Trial · NCT04697628
Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer
NCT04697628, Phase 3, Completed, Seagen, a wholly owned subsidiary of Pfizer; results first posted 2024-08-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer. Trials, record NCT04697628. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04697628
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer
- NCT number
- NCT04697628
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 502 participants, actual
- Lead sponsor
- Seagen, a wholly owned subsidiary of Pfizer
- Conditions
- Cervical Cancer
- Interventions
- tisotumab vedotin, topotecan, vinorelbine, gemcitabine, irinotecan, pemetrexed
- First posted
- 2021-01-06
- Last updated
- 2026-02-24
- Results first posted
- 2024-08-09
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | From randomization to date of death due to any cause or censoring date, whichever occurred first (maximum up to 25 months) | Overall survival is defined as the time from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive. |
| Secondary | Progression Free Survival (PFS) as Assessed by Investigator | From the date of randomization to first documentation of PD or death due to any cause, or censoring date whichever occurred first (maximum up to 25 months) | PFS per investigator was defined as the time from the date of randomization to the first documentation of disease progression (PD) as assessed by investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1, or death due to any cause, whichever occurred earlier. PD: at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). Participants without evidence of radiographic disease progression or death were censored at the date of last adequate tumor assessment prior to data cut-off date or start of new anti-cancer therapy. Participants with disease progression or death that occurred after 2 or more missed scans were censored at the last adequate tumor assessment prior to missed scans. Participants without post-baseline scan data were censored at the day of randomization. |
| Secondary | Confirmed Objective Response Rate (ORR) as Assessed by Investigator | From the date of randomization until date of confirmed CR or PR (maximum up to 25 months) | Confirmed objective response rate was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per RECIST v.1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The minimum criteria for stable disease (SD) duration are defined as ≥ 5 weeks after the date of randomization. For a response to be considered as confirmed, the subsequent response had to be at least 4 weeks after the initial response. Two-sided 95% exact confidence interval (CI) was computed using the Clopper-Pearson method. |
| Secondary | Time-to-Response (TTR) as Assessed by the Investigator | From the date of randomization to date of date of the first confirmed objective response (maximum up to 25 months) | TTR was defined as the time from the randomization date to the date of the first confirmed objective response (CR or PR that was subsequently confirmed). CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Duration of Response (DOR) by Investigator Assessment | From the date of first documented response of CR or PR to the first documented PD or death from any cause, whichever occurred first (maximum up to 25 months) | DOR was defined as the time from the date of the first confirmed objective response (CR or PR that was subsequently confirmed) to the date of the first documented PD per RECIST v1.1 or death from any cause, whichever occurred first. CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From start of treatment up to 30 days after last dose of study treatment (up to 25 months) | An AE was any untoward medical occurrence in a clinical study participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.. TEAE was defined as a newly occurring or worsening AE after the first dose of study treatment and with onset date on or before 30 days after the last dose of study treatment. |
| Secondary | EuroQOL Five Dimensions Five Level (EQ-5D-5L) Index Score | From start of treatment until end of follow-up | The EQ-5D-5L questionnaire is a 5-item self-reported measure of functioning and well-being, which assesses 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension comprises 5 levels (no problems, slight problems, moderate problems, severe problems and extreme problems). Responses to the 5 items are then converted to a weighted health state index (utility score) based on values derived from general population samples. This health utility score is between 0 and 1, where 0 is death and 1 is perfect health. |
| Secondary | EQ-5D Visual Analog Scale (VAS) Scores | From start of treatment until end of follow-up | EQ5D is a participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state) ; higher scores indicate a better health state. |
| Secondary | European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Total Score | From start of treatment until end of follow-up | The EORTC-QLQ-C30 questionnaire is composed of 30 questions for which the answers ranges either from 1 (not at all) to 4 (very much) for items 1 to 28, or from 1 (very poor) to 7 (excellent) for items 29 to 30. The EORTC QLQ-C30 scale scores will be calculated using the EORTC QLQ-C30 Scoring Manual. These include 5 functional scales, 3 symptom scales, a global health status/QoL scale, and 6 single items. Each of the multi-item scales includes a different set of items (i.e., no item occurs in more than one scale). All of the scales and single-item measures range in score from 0 to 100, with a high scale score representing a higher response level (e.g., a high level of functioning, a high QoL, or a high level of symptomatology/problems) |
| Secondary | EORTC Quality of Life Questionnaire Cervical Cancer Module (QLQ-CX24) Total Scores | From start of treatment until end of follow-up | The EORTC QLQ-CX24 questionnaire is meant for use among cervical cancer participants varying in disease stage and treatment modality. The EORTC-QLQ-CX24 questionnaire is composed of 24 questions for which the answers ranged from 1 (Not at all) to 4 (Very much). Four functional scales and 5 symptom scales will be calculated using the EORTC QLQ-CX24 Scoring Manual. The 9 scores computed from the EORTC-QLQ-CX24 questionnaire will be summarized by treatment arm using descriptive statistics. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | From randomization to date of death due to any cause or censoring date, whichever occurred first (maximum up to 25 months) | ITT analysis set included all randomized participants. Participants were included in the treatment group assigned at randomization regardless of any actual treatment received. | Months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) as Assessed by Investigator | From the date of randomization to first documentation of PD or death due to any cause, or censoring date whichever occurred first (maximum up to 25 months) | ITT analysis set included all randomized participants. Participants were included in the treatment group assigned at randomization regardless of any actual treatment received. | Months | MEDIAN |
