TriangleNCT03438396 · STUDY IN CONTEXT
A Trial of Tisotumab Vedotin in Cervical Cancer
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
The confirmed OR is defined as best overall response of confirmed complete response (CR) or confirmed partial response (PR) based upon RECIST v1.1, assessed by the IRC. The CR is disappearance of all target and non-target lesions and no new lesions. A confirmed CR is 2 CRs (CR-CR sequence) that were separated by at least 4 weeks with no evidence of progression in-between. The PR is ≥ 30% decrease in the sum of diameters of target lesions (compared to baseline) and no unequivocal progression of existing non-target lesions and no new lesion. A confirmed PR is PR-PR sequence or PR-CR sequence that were separated by at least 4 weeks. The intermediate missing (Not Evaluable \[NE\]) scan evaluations between response scan and confirmation scan were allowed, eg, PR-NE-PR and PR-NE-NE-PR was considered PR confirmed (a repeat scan not earlier than 4 weeks after initial scan documenting response). 95% CI was calculated using the Clopper-Pearson method.
The DOR is defined as the duration from the first documented response of CR or PR (the start date of response, not the date when response was confirmed) to the date of the first documented progression disease (PD) verified by IRC or death. Based upon RECIST v1.1, the CR is defined as disappearance of all target and non-target lesions and no new lesions; the PR is defined as ≥ 30% decrease in the sum of diameters of target lesions (compared to baseline) and no unequivocal progression of existing non-target lesions and no new lesion; and the PD is defined as at least 20% increase in the sum of diameters of target lesions (compared to baseline), unequivocal progression of existing non-target lesions, and/or new lesion. The DOR was estimated using Kaplan-Meier method.
The confirmed OR is defined as best overall response of confirmed CR or confirmed PR based upon RECIST v1.1, assessed by the investigator. The CR is defined as disappearance of all target and non-target lesions and no new lesions. A confirmed CR is defined as 2 CRs (CR-CR sequence) that were separated by at least 4 weeks with no evidence of progression in-between. The PR is defined as ≥ 30% decrease in the sum of diameters of target lesions (compared to baseline) and no unequivocal progression of existing non-target lesions and no new lesion. A confirmed PR is defined as PR-PR sequence or PR-CR sequence that were separated by at least 4 weeks. The intermediate missing (NE) scan evaluations between the response scan and the confirmation scan were allowed, eg, PR-NE-PR and PR-NE-NE-PR was considered PR confirmed (a repeat scan not earlier than 4 weeks after initial scan documenting response). 95% CI was calculated using the Clopper-Pearson method.
The DOR is defined as the duration from the first documented response of CR or PR (the start date of response, not the date when response was confirmed) to the date of the first documented PD verified by investigator or death. Based upon RECIST v1.1, the CR is defined as disappearance of all target and non-target lesions and no new lesions; the PR is defined as ≥ 30% decrease in the sum of diameters of target lesions (compared to baseline) and no unequivocal progression of existing non-target lesions and no new lesion; and the PD is defined as at least 20% increase in the sum of diameters of target lesions (compared to baseline), unequivocal progression of existing non-target lesions, and/or new lesion. The DOR was estimated using Kaplan-Meier method.
The TTR is defined as the duration from the start of study drug to the first documented response of either CR or PR based on RECIST v1.1, assessed by the IRC. A confirmed CR is defined as 2 CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 4 weeks with no evidence of progression in-between. A confirmed PR is defined as 2 PRs (≥ 30% decrease in the sum of diameters of target lesions compared to baseline and no unequivocal progression of existing non-target lesions and no new lesion) or an un-confirmed PR and an un-confirmed CR or achieved PR-NE-PR or PR-NE-NE-PR that were separated by at least 4 weeks with no evidence of progression in-between.
The TTR is defined as the duration from the start of study drug to the first documented response of either CR or PR based on RECIST v1.1, assessed by the investigator. A confirmed CR is defined as 2 CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 4 weeks with no evidence of progression in-between. A confirmed PR is defined as 2 PRs (≥ 30% decrease in the sum of diameters of target lesions compared to baseline and no unequivocal progression of existing non-target lesions and no new lesion) or an un-confirmed PR and an un-confirmed CR or achieved PR-NE-PR or PR-NE-NE-PR that were separated by at least 4 weeks with no evidence of progression in-between.
