Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors (innovaTV 207)

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.

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

Study Overview

• Status: Active, not recruiting
• Conditions: Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms; Exocrine Pancreatic Cancer; Carcinoma, Squamous Cell of Head and Neck
• Intervention / Treatment: Drug: tisotumab vedotin; Drug: cisplatin; Drug: pembrolizumab; Drug: carboplatin

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).

• Study Type: Interventional
• Enrollment (Actual): 350
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
• France
  • Bourgoin, France, 38300
    • Laboratoire Oriade Noviale Medipole
  • Bourgoin, France, 38300
    • Laboratoire Oriade Noviale Tixier
  • Lyon, France, 69424 CEDEX 03
    • Lbmms Du Chu de Lyon
  • Lyon, France, 69373
    • The Centre Léon Bérard
  • Marseille, France, 13005
    • CEPCM/CHU Timone, Batiment 3 -1er etage
  • Nantes, France, 44277
    • Hôpital Privé du Confluent S.A.S.
  • Nantes, France, 44277
    • L'hôpital Privé du Confluent - Pharmacie
  • Pont-de-Vaux, France, 01190
    • Synlab Bourgogne Pont de Vaux
  • Portes-lès-Valence, France, 26800
    • Laboratoire Cerballiance Portes Les Valence
  • Suresnes, France, 92150
    • Hopital Foch
  • Suresnes, France, 92150
    • Hôpital Foch Pharmacie - Essais Cliniques
  • Tain-l'Hermitage, France, 26600
    • LBM UNIBIO Jean Herve Lebras
  • Trévoux, France, 01600
    • Laboratoire Trevoux-Dyomedea Neolab
  • Villejuif, France, 94805
    • Gustave Roussy
  • Doubs
    • Besançon, Doubs, France, 25030
      • CHRU de Besançon- Hopital Jean Minjoz
• Germany
  • Karlsruhe, Germany, 76135
    • Vincentius-Diakonissen-Klinken Gag Augenklinik
  • Karlsruhe, Germany, 76137
    • Vincentius-Diakonissen-Kliniken gAG Medizinische Klinik 2
  • Karlsruhe, Germany, 76137
    • Vincentius-Diakonissen-Klinken Gag Radiologisches Institut
• Italy
  • Faenza, Italy, 48018
    • PO Ospedale degli Infermi Faenza, AUSL Romagna
  • Lugo, Italy, 48022
    • Ospedale Umberto I di Lugo, AUSL della Romagna, SSR Emilia-Romagna
  • Naples, Italy, 80131
    • AOU Università degli studi della Campania Luigi Vanvitelli, Policlinico di Napoli
  • Naples, Italy, 80131
    • Azienda Ospedaliera Universitaria - Universita della Campania Luigi Vanvitelli
  • Pistoia, Italy, 51100
    • Ospedale S.Jacopo di Pistoia, AUSL Toscana centro, SST
  • Ravenna, Italy, 48121
    • Farmacia Oncologica c/o Ospedale S.Maria delle Croci-AUSL Romagna
  • Emilia-Romagna
    • Meldola (Fc), Emilia-Romagna, Italy, 47014
      • IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori- IRST S.r.l
    • Ravenna, Emilia-Romagna, Italy, 48121
      • Oncologia Medica, Ospedale Civile S. Maria delle Croci
  • Forli-cesena
    • Meldola (FC), Forli-cesena, Italy, 47014
      • IRST IRCCS - Farmacia Oncologica
  • Lazio
    • Rome, Lazio, Italy, 00128
      • UOC Oncologia Medica
  • Lombardy
    • Brescia, Lombardy, Italy, 25123
      • U.O. Oncologia
  • MI
    • Milan, MI, Italy, 20141
      • Istituto Europeo di Oncologia
  • RN
    • Cattolica, RN, Italy, 47841
      • Ospedale Cervesi di Cattolica-AUSL Romagna
    • Rimini, RN, Italy, 47923
      • Ospedale degli Infermi -AUSL Romagna
• Spain
  • Barcelona, Spain, 08023
    • Hospital Quiron Salud Barcelona Plaza
  • Barcelona, Spain, 08035
    • Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca
  • Barcelona, Spain, 08023
    • Vall d'Hebron University Hospital
