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New drug combo shows promise for Tough-to-Treat cancers

NCT ID NCT03485209

Disease control Sponsor: Seagen, a wholly owned subsidiary of Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 23, 2026 · Updated 2 times

Summary

This study tests a drug called tisotumab vedotin, alone or with other cancer medicines, in people with advanced colorectal, lung, pancreatic, or head and neck cancers that have stopped responding to standard treatments. About 350 participants receive different dosing schedules to see if the drug shrinks tumors and what side effects occur. The goal is to control the disease, not cure it.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

350 people

The number who actually took part.

Started

Jun 2018

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm exocrine pancreatic carcinoma Head and Neck Neoplasms head and neck squamous cell carcinoma malignant exocrine pancreas neoplasm non-small cell lung carcinoma non-small cell squamous lung carcinoma pancreatic adenocarcinoma pancreatic neoplasm Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carcinoma, non-small-cell lung Carcinoma, squamous cell of head and neck Colorectal neoplasms Exocrine pancreatic cancer

Contacts and locations

Locations

  • ALTHAIA, Xarxa Assistencial Universitaria de Manresa.

    Manresa, Barcelona, 08243, Spain

  • AOU Università degli studi della Campania Luigi Vanvitelli, Policlinico di Napoli

    Naples, 80131, Italy

  • Atrium Health Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157, United States

  • Atrium Health Wake forest Baptist

    Winston-Salem, North Carolina, 27157, United States

  • Azienda Ospedaliera Universitaria - Universita della Campania Luigi Vanvitelli

    Naples, 80131, Italy

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • C/O Thomas Ferenez.RPh,BCOP,Smilow Cancer Hospital at Yale-New Haven

    New Haven, Connecticut, 06511, United States

  • CEPCM/CHU Timone, Batiment 3 -1er etage

    Marseille, 13005, France

  • CHRU de Besançon- Hopital Jean Minjoz

    Besançon, Doubs, 25030, France

  • Cancer Care & Hematology - Fort Collins

    Fort Collins, Colorado, 80528, United States

  • Cancer Care & Hematology - Greeley

    Greeley, Colorado, 80634, United States

  • Cancer Care & Hematology - Loveland

    Loveland, Colorado, 80538, United States

  • Cancer Center IDS Pharmacy

    Charlottesville, Virginia, 22903, United States

  • Clinical Research Facility - Clinical Research Facility

    London, London, CITY of, SE1 9RT, United Kingdom

  • Community Health Network, Inc.

    Indianapolis, Indiana, 46219, United States

  • Community Health Network, Inc.

    Indianapolis, Indiana, 46227, United States

  • Community Health Network, Inc.

    Indianapolis, Indiana, 46250, United States

  • Community Health Network, Inc.

    Indianapolis, Indiana, 46256, United States

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2, Canada

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Duke Cancer Center

    Durham, North Carolina, 27710, United States

  • Duke Raleigh Hospital

    Raleigh, North Carolina, 27609, United States

  • Emory University Hospital

    Atlanta, Georgia, 30322, United States

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308, United States

  • Eye Center of Northern Colorado

    Fort Collins, Colorado, 80525, United States

  • Eye Center of Northern Colorado

    Fort Collins, Colorado, 80528, United States

  • Family Focus Eye Care - Gainesville

    Gainesville, Florida, 32605, United States

  • Family Focus Eye Care - Lake City

    Lake City, Florida, 32025, United States

  • Farmacia Oncologica c/o Ospedale S.Maria delle Croci-AUSL Romagna

    Ravenna, 48121, Italy

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109, United States

  • Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca

    Barcelona, 08035, Spain

  • Fundación Privada Instituto de Investigación Oncológica Vall d'Hebron (hereinafter "VHIO")

    Barcelona, 08035, Spain

  • Gustave Roussy

    Villejuif, 94805, France

  • Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital

    London, London, CITY of, Se1 9Rt, United Kingdom

  • Guys and St Thomas Hospital

    London, Other, SE1 9RT, United Kingdom

  • Hopital prive du Confluent S.A.S.

