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NCT03485209 · ClinicalTrials.gov registry record · Phase 2

Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors

A Phase 2 study of Carcinoma, Non-Small Cell Lung and Colorectal Neoplasms, sponsored by Seagen, a wholly owned subsidiary of Pfizer.

Active
Registry status
Phase 2
Development phase
352
Enrollment target
20
Study locations

NCT03485209 is a Phase 2 study of Carcinoma, Non-Small Cell Lung and Colorectal Neoplasms that is active but no longer recruiting, run by Seagen, a wholly owned subsidiary of Pfizer. The registered enrollment target is 352 participants, above the 321-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (10% higher). The trial reports 20 study locations across 3 states.

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The verdict

NCT03485209, a Phase 2 study of Carcinoma, Non-Small Cell Lung and Colorectal Neoplasms, is active but no longer recruiting, sponsored by Seagen, a wholly owned subsidiary of Pfizer.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
352 participants
Enrollment target
20
Study locations

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

Carcinoma, Non-Small Cell Lung Colorectal Neoplasms Carcinoma, Squamous Cell of Head and Neck Exocrine Pancreatic Cancer

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

FieldValue
Enrollment Target 352 participants
Start Date 2018-06-25
Est. Completion 2027-03-31
Phase Phase 2

Sponsor

Seagen, a wholly owned subsidiary of Pfizer

28 total trials

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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, categorized as Phase 2. The registered enrollment target is 352 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 321-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (10% higher). The listed sponsor is Seagen, a wholly owned subsidiary of Pfizer, which has 28 total studies on file at ClinicalTrials.gov.

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.

NCT03485209 reports 20 study locations spanning 3 distinct geographic areas - top geographies include California, Colorado, Connecticut.

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.

What interventions are being tested in trial NCT03485209?

The interventions under investigation include: pembrolizumab (DRUG), cisplatin (DRUG), carboplatin (DRUG), tisotumab vedotin (DRUG).

Who is sponsoring clinical trial NCT03485209?

This trial is sponsored by Seagen, a wholly owned subsidiary of Pfizer, which has 28 total clinical trials registered on ClinicalTrials.gov.

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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.