TriangleNCT03595124 · STUDY IN CONTEXT
A Study to Compare Treatments for a Type of Kidney Cancer Called TFE/Translocation Renal Cell Carcinoma (tRCC)
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 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
Site(s) of disease at presentation (including extent of lymph node involvement), site(s) of relapse, surgical and radiotherapy practices on protocol therapy.
Levels of protocol-specified marker analytes and tumor expression before and after treatment and changes due to treatment will be described using descriptive statistics.
The Kaplan-Meier method will be used to estimate 1-year PFS, defined as the time from randomization to disease progression or death due to any cause. The 70% confidence interval was chosen to match the one-sided significance level of alpha = 0.15 specified in the protocol analysis plan.
The Kaplan-Meier method will be used to estimate 1-year OS, defined as the time from study entry until death. The 70% confidence interval was chosen to match the one-sided significance level of alpha = 0.15 specified in the protocol analysis plan.
The ORR will be defined as the proportion of patients that achieve a complete or partial response according to RECIST version 1.1 among patients who initiated protocol therapy and completed at least one subsequent imaging assessment. The 70% confidence interval was chosen to match the one-sided significance level of alpha = 0.15 specified in the protocol analysis plan.
Percentage of patients experiencing grade 3+ non-hematologic and all grade 4-5 AEs occurring during protocol therapy or within 30 days of treatment will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The 70% confidence interval was chosen to match the one-sided significance level of alpha = 0.15 specified in the protocol analysis plan.
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-renal-cell-cancer-proleukin-0a53719c
- nct id
- NCT03595124
- trial label
- A Study to Compare Treatments for a Type of Kidney Cancer Called TFE/Translocation Renal Cell Carcinoma (tRCC)
- 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
- 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
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer-proleukin-0a53719c
- nct id
- NCT03595124
- outcome key
- om-0004
- source section id
- NCT03595124-om-0004
- source outcome index
- 4
- endpoint
- Translocation Morphology Renal Cell Carcinoma Clinical Behavior
- endpoint definition
- Site(s) of disease at presentation (including extent of lymph node involvement), site(s) of relapse, surgical and radiotherapy practices on protocol therapy.
- time origin
- Up to 2 years from study entry
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer-proleukin-0a53719c
- nct id
- NCT03595124
- outcome key
- om-0005
- source section id
- NCT03595124-om-0005
- source outcome index
- 5
- endpoint
- Type of Antitumor Immune Response and Stability of T Cell Activation
- endpoint definition
- Levels of protocol-specified marker analytes and tumor expression before and after treatment and changes due to treatment will be described using descriptive statistics.
- time origin
- Up to 1 year from study entry
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer-proleukin-0a53719c
- nct id
- NCT03595124
- outcome key
- om-0000
- source section id
- NCT03595124-om-0000
- source outcome index
- 0
- endpoint
- Progression Free Survival (PFS)
- endpoint definition
- The Kaplan-Meier method will be used to estimate 1-year PFS, defined as the time from randomization to disease progression or death due to any cause. The 70% confidence interval was chosen to match the one-sided significance level of alpha = 0.15 specified in the protocol analysis plan.
- time origin
- Up to 1 year from study entry
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The data was analyzed with revised intention-to-treat approach. The following patients were excluded: Three (3) Arm B patients (as of Amendment 2A, the arm permanently closed to accrual and patients were randomly assigned to Arms A and C), One (1) Arm A patient who is ineligible for the study. 11 total patients were analyzed.
- 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-renal-cell-cancer-proleukin-0a53719c
- nct id
- NCT03595124
- outcome key
- om-0001
- source section id
- NCT03595124-om-0001
- source outcome index
- 1
- endpoint
- Overall Survival (OS)
- endpoint definition
- The Kaplan-Meier method will be used to estimate 1-year OS, defined as the time from study entry until death. The 70% confidence interval was chosen to match the one-sided significance level of alpha = 0.15 specified in the protocol analysis plan.
- time origin
- Up to 1 year from study entry
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The data was analyzed with revised intention-to-treat approach. The following patients were excluded: Three (3) Arm B patients (as of Amendment 2A, the arm permanently closed to accrual and patients were randomly assigned to Arms A and C), One (1) Arm A patient who is ineligible for the study. 11 total patients were analyzed.
- 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-renal-cell-cancer-proleukin-0a53719c
- nct id
- NCT03595124
- outcome key
- om-0002
- source section id
- NCT03595124-om-0002
- source outcome index
- 2
- endpoint
- Overall Response Rate (ORR)
- endpoint definition
- The ORR will be defined as the proportion of patients that achieve a complete or partial response according to RECIST version 1.1 among patients who initiated protocol therapy and completed at least one subsequent imaging assessment. The 70% confidence interval was chosen to match the one-sided significance level of alpha = 0.15 specified in the protocol analysis plan.
- time origin
- Up to 1 year from study entry
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The data was analyzed with revised intention-to-treat approach. The following patients were excluded: Three (3) Arm B patients (as of Amendment 2A, the arm permanently closed to accrual and patients were randomly assigned to Arms A and C), One (1) Arm A patient who is ineligible for the study. 11 total patients were analyzed.
