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Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors
NCT03485209 · View on ClinicalTrials.gov ↗
Study Summary
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
Conditions Studied
Interventions
- DRUG pembrolizumab
- DRUG cisplatin
- DRUG carboplatin
- DRUG tisotumab vedotin
Study Locations (20)
California
- UCSD Medical Center - Encinitas — Encinitas
- UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion) — La Jolla
- UC San Diego Moores Cancer Center — La Jolla
- UCSD Koman Family Outpatient Pavilion — La Jolla
- UC San Diego/Moores Cancer Center — La Jolla
- UCSD Shiley Eye Institute — La Jolla
- University of California Davis Medical Center — Sacramento
- University of California, Davis Comprehensive Cancer Center — Sacramento
- UC San Diego Medical Center- Hillcrest — San Diego
- UC San Diego Health - Rancho Bernardo — San Diego
- Stanford Cancer Center South Bay — San Jose
- UCSD Medical Center - Vista — Vista
Colorado
- Poudre Valley Hospital — Fort Collins
- Eye Center of Northern Colorado — Fort Collins
- Cancer Care & Hematology - Fort Collins — Fort Collins
- Eye Center of Northern Colorado — Fort Collins
- Cancer Care & Hematology - Greeley — Greeley
- Cancer Care & Hematology - Loveland — Loveland
Connecticut
- Simlow Cancer Hospitalat Yale-New Haven — New Haven
- Yale-New Haven Hospital- Yale Cancer Center — New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 352 participants |
| Start Date | 2018-06-25 |
| Est. Completion | 2027-03-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03485209
The ClinicalTrials.gov registry entry for NCT03485209 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 352 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seagen, a wholly owned subsidiary of Pfizer, which has 51 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Carcinoma, Non-Small-Cell Lung appearing as the primary indexed condition, and to 4 interventions — of which pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03485209 reports 20 study locations spanning 3 distinct geographic areas — top geographies include California, Colorado, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03485209 about?
NCT03485209 is a clinical study titled "Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors". 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 ev...
What is the current status of trial NCT03485209?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 352 participants. The study started on 2018-06-25. Estimated completion is 2027-03-31.
What conditions does trial NCT03485209 study?
This clinical trial studies the following conditions: Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Carcinoma, Squamous Cell of Head and Neck, Exocrine Pancreatic Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03485209?
The interventions under investigation include: pembrolizumab (DRUG), cisplatin (DRUG), carboplatin (DRUG), tisotumab vedotin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03485209?
This trial is sponsored by Seagen, a wholly owned subsidiary of Pfizer, which has 51 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03485209 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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