    Nantes, 44277, France

  • Hospital Quiron Salud Barcelona Plaza

    Barcelona, 08023, Spain

  • Hospital Quironsalud Barcelona Instituto Oncologico Baselga

    Barcelona, Catalonia, 08023, Spain

  • Hospital Universitario Dexeus - Grupo Quirónsalud

    Barcelona, 08028, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Hôpital Foch

    Suresnes, 92150, France

  • Hôpital Foch Pharmacie - Essais Cliniques

    Suresnes, 92150, France

  • IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori- IRST S.r.l

    Meldola (Fc), Emilia-Romagna, 47014, Italy

  • IRST IRCCS - Farmacia Oncologica

    Meldola (FC), Forli-cesena, 47014, Italy

  • Ingalls Family Care Center (Infusion Center)

    Flossmoor, Illinois, 60422, United States

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426, United States

  • Institut Catala D 'Oncologia-Hospital Germans Trias I Pujol,Servicio de Oncologia Medica

    Barcelona, Badalona, 08916, Spain

  • Institut Catala d'Oncologia (ICO BADALONA)

    Barcelona, 08908, Spain

  • Investigational Chemotherapy Service

    Durham, North Carolina, 27710, United States

  • Investigational Drug Service, Emory University Clinic

    Atlanta, Georgia, 30322, United States

  • Istituto Europeo di Oncologia

    Milan, MI, 20141, Italy

  • Joe Arrington Cancer Research and Treatment Center

    Lubbock, Texas, 79410, United States

  • John Hopkins Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21231, United States

  • John Hopkins Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21287, United States

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Karmanos Cancer Institute Weisberg Cancer Treatment Center

    Farmington Hills, Michigan, 48334, United States

  • L'hôpital Privé du Confluent - Pharmacie

    Nantes, 44277, France

  • LBM UNIBIO Jean Herve Lebras

    Tain-l'Hermitage, 26600, France

  • Laboratoire Cerballiance Portes Les Valence

    Portes-lès-Valence, 26800, France

  • Laboratoire Oriade Noviale Medipole

    Bourgoin, 38300, France

  • Laboratoire Oriade Noviale Tixier

    Bourgoin, 38300, France

  • Laboratoire Trevoux-Dyomedea Neolab

    Trévoux, 01600, France

  • Lbmms Du Chu de Lyon

    Lyon, 69424 CEDEX 03, France

  • MSK Basking Ridge.

    Basking Ridge, New Jersey, 07920, United States

  • MSK Bergen

    Montvale, New Jersey, 07645, United States

  • MSK Commack.

    Commack, New York, 11725, United States

  • MSK Monmouth

    Middletown, New Jersey, 07748, United States

  • MSK Nassau.

    Uniondale, New York, 11553, United States

  • MSK Westchester.

    Harrison, New York, 10604, United States

  • Massachusetts Eye and Ear Infirmary(MEEI)

    Boston, Massachusetts, 02114, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905, United States

  • Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).

    New York, New York, 10021, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Moffitt Cancer Center McKinley Hospital

