Phase 3 Trial of Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer

JRCT ID: jRCT2011210028

Registered date:06/08/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Cervical cancer
• Date of first enrollment: 24/10/2021
• Target sample size: 50
• Countries of recruitment: United States,Japan,Canada,Japan,Austria,Japan,Belgium,Japan,Czech Republic,Japan,Denmark,Japan,Finland,Japan,France,Japan,Germany,Japan,Hungary,Japan,Ireland,Japan,Italy,Japan,Netherlands,Japan,Norway,Japan,Poland,Japan,Spain,Japan,Sweden,Japan,UK,Japan,South Korea,Japan,Singapore,Japan,Taiwan,Japan,Argentina,Japan,Brazil,Japan,Mexico,Japan,Peru,Japan,China,Japan
• Study type: Interventional

Intervention(s)

Experimental:
Tisotumab vedotin: 2.0 mg/kg intravenous(IV) every 3 weeks

Active Comparator:
Investigator's choice, one of following chemotherapy treatment
- topotecan: 1 or 1.25 mg/m^2 IV on Days 1 to 5, every 21 days
- vinorelbine: 30 mg/m^2 IV on Days 1 and 8, every 21 days
- gemcitabine: 1000 mg/m^2 IV on Days 1 and 8, every 21 days
- irinotecan: 100 or 125 mg/m^2 IV weekly for 28 days, every 42 days
- pemetrexed: 500 mg/m^2 IV on Day 1, every 21 days

Outcome(s)

• Primary Outcome: Overall survival (OS)

Secondary Outcome

- Progression-free survival (PFS) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the investigator
- Confirmed objective response rate (ORR) based on RECIST v1.1 as assessed by the investigator
- Time-to-response (TTR) as assessed by the investigator
- Duration of response (DOR) as assessed by the investigator
- Incidence of adverse events (AEs)
- Health-related quality of life as assessed by EQ-5D-5L index
- Health-related quality of life as assessed by EQ-5D visual analog scale (VAS)
- Health-related quality of life as assessed by EORTC-QLQ-C30
- Health-related quality of life as assessed by EORTC-QLQ-CX24

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

- Age =>18 years, or considered an adult by local regulations, at time of consent.
- 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: only 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.

Exclude 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.

Related Information

• Primary Sponsor: Liz Whalley
• Source(s) of Monetary Support: Genmab A/S
• Secondary ID(s): NCT04697628,2019-001655-39