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← KEYTRUDA QLEX: advanced Endometrial Carcinoma with MSI-H stated without a specific alteration, DMMR stated without a specific alteration after prior therapy

NCT05714553 · STUDY IN CONTEXT

NUC-3373 in Combination With Other Agents in Patients With Advanced Solid Tumours

Draft scope assessment: unclear. Attached because the study's own record names MSI-H. 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

The outcome measure presented is the number of DLTs per module

The safety population was used and consisted of all patients who received at least one dose of study treatment (n=13 in Module 1 and n=4 in Module 2).

→

secondary · POSTED

Objective response rate, defined as the percentage of patients achieving a complete (CR) or partial response (PR) to treatment. Response was measured by MRI scan and assessed per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria in Module 2 and by immune RECIST (iRECIST) criteria in Module 1: CR= disappearance of all target lesions PR= at least a 30% decrease in the sum of the longest diameter of target lesions

The evaluable for response population was used and included all patients with measurable disease at baseline who had undergone at least two cycles of treatment, received at least 75% of planned treatment over the two cycles, and undergone a post-treatment objective disease assessment.

→

secondary · POSTED

Disease control rate, defined as the number of patients achieving a response (CR or PR) or stable disease (SD) as their best overall response. Disease control was measured by MRI scan and assessed using Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria in Module 2 and immune RECIST (iRECIST) criteria in Module 1: CR= disappearance of all target lesions PR= at least a 30% decrease in the sum of the longest diameter of target lesions SD= neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease

