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Antibody-Drug Conjugate

Tisotumab Vedotin Combinations for Cervical Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by Seagen Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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 (Arms F and G only)
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 not have
Has active ocular surface disease at baseline. Subjects with prior history of cicatricial conjunctivitis are ineligible
Clinically significant cardiac disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new cancer drug called tisotumab vedotin. The trial has two parts: a dose escalation part and an expansion part. The expansion part will start once the Recommended Phase 2 Dose (RP2D) of the combinations have been determined in the dose escalation part.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Potential side effects may include reactions related to infusion treatments, bleeding risks especially when combined with Bevacizumab, fatigue from treatment burden on the body's systems, and possible organ-specific issues such as gastrointestinal complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cervical cancer has worsened after 1-2 treatments.
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My cervical cancer has worsened after standard treatments or I can't tolerate them.
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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any current eye surface diseases or a history of severe eye inflammation.
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I have a serious heart condition.
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I have serious bleeding problems or am at high risk for bleeding.
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I have severe swelling in both kidneys that can't be fixed with a procedure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dose escalation: Dose Limiting Toxicities (DLTs)
Dose expansion: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Secondary study objectives
AUC (Arm G only)
Area under the concentration-time curve (AUC) (All Arms except G)
Cmax (Arm G only)
+8 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tisotumab Vedotin
2017
Completed Phase 2
~10
Bevacizumab
2013
Completed Phase 4
~5540
Pembrolizumab
2017
Completed Phase 3
~3130
Carboplatin
2014
Completed Phase 3
~6120

Find a Location

Who is running the clinical trial?

European Network of Gynaecological Oncological Trial Groups (ENGOT)OTHER
39 Previous Clinical Trials
17,992 Total Patients Enrolled
Belgian Gynaecological Oncology GroupOTHER
11 Previous Clinical Trials
2,637 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,032 Previous Clinical Trials
5,189,587 Total Patients Enrolled
GOG FoundationNETWORK
46 Previous Clinical Trials
17,436 Total Patients Enrolled
Gynecologic Oncology GroupNETWORK
250 Previous Clinical Trials
64,967 Total Patients Enrolled
Seagen Inc.Lead Sponsor
210 Previous Clinical Trials
74,124 Total Patients Enrolled
GenmabIndustry Sponsor
71 Previous Clinical Trials
14,588 Total Patients Enrolled

Media Library

Tisotumab Vedotin (Antibody-Drug Conjugate) Clinical Trial Eligibility Overview. Trial Name: NCT03786081 — Phase 1 & 2
Cervical Cancer Research Study Groups: A: Tisotumab Vedotin + bevacizumab, B: Tisotumab vedotin + pembrolizumab, C: Tisotumab vedotin + carboplatin, D: Tisotumab vedotin + carboplatin, E: Tisotumab vedotin + pembrolizumab, F: Tisotumab vedotin + pembrolizumab, G: Tisotumab vedotin monotherapy, H: Tisotumab vedotin + pembrolizumab + carboplatin +/- bevacizumab
Cervical Cancer Clinical Trial 2023: Tisotumab Vedotin Highlights & Side Effects. Trial Name: NCT03786081 — Phase 1 & 2
Tisotumab Vedotin (Antibody-Drug Conjugate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03786081 — Phase 1 & 2
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