TriangleNCT04637594 · STUDY IN CONTEXT
Trying to Find the Correct Length of Treatment With Immune Checkpoint Therapy
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 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
OS is the length of time patients are alive after registering to receive protocol treatment. Patients who are lost to follow-up or are not known to be deceased at the time of study analysis will be censored at the time of last patient contact. Cox models will be used to compare the outcome between the two treatment groups.
Progression-free survival (PFS) is the length of time patients are alive without disease progression. Progression will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Stratified Cox models will be used to compare the outcomes between the two treatment groups.
Immune-related progression-free survival (iPFS) is the length of time patients are alive without immune-related progression. Progression will be assessed using immune related (ir)RECIST criteria. Stratified Cox models will be used to compare the outcomes between the two treatment groups.
Treatment-free Interval is the length of time patients are off treatment. A Stratified Cox model will be used to evaluate this outcome.
Rate of response is the percentage of patients with response after re-initiation of immune checkpoint inhibitor (ICI) therapy after progression post-registration. Rate of response will be assessed using RECIST 1.1. A chi-square test (or Fisher's exact test) will be used to determine whether there is an association between the best tumor response prior to trial enrollment and that achieved upon ICI re-challenge.
Adverse events (AEs) are ailments occurring during treatment. AEs will be assessed using Common Terminology Criteria for Adverse Events version 5.0.
Reported safety
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-ureter-carcinoma
- nct id
- NCT04637594
- trial label
- Trying to Find the Correct Length of Treatment With Immune Checkpoint Therapy
- 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
- 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
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-ureter-carcinoma
- nct id
- NCT04637594
- outcome key
- om-0000
- source section id
- NCT04637594-om-0000
- source outcome index
- 0
- endpoint
- Overall Survival (OS) Rate at 12 Months
- endpoint definition
- OS is the length of time patients are alive after registering to receive protocol treatment. Patients who are lost to follow-up or are not known to be deceased at the time of study analysis will be censored at the time of last patient contact. Cox models will be used to compare the outcome between the two treatment groups.
- time origin
- 12 months
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-ureter-carcinoma
- nct id
- NCT04637594
- outcome key
- om-0001
- source section id
- NCT04637594-om-0001
- source outcome index
- 1
- endpoint
- Progression-free Survival (PFS) Rate at 12 Months
- endpoint definition
- Progression-free survival (PFS) is the length of time patients are alive without disease progression. Progression will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Stratified Cox models will be used to compare the outcomes between the two treatment groups.
- time origin
- 12 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Post baseline assessment was completed for only 1 participant, therefore PFS cannot be calculated
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-ureter-carcinoma
- nct id
- NCT04637594
- outcome key
- om-0002
- source section id
- NCT04637594-om-0002
- source outcome index
- 2
- endpoint
- Immune-related Progression-free Survival (iPFS) Rate at 12 Months
- endpoint definition
- Immune-related progression-free survival (iPFS) is the length of time patients are alive without immune-related progression. Progression will be assessed using immune related (ir)RECIST criteria. Stratified Cox models will be used to compare the outcomes between the two treatment groups.
- time origin
- 12 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Post baseline assessment was completed for only 1 participant, therefore iPFS cannot be calculated
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-ureter-carcinoma
- nct id
- NCT04637594
- outcome key
- om-0003
- source section id
- NCT04637594-om-0003
- source outcome index
- 3
- endpoint
- Treatment-free Interval (Arm B)
- endpoint definition
- Treatment-free Interval is the length of time patients are off treatment. A Stratified Cox model will be used to evaluate this outcome.
- time origin
- From last dose of immune checkpoint inhibitor (ICI) to initiation of a subsequent systemic treatment or death, assessed up to 5 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All patients randomized to arm B withdrew from trial before beginning treatment. No data is available to perform analysis.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-ureter-carcinoma
- nct id
- NCT04637594
- outcome key
- om-0004
- source section id
- NCT04637594-om-0004
- source outcome index
- 4
- endpoint
- Rate of Response After Immune Checkpoint Inhibitor (ICI) Rechallenge (Arm B)
- endpoint definition
- Rate of response is the percentage of patients with response after re-initiation of immune checkpoint inhibitor (ICI) therapy after progression post-registration. Rate of response will be assessed using RECIST 1.1. A chi-square test (or Fisher's exact test) will be used to determine whether there is an association between the best tumor response prior to trial enrollment and that achieved upon ICI re-challenge.
- time origin
- Up to 5 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All patients randomized to arm B withdrew from trial before beginning treatment. No data is available to perform analysis.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-ureter-carcinoma
- nct id
- NCT04637594
- outcome key
- om-0005
- source section id
- NCT04637594-om-0005
- source outcome index
- 5
- endpoint
- Number of Patients Experiencing Grade 3 or Greater Adverse Events (AEs)
- endpoint definition
- Adverse events (AEs) are ailments occurring during treatment. AEs will be assessed using Common Terminology Criteria for Adverse Events version 5.0.
