A Trial of Tisotumab Vedotin in Cervical Cancer

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.

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