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← recurrent Urethral Cancer

NCT03513952 · STUDY IN CONTEXT

Atezolizumab and CYT107 in Treating Participants With Locally Advanced, Inoperable, or Metastatic Urothelial Carcinoma

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.

exploratory · NOT_POSTED

The evaluation of the effect of the investigation treatment combination on the immune-bias of the tumor microenvironment, based upon baseline and post-baseline tumor biopsy comparisons of number, distribution, and phenotype of tumor-infiltrating cells; PD-L1 expression, and expression of Interferon gamma (IFN-gamma) and associated proinflammatory gene expression in the tumor microenvironment.

Source null

→

primary · POSTED

ORR is defined as the proportion of patients who have achieved Complete Response (CR) - disappearance of all target lesions or Partial Response (PR) - \>=30% decrease in the sum of the longest diameter of target lesions according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; Overall Response (OR) = CR + PR.

Source null

→

secondary · POSTED

CBR is defined as the percentage of patients with advanced or metastatic cancer who have achieved CR (disappearance of all target lesions), PR (\>=30% decrease in the sum of the longest diameter of target lesions), and stable disease (SD) (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference the smallest sum diameters of target lesions) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; CBR = CR + PR + SD. Will also assess CBR in patients stratified by PD-L1 expression levels in the tumor microenvironment.

The PD-L1 assay produced no data due to expired antibody. Stratification by PD-L1 expression levels in the tumor microenvironment cannot be reported.

→

secondary · POSTED

Progression is defined, per RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions (the sum must demonstrate an absolute increase of at least 5 mm), or the appearance of new lesions and/or unequivocal progression of non-target lesions. PFS will be summarized using Kaplan-Meier estimates. Will also assess PFS in patients stratified by PD-L1 expression levels in the tumor microenvironment.

Patients without documented PD or death are censored at the last disease assessment date. The PD-L1 assay produced no data due to expired antibody. Stratification by PD-L1 expression levels in the tumor microenvironment cannot be reported.

→

secondary · POSTED

DOR is measured by RECIST v1.1. DOR will be summarized using Kaplan-Meier estimates. Will also assess DOR in patients stratified by PD-L1 expression levels in the tumor microenvironment.

The PD-L1 assay produced no data due to expired antibody. Stratification by PD-L1 expression levels in the tumor microenvironment cannot be reported.

→

secondary · POSTED

OS will be summarized using Kaplan-Meier estimates. Will also assess OS in patients stratified by PD-L1 expression levels in the tumor microenvironment.

The PD-L1 assay produced no data due to expired antibody. Stratification by PD-L1 expression levels in the tumor microenvironment cannot be reported.