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-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT03438396
- trial label
- A Trial of Tisotumab Vedotin in Cervical Cancer
- 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
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT03438396
- outcome key
- om-0000
- source section id
- NCT03438396-om-0000
- source outcome index
- 0
- endpoint
- Percentage of Participants With Confirmed Objective Response (OR) as Assessed by the Independent Review Committee (IRC)
- endpoint definition
- The confirmed OR is defined as best overall response of confirmed complete response (CR) or confirmed partial response (PR) based upon RECIST v1.1, assessed by the IRC. The CR is disappearance of all target and non-target lesions and no new lesions. A confirmed CR is 2 CRs (CR-CR sequence) that were separated by at least 4 weeks with no evidence of progression in-between. The PR is ≥ 30% decrease in the sum of diameters of target lesions (compared to baseline) and no unequivocal progression of existing non-target lesions and no new lesion. A confirmed PR is PR-PR sequence or PR-CR sequence that were separated by at least 4 weeks. The intermediate missing (Not Evaluable \[NE\]) scan evaluations between response scan and confirmation scan were allowed, eg, PR-NE-PR and PR-NE-NE-PR was considered PR confirmed (a repeat scan not earlier than 4 weeks after initial scan documenting response). 95% CI was calculated using the Clopper-Pearson method.
- time origin
- From Day 1 through IRC verified disease progression, initiation of new anticancer therapy, study withdrawal, or death, whichever occurred first (approximately 20 months)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- FAS included all participants who received at least 1 dose of tisotumab vedotin.
- 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-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT03438396
- outcome key
- om-0001
- source section id
- NCT03438396-om-0001
- source outcome index
- 1
- endpoint
- Duration of Response (DOR) as Assessed by the IRC
- endpoint definition
- The DOR is defined as the duration from the first documented response of CR or PR (the start date of response, not the date when response was confirmed) to the date of the first documented progression disease (PD) verified by IRC or death. Based upon RECIST v1.1, the CR is defined as disappearance of all target and non-target lesions and no new lesions; the PR is defined as ≥ 30% decrease in the sum of diameters of target lesions (compared to baseline) and no unequivocal progression of existing non-target lesions and no new lesion; and the PD is defined as at least 20% increase in the sum of diameters of target lesions (compared to baseline), unequivocal progression of existing non-target lesions, and/or new lesion. The DOR was estimated using Kaplan-Meier method.
- time origin
- From Day 1 through IRC verified disease progression, initiation of new anticancer therapy, study withdrawal, or death, whichever occurred first (approximately 49 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- FAS included all participants who received at least 1 dose of tisotumab vedotin. The DOR was analyzed for those participants in FAS who achieved confirmed OR, as assessed by the IRC.
- 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-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT03438396
- outcome key
- om-0002
- source section id
- NCT03438396-om-0002
- source outcome index
- 2
- endpoint
- Percentage of Participants With Confirmed OR as Assessed by the Investigator
- endpoint definition
- The confirmed OR is defined as best overall response of confirmed CR or confirmed PR based upon RECIST v1.1, assessed by the investigator. The CR is defined as disappearance of all target and non-target lesions and no new lesions. A confirmed CR is defined as 2 CRs (CR-CR sequence) that were separated by at least 4 weeks with no evidence of progression in-between. The PR is defined as ≥ 30% decrease in the sum of diameters of target lesions (compared to baseline) and no unequivocal progression of existing non-target lesions and no new lesion. A confirmed PR is defined as PR-PR sequence or PR-CR sequence that were separated by at least 4 weeks. The intermediate missing (NE) scan evaluations between the response scan and the confirmation scan were allowed, eg, PR-NE-PR and PR-NE-NE-PR was considered PR confirmed (a repeat scan not earlier than 4 weeks after initial scan documenting response). 95% CI was calculated using the Clopper-Pearson method.
- time origin
- From Day 1 through investigator verified disease progression, initiation of new anticancer therapy, study withdrawal, or death, whichever occurred first (approximately 49 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- FAS included all participants who received at least 1 dose of tisotumab vedotin.
- 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-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT03438396
- outcome key
- om-0003
- source section id
- NCT03438396-om-0003
- source outcome index
- 3
- endpoint
- DOR as Assessed by the Investigator
- endpoint definition
- The DOR is defined as the duration from the first documented response of CR or PR (the start date of response, not the date when response was confirmed) to the date of the first documented PD verified by investigator or death. Based upon RECIST v1.1, the CR is defined as disappearance of all target and non-target lesions and no new lesions; the PR is defined as ≥ 30% decrease in the sum of diameters of target lesions (compared to baseline) and no unequivocal progression of existing non-target lesions and no new lesion; and the PD is defined as at least 20% increase in the sum of diameters of target lesions (compared to baseline), unequivocal progression of existing non-target lesions, and/or new lesion. The DOR was estimated using Kaplan-Meier method.
- time origin
- From Day 1 through investigator verified disease progression, initiation of new anticancer therapy, study withdrawal, or death, whichever occurred first (approximately 49 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- FAS included all participants who received at least 1 dose of tisotumab vedotin. The DOR was analyzed for those participants in FAS who achieved confirmed OR, as assessed by the investigator.
