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Clinical Trials in the UK / NCT03485209
Active, not recruiting Phase 2

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

NCT03485209 · tracked via the Priya Life Science UK tracker
Sponsor
Seagen, a wholly owned subsidiary of Pfizer
Phase
Phase 2
Started
2018-06-25
Last updated
2026-07-22

Condition(s) studied

Colorectal NeoplasmsCarcinoma, Non-Small-Cell LungExocrine Pancreatic CancerCarcinoma, Squamous Cell of Head and Neck

Investigational drug(s) / intervention(s)

tisotumab vedotinpembrolizumabcarboplatincisplatin

tisotumab vedotin: Given into the vein (IV; intravenously)

pembrolizumab: 200mg or 400mg given by IV

carboplatin: AUC 5mg/mL per minute or AUC 3.3mg/mL per minute given by IV

cisplatin: 100mg/m\^2 given by IV

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Parts A, B, and C * Relapsed, locally-advanced or metastatic colorectal or pancreatic cancer, sqNSCLC, or HNSCC participants who are not candidates for standard therapy. * All participants must have experienced disease progression on or after their most recent systemic therapy. * Colorectal cancer (closed to enrollment): participants must have received prior therapy with each of following agents, if eligible: a fluoropyrimidine, oxaliplatin, irinotecan, and/or bevacizumab. Participants should have received no more than 3 systemic regimens in the metastatic setting. * sqNSCLC (closed to enrollment): Participants with NSCLC must have predominant squamous histology. Participants must have received prior therapy with a platinum-based treatment and a checkpoint inhibitor (CPI), if eligible. Participants should have received no more than 3 lines of systemic therapy in the metastatic setting. * Participants eligible for a tyrosine kinase inhibitor should have received such therapy. These participants should have received no more than 4 lines of systemic therapy in the metastatic setting. * Exocrine pancreatic adenocarcinoma (closed to enrollment): Participants with exocrine pancreatic adenocarcinoma must have predominant adenocarcinoma histology. Participants must have received prior therapy with a gemcitabine-based or 5FU-based regimen, if eligible, and should have received no more than 1 systemic regimen in the unresectable or metastatic setting. * HNSCC (closed to enrollment): Participants with HNSCC in Part C must have received prior therapy with a platinum-based regimen and/or a checkpoint inhibitor (CPI), if eligible, and must have experienced disease progression following such therapy. Participants should have received no more than 3 systemic lines of therapy in the recurrent or metastatic setting. * Part E * Part E is closed to enrollment. * Participants with HNSCC must have experienced disease progression on or after their most recent systemic therapy. Participants should have received no more than 1 or 2 systemic lines of therapy in the recurrent/metastatic setting as specified below. Participants must have received a platinum-based regimen and a PD-(L)1 inhibitor. * Parts D, F, and G * Part D and F are closed to enrollment. Part G will enroll only participants with HNSCC. * Participants with HNSCC must have received no previous systemic therapy in the recurrent or metastatic disease setting. * Part D only * Participants with NSCLC must have histologically or cytologically documented squamous cell NSCLC and must have received no previous systemic therapy for metastatic disease or radiation therapy to the lung that is \> 30 Gy within 6 months of the first dose of study treatment. * PD-L1 biomarker expression as determined by a PD-L1 IHC assay should be available * Part F only * Participants must have CPS ≥1 by local PD-L1 IHC assay to be eligible for enrollment. Participants must be able to submit a tissue sample for retrospective PD-L1 testing. Tissue may be fresh biopsy or archival, collected within 2 years of Cycle 1 Day 1. * Part G only * Part G cohort was not opened. * Non-EU eligibility criteria: No CPS requirement for the cohort evaluating tisotumab vedotin in combination with pembrolizumab and carboplatin. * EU-specific eligibility criteria: Participants must have a CPS ≥1 by local PD-L1 IHC assay. * Participants must be able to submit a tissue sample for retrospective PD-L1 testing. Tissue may be fresh biopsy or archival, collected within 2 years of Cycle 1 Day 1. * Baseline measurable disease as measured by RECIST v1. 1. * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1. Exclusion Criteria: * Participants with primary neuroendocrine or sarcomatoid histologies. For HNSCC, participants may not have a primary site of nasopharynx or salivary gland. * Active bleeding conditions * Clinically significant cardiac disease including stable angina, acute myocardial infraction 6 months prior to screening * Ocular surface disease at the time of enrollment (Note: cataract is not considered active ocular surface disease for this protocol) * Other cancer: known past or current malignancy other than inclusion diagnosis. * Uncontrolled tumor-related pain * Inflammatory lung disease. Participants with pulmonary disease are allowed if systemic steroids and long-term oxygen are not required * Peripheral neuropathy greater than or equal to Grade 2 * Active brain metastasis * Ongoing clinically significant toxicity associated with prior treatment (including radiotherapy or surgery). * Part D, F, and G Only: Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor.

Primary outcome measure(s)

Trial sites (175)

FacilityCityRegionStatus
UCSD Medical Center - Encinitas Encinitas California
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion) La Jolla California
UC San Diego Moores Cancer Center La Jolla California
UCSD Koman Family Outpatient Pavilion La Jolla California
UC San Diego/Moores Cancer Center La Jolla California
UCSD Shiley Eye Institute La Jolla California
University of California Davis Medical Center Sacramento California
University of California, Davis Comprehensive Cancer Center Sacramento California
UC San Diego Medical Center- Hillcrest San Diego California
UC San Diego Health - Rancho Bernardo San Diego California
Stanford Cancer Center South Bay San Jose California
UCSD Medical Center - Vista Vista California
Poudre Valley Hospital Fort Collins Colorado
Eye Center of Northern Colorado Fort Collins Colorado
Cancer Care & Hematology - Fort Collins Fort Collins Colorado
Eye Center of Northern Colorado Fort Collins Colorado
Cancer Care & Hematology - Greeley Greeley Colorado
Cancer Care & Hematology - Loveland Loveland Colorado
Simlow Cancer Hospitalat Yale-New Haven New Haven Connecticut
Yale-New Haven Hospital- Yale Cancer Center New Haven Connecticut
C/O Thomas Ferenez.RPh,BCOP,Smilow Cancer Hospital at Yale-New Haven New Haven Connecticut
Family Focus Eye Care - Gainesville Gainesville Florida
UF Health Davis Cancer Pavilion and Shands Med Plaza Gainesville Florida
UF Health Shands Cancer Hospital Gainesville Florida
UF Health Shands Hospital Gainesville Florida
Family Focus Eye Care - Lake City Lake City Florida
Moffitt Cancer Center McKinley Hospital Tampa Florida
Moffitt Cancer Center Tampa Florida
Richard M Schulze Family Foundation Outpatient Center at McKinley Campus Tampa Florida
Emory University Hospital Midtown Atlanta Georgia
Emory University Hospital Atlanta Georgia
Investigational Drug Service, Emory University Clinic Atlanta Georgia
The Emory Clinic Atlanta Georgia
Winship Cancer Institute, Emory University Atlanta Georgia
Northwestern Medical Group Chicago Illinois
Northwestern Memorial Hospital Chicago Illinois
UChicago Medicine - River East Chicago Illinois
University of Chicago Medical Center Chicago Illinois
Northwestern Medicine Cancer Center Kishwaukee DeKalb Illinois
Northwestern Medicine Kishwaukee Hospital DeKalb Illinois

+ 135 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03485209 on ClinicalTrials.gov ↗ ← All trials in the UK