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← KEYTRUDA QLEX: recurrent Endometrial Carcinoma

NCT02142803 · STUDY IN CONTEXT

TORC1/2 Inhibitor MLN0128 and Bevacizumab in Treating Patients With Recurrent Glioblastoma or Advanced Solid Tumors

Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (R2PD) of TORC1/2 inhibitor MLN0128, determined according to incidence of dose-limiting toxicity, as graded using the National Cancer Institute (NCI) CTCAE version 4.0

Source null

→

primary · POSTED

Most common related toxicities that led to dose hold/reductions (AEs graded according to NCI CTCAE version 4.0). Safety assessed through summaries of adverse events, changes in selected laboratory test results, changes in vital signs, and TORC1/2 inhibitor MLN0128 and bevacizumab exposure.

AEs on the study are reported by dose level.

→

secondary · POSTED

Progression is defined as follows: 1. Non-GBM Solid Tumors (Endometrial \& Ovarian Cancers) - using Response Evaluation Criteria In Solid Tumors Criteria (RECIST) guideline (v.1.1): * Target Lesions: \>/= 20% increase in the sum of the longest diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. * Non-Target Lesions: The appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. 2. GBM - Using the Response Assessment in Neuro-Oncology (RANO) criteria, any of the criteria below qualify for progression: * \>/= 25% increase in sum of the products of perpendicular diameters of enhancing lesions on stable/increasing dose of corticosteroids * Significant increase in T2/FLAIR non-enhancing lesion on stable/increasing dose of corticosteroids * Any new lesion * Clear clinical deterioration not attributable to other cause

* Given the limited sample sizes for Dose Levels 1 \& 2 (3 patients each), the #s presented here may not be statistically valid. * Censoring \& Final PFS #s: 9 patients treated @ Dose Level 3 were censored from PFS analysis for initiation of new therapy or withdrawal of consent. 2 additional patients treated at Dose Level 3 were censored from PFS analysis because they never had a useable scan on study.

→

secondary · POSTED

Objective Response Rate (ORR), defined as a Complete Response (CR) or Partial Response (PR) utilizing: 1. RECIST criteria v.1.1 (Endometrial \& Ovarian Cancers): * CR: Disappearance of all target \& non-target lesions (+ normalization of tumor marker level) * PR: \>/= 30% decrease in sum of the longest diameters of target lesions (from baseline) \& no new lesions 2. RANO criteria (GBM patients): * CR: * Disappearance of all enhancing measurable \& non-measurable disease (sustained \>/= 4 wks) * No new lesions * No steroids (physiologic replacement doses only) * Stable or improved non-enhancing lesions * Clinically stable or improved * PR: * \>/= 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions (sustained \>/= 4 wks) * No progression of non-measurable disease * No new lesions * Steroid \</= dose at time of baseline scan * Stable or improved non-enhancing lesions * Clinically stable or improved

Source null

→

secondary · POSTED

Overall Survival (OS) listed for all patients by dose level.

* Given the limited sample sizes for Dose Levels 1 \& 2 (3 \& 2 patients respectively), the #s presented here may not be statistically valid. * Censoring \& Final OS #s: 1 patient treated at Dose Level 2 and 6 patients treated at Dose Level 3 were censored from OS analysis for withdrawal of consent or lost to follow-up, and were not followed for survival to their death.

→

secondary · POSTED

Number of Participants with Toxicities Leading to Missed Doses or Delays

Source null

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

FACT · Change in Circulating Plasma Levels of Angiogenic Growth Factors in Patients With Ovarian and Endometrial Cancers

