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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03485209
Other study ID # SGNTV-001
Secondary ID 2017-005076-26KE
Status Recruiting
Phase Phase 2
First received
Last updated
Start date June 25, 2018
Est. completion date November 30, 2026

Study information

Verified date June 2024
Source Seagen Inc.
Contact Seagen Trial Information Support
Phone 8663337436
Email clinicaltrials@seagen.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 692
Est. completion date November 30, 2026
Est. primary completion date April 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 - 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 is closed to enrollment. Part F and 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 - 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 - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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

Locations

Country Name City State
Canada University of Alberta / Cross Cancer Institute Edmonton Alberta
France Hospitalier Jean Minjoz Besancon Other
France Centre léon Bérard LYON cedex 08 Other
France APHM Hôpital Nord Marseille Cedex 20 Other
France Hopital Prive du Confluent Nantes Cedex 2 Other
France Hopital Foch Suresnes Other
France Institut Gustave Roussy Villejuif Cedex Other
Germany Ruhr-Uni. Bochum, St. Josef-Hospital Bochum Other
Germany Universitätsklinikum Halle-Universitätsklinik und Poliklinik Halle Other
Germany Vincentius-Diakonissen-Kliniken gAG Karlsruhe Other
Italy Azienda Ospedaliera Spedali Civili di Brescia Brescia Other
Italy Azienda Ospedaliero Universitaria (AOU) Master Domin U.O. Oncologia Medica Traslazzionale Catanzaro Other
Italy IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori- IRST S.r.l Meldola FC Other
Italy Istituto Europeo di Oncologia Milano Other
Italy Seconda Università degli Studi di Napoli, AOU Napoli Other
Italy Azienda USL Toscana Centro Pistoia Other
Italy Oncologia Medica, Ospedale Civile S. Maria delle Croci Ravenna Other
Italy PU Campus Bio-medico di Roma Roma Other
Puerto Rico Pan American Center for Oncology Trials, LLC Rio Piedras
Spain Hospital Universitari Germans Trias i Pujol Badalona Other
Spain Hospital Quironsalud Barcelona Instituto Oncologico Baselga Barcelona Other
Spain Hospital Universitari Vall d'Hebron Barcelona Other
Spain HM Centro Integral Oncologico Clara Campal Madrid Other
Spain Hospital Universitario Ramon y Cajal Servicio de Oncologia Medica Oficina de Ensayos Clinicos Madrid Other
Spain Althaia Xarxa Assistencial Manresa Manresa Other
Spain Son LLatzer University Hospital Palma de Mallorca Other
United Kingdom Guys and St Thomas Hospital London Other
United States University Cancer & Blood Center, LLC Athens Georgia
United States Winship Cancer Institute / Emory University School of Medicine Atlanta Georgia
United States Johns Hopkins Hospital Baltimore Maryland
United States Dana Farber Cancer Institute Boston Massachusetts
United States UNC Lineberger Comprehensive Cancer Center / University of North Carolina Chapel Hill North Carolina
United States University of Virginia Charlottesville Virginia
United States Northwestern Memorial Hospital Chicago Illinois
United States University of Chicago Medical Center Chicago Illinois
United States Texas Oncology - Fort Worth Dallas Texas
United States Northwestern Medicine Cancer Center Kishwaukee / Kishwaukee Cancer Center DeKalb Illinois
United States Karmanos Cancer Institute / Wayne State University Detroit Michigan
United States Duke University Medical Center Durham North Carolina
United States University of Kansas Cancer Center Fairway Kansas
United States Poudre Valley Health System (PVHS) Fort Collins Colorado
United States Shands Cancer Center / University of Florida Gainesville Florida
United States Northwestern Medicine Cancer Center Delnor Geneva Illinois
United States Ingalls Cancer Care / Ingalls Memorial Hospital Harvey Illinois
United States MD Anderson Cancer Center / University of Texas Houston Texas
United States Community Health Network Indianapolis Indiana
United States UC San Diego / Moores Cancer Center La Jolla California
United States Norton Cancer Institute Louisville Kentucky
United States Joe Arrington Cancer Research and Treatment Center Lubbock Texas
United States Yale Cancer Center New Haven Connecticut
United States Memorial Sloan Kettering Cancer Center New York New York
United States Weill Cornell Medicine New York New York
United States University of Pennsylvania / Perelman Center for Advanced Medicine Philadelphia Pennsylvania
United States Oregon Health and Science University Portland Oregon
United States Rhode Island Hospital Providence Rhode Island
United States University of California Davis Sacramento California
United States Washington University in St Louis Saint Louis Missouri
United States HealthPartners Institute Saint Louis Park Minnesota
United States Stanford Cancer Center / Blood and Marrow Transplant Program San Jose California
United States Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington Seattle Washington
United States H. Lee Moffitt Cancer Center and Research Institute Tampa Florida
United States Renovatio Clinical The Woodlands Texas
United States Northwestern Medicine Cancer Center Warrenville Warrenville Illinois
United States Wake Forest Baptist Medical Center / Wake Forest University Winston-Salem North Carolina

