of participants who achieve a CR or PR per RECIST v1.1. ORR and the corresponding 95% two-sided confidence interval were derived.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants who received intermittent dose of RMC-4630 80 mg on D1 and D4 of a 28-day cycle and Cobimetinib 20 mg QD 21days on and 7 days off of a 28-day cycle.
    id
    OG000
    title
    Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 20mg QD (21/7)
  2. description
    Participants who received intermittent dose of RMC-4630 80mg on D1 and D4 of a 28-day cycle and Cobimetinib 40mg QD 21days on and 7 days off of a 28-day cycle.
    id
    OG001
    title
    Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 40mg QD (21/7)
  3. description
    Participants who received intermittent dose of RMC-4630 140 mg on D1 and D4 of a 28-day cycle and Cobimetinib 20mg QD 21days on and 7 days off of a 28-day cycle.
    id
    OG002
    title
    Intermittent RMC-4630 140mg (D1D4) + Cobimetinib 20mg QD (21/7)
  4. description
    Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and Cobimetinib 20mg QD 21days on and 7 days off of a 28-day cycle.
    id
    OG003
    title
    Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 20mg QD (21/7)
  5. description
    Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and Cobimetinib 40mg D1 and D2 of a 28-day cycle.
    id
    OG004
    title
    Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 40mg (D1D2)
  6. description
    Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and Cobimetinib 60mg D1 and D2 of a 28-day cycle.
    id
    OG005
    title
    Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 60mg D1D2
  7. description
    Participants who received intermittent dose of RMC-4630 100 mg on D1 and D2 of a 28-day cycle and daily dose of Osimertinib 80 mg from D1 through D28 of a 28-day cycle.
    id
    OG006
    title
    Intermittent RMC-4630 100mg (D1D2) + Osimertinib 80mg (QD)
  8. description
    Participants who received intermittent dose of RMC-4630 140 mg on D1 and D2 of a 28-day cycle and daily dose of Osimertinib 80 mg from D1 through D28 of a 28-day cycle.
    id
    OG007
    title
    Intermittent RMC-4630 140mg (D1D2) + Osimertinib 80mg (QD)
param Type
NUMBER
reporting Status
POSTED
time Frame
Response assessment occurs from the start of intervention until the date of documented disease progression per RECIST 1.1 or the date of subsequent therapy, whichever occurs first.
title
Overall Response Rate (ORR)
type
SECONDARY
unit Of Measure
% of participants

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

Preserved source evidence · Not medical advice