A Study of Tisotumab Vedotin for Patients With Platinum-Resistant Ovarian Cancer With a Safety Run-in of a Dose-Dense Regimen (innovaTV 208)

The study objectives are to evaluate the safety, antitumor activity, and pharmacokinetics of
tisotumab vedotin (TV) administered every 3 weeks or on Days 1, 8, and 15 of every 4-week
cycle (dose-dense regimen) for patients with epithelial ovarian cancer, primary peritoneal
cancer, or fallopian tube cancer that has relapsed within 6 months of the completion of
platinum-based treatment. All patients must have platinum-resistant ovarian cancer (PROC) and
be eligible for single agent chemotherapy. Additionally, patients must have previously
received a bevacizumab-containing treatment regimen for ovarian cancer, if eligible.

Inclusion Criteria:

- Histologic documentation of epithelial ovarian cancer, primary peritoneal cancer, or
fallopian tube cancer

- If eligible, patients must have received previous treatment with a
bevacizumab-containing regimen for ovarian cancer.

- Safety run-in only: Patients with platinum-resistant ovarian cancer (PROC) who have
received up to 5 prior systemic treatment regimens for ovarian cancer

- Phase 2 only: Patients with PROC who have received at most 1 prior cytotoxic
chemotherapy regimen in the PROC setting

- Measureable disease according to RECIST v1.1 as assessed by the investigator

- An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1

- Life expectancy of at least 3 months

- Able to provide fresh tissue for biomarker analysis from a newly obtained core or
excisional biopsy of a tumor lesion. Some exceptions may apply, in which case archival
tissue will be used.

Exclusion Criteria:

- Primary platinum-refractory disease, defined as disease progression within 2 months of
completion of first line platinum-based therapy

- Patients with clinical symptoms or signs of gastrointestinal obstruction with the past
6 months or who currently require parenteral nutrition

- Hematological: Known past or current coagulation defects leading to an increased risk
of bleeding, diffuse alveolar hemorrhage from vasculitis, known bleeding diathesis,
ongoing major bleeding, or trauma with increased risk of life-threatening bleeding
within 8 weeks of trial entry

- Cardiovascular: Clinically significant cardiac disease including uncontrolled
hypertension, unstable angina, acute myocardial infarction with 6 months of screening,
serious cardiac arrhythmia requiring medication, medical history of congestive heart
failure, or medical history of decreased cardiac ejection fraction of <45%

- Ophthalmological: Active ocular surface disease at baseline or prior episode of
cicatricial conjunctivitis or Steven Johnson syndrome

- Prior treatment with MMAE-derived drugs

- Inflammatory bowel disease including Crohn's disease and ulcerative colitis

- Ongoing, acute, or chronic inflammatory skin disease

- Uncontrolled tumor-related pain

- Inflammatory lung disease requiring chronic medical therapy

- Grade 3 or higher pulmonary disease unrelated to underlying malignancy

- Uncontrolled pleural or pericardial effusions

- Grade >1 peripheral neuropathy

- Patients who are pregnant or breastfeeding