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

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

exploratory · NOT_POSTED

Site(s) of disease at presentation (including extent of lymph node involvement), site(s) of relapse, surgical and radiotherapy practices on protocol therapy.

Source null

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exploratory · NOT_POSTED

Levels of protocol-specified marker analytes and tumor expression before and after treatment and changes due to treatment will be described using descriptive statistics.

Source null

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primary · POSTED

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 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.

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secondary · POSTED

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.

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secondary · POSTED

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.

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secondary · POSTED

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.

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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-renal-cell-cancer-vegzelma-dfaad695
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-vegzelma-dfaad695
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-vegzelma-dfaad695
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-vegzelma-dfaad695
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-vegzelma-dfaad695
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-vegzelma-dfaad695
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-vegzelma-dfaad695
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-vegzelma-dfaad695
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-vegzelma-dfaad695
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-vegzelma-dfaad695
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-vegzelma-dfaad695
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-vegzelma-dfaad695
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-vegzelma-dfaad695
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-vegzelma-dfaad695
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-vegzelma-dfaad695
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-vegzelma-dfaad695
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-vegzelma-dfaad695
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-vegzelma-dfaad695
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