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


Active: Yes
Cancer Type: Colon/Rectal Cancer NCT ID: NCT03485209
Trial Phases: Phase II Protocol IDs: SGNTV-001 (primary)
NCI-2018-00676
Eligibility: 18 Years and older, Male and Female Study Type: Treatment
Study Sponsor: Seagen Inc.
NCI Full Details: http://clinicaltrials.gov/show/NCT03485209

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, 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.

Objectives

The primary goal of this trial is to assess the activity, safety, and tolerability of
tisotumab vedotin for the treatment of selected solid tumors. Patients will be treated
with single agent tisotumab vedotin or tisotumab vedotin in combination with other
anticancer agents. Patients who meet eligibility criteria will be enrolled into cohorts
based on tumor type. Tumor types to be evaluated include colorectal cancer, squamous
non-small cell lung cancer (sqNSCLC), exocrine pancreatic adenocarcinoma, and head and
neck squamous cell carcinoma (HNSCC).

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.