AzTrials
AzTrials

Colorectal NeoplasmsPhase 2innovaTV 207NCT03485209

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

A Phase 2 study testing tisotumab vedotin, pembrolizumab and carboplatin in people with Colorectal Neoplasms and Carcinoma, Non-Small-Cell Lung, run by Seagen, a wholly owned subsidiary of Pfizer at 175 sites in 7 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
tisotumab vedotin, pembrolizumab and carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
350 participants
Where
175 sitesin 7 countries
Study dates
25 Jun 2018to 31 Mar 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

175 sites in 7 countries.

175 sites in 7 countries

United States124 sites

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Investigational Drug Service, Emory University Clinic

    Atlanta, Georgia, 30322

  • The Emory Clinic

    Atlanta, Georgia, 30322

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia, 30322

  • John Hopkins Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21231

  • John Hopkins Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21287

  • MSK Basking Ridge.

    Basking Ridge, New Jersey, 07920

  • OHSU Knight Cancer Institute, Beaverton

    Beaverton, Oregon, 97006

  • Massachusetts Eye and Ear Infirmary(MEEI)

    Boston, Massachusetts, 02114

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Ophthalmic Consultants of Boston Inc (OCB)

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • North Carolina Basnight Cancer Hospital Infusion Pharmacy

    Chapel Hill, North Carolina, 27514

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

    Chapel Hill, North Carolina, 27514

  • The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Cancer Center IDS Pharmacy

    Charlottesville, Virginia, 22903

  • University of Virginia Comprehensive Cancer Center

    Charlottesville, Virginia, 22903

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

  • UVA Health System; Attention: GI Team

    Charlottesville, Virginia, 22908

  • Northwestern Medical Group

    Chicago, Illinois, 60611

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • UChicago Medicine - River East

    Chicago, Illinois, 60611

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Siteman Cancer Center - St. Peters

    City of Saint Peters, Missouri, 63376

  • MSK Commack.

    Commack, New York, 11725

  • Siteman Cancer Center - West County

    Creve Coeur, Missouri, 63141

  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, 60115

  • Northwestern Medicine Kishwaukee Hospital

    DeKalb, Illinois, 60115

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Duke Cancer Center

    Durham, North Carolina, 27710

  • Investigational Chemotherapy Service

    Durham, North Carolina, 27710

  • UCSD Medical Center - Encinitas

    Encinitas, California, 92024

  • Northwestern University

    Evanston, Illinois, 60208

  • The University of Kansas Cancer Center ,Investigational Drug Services

    Fairway, Kansas, 66205

  • The University of Kansas Clinical Research Center

    Fairway, Kansas, 66205

  • Karmanos Cancer Institute Weisberg Cancer Treatment Center

    Farmington Hills, Michigan, 48334

  • Siteman Cancer Center - North County

    Florissant, Missouri, 63031

  • Ingalls Family Care Center (Infusion Center)

    Flossmoor, Illinois, 60422

  • Primary Healthcare Associates

    Flossmoor, Illinois, 60422

  • UChicago Medicine at Ingalls - Flossmoor

    Flossmoor, Illinois, 60422

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Eye Center of Northern Colorado

    Fort Collins, Colorado, 80525

  • Cancer Care & Hematology - Fort Collins

    Fort Collins, Colorado, 80528

  • Eye Center of Northern Colorado

    Fort Collins, Colorado, 80528

  • Family Focus Eye Care - Gainesville

    Gainesville, Florida, 32605

  • UF Health Davis Cancer Pavilion and Shands Med Plaza

    Gainesville, Florida, 32608

  • UF Health Shands Cancer Hospital

    Gainesville, Florida, 32608

  • UF Health Shands Hospital

    Gainesville, Florida, 32610

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

  • Northwestern Medicine Delnor Hospital

    Geneva, Illinois, 60134

  • Cancer Care & Hematology - Greeley

    Greeley, Colorado, 80634

  • OHSU Knight Cancer Institute, Gresham

    Gresham, Oregon, 97030

  • MSK Westchester.

    Harrison, New York, 10604

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Primary Healthcare Associates

    Harvey, Illinois, 60426

  • UChicago Medicine Ingalls Memorial

    Harvey, Illinois, 60426

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Community Health Network, Inc.

    Indianapolis, Indiana, 46219

  • Community Health Network, Inc.

    Indianapolis, Indiana, 46227

  • Community Health Network, Inc.

    Indianapolis, Indiana, 46250

  • Community Health Network, Inc.

