A Randomized, Open-Label, Phase 3 Trial of Tisotumab Vedotin vs Investigator's Choice Chemotherapy in Second- or Third-Line Recurrent or Metastatic Cervical Cancer (innovaTV 301)

  • STATUS
    Recruiting
  • End date
    Feb 28, 2028
  • participants needed
    482
  • sponsor
    Seagen Inc.
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Updated on 29 October 2022
See if I qualify
paclitaxel
measurable disease
treatment regimen
pemetrexed
carboplatin
gemcitabine
pembrolizumab
bevacizumab
chemotherapy drugs
adenocarcinoma
immunomodulator
topotecan
metastatic cervical cancer
tisotumab vedotin

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.

Details
Condition Cervical Cancer
Treatment Topotecan, Gemcitabine, Irinotecan, Pemetrexed, Vinorelbine, Tisotumab Vedotin
Clinical Study IdentifierNCT04697628
SponsorSeagen Inc.
Last Modified on29 October 2022

Eligibility

 Yes No Not Sure

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
Measurable disease according to RECIST v1.1 as assessed by the investigator
not required
Has ECOG performance status of 0 or 1 prior to randomization
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
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
Any prior treatment with monomethyl auristatin E (MMAE)-containing drugs
Peripheral neuropathy ≥grade 2
There are additional inclusion and exclusion criteria. The study center will determine if
criteria for participation are met
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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