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02142803
qol key
qol-0011
source section id
NCT02142803-om-0011
source outcome index
11
instrument
FACT
instrument basis
matched 'factors' in the study's own wording
scale title
Change in Circulating Plasma Levels of Angiogenic Growth Factors in Patients With Ovarian and Endometrial Cancers
measure definition
Source null
time frame
Baseline to day 1 of last course of treatment
analysis role
exploratory
reporting status
NOT_POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT02142803
trial label
TORC1/2 Inhibitor MLN0128 and Bevacizumab in Treating Patients With Recurrent Glioblastoma or Advanced Solid Tumors
applicability
unclear
applicability note
Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
6
harms Count
3
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT02142803
    outcome key
    om-0000
    source section id
    NCT02142803-om-0000
    source outcome index
    0
    endpoint
    Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (R2PD) of Daily Oral MLN0128 When Administered With Bevacizumab
    endpoint definition
    Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (R2PD) of TORC1/2 inhibitor MLN0128, determined according to incidence of dose-limiting toxicity, as graded using the National Cancer Institute (NCI) CTCAE version 4.0
    time origin
    28 days
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT02142803
    outcome key
    om-0001
    source section id
    NCT02142803-om-0001
    source outcome index
    1
    endpoint
    Most Common Related Toxicities That Led to Dose Hold/Reductions
    endpoint definition
    Most common related toxicities that led to dose hold/reductions (AEs graded according to NCI CTCAE version 4.0). Safety assessed through summaries of adverse events, changes in selected laboratory test results, changes in vital signs, and TORC1/2 inhibitor MLN0128 and bevacizumab exposure.
    time origin
    Up to 2 years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    AEs on the study are reported by dose level.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT02142803
    outcome key
    om-0002
    source section id
    NCT02142803-om-0002
    source outcome index
    2
    endpoint
    Progression-free Survival (PFS)
    endpoint definition
    Progression is defined as follows: 1. Non-GBM Solid Tumors (Endometrial \& Ovarian Cancers) - using Response Evaluation Criteria In Solid Tumors Criteria (RECIST) guideline (v.1.1): * Target Lesions: \>/= 20% increase in the sum of the longest diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. * Non-Target Lesions: The appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. 2. GBM - Using the Response Assessment in Neuro-Oncology (RANO) criteria, any of the criteria below qualify for progression: * \>/= 25% increase in sum of the products of perpendicular diameters of enhancing lesions on stable/increasing dose of corticosteroids * Significant increase in T2/FLAIR non-enhancing lesion on stable/increasing dose of corticosteroids * Any new lesion * Clear clinical deterioration not attributable to other cause
    time origin
    Up to 2 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    * Given the limited sample sizes for Dose Levels 1 \& 2 (3 patients each), the #s presented here may not be statistically valid. * Censoring \& Final PFS #s: 9 patients treated @ Dose Level 3 were censored from PFS analysis for initiation of new therapy or withdrawal of consent. 2 additional patients treated at Dose Level 3 were censored from PFS analysis because they never had a useable scan on study.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT02142803
    outcome key
    om-0003
    source section id
    NCT02142803-om-0003
    source outcome index
    3
    endpoint
    Objective Response Rate (ORR)
    endpoint definition
    Objective Response Rate (ORR), defined as a Complete Response (CR) or Partial Response (PR) utilizing: 1. RECIST criteria v.1.1 (Endometrial \& Ovarian Cancers): * CR: Disappearance of all target \& non-target lesions (+ normalization of tumor marker level) * PR: \>/= 30% decrease in sum of the longest diameters of target lesions (from baseline) \& no new lesions 2. RANO criteria (GBM patients): * CR: * Disappearance of all enhancing measurable \& non-measurable disease (sustained \>/= 4 wks) * No new lesions * No steroids (physiologic replacement doses only) * Stable or improved non-enhancing lesions * Clinically stable or improved * PR: * \>/= 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions (sustained \>/= 4 wks) * No progression of non-measurable disease * No new lesions * Steroid \</= dose at time of baseline scan * Stable or improved non-enhancing lesions * Clinically stable or improved
    time origin
    Up to 2 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT02142803
    outcome key
    om-0004
    source section id
    NCT02142803-om-0004
    source outcome index
    4
    endpoint
    Overall Survival (OS)
    endpoint definition
    Overall Survival (OS) listed for all patients by dose level.
    time origin
    Up to 4 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    * Given the limited sample sizes for Dose Levels 1 \& 2 (3 \& 2 patients respectively), the #s presented here may not be statistically valid. * Censoring \& Final OS #s: 1 patient treated at Dose Level 2 and 6 patients treated at Dose Level 3 were censored from OS analysis for withdrawal of consent or lost to follow-up, and were not followed for survival to their death.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT02142803
    outcome key
    om-0005
    source section id
    NCT02142803-om-0005
    source outcome index
    5
    endpoint