    Indianapolis, Indiana, 46256

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

    La Jolla, California, 92037

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92037

  • UCSD Koman Family Outpatient Pavilion

    La Jolla, California, 92037

  • UC San Diego/Moores Cancer Center

    La Jolla, California, 92093

  • UCSD Shiley Eye Institute

    La Jolla, California, 92093

  • Family Focus Eye Care - Lake City

    Lake City, Florida, 32025

  • Norton Cancer Institute Pharmacy

    Louisville, Kentucky, 40202

  • Norton Cancer Institute, Downtown

    Louisville, Kentucky, 40202

  • Norton Hospital

    Louisville, Kentucky, 40202

  • The Eye Care Institute

    Louisville, Kentucky, 40206

  • Norton Audubon Hospital

    Louisville, Kentucky, 40217

  • Norton Cancer Institute, Audubon Hospital Campus

    Louisville, Kentucky, 40217

  • Norton Brownsboro Hospital

    Louisville, Kentucky, 40241

  • Norton Cancer Institute, Brownsboro Hospital Campus

    Louisville, Kentucky, 40241

  • Cancer Care & Hematology - Loveland

    Loveland, Colorado, 80538

  • Joe Arrington Cancer Research and Treatment Center

    Lubbock, Texas, 79410

  • MSK Monmouth

    Middletown, New Jersey, 07748

  • MSK Bergen

    Montvale, New Jersey, 07645

  • Simlow Cancer Hospitalat Yale-New Haven

    New Haven, Connecticut, 06510

  • Yale-New Haven Hospital- Yale Cancer Center

    New Haven, Connecticut, 06510

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

    New Haven, Connecticut, 06511

  • University of Chicago Comprehensive Cancer Center at Silver Cross Hospital

    New Lenox, Illinois, 60451

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

    New York, New York, 10021

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

    Orland Park, Illinois, 60462

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • OHSU Knight Cancer Institute, Northwest Portland

    Portland, Oregon, 97210

  • OHSU Knight Cancer Institute, East Portland

    Portland, Oregon, 97216

  • OHSU Center for Health and Healing 2

    Portland, Oregon, 97239

  • OHSU Center for Health and Healing

    Portland, Oregon, 97239

  • Oregon Health and Science University Research Pharmacy Services

    Portland, Oregon, 97239

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • The Miriam Hospital

    Providence, Rhode Island, 02906

  • Duke Raleigh Hospital

    Raleigh, North Carolina, 27609

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

  • University of California Davis Medical Center

    Sacramento, California, 95817

  • University of California, Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • Oncology Research, HealthPartners Institute

    Saint Louis Park, Minnesota, 55426

  • Park Nicollet Frauenshuh Cancer Center

    Saint Louis Park, Minnesota, 55426

  • UC San Diego Medical Center- Hillcrest

    San Diego, California, 92103

  • UC San Diego Health - Rancho Bernardo

    San Diego, California, 92127

  • Stanford Cancer Center South Bay

    San Jose, California, 95124

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Washington University - Investigational Drug Service Pharmacy

    St Louis, Missouri, 63110

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Siteman Cancer Center - South County

    St Louis, Missouri, 63129

  • Moffitt Cancer Center McKinley Hospital

    Tampa, Florida, 33612

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Richard M Schulze Family Foundation Outpatient Center at McKinley Campus

    Tampa, Florida, 33612

  • Renovatio Clinical.

    The Woodlands, Texas, 77380

  • Primary Healthcare Associates

    Tinley Park, Illinois, 60477

  • UChicago Medicine at Ingalls - Tinley Park

    Tinley Park, Illinois, 60477

  • OHSU Knight Cancer Institute, Tualatin

    Tualatin, Oregon, 97062

  • MSK Nassau.

    Uniondale, New York, 11553

  • UCSD Medical Center - Vista

    Vista, California, 92081

  • Northwestern Medicine Cancer Center Warrenville

    Warrenville, Illinois, 60555

  • The University of Kansas Cancer Center

    Westwood, Kansas, 66205

  • Atrium Health Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157

  • Atrium Health Wake forest Baptist

    Winston-Salem, North Carolina, 27157

Other trials in United States

France15 sites

  • CHRU de Besançon- Hopital Jean Minjoz

    Besançon, Doubs, 25030

  • Laboratoire Oriade Noviale Medipole

    Bourgoin, 38300

  • Laboratoire Oriade Noviale Tixier

    Bourgoin, 38300

  • The Centre Léon Bérard

    Lyon, 69373

  • Lbmms Du Chu de Lyon

    Lyon, 69424 CEDEX 03

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

    Marseille, 13005

  • Hopital prive du Confluent S.A.S.