Sponsors (3)

Lead Sponsor Collaborator
Seagen Inc. Genmab, Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Italy,  Puerto Rico,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Confirmed Objective Response Rate (ORR) (Parts A, B, C, D, F, and G) Proportion of patients who achieve a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by the investigator Up to approximately 3 years
Primary Confirmed ORR per blinded independent central review (BICR) (Part E) Proportion of patients who achieve a confirmed CR or PR according to RECIST v1.1 as assessed by BICR Up to approximately 3 years
Secondary Incidence of Adverse Events (AEs) Type, severity, and relatedness of adverse events. An AE is any untoward medical occurrence in a subject or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Up to approximately 3 years
Secondary Confirmed and Unconfirmed ORR Proportion of patients who achieve a CR or PR according to RECIST v1.1 as assessed by the investigator Up to approximately 3 years
Secondary Confirmed and Unconfirmed ORR per BICR (Part E) Proportion of patients who achieve a CR or PR according to RECIST v1.1 as assessed by BICR Up to approximately 3 years
Secondary Disease Control Rate (DCR) Proportion of patients who achieve a confirmed CR or PR according to RECIST v1.1 as assessed by the investigator, or meet the stable disease (SD) criteria at least once after start of study treatment at a minimum interval of 12 weeks Up to approximately 3 years
Secondary DCR per BICR (Part E) Proportion of patients who achieve a confirmed CR or PR according to RECIST v1.1 as assessed by BICR, or meet the stable disease (SD) criteria at least once after start of study treatment at a minimum interval of 12 weeks Up to approximately 3 years
Secondary Duration of Response (DOR) Time from the first documentation of objective response to the first documentation of PD or death due to any cause, whichever comes first, as assessed by the investigator Up to approximately 3 years
Secondary DOR per BICR (Part E) Time from the first documentation of objective response to the first documentation of PD or death due to any cause, whichever comes first, as assessed by BICR Up to approximately 3 years
Secondary Time to Response (TTR) Time from the start of study treatment to the first documentation of objective response, as assessed by investigator Up to approximately 1 year
Secondary TTR per BICR (Part E) Time from the start of study treatment to the first documentation of objective response, as assessed by BICR Up to approximately 1 year
Secondary Progression-free survival (PFS) Time from the start of study treatment to the first documentation of PD according to RECIST v1.1 or death due to any cause, whichever comes first, as assessed by the investigator Up to approximately 3 years
Secondary PFS per BICR (Part E) Time from the start of study treatment to the first documentation of PD according to RECIST v1.1 or death due to any cause, whichever comes first, as assessed by BICR Up to approximately 3 years
Secondary Overall Survival (OS) Time from the start of study treatment to date of death due to any cause Up to approximately 4 years
Secondary Cmax Maximum observed plasma concentration Through 30-37 days following the last dose; up to approximately 3 years
Secondary Ctrough Observed plasma concentration at the end of the dosing interval Through 30-37 days following the last dose; up to approximately 3 years
Secondary Incidence of anti-therapeutic antibodies (ATAs) Through 30-37 days following the last dose; up to approximately 3 years
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