    Number of Participants With Toxicities Leading to Missed Doses or Delays
    endpoint definition
    Number of Participants with Toxicities Leading to Missed Doses or Delays
    time origin
    Up to 2 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT02142803
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Stage 1: Dose Escalation to Estimate MTD/RP2D
    regimen
    Participants enrolled onto Stage 1 - Dose escalation to estimate MTD/RP2D
    analyzed count
    12
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02142803-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT02142803
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Dose Level 1 - 3 mg MLN0128 Daily
    regimen
    Stage 1 - Dose Level 1 participants: * 3 mg MLN0128 daily * \+ 10 mg/kg bevacizumab every 2 weeks
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02142803-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT02142803
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Dose Level 2 - 4 mg MLN0128 Daily
    regimen
    Stage 1 - Dose Level 2 participants: * 4 mg MLN0128 daily * \+ 10 mg/kg bevacizumab every 2 weeks
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02142803-om-0001#groups/OG001
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT02142803
    outcome key
    om-0001
    arm key
    OG002
    arm label
    Dose Level 3 - 5 mg MLN0128 Daily
    regimen
    Inclusive of both Stage 1 - Dose Level 3 participants and Stage 2 participants treated at the MTD: * 5 mg MLN0128 daily * \+ 10 mg/kg bevacizumab every 2 weeks
    analyzed count
    43
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02142803-om-0001#groups/OG002
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT02142803
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Dose Level 1
    regimen
    3 mg/day MLN0128
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02142803-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT02142803
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Dose Level 2
    regimen
    4 mg/day MLN0128
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02142803-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT02142803
    outcome key
    om-0002
    arm key
    OG002
    arm label
    Dose Level 3 (MTD)
    regimen
    5 mg/day MLN0128
    analyzed count
    33
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02142803-om-0002#groups/OG002
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT02142803
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Dose Level 1
    regimen
    3 mg MLN0128 Daily
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02142803-om-0003#groups/OG000
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT02142803
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Dose Level 2
    regimen
    4 mg MLN0128 Daily
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02142803-om-0003#groups/OG001
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT02142803
    outcome key
    om-0003
    arm key
    OG002
    arm label
    Dose Level 3 (MTD)
    regimen
    5 mg MLN0128 Daily
    analyzed count
    43
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02142803-om-0003#groups/OG002
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT02142803
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Dose Level 1
    regimen
    3 mg/day MLN0128
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02142803-om-0004#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT02142803
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Dose Level 2
    regimen
    4 mg/day MLN0128
    analyzed count
    2
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02142803-om-0004#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT02142803
    harm key
    EG000
    source section id
    NCT02142803-ae
    event group key
    EG000
    event group label
    Dose Level 1 - 3 mg MLN0128 Daily
    serious affected
    0
    serious at risk
    3
    other affected
    3
    other at risk
    3
    frequency threshold
    5
    collection period
    Up to 2 years
    event definition
    Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT02142803
    harm key
    EG001
    source section id
    NCT02142803-ae
    event group key
    EG001
    event group label
    Dose Level 2 - 4 mg MLN0128 Daily
    serious affected
    0
    serious at risk
    3
    other affected
    3
    other at risk
    3
    frequency threshold
    5
    collection period
    Up to 2 years
    event definition
    Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT02142803
    harm key
    EG002
    source section id
    NCT02142803-ae
    event group key
    EG002
    event group label
    Dose Level 3 - 5 mg MLN0128 Daily
    serious affected
    19
    serious at risk
    43
    other affected
    43
    other at risk
    43
    frequency threshold
    5
    collection period
    Up to 2 years
    event definition
    Adverse Events monitored/assessed up to 2 years and All-Cause Mortality was monitored until death, withdrawal of consent, or lost-to-follow-up (maximum # of days a patient was on study was 1443 days).
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-1191efca
    nct id
    NCT02142803
    qol key
    qol-0011
    source section id
    NCT02142803-om-0011
    source outcome index
    11
    instrument
    FACT
    instrument basis
    matched 'factors' in the study's own wording
    scale title
    Change in Circulating Plasma Levels of Angiogenic Growth Factors in Patients With Ovarian and Endometrial Cancers
    measure definition
    Source null
    time frame
    Baseline to day 1 of last course of treatment
    analysis role
    exploratory
    reporting status
    NOT_POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice