TriangleNCT02552121 · STUDY IN CONTEXT
Tisotumab Vedotin (HuMax®-TF-ADC) Safety Study in Patients With Solid Tumors
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
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
A SAE is defined as an AE that met one or more of the following criteria/outcomes which were classified as serious: Required inpatient hospitalization or prolongation of existing hospitalization. Resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. Was a congenital anomaly/birth defect. Medically important determined by the investigator. Resulted in death. Was life-threatening.
A SAE is defined as an AE that met one or more of the following criteria/outcomes which were classified as serious: Required inpatient hospitalization or prolongation of existing hospitalization. Resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. Was a congenital anomaly/birth defect. Medically important determined by the investigator. Resulted in death. Was life-threatening.
An infusion-related adverse event (AE) was defined as an AE occurring during infusion where the onset date and time of the event occurred within infusion time (+24 hours), and the event was judged as related to tisotumab vedotin by the investigator.
An infusion-related adverse event (AE) was defined as an AE occurring during infusion where the onset date and time of the event occurred within infusion time (+24 hours), and the event was judged as related to tisotumab vedotin by the investigator.
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-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02552121
- trial label
- Tisotumab Vedotin (HuMax®-TF-ADC) Safety Study in Patients With Solid Tumors
- 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
- 8
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02552121
- outcome key
- om-0000
- source section id
- NCT02552121-om-0000
- source outcome index
- 0
- endpoint
- Part 1: Number of Participants Who Experience at Least One Adverse Event (AE)
- endpoint definition
- An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
- time origin
- Baseline to end of follow-up; maximum time of follow-up was 24 weeks
- 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-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02552121
- outcome key
- om-0001
- source section id
- NCT02552121-om-0001
- source outcome index
- 1
- endpoint
- Part 2: Number of Participants Who Experience at Least One Adverse Event (AE)
- endpoint definition
- An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
- time origin
- Baseline to end of trial (Part 2), up to 36 weeks
- 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-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02552121
- outcome key
- om-0002
- source section id
- NCT02552121-om-0002
- source outcome index
- 2
- endpoint
- Part 1: Number of Participants Who Experienced at Least One or More Serious Adverse Event (SAE)
- endpoint definition
- A SAE is defined as an AE that met one or more of the following criteria/outcomes which were classified as serious: Required inpatient hospitalization or prolongation of existing hospitalization. Resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. Was a congenital anomaly/birth defect. Medically important determined by the investigator. Resulted in death. Was life-threatening.
- time origin
- Baseline to end of follow-up; maximum time of follow-up was 24 weeks
- 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-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02552121
- outcome key
- om-0003
- source section id
- NCT02552121-om-0003
- source outcome index
- 3
- endpoint
- Part 2: Number of Participants Reporting One or More Serious Adverse Events (SAE)
- endpoint definition
- A SAE is defined as an AE that met one or more of the following criteria/outcomes which were classified as serious: Required inpatient hospitalization or prolongation of existing hospitalization. Resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. Was a congenital anomaly/birth defect. Medically important determined by the investigator. Resulted in death. Was life-threatening.
- time origin
- Baseline to end of trial (Part 2), up to 36 weeks
- 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-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02552121
- outcome key
- om-0004
- source section id
- NCT02552121-om-0004
- source outcome index
- 4
- endpoint
- Part 1: Number of Participants Reporting One or More Infusion-related Adverse Events
- endpoint definition
- An infusion-related adverse event (AE) was defined as an AE occurring during infusion where the onset date and time of the event occurred within infusion time (+24 hours), and the event was judged as related to tisotumab vedotin by the investigator.
- time origin
- Day 1, Day 8 & Day 15 (+1 day) until end of treatment (Part 1), approximately 48 weeks
- 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-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02552121
- outcome key
- om-0005
- source section id
- NCT02552121-om-0005
- source outcome index
- 5
- endpoint
- Part 2: Number of Participants Reporting One or More Infusion-related Adverse Events
- endpoint definition
- An infusion-related adverse event (AE) was defined as an AE occurring during infusion where the onset date and time of the event occurred within infusion time (+24 hours), and the event was judged as related to tisotumab vedotin by the investigator.
- time origin
- Day 1, Day 8 & Day 15 (+1 day) until end of trial (Part 2), up to 36 weeks
- 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
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02552121
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
- regimen
- Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02552121-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02552121
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
- regimen
- Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02552121-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02552121
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
- regimen
- Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials \[RP2D\] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
- analyzed count
- 11
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02552121-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02552121
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
- regimen
- Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials \[RP2D\] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02552121-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02552121
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
- regimen
- Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02552121-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02552121
- outcome key
- om-0001
- arm key
- OG003
- arm label
- Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical
- regimen
- Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02552121-om-0001#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02552121
- outcome key
- om-0001
- arm key
- OG004
- arm label
- Part 2 Cohort Expansion: Cohort 5 1q3w Ovarian
- regimen
- Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02552121-om-0001#groups/OG004
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02552121
- outcome key
- om-0001
- arm key
- OG005
- arm label
- Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
- regimen
- Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02552121-om-0001#groups/OG005
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02552121
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
- regimen
- Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02552121-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02552121
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
- regimen
- Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02552121-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02552121
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
- regimen
- Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials \[RP2D\] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
- analyzed count
- 11
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02552121-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02552121
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
- regimen
- Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials \[RP2D\] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02552121-om-0003#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02552121
- harm key
- EG000
- source section id
- NCT02552121-ae
- event group key
- EG000
- event group label
- Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
- serious affected
- 1
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 5
- collection period
- Part 1: Dose Escalation: Baseline to follow-up; maximum time of follow-up was 24 weeks. Part 2: Cohort Expansion: Baseline to a maximum of 36 weeks.
- 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-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02552121
- harm key
- EG001
- source section id
- NCT02552121-ae
- event group key
- EG001
- event group label
- Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
- serious affected
- 2
- serious at risk
- 6
- other affected
- 6
- other at risk
- 6
- frequency threshold
- 5
- collection period
- Part 1: Dose Escalation: Baseline to follow-up; maximum time of follow-up was 24 weeks. Part 2: Cohort Expansion: Baseline to a maximum of 36 weeks.
- 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-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02552121
- harm key
- EG002
- source section id
- NCT02552121-ae
- event group key
- EG002
- event group label
- Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
- serious affected
- 9
- serious at risk
- 11
- other affected
- 10
- other at risk
- 11
- frequency threshold
- 5
- collection period
- Part 1: Dose Escalation: Baseline to follow-up; maximum time of follow-up was 24 weeks. Part 2: Cohort Expansion: Baseline to a maximum of 36 weeks.
- 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-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02552121
- harm key
- EG003
- source section id
- NCT02552121-ae
- event group key
- EG003
- event group label
- Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
- serious affected
- 2
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 5
- collection period
- Part 1: Dose Escalation: Baseline to follow-up; maximum time of follow-up was 24 weeks. Part 2: Cohort Expansion: Baseline to a maximum of 36 weeks.
- 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-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02552121
- harm key
- EG004
- source section id
- NCT02552121-ae
- event group key
- EG004
- event group label
- Part 2 Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
- serious affected
- 0
- serious at risk
- 1
- other affected
- 1
- other at risk
- 1
- frequency threshold
- 5
- collection period
- Part 1: Dose Escalation: Baseline to follow-up; maximum time of follow-up was 24 weeks. Part 2: Cohort Expansion: Baseline to a maximum of 36 weeks.
- 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-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02552121
- harm key
- EG005
- source section id
- NCT02552121-ae
- event group key
- EG005
- event group label
- Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical
- serious affected
- 2
- serious at risk
- 5
- other affected
- 5
- other at risk
- 5
- frequency threshold
- 5
- collection period
- Part 1: Dose Escalation: Baseline to follow-up; maximum time of follow-up was 24 weeks. Part 2: Cohort Expansion: Baseline to a maximum of 36 weeks.
- 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-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02552121
- harm key
- EG006
- source section id
- NCT02552121-ae
- event group key
- EG006
- event group label
- Part 2 Cohort Expansion: Cohort 5 1q3w Ovarian
- serious affected
- 0
- serious at risk
- 1
- other affected
- 0
- other at risk
- 1
- frequency threshold
- 5
- collection period
- Part 1: Dose Escalation: Baseline to follow-up; maximum time of follow-up was 24 weeks. Part 2: Cohort Expansion: Baseline to a maximum of 36 weeks.
- 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-prostate-cancer-abiraterone-acetate-159cbe11
- nct id
- NCT02552121
- harm key
- EG007
- source section id
- NCT02552121-ae
- event group key
- EG007
- event group label
- Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
- serious affected
- 1
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 5
- collection period
- Part 1: Dose Escalation: Baseline to follow-up; maximum time of follow-up was 24 weeks. Part 2: Cohort Expansion: Baseline to a maximum of 36 weeks.
- 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