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

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

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

Interventions

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

Sponsors & Collaborators

• Genmab

  collaborator INDUSTRY

• Merck Sharp & Dohme LLC

  collaborator INDUSTRY

• Seagen, a wholly owned subsidiary of Pfizer

  lead INDUSTRY

Principal Investigators

• Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-06-25

Primary Completion

2026-03-20

Completion

2027-03-31

FDA Drug

Yes

Countries

• United States
• Canada
• France
• Germany
• Italy
• Spain
• United Kingdom

Study Locations