Skip to content
Triangle logo TriangleGet started
← Anal Cancer

NCT02314169 · STUDY IN CONTEXT

Nivolumab With or Without Ipilimumab in Treating Patients With Refractory Metastatic Anal Canal Cancer

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

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

Responses assessed using computed tomography (CT) scans or magnetic resonance imaging according to standard Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria in order to assess disease progression. Complete Response (CR): Disappearance all target lesions; any pathological lymph nodes reduction in short axis to \< 10 mm (\< 1 cm). Partial Response (PR): \> 30% decrease in sum diameters of target lesions. Progressive Disease (PD): \> 20% increase in sum diameters lesions. (Note: appearance of one or \> new lesions considered progressions). Stable Disease (SD): Neither shrinkage qualify for PR nor increase for PD.

Source null

→

primary · POSTED

From initiation of treatment with nivolumab until the time of disease progression, time measured in months. Kaplan-Meier analysis performed to estimate the median progression-free survival with a 90% confidence interval.

Source null

→

secondary · POSTED

Toxicities were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The highest grade that occurred for a participant was recorded per toxicity.

This analysis includes only those patients who received at least one dose of study drug.

→

secondary · POSTED

Time measured from initiation of treatment till death. Kaplan-Meier analysis will be performed to estimate the median overall survival with a 95% confidence interval.

Source null

→

secondary · POSTED

Time measured from initiation of treatment till death. Kaplan-Meier analysis will be performed to estimate the median overall survival with a 90% confidence interval.

Source null

→

secondary · POSTED

From initiation of treatment with nivolumab until the time of disease progression, time measured in months. Kaplan-Meier analysis performed to estimate the median progression-free survival with a 95% confidence interval.

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

FACT · Expression of Biomarkers Using Immunohistochemistry and Blood Samples (Part A)

