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← OPDIVO: unresectable metastatic Squamous Cell Carcinoma after prior therapy

NCT01682031 · STUDY IN CONTEXT

Selenomethionine in Reducing Mucositis in Patients With Locally Advanced Head and Neck Cancer Who Are Receiving Cisplatin and Radiation Therapy

Draft scope assessment: unclear. Attached because the study's own record describes metastatic 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

Will be compared as difference in proportions with 95% confidence intervals.

Due to the study's early termination and inadequate number of patients, no patients were analyzed.

→

secondary · POSTED

Will be compared as difference in proportions with 95% confidence intervals. Disease will be measured according to the Response Evaluation Criteria in Solid Tumors (RECIST).

Due to the study's early termination and inadequate number of patients, no patients were analyzed.

→

secondary · POSTED

Assessed by Kaplan-Meier RFS curves and the proportion with an event at 1 year for RFS will be compared simultaneously to obtain more global sensitivity to differences in time-to-event.

Due to the study's early termination and inadequate number of patients, no patients were analyzed.

→

secondary · POSTED

Estimated using the Kaplan-Meier method. Log-rank tests will be used for the comparison of survival distributions among study groups. Continuous endpoints will be summarized using means, standard deviations and percentiles.

Due to the study's early termination and inadequate number of patients, no patients were analyzed.

→

secondary · POSTED

Quality of Life

Due to the study's early termination and inadequate number of patients, no patients were analyzed.

→

secondary · POSTED

Will be compared as difference in proportions with 95% confidence intervals.

