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NCT05256381 · OUTCOME

Percentage of Patients With Clinical Benefit Rate According to iRECIST

A Study of SOT101 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety in Patients With Selected Advanced Solid Tumors · Source last updated 2025-11-17

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
95% Confidence Interval
Time frame
Day 1 up to approximately 2 years and 2 months

Groups in this outcome

Non-small Cell Lung Cancer

Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment

Colorectal Cancer

Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic

Cutaneous Squamous Cell Carcinoma

Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible

Hepatocellular Carcinoma

Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)

Metastatic Castration-resistant Prostate Cancer

Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent

Ovarian Cancer

Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months

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

Analysis denominator · Participants

GroupSource count
Non-small Cell Lung Cancer39
Colorectal Cancer6
Cutaneous Squamous Cell Carcinoma11
Hepatocellular Carcinoma11
Metastatic Castration-resistant Prostate Cancer40
Ovarian Cancer35

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Non-small Cell Lung Cancer46.2Not reported30.162.8Not reported
Colorectal Cancer83.3Not reported35.999.6Not reported
Cutaneous Squamous Cell Carcinoma54.5Not reported23.483.3Not reported
Hepatocellular Carcinoma45.5Not reported16.776.6Not reported
Metastatic Castration-resistant Prostate Cancer50.0Not reported33.866.2Not reported
Ovarian Cancer22.9Not reported10.440.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        30.1
        upper Limit
        62.8
        value
        46.2
      2. group Id
        OG001
        lower Limit
        35.9
        upper Limit
        99.6
        value
        83.3
      3. group Id
        OG002
        lower Limit
        23.4
        upper Limit
        83.3
        value
        54.5
      4. group Id
        OG003
        lower Limit
        16.7
        upper Limit
        76.6
        value
        45.5
      5. group Id
        OG004
        lower Limit
        33.8
        upper Limit
        66.2
        value
        50.0
      6. group Id
        OG005
        lower Limit
        10.4
        upper Limit
        40.1
        value
        22.9
denoms
  1. counts
    1. group Id
      OG000
      value
      39
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      11
    4. group Id
      OG003
      value
      11
    5. group Id
      OG004
      value
      40
    6. group Id
      OG005
      value
      35
    units
    Participants
dispersion Type
95% Confidence Interval
groups
  1. description
    Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
    id
    OG000
    title
    Non-small Cell Lung Cancer
  2. description
    Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
    id
    OG001
    title
    Colorectal Cancer
  3. description
    Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
    id
    OG002
    title
    Cutaneous Squamous Cell Carcinoma
  4. description
    Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)
    id
    OG003
    title
    Hepatocellular Carcinoma
  5. description
    Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent
    id
    OG004
    title
    Metastatic Castration-resistant Prostate Cancer
  6. description
    Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months
    id
    OG005
    title
    Ovarian Cancer
param Type
NUMBER
reporting Status
POSTED
time Frame
Day 1 up to approximately 2 years and 2 months
title
Percentage of Patients With Clinical Benefit Rate According to iRECIST
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice