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Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or Metastatic Disease in Solid Tumors

  • Protocol Number: 202303002
  • Principal Investigator: Adkins, Douglas
  • Cancer Types: Head & Neck

Learn more about this study at: clinicaltrials.gov

For more information on this trial, contact us here:

Phone
800-600-3606
Email
[email protected]

Brief Summary

This trial will study tisotumab vedotin to find out whether it is an effective treatment for certain solid tumors and what side effects (unwanted effects) may occur. There are seven parts to this study.

In Part A, the treatment will be given to participants every 3 weeks (3-week cycles).
In Part B, participants will receive tisotumab vedotin on Days 1, 8, and 15 every 4-week cycle.
In Part C, participants will receive tisotumab vedotin on Days 1 and 15 of every 4-week cycle.

In Part D, participants will be given treatment on Day 1 of every 3-week cycle. Participants in Part D will get tisotumab vedotin with either:

Pembrolizumab or,
Pembrolizumab and carboplatin, or
Pembrolizumab and cisplatin
In Part E, participants will receive tisotumab vedotin on Days 1 and 15 of every 4-week cycle.
In Part F, participants will receive tisotumab vedotin on Days 1, 15, and 29 of every 6-week cycle. Participants in Part F will get tisotumab vedotin with pembrolizumab.
In Part G, participants will receive tisotumab vedotin on Days 1, 15, and 29 of every 6-week cycle. Participants in Part G will get tisotumab vedotin with pembrolizumab and carboplatin.

Protocol Interventions

tisotumab vedotin, pembrolizumab, carboplatin, cisplatin