A Trial of Tisotumab Vedotin in Cervical Cancer

Seagen

Status and phase: Completed; Phase 2

Conditions: Cervical Cancer

Treatments: Drug: tisotumab vedotin

Study type: Interventional

Funder types: Other; NETWORK; Industry

Identifiers

NCT03438396

innovaTV 204 (Other Identifier)

GCT1015-04

Details and patient eligibility

About

A Single arm, Multicenter, International Trial of Tisotumab Vedotin (HuMax®-TF-ADC) in Previously Treated, Recurrent or Metastatic Cervical Cancer.

Full description

The purpose of the trial is to evaluate the efficacy and safety/tolerability of tisotumab vedotin in patients with previously treated, recurrent or metastatic cervical cancer. Tisotumab vedotin is an antibody-drug conjugate (ADC) targeting tissue factor (TF), a protein aberrantly expressed in a wide number of tumors including cervical cancer. Preliminary safety and efficacy data observed in a cohort of previously treated cervical cancer patients suggest a positive benefit risk profile for this population of high unmet need.

Enrollment: 102 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Patients with extra-pelvic metastatic or recurrent cervical cancer including squamous cell, adenocarcinoma or adenosquamous histology who have experienced disease progressed on standard of care chemotherapy in combination with bevacizumab, if eligible.
• Measurable disease according to RECIST v1.1 as assessed by IRC.
• Age ≥ 18 years.
• Acceptable renal function
• Acceptable liver function
• Acceptable hematological status
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• A negative serum pregnancy test for patients of reproductive potential.
• All patients must provide a fresh or archival biopsy during screening.
• Following receipt of verbal and written information about the trial, patients must provide signed informed consent before any trial-related activity is carried out.

Exclusion Criteria

• Have received no more than 2 prior systemic treatment regimens for recurrent or metastatic cervical cancer.
• Known past or current coagulation defects leading to an increased risk of bleeding;
• Ongoing major bleeding
• Active ocular surface disease
• Known past or current malignancy other than the inclusion diagnosis.
• Peripheral neuropathy grade ≥ 2

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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102 participants in 1 patient group

Single arm

Experimental group

Description:

tisotumab vedotin (IV), 2.0 mg/kg, every 3 weeks (1Q3W)

Treatment:

Drug: tisotumab vedotin