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Tisotumab Vedotin Combinations for Cervical Cancer

Recruiting in Palo Alto (17 mi)

+70 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Seagen, a wholly owned subsidiary of Pfizer

No Placebo Group

Breakthrough Therapy

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

This trial is for individuals with recurrent or stage IVB cervical cancer who haven't had systemic therapy (for certain arms) or have tried at most two therapies. Participants must not be pregnant, agree to contraception, and understand the trial's procedures. They should have a performance status of 0 or 1, indicating they are fully active or restricted in physically strenuous activity but ambulatory.

Inclusion Criteria

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

My cervical cancer has worsened after 1-2 treatments.

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

See 5 more

Exclusion Criteria

I've had recent wound healing issues that needed medical help.

I do not have any current eye surface diseases or a history of severe eye inflammation.

I have had serious bleeding that needed a blood transfusion in the last 4 weeks.

See 6 more

Treatment Details

Interventions

Bevacizumab (Monoclonal Antibody)
Carboplatin (Alkylating Agent)
Pembrolizumab (Monoclonal Antibody)
Tisotumab Vedotin (Antibody-Drug Conjugate)

Trial OverviewThe study tests Tisotumab Vedotin alone and combined with Bevacizumab, Pembrolizumab, or Carboplatin in patients with advanced cervical cancer. It includes dose escalation to find safe levels followed by an expansion phase to further assess effectiveness at these doses.

Participant Groups

8Treatment groups

Experimental Treatment

Group I: H: Tisotumab vedotin + pembrolizumab + carboplatin +/- bevacizumabExperimental Treatment4 Interventions

Dose expansion: Tisotumab vedotin in combination with pembrolizumab and carboplatin with or without bevacizumab once every three weeks in previously untreated patients

Group II: G: Tisotumab vedotin monotherapyExperimental Treatment1 Intervention

Dose expansion: Tisotumab vedotin monotherapy weekly for three weeks and 1 week off (28 day treatment cycle) in previously treated patients.

Group III: F: Tisotumab vedotin + pembrolizumabExperimental Treatment2 Interventions

Dose expansion: Tisotumab vedotin in combination with pembrolizumab once every three weeks in previously treated patients

Group IV: E: Tisotumab vedotin + pembrolizumabExperimental Treatment2 Interventions

Dose expansion: Tisotumab vedotin in combination with pembrolizumab once every three weeks in previously untreated patients

Group V: D: Tisotumab vedotin + carboplatinExperimental Treatment2 Interventions

Dose expansion:Tisotumab vedotin in combination with carboplatin once every three weeks in previously untreated patients

Group VI: C: Tisotumab vedotin + carboplatinExperimental Treatment2 Interventions

Dose escalation: Tisotumab vedotin in combination with carboplatin once every three weeks in previously treated patients

Group VII: B: Tisotumab vedotin + pembrolizumabExperimental Treatment2 Interventions

Dose escalation: Tisotumab vedotin in combination with pembrolizumab once every three weeks in previously treated patients

Group VIII: A: Tisotumab Vedotin + bevacizumabExperimental Treatment2 Interventions

Dose escalation: Tisotumab vedotin in combination with bevacizumab once every three weeks in previously treated patients

Find a Clinic Near You

Who Is Running the Clinical Trial?

Seagen, a wholly owned subsidiary of Pfizer

Lead Sponsor

Trials

Recruited

4,900+

Seagen Inc.

Lead Sponsor

Trials

212

Recruited

73,800+

Founded

1997

Headquarters

Bothell, USA

Known For

Antibody-Drug Conjugates

Top Products

Adcetris (brentuximab vedotin), Tukysa (tucatinib), Padcev (enfortumab vedotin-ejfv), Tivdak (tisotumab vedotin-tftv)

Dr. Roger Dansey

Seagen Inc.

Chief Medical Officer since 2018

MD from University of Witwatersrand

David R. Epstein

Seagen Inc.

Chief Executive Officer since 2022

BSc in Pharmacy from Rutgers University, MBA from Columbia University

European Network of Gynaecological Oncological Trial Groups (ENGOT)

Collaborator

Trials

Recruited

19,200+

Belgian Gynaecological Oncology Group

Collaborator

Trials

Recruited

4,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

GOG Foundation

Collaborator

Trials

Recruited

18,500+

Gynecologic Oncology Group

Collaborator

Trials

251

Recruited

65,400+