NCT02689219 · STUDY IN CONTEXT

Brentuximab Vedotin in Relapsed/Refractory Germ Cell Tumors

Draft scope assessment: unclear. Attached because the study's own record describes refractory 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.

primary · POSTED

Measured by RECIST v1.1 and tumor markers (AFP and BhCG). CR - disappearance of all target lesions and normalization of serum tumor markers for at least 4 weeks. When only evidence of disease is elevated serum tumor markers, then values must fall below the upper limit of normal for the assay and remain at that level for at least 4 weeks. PR - at least a 30% decrease in the sum of the diameters of target lesions compared to the baseline sum diameters for at least 2 measurements 1 month apart with the serum markers as stable/decreasing. When only evidence of disease is elevated serum tumor markers, then values must fall \>=90% below baseline pretreatment levels for BhCG or 50% decrease below baseline pretreatment levels for AFP and persist for 6 weeks. If both tumor markers are elevated and one falls below 90% the other should fall at least below 50% of baseline pretreatment levels.The percent of patients with objective response and its 95% exact confidence interval will be provided.

All patients who received at least one dose of study medication and at least one evaluable assessment after treatment.

→

secondary · POSTED

Duration of time from the start of treatment to time of documented progression or death. Patients who did not progress or die were censored on their last evaluation date. Kaplan-Meier methods will be used and the median and 95% confidence intervals will be calculated.

All patients who received at least one dose of study medication.

→

secondary · POSTED

Duration of time from the start of treatment to time of death due to any causes. Patients who did not die were censored on their last known alive date. Kaplan-Meier methods will be used and the median and 95% confidence intervals will be calculated.

All patients who received at least one dose of study medication.

→

secondary · POSTED

Number of unique patients who had a treatment related (possible, probable or definite) adverse event with grade \>= 3 using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

All patients who received at least one dose of study medication.

