Safety and Efficacy of Tisotumab Vedotin Monotherapy & in Combination With Other Cancer Agents in Subjects With Cervical Cancer

• Status: Active, not recruiting
• Trial end date: 2024-07-31
• Target enrollment: 0
• Participant gender: Female

Summary

This is an open label, multi-center trial of tisotumab vedotin monotherapy and in combination with bevacizumab, pembrolizumab, or carboplatin in subjects with recurrent or stage IVB cervical cancer.

The trial consists of two-parts a dose escalation part and an expansion part. The expansion part of the trial will be initiated once the Recommended Phase 2 Dose (RP2D) of the combinations have been determined in the dose escalation part.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genmab; Seagen Inc.
• Collaborators: Belgian Gynaecological Oncology Group; European Network of Gynaecological Oncological Trial Groups (ENGOT); Genmab; Gynecologic Oncology Group; Merck Sharp & Dohme Corp.; Seattle Genetics, Inc.
• Treatments: Bevacizumab; Carboplatin; Pembrolizumab; Tisotumab vedotin

Criteria

Inclusion Criteria:

• Must have squamous, adenosquamous, or adenocarcinoma of the cervix and progressed on or after standard of care treatments or are ineligible or intolerant to standard of care for recurrent or stage IVB cervical cancer (Arms A, B and C only).

• Must have squamous, adenosquamous, or adenocarcinoma of the cervix and must not have received prior systemic therapy for recurrent or stage IVB cervical cancer (Arms D and E only).

• Must have squamous, adenosquamous, or adenocarcinoma of the cervix and progressed on or after at least one but no more than two prior systemic therapies for recurrent or stage IVB cervical cancer (Arm F and G only).

• Must have baseline measurable disease per RECIST v1.1.

• Must be at least 18 years of age on the day of signing informed consent (All Arms).

• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (All Arms).

• Is not pregnant, breastfeeding, or expecting to conceive children within the projected duration of the trial and for at least 6 months after the last trial treatment administration

• Women of childbearing potential must agree to use adequate contraception during and for 6 months after the last dose of trial treatment administration.

• Must sign an informed consent form (ICF) indicating the trial subject understands the purpose of and procedures required for the trial and are willing to participate in the trial (All Arms).

Exclusion Criteria:

• Has clinically relevant bilateral hydronephrosis which cannot be alleviated by ureteral stents or percutaneous drainage. (All Arms)

• Has clinical signs or symptoms of gastrointestinal obstruction and requires parenteral hydration and/or nutrition. Post-operative obstructions within 4 weeks of abdominal surgery are permitted. (All Arms)

• Has clinically significant bleeding issues or risks

• Prior history (within 3 months) or current evidence of hemoptysis (1/2 teaspoon or more) (Arm A only)

• Recent (within 4 weeks of first dose of trial treatment) clinically significant gastrointestinal or vaginal bleeding requiring PRBC transfusion (Arm A only)

• Recent (within 4 weeks of first dose of trial treatment) evidence of wound healing complications that require medical intervention (Arm A only)

• Has active ocular surface disease at baseline. Subjects with prior history of cicatricial conjunctivitis are ineligible (All Arms).

• Clinically significant cardiac disease

• Requires anti-coagulation therapy