All treated and eligible patients

→

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

Unnamed quality-of-life measure · Quality of Life

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-squamous-cell-carcinoma-opdivo-8e2ac10c
nct id
NCT01682031
qol key
qol-0004
source section id
NCT01682031-om-0004
source outcome index
4
instrument
Unnamed quality-of-life measure
instrument basis
matched 'quality of life' in the study's own wording
scale title
Quality of Life
measure definition
Source null
time frame
Up to 1 year post-treatment
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Due to the study's early termination and inadequate number of patients, no patients were analyzed.
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-squamous-cell-carcinoma-opdivo-8e2ac10c
nct id
NCT01682031
trial label
Selenomethionine in Reducing Mucositis in Patients With Locally Advanced Head and Neck Cancer Who Are Receiving Cisplatin and Radiation Therapy
applicability
unclear
applicability note
Attached because the study's own record describes metastatic 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
2
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-squamous-cell-carcinoma-opdivo-8e2ac10c
    nct id
    NCT01682031
    outcome key
    om-0000
    source section id
    NCT01682031-om-0000
    source outcome index
    0
    endpoint
    Incidence of >= Grade 3 Mucositis
    endpoint definition
    Will be compared as difference in proportions with 95% confidence intervals.
    time origin
    Up to 5 years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Due to the study's early termination and inadequate number of patients, no patients were analyzed.
    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-squamous-cell-carcinoma-opdivo-8e2ac10c
    nct id
    NCT01682031
    outcome key
    om-0001
    source section id
    NCT01682031-om-0001
    source outcome index
    1
    endpoint
    Tumor Complete Response Rate
    endpoint definition
    Will be compared as difference in proportions with 95% confidence intervals. Disease will be measured according to the Response Evaluation Criteria in Solid Tumors (RECIST).
    time origin
    Up to 5 years post-treatment
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Due to the study's early termination and inadequate number of patients, no patients were analyzed.
    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-squamous-cell-carcinoma-opdivo-8e2ac10c
    nct id
    NCT01682031
    outcome key
    om-0002
    source section id
    NCT01682031-om-0002
    source outcome index
    2
    endpoint
    Relapse-free Survival (RFS)
    endpoint definition
    Assessed by Kaplan-Meier RFS curves and the proportion with an event at 1 year for RFS will be compared simultaneously to obtain more global sensitivity to differences in time-to-event.
    time origin
    At 1 year
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Due to the study's early termination and inadequate number of patients, no patients were analyzed.
    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-squamous-cell-carcinoma-opdivo-8e2ac10c
    nct id
    NCT01682031
    outcome key
    om-0003
    source section id
    NCT01682031-om-0003
    source outcome index
    3
    endpoint
    Overall Survival
    endpoint definition
    Estimated using the Kaplan-Meier method. Log-rank tests will be used for the comparison of survival distributions among study groups. Continuous endpoints will be summarized using means, standard deviations and percentiles.
    time origin
    Up to 5 years post-treatment
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Due to the study's early termination and inadequate number of patients, no patients were analyzed.
    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-squamous-cell-carcinoma-opdivo-8e2ac10c
    nct id
    NCT01682031
    outcome key
    om-0004
    source section id
    NCT01682031-om-0004
    source outcome index
    4
    endpoint
    Quality of Life
    endpoint definition
    Quality of Life
    time origin
    Up to 1 year post-treatment
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Due to the study's early termination and inadequate number of patients, no patients were analyzed.
    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-squamous-cell-carcinoma-opdivo-8e2ac10c
    nct id
    NCT01682031
    outcome key
    om-0005
    source section id
    NCT01682031-om-0005
    source outcome index
    5
    endpoint
    Incidence of Grade 3 or 4 Treatment-related Toxicities, Including Xerostomia
    endpoint definition
    Will be compared as difference in proportions with 95% confidence intervals.
    time origin
    Up to 5 years post-treatment
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All treated and eligible patients
    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-squamous-cell-carcinoma-opdivo-8e2ac10c
    nct id
    NCT01682031
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Arm I (Placebo, Cisplatin, and Radiotherapy)
    regimen
    Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8. placebo: Given PO cisplatin: Given IV radiation therapy: Undergo radiotherapy quality-of-life assessment: Ancillary studies
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01682031-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-squamous-cell-carcinoma-opdivo-8e2ac10c
    nct id
    NCT01682031
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Arm II (Selenomethionine, Cisplatin, and Radiotherapy)
    regimen
    Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I. selenomethionine: Given PO cisplatin: Given IV radiation therapy: Undergo radiotherapy quality-of-life assessment: Ancillary studies
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01682031-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-squamous-cell-carcinoma-opdivo-8e2ac10c
    nct id
    NCT01682031
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Arm I (Placebo, Cisplatin, and Radiotherapy)
    regimen
    Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8. placebo: Given PO cisplatin: Given IV radiation therapy: Undergo radiotherapy quality-of-life assessment: Ancillary studies
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01682031-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-squamous-cell-carcinoma-opdivo-8e2ac10c
    nct id
    NCT01682031
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Arm II (Selenomethionine, Cisplatin, and Radiotherapy)
    regimen
    Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I. selenomethionine: Given PO cisplatin: Given IV radiation therapy: Undergo radiotherapy quality-of-life assessment: Ancillary studies
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01682031-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-squamous-cell-carcinoma-opdivo-8e2ac10c
    nct id
    NCT01682031
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Arm I (Placebo, Cisplatin, and Radiotherapy)
    regimen
    Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8. placebo: Given PO cisplatin: Given IV radiation therapy: Undergo radiotherapy quality-of-life assessment: Ancillary studies
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01682031-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-squamous-cell-carcinoma-opdivo-8e2ac10c
    nct id
    NCT01682031
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Arm II (Selenomethionine, Cisplatin, and Radiotherapy)
    regimen
    Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I. selenomethionine: Given PO cisplatin: Given IV radiation therapy: Undergo radiotherapy quality-of-life assessment: Ancillary studies
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01682031-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-squamous-cell-carcinoma-opdivo-8e2ac10c
    nct id
    NCT01682031
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Arm I (Placebo, Cisplatin, and Radiotherapy)
    regimen
    Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8. placebo: Given PO cisplatin: Given IV radiation therapy: Undergo radiotherapy quality-of-life assessment: Ancillary studies
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01682031-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-squamous-cell-carcinoma-opdivo-8e2ac10c
    nct id
    NCT01682031
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Arm II (Selenomethionine, Cisplatin, and Radiotherapy)
    regimen
    Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I. selenomethionine: Given PO cisplatin: Given IV radiation therapy: Undergo radiotherapy quality-of-life assessment: Ancillary studies
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01682031-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-squamous-cell-carcinoma-opdivo-8e2ac10c
    nct id
    NCT01682031
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Arm I (Placebo, Cisplatin, and Radiotherapy)
    regimen
    Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8. placebo: Given PO cisplatin: Given IV radiation therapy: Undergo radiotherapy quality-of-life assessment: Ancillary studies
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01682031-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-squamous-cell-carcinoma-opdivo-8e2ac10c
    nct id
    NCT01682031
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Arm II (Selenomethionine, Cisplatin, and Radiotherapy)
    regimen
    Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I. selenomethionine: Given PO cisplatin: Given IV radiation therapy: Undergo radiotherapy quality-of-life assessment: Ancillary studies
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01682031-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-squamous-cell-carcinoma-opdivo-8e2ac10c
    nct id
    NCT01682031
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Arm I (Placebo, Cisplatin, and Radiotherapy)
    regimen
    Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8. placebo: Given PO cisplatin: Given IV radiation therapy: Undergo radiotherapy quality-of-life assessment: Ancillary studies
    analyzed count
    8
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01682031-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-squamous-cell-carcinoma-opdivo-8e2ac10c
    nct id
    NCT01682031
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Arm II (Selenomethionine, Cisplatin, and Radiotherapy)
    regimen
    Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I. selenomethionine: Given PO cisplatin: Given IV radiation therapy: Undergo radiotherapy quality-of-life assessment: Ancillary studies
    analyzed count
    10
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01682031-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-squamous-cell-carcinoma-opdivo-8e2ac10c
    nct id
    NCT01682031
    harm key
    EG000
    source section id
    NCT01682031-ae
    event group key
    EG000
    event group label
    Arm I (Placebo, Cisplatin, and Radiotherapy)
    serious affected
    4
    serious at risk
    8
    other affected
    8
    other at risk
    8
    frequency threshold
    0
    collection period
    Source null
    event definition
    Source null
    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-squamous-cell-carcinoma-opdivo-8e2ac10c
    nct id
    NCT01682031
    harm key
    EG001
    source section id
    NCT01682031-ae
    event group key
    EG001
    event group label
    Arm II (Selenomethionine, Cisplatin, and Radiotherapy)
    serious affected
    2
    serious at risk
    10
    other affected
    10
    other at risk
    10
    frequency threshold
    0
    collection period
    Source null
    event definition
    Source null
    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-squamous-cell-carcinoma-opdivo-8e2ac10c
    nct id
    NCT01682031
    qol key
    qol-0004
    source section id
    NCT01682031-om-0004
    source outcome index
    4
    instrument
    Unnamed quality-of-life measure
    instrument basis
    matched 'quality of life' in the study's own wording
    scale title
    Quality of Life
    measure definition
    Source null
    time frame
    Up to 1 year post-treatment
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Due to the study's early termination and inadequate number of patients, no patients were analyzed.
    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