Phase 3
N=502
Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer
Cervical Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04697628 ↗Enrolled (actual)
502
Serious AEs
36.0%
Results posted
Aug 2024
Primary outcome: Primary: Overall Survival — 11.5; 9.5 Months — p=0.0038
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- tisotumab vedotin (Drug); topotecan (Drug); vinorelbine (Drug); gemcitabine (Drug); irinotecan (Drug); pemetrexed (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
11.5; 9.5 | 0.0038 sig |
| SECONDARY Progression Free Survival (PFS) as Assessed by Investigator |
4.2; 2.9 | <0.0001 sig |
| SECONDARY Confirmed Objective Response Rate (ORR) as Assessed by Investigator |
17.8; 5.2 | <0.0001 sig |
| SECONDARY Time-to-Response (TTR) as Assessed by the Investigator |
1.58; 1.74 | — |
| SECONDARY Duration of Response (DOR) by Investigator Assessment |
5.3; 5.7 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
246; 237 | — |
| SECONDARY EuroQOL Five Dimensions Five Level (EQ-5D-5L) Index Score |
— | — |
| SECONDARY EQ-5D Visual Analog Scale (VAS) Scores |
— | — |
| SECONDARY European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Total Score |
— | — |
| SECONDARY EORTC Quality of Life Questionnaire Cervical Cancer Module (QLQ-CX24) Total Scores |
— | — |
Summary
This trial is being done to find out whether tisotumab vedotin works better than chemotherapy to treat cervical cancer. People in this study have cervical cancer that has spread to other parts of the body (metastatic) or has come back after being treated (recurrent).
Participants in this trial will be randomly assigned to one of two groups. One group will be treated with tisotumab vedotin. Participants in the other group will get one of five different chemotherapy drugs (topotecan, vinorelbine, gemcitabine, pemetrexed, or irinotecan). Participants and their doctors will know which group they are in. Participants in the chemotherapy group will decide with their study doctor which drug they will take.
Eligibility Criteria
Inclusion Criteria
- Has recurrent or metastatic cervical cancer with squamous cell, adenocarcinoma, or adenosquamous histology, and:
- Has experienced disease progression during or after treatment with a standard of care systemic chemotherapy doublet, or platinum-based therapy (if eligible), defined as either:
- paclitaxel + cisplatin + bevacizumab + anti-PD-(L)1 agent, or
- paclitaxel + carboplatin + bevacizumab + anti-PD-(L)1 agent, or
- paclitaxel + topotecan/nogitecan + bevacizumab + anti-PD-(L)1 agent
- Note: In cases where bevacizumab and/or anti-PD-(L)1 agent is not a standard of care therapy or the participant was ineligible for such treatment according to local standards, prior treatment with bevacizumab and/or anti-PD-(L)1 agent is not required.
- Has received 1 or 2 prior systemic therapy regimens for recurrent and/or metastatic cervical cancer. Chemotherapy administered in the adjuvant or neoadjuvant setting, or in combination with radiation therapy, should not be counted as a systemic therapy regimen. Single agent therapy with an anti-PD(L)1 agent for r/mCC cancer should be counted.
- Measurable disease according to RECIST v1.1 as assessed by the investigator.
- Has ECOG performance status of 0 or 1 prior to randomization.
- Has life expectancy of at least 3 months.
Exclusion Criteria
- Has primary neuroendocrine, lymphoid, sarcomatoid, or other histologies not mentioned as part of the inclusion criteria above.
- Has clinically significant bleeding issues or risks. This includes known past or current coagulation defects leading to an increased risk of bleeding; diffuse alveolar hemorrhage from vasculitis; known bleeding diathesis; ongoing major bleeding; trauma with increased risk of life-threatening bleeding or history of severe head trauma or intracranial surgery within 8 weeks of trial entry.
- Has any history of intracerebral arteriovenous malformation, cerebral aneurysm, or stroke (transient ischemic attack >1 month prior to screening is allowed).
- Active ocular surface disease or a history of cicatricial conjunctivitis or inflammatory conditions that predispose to cicatrizing conjunctivitis (e.g. Wagner syndrome, atopic keratoconjunctivitis, autoimmune disease affecting the eyes), ocular Stevens-Johnson syndrome or toxic epidermal necrolysis, mucus pemphigoid, and participants with penetrating ocular transplants. Cataracts alone is not an exclusion criterion.
- Major surgery within 4 weeks or minor surgery within 7 days prior to the first study treatment administration.
- Peripheral neuropathy ≥grade 2.
- Any prior treatment with monomethyl auristatin E (MMAE)-containing drugs.
There are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met.
Data sourced from ClinicalTrials.gov (NCT04697628). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.