    Nantes, 44277

  • L'hôpital Privé du Confluent - Pharmacie

    Nantes, 44277

  • Synlab Bourgogne Pont de Vaux

    Pont-de-Vaux, 01190

  • Laboratoire Cerballiance Portes Les Valence

    Portes-lès-Valence, 26800

  • Hôpital Foch Pharmacie - Essais Cliniques

    Suresnes, 92150

  • Hôpital Foch

    Suresnes, 92150

  • LBM UNIBIO Jean Herve Lebras

    Tain-l'Hermitage, 26600

  • Laboratoire Trevoux-Dyomedea Neolab

    Trévoux, 01600

  • Gustave Roussy

    Villejuif, 94805

Other trials in France

Italy14 sites

  • U.O. Oncologia

    Brescia, Lombardy, 25123

  • Ospedale Cervesi di Cattolica-AUSL Romagna

    Cattolica, RN, 47841

  • PO Ospedale degli Infermi Faenza, AUSL Romagna

    Faenza, 48018

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

    Lugo, 48022

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

    Meldola (Fc), Emilia-Romagna, 47014

  • IRST IRCCS - Farmacia Oncologica

    Meldola (FC), Forli-cesena, 47014

  • Istituto Europeo di Oncologia

    Milan, MI, 20141

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

    Naples, 80131

  • Azienda Ospedaliera Universitaria - Universita della Campania Luigi Vanvitelli

    Naples, 80131

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

    Pistoia, 51100

  • Oncologia Medica, Ospedale Civile S. Maria delle Croci

    Ravenna, Emilia-Romagna, 48121

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

    Ravenna, 48121

  • Ospedale degli Infermi -AUSL Romagna

    Rimini, RN, 47923

  • UOC Oncologia Medica

    Rome, Lazio, 00128

Other trials in Italy

Spain10 sites

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

    Barcelona, Badalona, 08916

  • Hospital Quironsalud Barcelona Instituto Oncologico Baselga

    Barcelona, Catalonia, 08023

  • Hospital Quiron Salud Barcelona Plaza

    Barcelona, 08023

  • Vall d'Hebron University Hospital

    Barcelona, 08023

  • Hospital Universitario Dexeus - Grupo Quirónsalud

    Barcelona, 08028

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

    Barcelona, 08035

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

    Barcelona, 08035

  • Institut Catala d'Oncologia (ICO BADALONA)

    Barcelona, 08908

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • ALTHAIA, Xarxa Assistencial Universitaria de Manresa.

    Manresa, Barcelona, 08243

Other trials in Spain

United Kingdom7 sites

  • Clinical Research Facility - Clinical Research Facility

    London, London, CITY of, SE1 9RT

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

    London, London, CITY of, Se1 9Rt

  • Guys and St Thomas Hospital

    London, Other, SE1 9RT

  • The Royal Marsden NHS Foundation Trust (RM).

    London, SW3 6JJ

  • Pharmacy Stores (CCR5916) - The Royal Marsden

    Sutton, Surrey, SM2 5PT

  • Royal Marsden Hospital NHS Foundation Trust - HNTU

    Sutton, SM2 5PT

  • The Royal Marsden NHS Foundation trust (RM)

    Sutton, SM2 5PT

Other trials in United Kingdom

Germany4 sites

  • Vincentius-Diakonissen-Klinken Gag Augenklinik

    Karlsruhe, 76135

  • Vincentius-Diakonissen-Kliniken gAG Medizinische Klinik 2

    Karlsruhe, 76137

  • Vincentius-Diakonissen-Klinken Gag Radiologisches Institut

    Karlsruhe, 76137

  • Vincentius-Diakonissen-Klinken Gag Zentralapotheke

    Karlsruhe, 76137

Other trials in Germany

Canada1 site

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

Other trials in Canada

About this study

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

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.
Read more

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
Read the 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).

Being tested
tisotumab vedotin, pembrolizumab, carboplatin, cisplatin
Keywords
Colorectal cancer, NSCLC, sqNSCLC, CRC, Pancreatic cancer, Head and neck cancer, Seattle Genetics, HNSCC
Medical subject headings
Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Pancreatic Neoplasms, Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tisotumab vedotinDrug

    Also called TIVDAK

    Given into the vein (IV; intravenously)

