Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors (NCT03485209)
Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or Metastatic Disease in Solid Tumors
🩺 Plain-English Summary (8th-Grade Level)
This trial will study tisotumab vedotin to find out whether it is an effective treatment alone or with other anticancer drugs for certain solid tumors and what side effects (unwanted effects) may occur. There are seven parts to this study. * In Part A, participants will receive tisotumab vedotin 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. The objectives of the study have been achieved. Therefore, the study will transition to a long-term extension phase (LTEP). * In LTEP, participants still receiving clinical benefit based on the investigator's assessment and remaining on treatment may continue receiving treatment. * Participants will still receive tisotumab vedotin with either: * Pembrolizumab or, * Pembrolizumab and carboplatin, or * Pembrolizumab and cisplatin
Who can join: Review the eligibility criteria below.
Location: UCSD Medical Center - Encinitas — Encinitas, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (175 Sites)
Showing the first 25 of 175 sites.
- UCSD Medical Center - Encinitas — Encinitas, California
- UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion) — La Jolla, California
- UC San Diego Moores Cancer Center — La Jolla, California
- UCSD Koman Family Outpatient Pavilion — La Jolla, California
- UC San Diego/Moores Cancer Center — La Jolla, California
- UCSD Shiley Eye Institute — La Jolla, California
- University of California Davis Medical Center — Sacramento, California
- University of California, Davis Comprehensive Cancer Center — Sacramento, California
- UC San Diego Medical Center- Hillcrest — San Diego, California
- UC San Diego Health - Rancho Bernardo — San Diego, California
- Stanford Cancer Center South Bay — San Jose, California
- UCSD Medical Center - Vista — Vista, California
- Poudre Valley Hospital — Fort Collins, Colorado
- Eye Center of Northern Colorado — Fort Collins, Colorado
- Cancer Care & Hematology - Fort Collins — Fort Collins, Colorado
- Eye Center of Northern Colorado — Fort Collins, Colorado
- Cancer Care & Hematology - Greeley — Greeley, Colorado
- Cancer Care & Hematology - Loveland — Loveland, Colorado
- Simlow Cancer Hospitalat Yale-New Haven — New Haven, Connecticut
- Yale-New Haven Hospital- Yale Cancer Center — New Haven, Connecticut
- C/O Thomas Ferenez.RPh,BCOP,Smilow Cancer Hospital at Yale-New Haven — New Haven, Connecticut
- Family Focus Eye Care - Gainesville — Gainesville, Florida
- UF Health Davis Cancer Pavilion and Shands Med Plaza — Gainesville, Florida
- UF Health Shands Cancer Hospital — Gainesville, Florida
- UF Health Shands Hospital — Gainesville, Florida
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.