Purpose of this Study
We are doing this study to find the most effective, safe dose of an experimental drug called tisotumab vedotin (the study drug). We want to know how well this study drug works in people with squamous cell cancer of the head and neck (SCCHN) when it is given in combination with other anti-cancer drugs (pembrolizumab and carboplatin).
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with SCCHN
- Have had their disease progress during or after their most recent therapy
For more information about who can join this study, please contact the study team at 919-684-1573.
- Are diagnosed with SCCHN
- Have had their disease progress during or after their most recent therapy
For more information about who can join this study, please contact the study team at 919-684-1573.
What is Involved?
If you choose to join this study, you will go through a screening period to find out if you are eligible. During this screening period, you will:
- Have a physical exam
- Have an eye Exam
- Have a heart scan (ECG)
- Have blood draws
- Get a chest x-ray
If you are eligible based on screening, you will proceed to the study drug regimen portion of the study. Duke is participating in Parts E, F, and G of this study. The part of the study in which you participate will depend on when you join the study.
The study drug regimens for the different parts of the study are as follows:
- Part E: you will get the study drug once every 2 weeks for 4 weeks (28-day cycles)
- Part F: you will get the study drug once every 2 weeks and pembrolizumab once every 6 weeks.
- Part G: you will get the study drug and carboplatin once every 2 weeks and pembrolizumab every 6 weeks.
If you are in Parts F or G, you can keep getting pembrolizumab up to 18 times, which will take about 2 years. You may only get carboplatin up to 6 times.
After you have stopped your study regimen, we will ask you to have follow-up phone calls about every 12 weeks or so to see how you are doing.
- Have a physical exam
- Have an eye Exam
- Have a heart scan (ECG)
- Have blood draws
- Get a chest x-ray
If you are eligible based on screening, you will proceed to the study drug regimen portion of the study. Duke is participating in Parts E, F, and G of this study. The part of the study in which you participate will depend on when you join the study.
The study drug regimens for the different parts of the study are as follows:
- Part E: you will get the study drug once every 2 weeks for 4 weeks (28-day cycles)
- Part F: you will get the study drug once every 2 weeks and pembrolizumab once every 6 weeks.
- Part G: you will get the study drug and carboplatin once every 2 weeks and pembrolizumab every 6 weeks.
If you are in Parts F or G, you can keep getting pembrolizumab up to 18 times, which will take about 2 years. You may only get carboplatin up to 6 times.
After you have stopped your study regimen, we will ask you to have follow-up phone calls about every 12 weeks or so to see how you are doing.
Study Details
Full Title
Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or Metastatic Disease in Solid Tumors
Principal Investigator
Jameel
Muzaffar
Protocol Number
PRO00113985
NCT ID
NCT03485209
Phase
II
Enrollment Status
Open to Enrollment