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-anal-cancer
nct id
NCT02314169
qol key
qol-0008
source section id
NCT02314169-om-0008
source outcome index
8
instrument
FACT
instrument basis
matched 'factors' in the study's own wording
scale title
Expression of Biomarkers Using Immunohistochemistry and Blood Samples (Part A)
measure definition
Descriptive statistics including plots, mean, median and standard deviations will be used to summarize data. For continuous outcomes, t-test and analysis of variance will be used to compare outcome measures across patient characteristics. Pair-wise comparisons will be performed using pre- and post-therapy samples from each patient. The chi-square test or Fisher's exact test will be used to test the association between two categorical variables. Both univariate and multivariate logistic regressions will be performed to model prognostic factors.
time frame
Up to time of treatment discontinuation
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-anal-cancer
nct id
NCT02314169
trial label
Nivolumab With or Without Ipilimumab in Treating Patients With Refractory Metastatic Anal Canal Cancer
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
3
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-anal-cancer
    nct id
    NCT02314169
    outcome key
    om-0000
    source section id
    NCT02314169-om-0000
    source outcome index
    0
    endpoint
    Overall Response Rate: Number of Participants With Response (Part A)
    endpoint definition
    Responses assessed using computed tomography (CT) scans or magnetic resonance imaging according to standard Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria in order to assess disease progression. Complete Response (CR): Disappearance all target lesions; any pathological lymph nodes reduction in short axis to \< 10 mm (\< 1 cm). Partial Response (PR): \> 30% decrease in sum diameters of target lesions. Progressive Disease (PD): \> 20% increase in sum diameters lesions. (Note: appearance of one or \> new lesions considered progressions). Stable Disease (SD): Neither shrinkage qualify for PR nor increase for PD.
    time origin
    Up to 2 years
    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-anal-cancer
    nct id
    NCT02314169
    outcome key
    om-0001
    source section id
    NCT02314169-om-0001
    source outcome index
    1
    endpoint
    Progression-free Survival (PFS) (Part B)
    endpoint definition
    From initiation of treatment with nivolumab until the time of disease progression, time measured in months. Kaplan-Meier analysis performed to estimate the median progression-free survival with a 90% confidence interval.
    time origin
    Time period from the date of randomization to the date of PD or death whichever occurred first, assessed up to 2 years
    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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-anal-cancer
    nct id
    NCT02314169
    outcome key
    om-0002
    source section id
    NCT02314169-om-0002
    source outcome index
    2
    endpoint
    Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
    endpoint definition
    Toxicities were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The highest grade that occurred for a participant was recorded per toxicity.
    time origin
    Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    This analysis includes only those patients who received at least one dose of study drug.
    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-anal-cancer
    nct id
    NCT02314169
    outcome key
    om-0003
    source section id
    NCT02314169-om-0003
    source outcome index
    3
    endpoint
    Overall Survival (Part A)
    endpoint definition
    Time measured from initiation of treatment till death. Kaplan-Meier analysis will be performed to estimate the median overall survival with a 95% confidence interval.
    time origin
    From initiation of treatment until death, assessed 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-anal-cancer
    nct id
    NCT02314169
    outcome key
    om-0004
    source section id
    NCT02314169-om-0004
    source outcome index
    4
    endpoint
    Overall Survival (Part B)
    endpoint definition
    Time measured from initiation of treatment till death. Kaplan-Meier analysis will be performed to estimate the median overall survival with a 90% confidence interval.
    time origin
    From initiation of treatment until death, assessed 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
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-anal-cancer
    nct id
    NCT02314169
    outcome key
    om-0005
    source section id
    NCT02314169-om-0005
    source outcome index
    5
    endpoint
    Progression-free Survival (Part A)
    endpoint definition
    From initiation of treatment with nivolumab until the time of disease progression, time measured in months. Kaplan-Meier analysis performed to estimate the median progression-free survival with a 95% confidence interval.
    time origin
    From initiation of treatment with nivolumab until the time of disease progression, assessed 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-anal-cancer
    nct id
    NCT02314169
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Part A: Nivolumab
    regimen
    This primary outcome measure is assessed from patients enrolled onto Part A of this study.
    analyzed count
    37
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02314169-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-anal-cancer
    nct id
    NCT02314169
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Part B Arm I (Nivolumab)
    regimen
    Participants enrolled into Arm I received single agent Nivolumab.
    analyzed count
    52
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02314169-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-anal-cancer
    nct id
    NCT02314169
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Part B Arm II (Nivolumab, Ipilimumab
    regimen
    Participants enrolled into Arm II received combination Nivolumab plus Ipilimumab.
    analyzed count
    48
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02314169-om-0001#groups/OG001
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-anal-cancer
    nct id
    NCT02314169
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Part A: Nivolumab
    regimen
    This primary outcome measure is assessed from patients enrolled onto Part A of this study.
    analyzed count
    37
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02314169-om-0002#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-anal-cancer
    nct id
    NCT02314169
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Part A: Nivolumab
    regimen
    This outcome measure is assessed from patients enrolled onto Part A of this study.
    analyzed count
    37
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02314169-om-0003#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-anal-cancer
    nct id
    NCT02314169
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Part B Arm 1 (Nivolumab)
    regimen
    Patients received single-agent Nivolumab IV
    analyzed count
    52
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02314169-om-0004#groups/OG000
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-anal-cancer
    nct id
    NCT02314169
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Part B Arm II (Nivolumab, Ipilimumab)
    regimen
    Patients received combination Nivolumab and Ipilimumab IV
    analyzed count
    48
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02314169-om-0004#groups/OG001
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-anal-cancer
    nct id
    NCT02314169
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Part A: Nivolumab
    regimen
    This outcome measure is assessed from patients enrolled onto Part A of this study.
    analyzed count
    37
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02314169-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-anal-cancer
    nct id
    NCT02314169
    harm key
    EG000
    source section id
    NCT02314169-ae
    event group key
    EG000
    event group label
    Part A (Nivolumab)
    serious affected
    14
    serious at risk
    37
    other affected
    36
    other at risk
    37
    frequency threshold
    5
    collection period
    Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
    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-anal-cancer
    nct id
    NCT02314169
    harm key
    EG001
    source section id
    NCT02314169-ae
    event group key
    EG001
    event group label
    Part B1 (Nivolumab)
    serious affected
    25
    serious at risk
    52
    other affected
    48
    other at risk
    52
    frequency threshold
    5
    collection period
    Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
    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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-anal-cancer
    nct id
    NCT02314169
    harm key
    EG002
    source section id
    NCT02314169-ae
    event group key
    EG002
    event group label
    Part B2 (Nivolumab + Ipilimumab)
    serious affected
    19
    serious at risk
    48
    other affected
    46
    other at risk
    48
    frequency threshold
    5
    collection period
    Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
    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-anal-cancer
    nct id
    NCT02314169
    qol key
    qol-0008
    source section id
    NCT02314169-om-0008
    source outcome index
    8
    instrument
    FACT
    instrument basis
    matched 'factors' in the study's own wording
    scale title
    Expression of Biomarkers Using Immunohistochemistry and Blood Samples (Part A)
    measure definition
    Descriptive statistics including plots, mean, median and standard deviations will be used to summarize data. For continuous outcomes, t-test and analysis of variance will be used to compare outcome measures across patient characteristics. Pair-wise comparisons will be performed using pre- and post-therapy samples from each patient. The chi-square test or Fisher's exact test will be used to test the association between two categorical variables. Both univariate and multivariate logistic regressions will be performed to model prognostic factors.
    time frame
    Up to time of treatment discontinuation
    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