| SECONDARY | Confirmed Objective Response Rate (ORR) as Assessed by Investigator | From the date of randomization until date of confirmed CR or PR (maximum up to 25 months) | ITT analysis set included all randomized participants. Participants were included in the treatment group assigned at randomization regardless of any actual treatment received. | Percentage of participants | NUMBER |
| SECONDARY | Time-to-Response (TTR) as Assessed by the Investigator | From the date of randomization to date of date of the first confirmed objective response (maximum up to 25 months) | ITT analysis set included all randomized participants. Participants were included in the treatment group assigned at randomization regardless of any actual treatment received. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Only participants who achieved a confirmed CR or PR based on investigator assessment were included in the analysis. | Months | MEDIAN |
| SECONDARY | Duration of Response (DOR) by Investigator Assessment | From the date of first documented response of CR or PR to the first documented PD or death from any cause, whichever occurred first (maximum up to 25 months) | ITT analysis set included all randomized participants. Participants were included in the treatment group assigned at randomization regardless of any actual treatment received. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Only participants who achieved a confirmed CR or PR based on investigator assessment were included in the analysis. | Months | MEDIAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From start of treatment up to 30 days after last dose of study treatment (up to 25 months) | Safety analysis set included all randomized participants who received at least 1 dose of study treatment (tisotumab vedotin or chemotherapy). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | EuroQOL Five Dimensions Five Level (EQ-5D-5L) Index Score | From start of treatment until end of follow-up | |||
| SECONDARY | EQ-5D Visual Analog Scale (VAS) Scores | From start of treatment until end of follow-up | |||
| SECONDARY | European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Total Score | From start of treatment until end of follow-up | |||
| SECONDARY | EORTC Quality of Life Questionnaire Cervical Cancer Module (QLQ-CX24) Total Scores | From start of treatment until end of follow-up |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Tisotumab Vedotin | 11.5 | 95% Confidence Interval 9.8 to 14.9 | Months | |
| Overall Survival | Chemotherapy | 9.5 | 95% Confidence Interval 7.9 to 10.7 | Months | |
| Progression Free Survival (PFS) as Assessed by Investigator | Tisotumab Vedotin | 4.2 | 95% Confidence Interval 4.0 to 4.4 | Months | |
| Progression Free Survival (PFS) as Assessed by Investigator | Chemotherapy | 2.9 | 95% Confidence Interval 2.6 to 3.1 | Months | |
| Confirmed Objective Response Rate (ORR) as Assessed by Investigator | Tisotumab Vedotin | 17.8 | 95% Confidence Interval 13.3 to 23.1 | Percentage of participants | |
| Confirmed Objective Response Rate (ORR) as Assessed by Investigator | Chemotherapy | 5.2 | 95% Confidence Interval 2.8 to 8.8 | Percentage of participants | |
| Time-to-Response (TTR) as Assessed by the Investigator | Tisotumab Vedotin | 1.58 | 95% Confidence Interval 1.2 to 4.5 | Months | |
| Time-to-Response (TTR) as Assessed by the Investigator | Chemotherapy | 1.74 | 95% Confidence Interval 1.2 to 3.9 | Months | |
| Duration of Response (DOR) by Investigator Assessment | Tisotumab Vedotin | 5.3 | 95% Confidence Interval 4.2 to 8.3 | Months | |
| Duration of Response (DOR) by Investigator Assessment | Chemotherapy | 5.7 | 95% Confidence Interval 2.8 to NA | Months |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tisotumab Vedotin | 253 | |
| Overall Study | STARTED | Chemotherapy | 249 | |
| Overall Study | Treated | Tisotumab Vedotin | 250 | |
| Overall Study | Treated | Chemotherapy | 239 | |
| Overall Study | COMPLETED | Tisotumab Vedotin | 114 | |
| Overall Study | COMPLETED | Chemotherapy | 131 | |
| Overall Study | NOT COMPLETED | Tisotumab Vedotin | 139 | |
| Overall Study | NOT COMPLETED | Chemotherapy | 118 |
Source ClinicalTrials.gov
Adverse events350
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Tisotumab Vedotin | 56 | 250 | 69 |
| other | Anaemia | Blood and lymphatic system disorders | Chemotherapy | 119 | 239 | 160 |
| other | Leukopenia | Blood and lymphatic system disorders | Tisotumab Vedotin | 3 | 250 | 3 |
| other | Leukopenia | Blood and lymphatic system disorders | Chemotherapy | 16 | 239 | 24 |
| other | Neutropenia | Blood and lymphatic system disorders | Tisotumab Vedotin | 15 | 250 | 18 |
| other | Neutropenia | Blood and lymphatic system disorders | Chemotherapy | 52 | 239 | 119 |
| other | Dry eye | Eye disorders | Tisotumab Vedotin | 33 | 250 | 41 |
| other | Dry eye | Eye disorders | Chemotherapy | 1 | 239 | 1 |
| other | Keratitis | Eye disorders | Tisotumab Vedotin | 39 | 250 | 53 |
| other | Keratitis | Eye disorders | Chemotherapy | 0 | 239 | 0 |
1 to 10 of 350Source ClinicalTrials.gov
See all 350 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tisotumab Vedotin | 123 | 253 |
| Total, all-cause mortality | Chemotherapy | 140 | 249 |
| Total, other adverse events | Tisotumab Vedotin | 233 | 250 |
| Total, other adverse events | Chemotherapy | 223 | 239 |
| Total, serious adverse events | Tisotumab Vedotin | 82 | 250 |
| Total, serious adverse events | Chemotherapy | 94 | 239 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tisotumab Vedotin vs Chemotherapy: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Trial comparisons |
| Tisotumab Vedotin vs Chemotherapy: deaths from any cause | Trial comparisons |
| Tisotumab Vedotin vs Chemotherapy: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04697628
GET https://conductscience.org/api/trials/v1/NCT04697628/events?page=2