  • pembrolizumabDrug

    Also called KEYTRUDA®

    200mg or 400mg given by IV

  • carboplatinDrug

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

  • cisplatinDrug

    100mg/m^2 given by IV

Study groups in NCT03485209
Study groupRoleWhat they receive
Part A: Tisotumab Vedotin - Q3W ScheduleExperimentalTisotumab Vedotin on Day 1 of every 21-day cycle in participants with various solid tumors in 2L+
Receives: Drug: tisotumab vedotin
Part B: Tisotumab Vedotin - 3Q4W ScheduleExperimentalTisotumab Vedotin on Days 1, 8, and 15 of 28-day cycle in participants with various solid tumors in 2L+
Receives: Drug: tisotumab vedotin
Part C: Tisotumab Vedotin - 2Q4W ScheduleExperimentalTisotumab Vedotin on Days 1 and 15 of every 28-day cycle in participants with HNSCC or sqNSCLC in 2L+
Receives: Drug: tisotumab vedotin
Part D: Tisotumab Vedotin Combination Therapy - Q3W ScheduleExperimentalTisotumab Vedotin + pembrolizumab + (carboplatin or cisplatin). Given on Day 1 of every 21-day cycle in participants with various solid tumors in 1L HNSCC or sqNSCLC
Receives: Drug: tisotumab vedotin; Drug: pembrolizumab; Drug: carboplatin; Drug: cisplatin
Part E: Tisotumab Vedotin - 2Q4W ScheduleExperimentalTisotumab Vedotin on Days 1 and 15 of every 28-day cycle in participants with HNSCC in the second- or third-line setting
Receives: Drug: tisotumab vedotin
Part F: Tisotumab Vedotin Combination Therapy - Q2W ScheduleExperimentalTisotumab Vedotin + pembrolizumab. Tisotumab Vedotin given on Days 1, 15, and 29 of every 6-week cycle. Pembrolizumab given on Day 1 of every 6-week cycle in participants with HNSCC in the first line setting
Receives: Drug: tisotumab vedotin; Drug: pembrolizumab
Part G: Tisotumab Vedotin Combination Therapy - Q2W ScheduleExperimentalTisotumab Vedotin + pembrolizumab + carboplatin. Tisotumab Vedotin and carboplatin given on Days 1, 15, and 29 of every 6-week cycle. Pembrolizumab given on Day 1 of every 6-week cycle in participants with HNSCC in the first line setting
Receives: Drug: tisotumab vedotin; Drug: pembrolizumab; Drug: carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Confirmed Objective Response Rate (ORR) (Parts A, B, C, D, E, 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

    Measured: Up to approximately 3 years

Secondary outcomes (10)

  1. 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.

    Measured: Up to approximately 3 years

  2. Confirmed and Unconfirmed ORR

    Proportion of patients who achieve a CR or PR according to RECIST v1.1 as assessed by the investigator

    Measured: Up to approximately 3 years

  3. 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

    Measured: Up to approximately 3 years

  4. 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

    Measured: Up to approximately 3 years

  5. Time to Response (TTR)

    Time from the start of study treatment to the first documentation of objective response, as assessed by investigator

    Measured: Up to approximately 1 year

  6. 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

    Measured: Up to approximately 3 years

  7. Overall Survival (OS)

    Time from the start of study treatment to date of death due to any cause

    Measured: Up to approximately 4 years

  8. Cmax

    Maximum observed plasma concentration

    Measured: Through 30-37 days following the last dose; up to approximately 3 years

  9. Ctrough

    Observed plasma concentration at the end of the dosing interval

    Measured: Through 30-37 days following the last dose; up to approximately 3 years

  10. Incidence of anti-therapeutic antibodies (ATAs)

    Measured: Through 30-37 days following the last dose; up to approximately 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2018
  2. Study start25 Jun 2018
  3. Primary completion20 Mar 2026
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
350 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03485209
Sponsor's protocol ID
SGNTV-001
Other IDs
C5721001; innovaTV 207, 2023-503812-34-00, 2023
Acronym
innovaTV 207
Status last verified
Jul 2026
First submitted
8 Mar 2018
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

  • Feng S, Gunawan R, Passey C, Voellinger J, Polhamus D, Gerritsen A, O'Day C, Carret AS, Soumaoro I, Gupta M, Hanley WD. Exposure-safety Markov modeling of ocular adverse events in patient populations treated with tisotumab vedotin. J Pharmacokinet Pharmacodyn. 2025 Oct 3;52(5):55. doi: 10.1007/s10928-025-10003-w.

    PubMed 41044356

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing tisotumab vedotin, pembrolizumab and carboplatin in people with Colorectal Neoplasms and Carcinoma, Non-Small-Cell Lung, run by Seagen, a wholly owned subsidiary of Pfizer at 175 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 175 sites in United States, France, Italy, Spain, United Kingdom and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Confirmed Objective Response Rate (ORR) (Parts A, B, C, D, E, F, and G) (time frame: Up to approximately 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03485209, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.

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