→

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-urethral-cancer-recurrent-b677a38b
nct id
NCT03513952
trial label
Atezolizumab and CYT107 in Treating Participants With Locally Advanced, Inoperable, or Metastatic Urothelial Carcinoma
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
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-urethral-cancer-recurrent-b677a38b
    nct id
    NCT03513952
    outcome key
    om-0005
    source section id
    NCT03513952-om-0005
    source outcome index
    5
    endpoint
    Assessment of Investigation Treatment Combination on the Immune-bias of the Tumor Microenvironment
    endpoint definition
    The evaluation of the effect of the investigation treatment combination on the immune-bias of the tumor microenvironment, based upon baseline and post-baseline tumor biopsy comparisons of number, distribution, and phenotype of tumor-infiltrating cells; PD-L1 expression, and expression of Interferon gamma (IFN-gamma) and associated proinflammatory gene expression in the tumor microenvironment.
    time origin
    Up to 2 years
    analysis role
    exploratory
    reporting status
    NOT_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-urethral-cancer-recurrent-b677a38b
    nct id
    NCT03513952
    outcome key
    om-0000
    source section id
    NCT03513952-om-0000
    source outcome index
    0
    endpoint
    Objective Response Rate (ORR)
    endpoint definition
    ORR is defined as the proportion of patients who have achieved Complete Response (CR) - disappearance of all target lesions or Partial Response (PR) - \>=30% decrease in the sum of the longest diameter of target lesions according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; Overall Response (OR) = CR + PR.
    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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-urethral-cancer-recurrent-b677a38b
    nct id
    NCT03513952
    outcome key
    om-0001
    source section id
    NCT03513952-om-0001
    source outcome index
    1
    endpoint
    Clinical Benefit Rate (CBR) Measured by RECIST v1.1
    endpoint definition
    CBR is defined as the percentage of patients with advanced or metastatic cancer who have achieved CR (disappearance of all target lesions), PR (\>=30% decrease in the sum of the longest diameter of target lesions), and stable disease (SD) (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference the smallest sum diameters of target lesions) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; CBR = CR + PR + SD. Will also assess CBR in patients stratified by PD-L1 expression levels in the tumor microenvironment.
    time origin
    Up to 2 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The PD-L1 assay produced no data due to expired antibody. Stratification by PD-L1 expression levels in the tumor microenvironment cannot be reported.
    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-urethral-cancer-recurrent-b677a38b
    nct id
    NCT03513952
    outcome key
    om-0002
    source section id
    NCT03513952-om-0002
    source outcome index
    2
    endpoint
    Progression-free Survival (PFS)
    endpoint definition
    Progression is defined, per RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions (the sum must demonstrate an absolute increase of at least 5 mm), or the appearance of new lesions and/or unequivocal progression of non-target lesions. PFS will be summarized using Kaplan-Meier estimates. Will also assess PFS in patients stratified by PD-L1 expression levels in the tumor microenvironment.
    time origin
    Time from start of treatment to time of progression or death, whichever occurs first, assessed up to 2 years.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients without documented PD or death are censored at the last disease assessment date. The PD-L1 assay produced no data due to expired antibody. Stratification by PD-L1 expression levels in the tumor microenvironment cannot be reported.
    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-urethral-cancer-recurrent-b677a38b
    nct id
    NCT03513952
    outcome key
    om-0003
    source section id
    NCT03513952-om-0003
    source outcome index
    3
    endpoint
    Duration of Response (DOR)
    endpoint definition
    DOR is measured by RECIST v1.1. DOR will be summarized using Kaplan-Meier estimates. Will also assess DOR in patients stratified by PD-L1 expression levels in the tumor microenvironment.
    time origin
    Time interval between the date of first response (CR/PR) and the date of progression, assessed up to 2 years.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The PD-L1 assay produced no data due to expired antibody. Stratification by PD-L1 expression levels in the tumor microenvironment cannot be reported.
    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-urethral-cancer-recurrent-b677a38b
    nct id
    NCT03513952
    outcome key
    om-0004
    source section id
    NCT03513952-om-0004
    source outcome index
    4
    endpoint
    Overall Survival (OS)
    endpoint definition
    OS will be summarized using Kaplan-Meier estimates. Will also assess OS in patients stratified by PD-L1 expression levels in the tumor microenvironment.
    time origin
    Time interval between start of treatment to death due to any cause, assessed up to 48 months.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The PD-L1 assay produced no data due to expired antibody. Stratification by PD-L1 expression levels in the tumor microenvironment cannot be reported.
    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-urethral-cancer-recurrent-b677a38b
    nct id
    NCT03513952
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Group 1 (CYT107, Atezolizumab)
    regimen
    Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM
    analyzed count
    19
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03513952-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-urethral-cancer-recurrent-b677a38b
    nct id
    NCT03513952
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Group 2 (Atezolizumab)