    Tampa, Florida, 33612, United States

  • North Carolina Basnight Cancer Hospital Infusion Pharmacy

    Chapel Hill, North Carolina, 27514, United States

  • Northwestern Medical Group

    Chicago, Illinois, 60611, United States

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134, United States

  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, 60115, United States

  • Northwestern Medicine Cancer Center Warrenville

    Warrenville, Illinois, 60555, United States

  • Northwestern Medicine Delnor Hospital

    Geneva, Illinois, 60134, United States

  • Northwestern Medicine Kishwaukee Hospital

    DeKalb, Illinois, 60115, United States

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611, United States

  • Northwestern University

    Evanston, Illinois, 60208, United States

  • Norton Audubon Hospital

    Louisville, Kentucky, 40217, United States

  • Norton Brownsboro Hospital

    Louisville, Kentucky, 40241, United States

  • Norton Cancer Institute Pharmacy

    Louisville, Kentucky, 40202, United States

  • Norton Cancer Institute, Audubon Hospital Campus

    Louisville, Kentucky, 40217, United States

  • Norton Cancer Institute, Brownsboro Hospital Campus

    Louisville, Kentucky, 40241, United States

  • Norton Cancer Institute, Downtown

    Louisville, Kentucky, 40202, United States

  • Norton Hospital

    Louisville, Kentucky, 40202, United States

  • OHSU Center for Health and Healing

    Portland, Oregon, 97239, United States

  • OHSU Center for Health and Healing 2

    Portland, Oregon, 97239, United States

  • OHSU Knight Cancer Institute, Beaverton

    Beaverton, Oregon, 97006, United States

  • OHSU Knight Cancer Institute, East Portland

    Portland, Oregon, 97216, United States

  • OHSU Knight Cancer Institute, Gresham

    Gresham, Oregon, 97030, United States

  • OHSU Knight Cancer Institute, Northwest Portland

    Portland, Oregon, 97210, United States

  • OHSU Knight Cancer Institute, Tualatin

    Tualatin, Oregon, 97062, United States

  • Oncologia Medica, Ospedale Civile S. Maria delle Croci

    Ravenna, Emilia-Romagna, 48121, Italy

  • Oncology Research, HealthPartners Institute

    Saint Louis Park, Minnesota, 55426, United States

  • Ophthalmic Consultants of Boston Inc (OCB)

    Boston, Massachusetts, 02114, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Oregon Health and Science University Research Pharmacy Services

    Portland, Oregon, 97239, United States

  • Ospedale Cervesi di Cattolica-AUSL Romagna

    Cattolica, RN, 47841, Italy

  • Ospedale S.Jacopo di Pistoia, AUSL Toscana centro, SST

    Pistoia, 51100, Italy

  • Ospedale Umberto I di Lugo, AUSL della Romagna, SSR Emilia-Romagna

    Lugo, 48022, Italy

  • Ospedale degli Infermi -AUSL Romagna

    Rimini, RN, 47923, Italy

  • PO Ospedale degli Infermi Faenza, AUSL Romagna

    Faenza, 48018, Italy

  • Park Nicollet Frauenshuh Cancer Center

    Saint Louis Park, Minnesota, 55426, United States

  • Pharmacy Stores (CCR5916) - The Royal Marsden

    Sutton, Surrey, SM2 5PT, United Kingdom

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524, United States

  • Primary Healthcare Associates

    Flossmoor, Illinois, 60422, United States

  • Primary Healthcare Associates

    Harvey, Illinois, 60426, United States

  • Primary Healthcare Associates

    Tinley Park, Illinois, 60477, United States

  • Renovatio Clinical.

    The Woodlands, Texas, 77380, United States

  • Rhode Island Hospital

    Providence, Rhode Island, 02903, United States

  • Richard M Schulze Family Foundation Outpatient Center at McKinley Campus

    Tampa, Florida, 33612, United States

  • Royal Marsden Hospital NHS Foundation Trust - HNTU

    Sutton, SM2 5PT, United Kingdom

  • Simlow Cancer Hospitalat Yale-New Haven

    New Haven, Connecticut, 06510, United States

  • Siteman Cancer Center - North County

    Florissant, Missouri, 63031, United States

  • Siteman Cancer Center - South County

    St Louis, Missouri, 63129, United States

  • Siteman Cancer Center - St. Peters

    City of Saint Peters, Missouri, 63376, United States

  • Siteman Cancer Center - West County

    Creve Coeur, Missouri, 63141, United States

  • Stanford Cancer Center South Bay

    San Jose, California, 95124, United States

  • Synlab Bourgogne Pont de Vaux

    Pont-de-Vaux, 01190, France

  • The Centre Léon Bérard

    Lyon, 69373, France

  • The Emory Clinic

    Atlanta, Georgia, 30322, United States

  • The Eye Care Institute

    Louisville, Kentucky, 40206, United States

  • The Miriam Hospital

    Providence, Rhode Island, 02906, United States

  • The Royal Marsden NHS Foundation Trust (RM).

