TriangleNCT02689219 · STUDY IN CONTEXT
Brentuximab Vedotin in Relapsed/Refractory Germ Cell Tumors
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
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.
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.
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.
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.
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-testicular-cancer
- nct id
- NCT02689219
- trial label
- Brentuximab Vedotin in Relapsed/Refractory Germ Cell Tumors
- 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
- 4
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-testicular-cancer
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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