    regimen
    Patients receive atezolizumab on day 1 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV
    analyzed count
    21
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03513952-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-urethral-cancer-recurrent-b677a38b
    nct id
    NCT03513952
    outcome key
    om-0000
    arm key
    OG002
    arm label
    Safety Run in Phase
    regimen
    Patients were not randomized; they were assigned to the experimental arm treatment (atezolizumab + CYT107). Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM
    analyzed count
    7
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03513952-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-urethral-cancer-recurrent-b677a38b
    nct id
    NCT03513952
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Group 1 (CYT107, Atezolizumab)
    regimen
    Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM
    analyzed count
    19
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03513952-om-0001#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-urethral-cancer-recurrent-b677a38b
    nct id
    NCT03513952
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Group 2 (Atezolizumab)
    regimen
    Patients receive atezolizumab on day 1 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV
    analyzed count
    21
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03513952-om-0001#groups/OG001
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-urethral-cancer-recurrent-b677a38b
    nct id
    NCT03513952
    outcome key
    om-0001
    arm key
    OG002
    arm label
    Safety Run in Phase
    regimen
    Patients were not randomized; they were assigned to the experimental arm treatment (atezolizumab + CYT107). Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM
    analyzed count
    7
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03513952-om-0001#groups/OG002
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-urethral-cancer-recurrent-b677a38b
    nct id
    NCT03513952
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Group 1 (CYT107, Atezolizumab)
    regimen
    Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM
    analyzed count
    19
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03513952-om-0002#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-urethral-cancer-recurrent-b677a38b
    nct id
    NCT03513952
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Group 2 (Atezolizumab)
    regimen
    Patients receive atezolizumab on day 1 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV
    analyzed count
    21
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03513952-om-0002#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-urethral-cancer-recurrent-b677a38b
    nct id
    NCT03513952
    outcome key
    om-0002
    arm key
    OG002
    arm label
    Safety Run in Phase
    regimen
    Patients were not randomized; they were assigned to the experimental arm treatment (atezolizumab + CYT107). Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM
    analyzed count
    7
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03513952-om-0002#groups/OG002
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-urethral-cancer-recurrent-b677a38b
    nct id
    NCT03513952
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Group 1 (CYT107, Atezolizumab)
    regimen
    Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM
    analyzed count
    19
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03513952-om-0003#groups/OG000
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-urethral-cancer-recurrent-b677a38b
    nct id
    NCT03513952
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Group 2 (Atezolizumab)
    regimen
    Patients receive atezolizumab on day 1 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV
    analyzed count
    21
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03513952-om-0003#groups/OG001
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-urethral-cancer-recurrent-b677a38b
    nct id
    NCT03513952
    outcome key
    om-0003
    arm key
    OG002
    arm label
    Safety Run in Phase
    regimen
    Patients were not randomized; they were assigned to the experimental arm treatment (atezolizumab + CYT107). Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03513952-om-0003#groups/OG002
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-urethral-cancer-recurrent-b677a38b
    nct id
    NCT03513952
    harm key
    EG000
    source section id
    NCT03513952-ae
    event group key
    EG000
    event group label
    Group 1 (CYT107, Atezolizumab)
    serious affected
    13
    serious at risk
    19
    other affected
    18
    other at risk
    19
    frequency threshold
    5
    collection period
    Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
    event definition
    Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
    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-urethral-cancer-recurrent-b677a38b
    nct id
    NCT03513952
    harm key
    EG001
    source section id
    NCT03513952-ae
    event group key
    EG001
    event group label
    Group 2 (Atezolizumab)
    serious affected
    11
    serious at risk
    19
    other affected
    19
    other at risk
    19
    frequency threshold
    5
    collection period
    Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
    event definition
    Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
    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-urethral-cancer-recurrent-b677a38b
    nct id
    NCT03513952
    harm key
    EG002
    source section id
    NCT03513952-ae
    event group key
    EG002
    event group label
    Safety Run in Phase
    serious affected
    5
    serious at risk
    7
    other affected
    7
    other at risk
    7
    frequency threshold
    5
    collection period
    Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
    event definition
    Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
    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