- time origin
- 2.5 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-ureter-carcinoma
- nct id
- NCT04637594
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Arm A (Immune Checkpoint Inhibitor)
- regimen
- CONTINUATION OF ICI TREATMENT: Patients receive either pembrolizumab intravenously (IV) over 30 minutes on day 1, nivolumab IV over 30 minutes on days 1 and 15, atezolizumab IV over 30-60 minutes on day 1, durvalumab IV over 60 minutes on days 1 and 15, or avelumab IV over 60 minutes on days 1 and 15. Cycles repeat every 21 or 42 days for pembrolizumab, every 21 days for atezolizumab, and 28 days for nivolumab, durvalumab, and avelumab in the absence of disease progression or unacceptable toxicity. Pembrolizumab: Given IV Nivolumab: Given IV Atezolizumab: Given IV Durvalumab: Given IV Avelumab: Given IV
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04637594-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ureter-carcinoma
- nct id
- NCT04637594
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Arm B (Immune Checkpoint Inhibitor)
- regimen
- DISCONTINUATION OF ICI TREATMENT: Patients receiving ICI treatment will discontinue ICI treatment within 1 cycle length after randomization. Cycle length is determined by the ICI regimen the patient is receiving at randomization. At disease progression patients may restart the same ICI treatment they were receiving upon randomization at physician discretion. Pembrolizumab: Given IV Nivolumab: Given IV Atezolizumab: Given IV Durvalumab: Given IV Avelumab: Given IV
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04637594-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-ureter-carcinoma
- nct id
- NCT04637594
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Arm A (Immune Checkpoint Inhibitor)
- regimen
- CONTINUATION OF ICI TREATMENT: Patients receive either pembrolizumab intravenously (IV) over 30 minutes on day 1, nivolumab IV over 30 minutes on days 1 and 15, atezolizumab IV over 30-60 minutes on day 1, durvalumab IV over 60 minutes on days 1 and 15, or avelumab IV over 60 minutes on days 1 and 15. Cycles repeat every 21 or 42 days for pembrolizumab, every 21 days for atezolizumab, and 28 days for nivolumab, durvalumab, and avelumab in the absence of disease progression or unacceptable toxicity. Pembrolizumab: Given IV Nivolumab: Given IV Atezolizumab: Given IV Durvalumab: Given IV Avelumab: Given IV
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04637594-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ureter-carcinoma
- nct id
- NCT04637594
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Arm B (Immune Checkpoint Inhibitor)
- regimen
- DISCONTINUATION OF ICI TREATMENT: Patients receiving ICI treatment will discontinue ICI treatment within 1 cycle length after randomization. Cycle length is determined by the ICI regimen the patient is receiving at randomization. At disease progression patients may restart the same ICI treatment they were receiving upon randomization at physician discretion. Pembrolizumab: Given IV Nivolumab: Given IV Atezolizumab: Given IV Durvalumab: Given IV Avelumab: Given IV
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04637594-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-ureter-carcinoma
- nct id
- NCT04637594
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Arm A (Immune Checkpoint Inhibitor)
- regimen
- CONTINUATION OF ICI TREATMENT: Patients receive either pembrolizumab intravenously (IV) over 30 minutes on day 1, nivolumab IV over 30 minutes on days 1 and 15, atezolizumab IV over 30-60 minutes on day 1, durvalumab IV over 60 minutes on days 1 and 15, or avelumab IV over 60 minutes on days 1 and 15. Cycles repeat every 21 or 42 days for pembrolizumab, every 21 days for atezolizumab, and 28 days for nivolumab, durvalumab, and avelumab in the absence of disease progression or unacceptable toxicity. Pembrolizumab: Given IV Nivolumab: Given IV Atezolizumab: Given IV Durvalumab: Given IV Avelumab: Given IV
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04637594-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ureter-carcinoma
- nct id
- NCT04637594
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Arm B (Immune Checkpoint Inhibitor)
- regimen
- DISCONTINUATION OF ICI TREATMENT: Patients receiving ICI treatment will discontinue ICI treatment within 1 cycle length after randomization. Cycle length is determined by the ICI regimen the patient is receiving at randomization. At disease progression patients may restart the same ICI treatment they were receiving upon randomization at physician discretion. Pembrolizumab: Given IV Nivolumab: Given IV Atezolizumab: Given IV Durvalumab: Given IV Avelumab: Given IV
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04637594-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-ureter-carcinoma
- nct id
- NCT04637594
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Arm A (Immune Checkpoint Inhibitor)
- regimen