- 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-renal-cell-cancer-proleukin-0a53719c
- nct id
- NCT03595124
- outcome key
- om-0003
- source section id
- NCT03595124-om-0003
- source outcome index
- 3
- endpoint
- Percentage of Patients Experiencing Adverse Events (AEs)
- endpoint definition
- Percentage of patients experiencing grade 3+ non-hematologic and all grade 4-5 AEs occurring during protocol therapy or within 30 days of treatment will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The 70% confidence interval was chosen to match the one-sided significance level of alpha = 0.15 specified in the protocol analysis plan.
- time origin
- Up to 2 years from study entry
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The data was analyzed with revised intention-to-treat approach. The following patients were excluded: Three (3) Arm B patients (as of Amendment 2A, the arm permanently closed to accrual and patients were randomly assigned to Arms A and C), One (1) Arm A patient who is ineligible for the study. 11 total patients were analyzed.
- 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-renal-cell-cancer-proleukin-0a53719c
- nct id
- NCT03595124
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Arm A (Axitinib, Nivolumab)
- regimen
- Patients receive axitinib PO BID on days 1-28 and nivolumab intravenously (IV) over 30 minutes, or per institutional guidelines, on days 1 and 15 (if \< 18 years old) or on day 1 (if \>= 18 years old). Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03595124-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer-proleukin-0a53719c
- nct id
- NCT03595124
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Arm C (Nivolumab)
- regimen
- Patients receive nivolumab IV over 30 minutes, or per institutional guidelines, on days 1 and 15 (if \< 18 years old) or on day 1 (if \>= 18 years old). Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03595124-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer-proleukin-0a53719c
- nct id
- NCT03595124
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Arm A (Axitinib, Nivolumab)
- regimen
- Patients receive axitinib PO BID on days 1-28 and nivolumab intravenously (IV) over 30 minutes, or per institutional guidelines, on days 1 and 15 (if \< 18 years old) or on day 1 (if \>= 18 years old). Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03595124-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer-proleukin-0a53719c
- nct id
- NCT03595124
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Arm C (Nivolumab)
- regimen
- Patients receive nivolumab IV over 30 minutes, or per institutional guidelines, on days 1 and 15 (if \< 18 years old) or on day 1 (if \>= 18 years old). Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03595124-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer-proleukin-0a53719c
- nct id
- NCT03595124
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Arm A (Axitinib, Nivolumab)
- regimen
- Patients receive axitinib PO BID on days 1-28 and nivolumab intravenously (IV) over 30 minutes, or per institutional guidelines, on days 1 and 15 (if \< 18 years old) or on day 1 (if \>= 18 years old). Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03595124-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer-proleukin-0a53719c
- nct id
- NCT03595124
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Arm C (Nivolumab)
- regimen
- Patients receive nivolumab IV over 30 minutes, or per institutional guidelines, on days 1 and 15 (if \< 18 years old) or on day 1 (if \>= 18 years old). Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03595124-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer-proleukin-0a53719c
- nct id
- NCT03595124
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Arm A (Axitinib, Nivolumab)
- regimen
- Patients receive axitinib PO BID on days 1-28 and nivolumab intravenously (IV) over 30 minutes, or per institutional guidelines, on days 1 and 15 (if \< 18 years old) or on day 1 (if \>= 18 years old). Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03595124-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer-proleukin-0a53719c
- nct id
- NCT03595124
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Arm C (Nivolumab)
- regimen
- Patients receive nivolumab IV over 30 minutes, or per institutional guidelines, on days 1 and 15 (if \< 18 years old) or on day 1 (if \>= 18 years old). Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03595124-om-0003#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer-proleukin-0a53719c
- nct id
- NCT03595124
- harm key
- EG000
- source section id
- NCT03595124-ae
- event group key
- EG000
- event group label
- Arm A (Axitinib, Nivolumab)
- serious affected
- 4
- serious at risk
- 6
- other affected
- 2
- other at risk
- 6
- frequency threshold
- 0
- collection period
- Up to 5 years after randomization
- event definition
- Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
- 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-renal-cell-cancer-proleukin-0a53719c
- nct id
- NCT03595124
- harm key
- EG001
- source section id
- NCT03595124-ae
- event group key
- EG001
- event group label
- Arm B (Axitinib)
- serious affected
- 2
- serious at risk
- 2
- other affected
- 0
- other at risk
- 2
- frequency threshold
- 0
- collection period
- Up to 5 years after randomization
- event definition
- Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
- 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-renal-cell-cancer-proleukin-0a53719c
- nct id
- NCT03595124
- harm key
- EG002
- source section id
- NCT03595124-ae
- event group key
- EG002
- event group label
- Arm C (Nivolumab)
- serious affected
- 5
- serious at risk
- 5
- other affected
- 1
- other at risk
- 5
- frequency threshold
- 0
- collection period
- Up to 5 years after randomization
- event definition
- Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
- 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