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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My cervical cancer has worsened after 1-2 treatments.
Select...
My cervical cancer has worsened after standard treatments or I can't tolerate them.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
AUC (Arm G only)
Anti-drug antibodies (ADAs)
Area under the concentration-time curve (AUC) (All Arms except G)
+9 moreTrial 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
~5280
Pembrolizumab
2017
Completed Phase 2
~2010
Carboplatin
2014
Completed Phase 3
~6670
Find a Location
Who is running the clinical trial?
European Network of Gynaecological Oncological Trial Groups (ENGOT)OTHER
35 Previous Clinical Trials
16,425 Total Patients Enrolled
Belgian Gynaecological Oncology GroupOTHER
11 Previous Clinical Trials
2,634 Total Patients Enrolled
GOG FoundationNETWORK
41 Previous Clinical Trials
15,927 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had recent wound healing issues that needed medical help.My cervical cancer has worsened after 1-2 treatments.My cervical cancer is untreated in its advanced or recurrent stage.I do not have any current eye surface diseases or a history of severe eye inflammation.My cervical cancer has worsened after standard treatments or I can't tolerate them.I have had serious bleeding that needed a blood transfusion in the last 4 weeks.I am fully active or restricted in physically strenuous activity but can do light work.I have not coughed up blood (1/2 teaspoon or more) in the last 3 months.I need blood-thinning medication.I have a serious heart condition.I have serious bleeding problems or am at high risk for bleeding.I need IV fluids or nutrition due to a blockage in my digestive tract.I have severe swelling in both kidneys that can't be fixed with a procedure.
Research Study Groups:
This trial has the following groups:- Group 1: A: Tisotumab Vedotin + bevacizumab
- Group 2: B: Tisotumab vedotin + pembrolizumab
- Group 3: C: Tisotumab vedotin + carboplatin
- Group 4: D: Tisotumab vedotin + carboplatin
- Group 5: E: Tisotumab vedotin + pembrolizumab
- Group 6: F: Tisotumab vedotin + pembrolizumab
- Group 7: G: Tisotumab vedotin monotherapy
- Group 8: H: Tisotumab vedotin + pembrolizumab + carboplatin +/- bevacizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people are being given the chance to participate in this research?
"The sponsor, Genmab, needs to recruit 220 patients that fulfil the inclusion criteria in order to carry out the study. The trial will be conducted at various sites including Fox Chase Cancer Center in Philadelphia, Pennsylvania and Carilion Clinic in Roanoke, Virginia."
Answered by AI
With Tisotumab Vedotin having completed Phase 1 clinical trials, are there plans to move onto larger testing?
"Tisotumab Vedotin was first studied 18 years ago in 2002. Since then, there have been a total of 1953 completed clinical trials. Out of those, 1912 are currently ongoing with many of them based in Philadelphia, Pennsylvania."
Answered by AI
Across how many distinct locations is this experiment being conducted?
"There are a total of 19 sites running this trial, with the primary locations being Fox Chase Cancer Center in Philadelphia, Pennsylvania, Carilion Clinic in Roanoke, Virginia and University of Kansas Medical Center in Westwood, Kansas."
Answered by AI
Are subjects still needed for this test?
"According to the latest information available on clinicaltrials.gov, this research is currently seeking participants. The study was originally posted on February 27th, 2019 and last updated on November 15th, 2020."
Answered by AI
What are the FDA-approved indications for Tisotumab Vedotin?
"Tisotumab Vedotin is most often administered as a treatment for malignant neoplasms. Additionally, this medication can be used to manage unresectable melanoma, microsatellite instability high, and locally advanced nonsquamous non-small cell lung cancer."
Answered by AI
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