- CONTINUATION OF ICI TREATMENT: Patients receive either pembrolizumab intravenously (IV) over 30 minutes on day 1, nivolumab IV over 30 minutes on days 1 and 15, atezolizumab IV over 30-60 minutes on day 1, durvalumab IV over 60 minutes on days 1 and 15, or avelumab IV over 60 minutes on days 1 and 15. Cycles repeat every 21 or 42 days for pembrolizumab, every 21 days for atezolizumab, and 28 days for nivolumab, durvalumab, and avelumab in the absence of disease progression or unacceptable toxicity. Pembrolizumab: Given IV Nivolumab: Given IV Atezolizumab: Given IV Durvalumab: Given IV Avelumab: Given IV
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04637594-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ureter-carcinoma
- nct id
- NCT04637594
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Arm B (Immune Checkpoint Inhibitor)
- regimen
- DISCONTINUATION OF ICI TREATMENT: Patients receiving ICI treatment will discontinue ICI treatment within 1 cycle length after randomization. Cycle length is determined by the ICI regimen the patient is receiving at randomization. At disease progression patients may restart the same ICI treatment they were receiving upon randomization at physician discretion. Pembrolizumab: Given IV Nivolumab: Given IV Atezolizumab: Given IV Durvalumab: Given IV Avelumab: Given IV
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04637594-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-ureter-carcinoma
- nct id
- NCT04637594
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Arm A (Immune Checkpoint Inhibitor)
- regimen
- CONTINUATION OF ICI TREATMENT: Patients receive either pembrolizumab intravenously (IV) over 30 minutes on day 1, nivolumab IV over 30 minutes on days 1 and 15, atezolizumab IV over 30-60 minutes on day 1, durvalumab IV over 60 minutes on days 1 and 15, or avelumab IV over 60 minutes on days 1 and 15. Cycles repeat every 21 or 42 days for pembrolizumab, every 21 days for atezolizumab, and 28 days for nivolumab, durvalumab, and avelumab in the absence of disease progression or unacceptable toxicity. Pembrolizumab: Given IV Nivolumab: Given IV Atezolizumab: Given IV Durvalumab: Given IV Avelumab: Given IV
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04637594-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ureter-carcinoma
- nct id
- NCT04637594
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Arm B (Immune Checkpoint Inhibitor)
- regimen
- DISCONTINUATION OF ICI TREATMENT: Patients receiving ICI treatment will discontinue ICI treatment within 1 cycle length after randomization. Cycle length is determined by the ICI regimen the patient is receiving at randomization. At disease progression patients may restart the same ICI treatment they were receiving upon randomization at physician discretion. Pembrolizumab: Given IV Nivolumab: Given IV Atezolizumab: Given IV Durvalumab: Given IV Avelumab: Given IV
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04637594-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-ureter-carcinoma
- nct id
- NCT04637594
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Arm A (Immune Checkpoint Inhibitor)
- regimen
- CONTINUATION OF ICI TREATMENT: Patients receive either pembrolizumab intravenously (IV) over 30 minutes on day 1, nivolumab IV over 30 minutes on days 1 and 15, atezolizumab IV over 30-60 minutes on day 1, durvalumab IV over 60 minutes on days 1 and 15, or avelumab IV over 60 minutes on days 1 and 15. Cycles repeat every 21 or 42 days for pembrolizumab, every 21 days for atezolizumab, and 28 days for nivolumab, durvalumab, and avelumab in the absence of disease progression or unacceptable toxicity. Pembrolizumab: Given IV Nivolumab: Given IV Atezolizumab: Given IV Durvalumab: Given IV Avelumab: Given IV
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04637594-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ureter-carcinoma
- nct id
- NCT04637594
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Arm B (Immune Checkpoint Inhibitor)
- regimen
- DISCONTINUATION OF ICI TREATMENT: Patients receiving ICI treatment will discontinue ICI treatment within 1 cycle length after randomization. Cycle length is determined by the ICI regimen the patient is receiving at randomization. At disease progression patients may restart the same ICI treatment they were receiving upon randomization at physician discretion. Pembrolizumab: Given IV Nivolumab: Given IV Atezolizumab: Given IV Durvalumab: Given IV Avelumab: Given IV
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04637594-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-ureter-carcinoma
- nct id
- NCT04637594
- harm key
- EG000
- source section id
- NCT04637594-ae
- event group key
- EG000
- event group label
- Arm A (Immune Checkpoint Inhibitor)
- serious affected
- 0
- serious at risk
- 1
- other affected
- 1
- other at risk
- 1
- frequency threshold
- 0
- collection period
- 2.5 years
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-ureter-carcinoma
- nct id
- NCT04637594
- harm key
- EG001
- source section id
- NCT04637594-ae
- event group key
- EG001
- event group label
- Arm B (Immune Checkpoint Inhibitor)
- serious affected
- 0
- serious at risk
- 2
- other affected
- 1
- other at risk
- 2
- frequency threshold
- 0
- collection period
- 2.5 years
- 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
- setting source links
Preserved source evidence · Not medical advice