NCT03485209

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 352 (actual)
• Sponsor: Seagen, a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

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).

Conditions

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

Interventions

Type	Name	Description
DRUG	tisotumab vedotin	Given into the vein (IV; intravenously)
DRUG	pembrolizumab	200mg or 400mg given by IV
DRUG	carboplatin	AUC 5mg/mL per minute or AUC 3.3mg/mL per minute given by IV
DRUG	cisplatin	100mg/m\^2 given by IV

Timeline

• Start date: 2018-06-25
• Primary completion: 2026-03-23
• Completion: 2027-03-31
• First posted: 2018-04-02
• Last updated: 2026-04-07

Locations

173 sites across 7 countries: United States, Canada, France, Germany, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated drug study