Titre |
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 |
Protocole ID |
innovaTV 301 (SGNTV-003) |
ClinicalTrials.gov ID |
NCT04697628 |
Type(s) de cancer |
Col |
Phase |
Phase III |
Type étude |
Clinique |
Médicament |
Tisotumab védotine versus une chimiothérapie au choix de l'investigateur |
Institution |
CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL
|
Ville |
Montréal |
Investigateur(trice) principal(e) |
Dre Vanessa Samouëlian
|
Coordonnateur(trice) |
France Gauthier
514-890-8000 poste 30921
|
Statut |
Fermé |
Date d'activation |
08-12-2022 |
Critètes d'éligibilité |
- 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.
|
Critètes d'exclusion |
- 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.
|