    London, SW3 6JJ, United Kingdom

  • The Royal Marsden NHS Foundation trust (RM)

    Sutton, SM2 5PT, United Kingdom

  • The University of Chicago Medicine Center for Advanced Care Orland Park

    Orland Park, Illinois, 60462, United States

  • The University of Kansas Cancer Center

    Westwood, Kansas, 66205, United States

  • The University of Kansas Cancer Center ,Investigational Drug Services

    Fairway, Kansas, 66205, United States

  • The University of Kansas Clinical Research Center

    Fairway, Kansas, 66205, United States

  • The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • U.O. Oncologia

    Brescia, Lombardy, 25123, Italy

  • UC San Diego Health - Rancho Bernardo

    San Diego, California, 92127, United States

  • UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)

    La Jolla, California, 92037, United States

  • UC San Diego Medical Center- Hillcrest

    San Diego, California, 92103, United States

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92037, United States

  • UC San Diego/Moores Cancer Center

    La Jolla, California, 92093, United States

  • UCSD Koman Family Outpatient Pavilion

    La Jolla, California, 92037, United States

  • UCSD Medical Center - Encinitas

    Encinitas, California, 92024, United States

  • UCSD Medical Center - Vista

    Vista, California, 92081, United States

  • UCSD Shiley Eye Institute

    La Jolla, California, 92093, United States

  • UChicago Medicine - River East

    Chicago, Illinois, 60611, United States

  • UChicago Medicine Ingalls Memorial

    Harvey, Illinois, 60426, United States

  • UChicago Medicine at Ingalls - Flossmoor

    Flossmoor, Illinois, 60422, United States

  • UChicago Medicine at Ingalls - Tinley Park

    Tinley Park, Illinois, 60477, United States

  • UF Health Davis Cancer Pavilion and Shands Med Plaza

    Gainesville, Florida, 32608, United States

  • UF Health Shands Cancer Hospital

    Gainesville, Florida, 32608, United States

  • UF Health Shands Hospital

    Gainesville, Florida, 32610, United States

  • UNC Hospitals, The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514, United States

  • UOC Oncologia Medica

    Rome, Lazio, 00128, Italy

  • UVA Health System; Attention: GI Team

    Charlottesville, Virginia, 22908, United States

  • University of California Davis Medical Center

    Sacramento, California, 95817, United States

  • University of California, Davis Comprehensive Cancer Center

    Sacramento, California, 95817, United States

  • University of Chicago Comprehensive Cancer Center at Silver Cross Hospital

    New Lenox, Illinois, 60451, United States

  • University of Chicago Medical Center

    Chicago, Illinois, 60637, United States

  • University of Virginia Comprehensive Cancer Center

    Charlottesville, Virginia, 22903, United States

  • University of Virginia Health System

    Charlottesville, Virginia, 22908, United States

  • Vall d'Hebron University Hospital

    Barcelona, 08023, Spain

  • Vincentius-Diakonissen-Kliniken gAG Medizinische Klinik 2

    Karlsruhe, 76137, Germany

  • Vincentius-Diakonissen-Klinken Gag Augenklinik

    Karlsruhe, 76135, Germany

  • Vincentius-Diakonissen-Klinken Gag Radiologisches Institut

    Karlsruhe, 76137, Germany

  • Vincentius-Diakonissen-Klinken Gag Zentralapotheke

    Karlsruhe, 76137, Germany

  • Washington University - Investigational Drug Service Pharmacy

    St Louis, Missouri, 63110, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia, 30322, United States

  • Yale-New Haven Hospital- Yale Cancer Center

    New Haven, Connecticut, 06510, United States

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