Source null

→

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

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-81f4e658
nct id
NCT05714553
trial label
NUC-3373 in Combination With Other Agents in Patients With Advanced Solid Tumours
applicability
unclear
applicability note
Attached because the study's own record names MSI-H. 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
3
harms Count
2
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-81f4e658
    nct id
    NCT05714553
    outcome key
    om-0000
    source section id
    NCT05714553-om-0000
    source outcome index
    0
    endpoint
    Number of Participants With DLTs in Each Module
    endpoint definition
    The outcome measure presented is the number of DLTs per module
    time origin
    Assessed during Cycle 1 (first 28 days) in Module 1 and during Cycles 1 and 2 (first 56 days) in Module 2
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The safety population was used and consisted of all patients who received at least one dose of study treatment (n=13 in Module 1 and n=4 in Module 2).
    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-81f4e658
    nct id
    NCT05714553
    outcome key
    om-0001
    source section id
    NCT05714553-om-0001
    source outcome index
    1
    endpoint
    Number of Patients Achieving a Reduction in Tumour Volume (Objective Response Rate; ORR)
    endpoint definition
    Objective response rate, defined as the percentage of patients achieving a complete (CR) or partial response (PR) to treatment. Response was measured by MRI scan and assessed per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria in Module 2 and by immune RECIST (iRECIST) criteria in Module 1: CR= disappearance of all target lesions PR= at least a 30% decrease in the sum of the longest diameter of target lesions
    time origin
    Assessed from baseline to 30 days after last dose of study drug, up to 20 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The evaluable for response population was used and included all patients with measurable disease at baseline who had undergone at least two cycles of treatment, received at least 75% of planned treatment over the two cycles, and undergone a post-treatment objective disease assessment.
    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-81f4e658
    nct id
    NCT05714553
    outcome key
    om-0002
    source section id
    NCT05714553-om-0002
    source outcome index
    2
    endpoint
    Number of Patients Achieving a Reduction or Stabilisation in Tumor Volume (Disease Control Rate; DCR)
    endpoint definition
    Disease control rate, defined as the number of patients achieving a response (CR or PR) or stable disease (SD) as their best overall response. Disease control was measured by MRI scan and assessed using Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria in Module 2 and immune RECIST (iRECIST) criteria in Module 1: CR= disappearance of all target lesions PR= at least a 30% decrease in the sum of the longest diameter of target lesions SD= neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease
    time origin
    Assessed from baseline to 30 days after the last dose of study drug, up to 20 months
    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-81f4e658
    nct id
    NCT05714553
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Module 1 (NUC-3373 + LV + Pembrolizumab)
    regimen
    This Module is designed to evaluate the tolerability and the overall safety profile of NUC-3373 (1875 mg/m2) + LV (400 mg/m2) + pembrolizumab (200 mg) in the treatment of patients with advanced solid tumours (dose validation phase). NUC-3373 and LV will be administered on Days 1, 8 and 15 and pembrolizumab will be administered on Day 1 of 21-day cycles. The dosing schedule may be adjusted based on emerging data with agreement from the Safety Review Committee. Following completion of the dose validation phase, expansion cohorts may be initiated at the selected dose level.
    analyzed count
    13
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05714553-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-81f4e658
    nct id
    NCT05714553
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Module 2 (NUC-3373 + LV + Docetaxel)
    regimen
    This Module is designed to assess NUC-3373 (750 mg/m2) + LV (400 mg/m2) + docetaxel (55 mg/m2) for the treatment of patients with advanced/metastatic NSCLC or pleural mesothelioma who have progressed on, or were unable to tolerate, 1 or 2 prior lines of cytotoxic chemotherapy-containing regimens for advanced/metastatic disease (dose validation phase). NUC-3373 and LV will be administered on Days 1 and 22 and docetaxel will be administered on Day 8 of 28-day cycles. The dosing schedule may be adjusted based on emerging data with agreement from the Safety Review Committee. Following completion of the dose validation phase, expansion cohorts may be initiated at the selected dose level.
    analyzed count
    4
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05714553-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-81f4e658
    nct id
    NCT05714553
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Module 1 (NUC-3373 + LV + Pembrolizumab)
    regimen
    This Module is designed to evaluate the tolerability and the overall safety profile of NUC-3373 (1875 mg/m2) + LV (400 mg/m2) + pembrolizumab (200 mg) in the treatment of patients with advanced solid tumours (dose validation phase). NUC-3373 and LV will be administered on Days 1, 8 and 15 and pembrolizumab will be administered on Day 1 of 21-day cycles. The dosing schedule may be adjusted based on emerging data with agreement from the Safety Review Committee. Following completion of the dose validation phase, expansion cohorts may be initiated at the selected dose level.
    analyzed count
    9
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05714553-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-81f4e658
    nct id
    NCT05714553
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Module 2 (NUC-3373 + LV + Docetaxel)
    regimen
    This Module is designed to assess NUC-3373 (750 mg/m2) + LV (400 mg/m2) + docetaxel (55 mg/m2) for the treatment of patients with advanced/metastatic NSCLC or pleural mesothelioma who have progressed on, or were unable to tolerate, 1 or 2 prior lines of cytotoxic chemotherapy-containing regimens for advanced/metastatic disease (dose validation phase). NUC-3373 and LV will be administered on Days 1 and 22 and docetaxel will be administered on Day 8 of 28-day cycles. The dosing schedule may be adjusted based on emerging data with agreement from the Safety Review Committee. Following completion of the dose validation phase, expansion cohorts may be initiated at the selected dose level.
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05714553-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-81f4e658
    nct id
    NCT05714553
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Module 1 (NUC-3373 + LV + Pembrolizumab)
    regimen
    This Module is designed to evaluate the tolerability and the overall safety profile of NUC-3373 (1875 mg/m2) + LV (400 mg/m2) + pembrolizumab (200 mg) in the treatment of patients with advanced solid tumours (dose validation phase). NUC-3373 and LV will be administered on Days 1, 8 and 15 and pembrolizumab will be administered on Day 1 of 21-day cycles. The dosing schedule may be adjusted based on emerging data with agreement from the Safety Review Committee. Following completion of the dose validation phase, expansion cohorts may be initiated at the selected dose level.
    analyzed count
    9
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05714553-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-81f4e658
    nct id
    NCT05714553
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Module 2 (NUC-3373 + LV + Docetaxel)
    regimen
    This Module is designed to assess NUC-3373 (750 mg/m2) + LV (400 mg/m2) + docetaxel (55 mg/m2) for the treatment of patients with advanced/metastatic NSCLC or pleural mesothelioma who have progressed on, or were unable to tolerate, 1 or 2 prior lines of cytotoxic chemotherapy-containing regimens for advanced/metastatic disease (dose validation phase). NUC-3373 and LV will be administered on Days 1 and 22 and docetaxel will be administered on Day 8 of 28-day cycles. The dosing schedule may be adjusted based on emerging data with agreement from the Safety Review Committee. Following completion of the dose validation phase, expansion cohorts may be initiated at the selected dose level.
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05714553-om-0002#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-endometrial-cancer-keytruda-qlex-81f4e658
    nct id
    NCT05714553
    harm key
    EG000
    source section id
    NCT05714553-ae
    event group key
    EG000
    event group label
    Module 1 (NUC-3373 + LV + Pembrolizumab)
    serious affected
    7
    serious at risk
    13
    other affected
    13
    other at risk
    13
    frequency threshold
    0
    collection period
    Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
    event definition
    Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
    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-81f4e658
    nct id
    NCT05714553
    harm key
    EG001
    source section id
    NCT05714553-ae
    event group key
    EG001
    event group label
    Module 2 (NUC-3373 + LV + Docetaxel)
    serious affected
    3
    serious at risk
    4
    other affected
    4
    other at risk
    4
    frequency threshold
    0
    collection period
    Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study drug, up to 20 months.
    event definition
    Adverse events and all-cause mortality were assessed in the safety population of patients who received at least one dose of study treatment. Compared to the participant flow numbers, there are two patients less in the Module 1 safety population as they did not receive any study treatment.
    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
    setting source links

      Preserved source evidence · Not medical advice