- 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-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT03438396
- outcome key
- om-0004
- source section id
- NCT03438396-om-0004
- source outcome index
- 4
- endpoint
- Time to Response (TTR) as Assessed by the IRC
- endpoint definition
- The TTR is defined as the duration from the start of study drug to the first documented response of either CR or PR based on RECIST v1.1, assessed by the IRC. A confirmed CR is defined as 2 CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 4 weeks with no evidence of progression in-between. A confirmed PR is defined as 2 PRs (≥ 30% decrease in the sum of diameters of target lesions compared to baseline and no unequivocal progression of existing non-target lesions and no new lesion) or an un-confirmed PR and an un-confirmed CR or achieved PR-NE-PR or PR-NE-NE-PR that were separated by at least 4 weeks with no evidence of progression in-between.
- time origin
- From Day 1 through IRC verified disease progression, initiation of new anticancer therapy, study withdrawal, or death, whichever occurred first (approximately 49 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- FAS included all participants who received at least 1 dose of tisotumab vedotin. The TTR was analyzed for those participants in FAS who achieved confirmed OR, as assessed by the IRC.
- 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-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT03438396
- outcome key
- om-0005
- source section id
- NCT03438396-om-0005
- source outcome index
- 5
- endpoint
- TTR as Assessed by the Investigator
- endpoint definition
- The TTR is defined as the duration from the start of study drug to the first documented response of either CR or PR based on RECIST v1.1, assessed by the investigator. A confirmed CR is defined as 2 CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 4 weeks with no evidence of progression in-between. A confirmed PR is defined as 2 PRs (≥ 30% decrease in the sum of diameters of target lesions compared to baseline and no unequivocal progression of existing non-target lesions and no new lesion) or an un-confirmed PR and an un-confirmed CR or achieved PR-NE-PR or PR-NE-NE-PR that were separated by at least 4 weeks with no evidence of progression in-between.
- time origin
- From Day 1 through investigator verified disease progression, initiation of new anticancer therapy, study withdrawal, or death, whichever occurred first (approximately 49 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- FAS included all participants who received at least 1 dose of tisotumab vedotin. The TTR was analyzed for those participants in FAS who achieved confirmed OR, as assessed by the investigator.
- 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-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT03438396
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Tisotumab Vedotin
- regimen
- Participants received IV tisotumab vedotin 2.0 mg/kg Q3W until radiographic disease progression verified by the IRC, unacceptable AEs requiring drug discontinuation, withdrawal of consent, lost to follow up or death, whichever occurred first.
- analyzed count
- 101
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03438396-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT03438396
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Tisotumab Vedotin
- regimen
- Participants received IV tisotumab vedotin 2.0 mg/kg Q3W until radiographic disease progression verified by the IRC, unacceptable AEs requiring drug discontinuation, withdrawal of consent, lost to follow up or death, whichever occurred first.
- analyzed count
- 24
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03438396-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT03438396
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Tisotumab Vedotin
- regimen
- Participants received IV tisotumab vedotin 2.0 mg/kg Q3W until radiographic disease progression verified by the IRC, unacceptable AEs requiring drug discontinuation, withdrawal of consent, lost to follow up or death, whichever occurred first.
- analyzed count
- 101
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03438396-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT03438396
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Tisotumab Vedotin
- regimen
- Participants received IV tisotumab vedotin 2.0 mg/kg Q3W until radiographic disease progression verified by the IRC, unacceptable AEs requiring drug discontinuation, withdrawal of consent, lost to follow up or death, whichever occurred first.
- analyzed count
- 21
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03438396-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT03438396
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Tisotumab Vedotin
- regimen
- Participants received IV tisotumab vedotin 2.0 mg/kg Q3W until radiographic disease progression verified by the IRC, unacceptable AEs requiring drug discontinuation, withdrawal of consent, lost to follow up or death, whichever occurred first.
- analyzed count
- 24
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03438396-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT03438396
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Tisotumab Vedotin
- regimen
- Participants received IV tisotumab vedotin 2.0 mg/kg Q3W until radiographic disease progression verified by the IRC, unacceptable AEs requiring drug discontinuation, withdrawal of consent, lost to follow up or death, whichever occurred first.
- analyzed count
- 21
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03438396-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer-alymsys-b45b43f7
- nct id
- NCT03438396
- harm key
- EG000
- source section id
- NCT03438396-ae
- event group key
- EG000
- event group label
- Tisotumab Vedotin
- serious affected
- 44
- serious at risk
- 101
- other affected
- 99
- other at risk
- 101
- frequency threshold
- 0
- collection period
- From Day 1 through 30 days after the last dose of study drug (approximately 49 months)
- 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