→

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-testicular-cancer-avopef-9e524ceb
nct id: NCT02689219
trial label: Brentuximab Vedotin in Relapsed/Refractory Germ Cell Tumors
applicability: unclear
applicability note: Attached because the study's own record describes refractory 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: 4
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-testicular-cancer-avopef-9e524ceb
nct id
NCT02689219
outcome key
om-0000
source section id
NCT02689219-om-0000
source outcome index
0
endpoint
Objective Response (Percent of Patients With Complete Response or Partial Response)
endpoint definition
Measured by RECIST v1.1 and tumor markers (AFP and BhCG). CR - disappearance of all target lesions and normalization of serum tumor markers for at least 4 weeks. When only evidence of disease is elevated serum tumor markers, then values must fall below the upper limit of normal for the assay and remain at that level for at least 4 weeks. PR - at least a 30% decrease in the sum of the diameters of target lesions compared to the baseline sum diameters for at least 2 measurements 1 month apart with the serum markers as stable/decreasing. When only evidence of disease is elevated serum tumor markers, then values must fall \>=90% below baseline pretreatment levels for BhCG or 50% decrease below baseline pretreatment levels for AFP and persist for 6 weeks. If both tumor markers are elevated and one falls below 90% the other should fall at least below 50% of baseline pretreatment levels.The percent of patients with objective response and its 95% exact confidence interval will be provided.
time origin
Up to 1 year
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All patients who received at least one dose of study medication and at least one evaluable assessment after treatment.
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-testicular-cancer-avopef-9e524ceb
nct id
NCT02689219
outcome key
om-0001
source section id
NCT02689219-om-0001
source outcome index
1
endpoint
Progression Free Survival
endpoint definition
Duration of time from the start of treatment to time of documented progression or death. Patients who did not progress or die were censored on their last evaluation date. Kaplan-Meier methods will be used and the median and 95% confidence intervals will be calculated.
time origin
Up to 2 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All patients who received at least one dose of study medication.
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-testicular-cancer-avopef-9e524ceb
nct id
NCT02689219
outcome key
om-0002
source section id
NCT02689219-om-0002
source outcome index
2
endpoint
Overall Survival
endpoint definition
Duration of time from the start of treatment to time of death due to any causes. Patients who did not die were censored on their last known alive date. Kaplan-Meier methods will be used and the median and 95% confidence intervals will be calculated.
time origin
Up to 2 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All patients who received at least one dose of study medication.
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-testicular-cancer-avopef-9e524ceb
nct id
NCT02689219
outcome key
om-0003
source section id
NCT02689219-om-0003
source outcome index
3
endpoint
Number of Patients With Treatment Related Adverse Events Grade 3 or Above
endpoint definition
Number of unique patients who had a treatment related (possible, probable or definite) adverse event with grade \>= 3 using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
time origin
Up to 2 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All patients who received at least one dose of study medication.
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-testicular-cancer-avopef-9e524ceb
nct id
NCT02689219
outcome key
om-0000
arm key
OG000
arm label
CD30 Negative/Unknown
regimen
Brentuximab Vedotin 1.8 mg/kg (1.2 mg/kg in patients with grade 2 peripheral neuropathy at enrollment) administered by IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle for CD30 Negative/Unknown cohort.
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02689219-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-testicular-cancer-avopef-9e524ceb
nct id
NCT02689219
outcome key
om-0000
arm key
OG001
arm label
CD30 Positive
regimen
Brentuximab Vedotin 1.8 mg/ kg (1.2 mg/kg in patients with grade 2 peripheral neuropathy at enrollment) administered by IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle for CD30 Positive cohort.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02689219-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-testicular-cancer-avopef-9e524ceb
nct id
NCT02689219
outcome key
om-0001
arm key
OG000
arm label
CD30 Negative/Unknown
regimen
Brentuximab Vedotin 1.8 mg/kg (1.2 mg/kg in patients with grade 2 peripheral neuropathy at enrollment) administered by IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle for CD30 Negative/Unknown cohort.
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02689219-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-testicular-cancer-avopef-9e524ceb
nct id
NCT02689219
outcome key
om-0001
arm key
OG001
arm label
CD30 Positive
regimen
Brentuximab Vedotin 1.8 mg/ kg (1.2 mg/kg in patients with grade 2 peripheral neuropathy at enrollment) administered by IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle for CD30 Positive cohort.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02689219-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-testicular-cancer-avopef-9e524ceb
nct id
NCT02689219
outcome key
om-0002
arm key
OG000
arm label
CD30 Negative/Unknown
regimen
Brentuximab Vedotin 1.8 mg/kg (1.2 mg/kg in patients with grade 2 peripheral neuropathy at enrollment) administered by IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle for CD30 Negative/Unknown cohort.
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02689219-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-testicular-cancer-avopef-9e524ceb
nct id
NCT02689219
outcome key
om-0002
arm key
OG001
arm label
CD30 Positive
regimen
Brentuximab Vedotin 1.8 mg/ kg (1.2 mg/kg in patients with grade 2 peripheral neuropathy at enrollment) administered by IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle for CD30 Positive cohort.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02689219-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-testicular-cancer-avopef-9e524ceb
nct id
NCT02689219
outcome key
om-0003
arm key
OG000
arm label
CD30 Negative/Unknown
regimen
Brentuximab Vedotin 1.8 mg/kg (1.2 mg/kg in patients with grade 2 peripheral neuropathy at enrollment) administered by IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle for CD30 Negative/Unknown cohort.
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02689219-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-testicular-cancer-avopef-9e524ceb
nct id
NCT02689219
outcome key
om-0003
arm key
OG001
arm label
CD30 Positive
regimen
Brentuximab Vedotin 1.8 mg/ kg (1.2 mg/kg in patients with grade 2 peripheral neuropathy at enrollment) administered by IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle for CD30 Positive cohort.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02689219-om-0003#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-testicular-cancer-avopef-9e524ceb
nct id
NCT02689219
harm key
EG000
source section id
NCT02689219-ae
event group key
EG000
event group label
CD30 Negative/Unknown
serious affected
2
serious at risk
11
other affected
11
other at risk
11
frequency threshold
5
collection period
Up to 1 year
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-testicular-cancer-avopef-9e524ceb
nct id
NCT02689219
harm key
EG001
source section id
NCT02689219-ae
event group key
EG001
event group label
CD30 Positive
serious affected
3
serious at risk
7
other affected
7
other at risk
7
frequency threshold
5
collection period
Up to 1 year
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