  • Barcelona, Spain, 08028
    • Hospital Universitario Dexeus - Grupo Quirónsalud
  • Barcelona, Spain, 08908
    • Institut Catala d'Oncologia (ICO BADALONA)
  • Barcelona, Spain, 08035
    • Fundación Privada Instituto de Investigación Oncológica Vall d'Hebron (hereinafter "VHIO")
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Badalona
    • Barcelona, Badalona, Spain, 08916
      • Institut Catala D 'Oncologia-Hospital Germans Trias I Pujol,Servicio de Oncologia Medica
  • Barcelona
    • Manresa, Barcelona, Spain, 08243
      • ALTHAIA, Xarxa Assistencial Universitaria de Manresa.
  • Catalonia
    • Barcelona, Catalonia, Spain, 08023
      • Hospital Quironsalud Barcelona Instituto Oncologico Baselga
• United Kingdom
  • London, United Kingdom, SW3 6JJ
    • The Royal Marsden NHS Foundation Trust (RM).
  • Sutton, United Kingdom, SM2 5PT
    • Royal Marsden Hospital NHS Foundation Trust - HNTU
  • Sutton, United Kingdom, SM2 5PT
    • The Royal Marsden NHS Foundation Trust (RM)
  • London, CITY of
    • London, London, CITY of, United Kingdom, SE1 9RT
      • Clinical Research Facility - Clinical Research Facility
    • London, London, CITY of, United Kingdom, Se1 9Rt
      • Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
  • Other
    • London, Other, United Kingdom, SE1 9RT
      • Guys and St Thomas Hospital
  • Surrey
    • Sutton, Surrey, United Kingdom, SM2 5PT
      • Pharmacy Stores (CCR5916) - The Royal Marsden
• United States
  • California
    • Encinitas, California, United States, 92024
      • UCSD Medical Center - Encinitas
    • La Jolla, California, United States, 92037
      • UC San Diego Moores Cancer Center
    • La Jolla, California, United States, 92093
      • UCSD Shiley Eye Institute
    • La Jolla, California, United States, 92037
      • UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
    • La Jolla, California, United States, 92093
      • UC San Diego/Moores Cancer Center
    • La Jolla, California, United States, 92037
      • UCSD Koman Family Outpatient Pavilion
    • Sacramento, California, United States, 95817
      • University of California Davis Medical Center
    • Sacramento, California, United States, 95817
      • University of California, Davis Comprehensive Cancer Center
    • San Diego, California, United States, 92103
      • UC San Diego Medical Center- Hillcrest
    • San Diego, California, United States, 92127
      • UC San Diego Health - Rancho Bernardo
    • San Jose, California, United States, 95124
      • Stanford Cancer Center South Bay
    • Vista, California, United States, 92081
      • UCSD Medical Center - Vista
  • Colorado
    • Fort Collins, Colorado, United States, 80524
      • Poudre Valley Hospital
    • Fort Collins, Colorado, United States, 80525
      • Eye Center of Northern Colorado
    • Fort Collins, Colorado, United States, 80528
      • Cancer Care & Hematology - Fort Collins
    • Fort Collins, Colorado, United States, 80528
      • Eye Center of Northern Colorado
    • Greeley, Colorado, United States, 80634
      • Cancer Care & Hematology - Greeley
    • Loveland, Colorado, United States, 80538
      • Cancer Care & Hematology - Loveland
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale University
    • New Haven, Connecticut, United States, 06510
      • Simlow Cancer Hospitalat Yale-New Haven
    • New Haven, Connecticut, United States, 06510
      • Yale-New Haven Hospital- Yale Cancer Center
    • New Haven, Connecticut, United States, 06511
      • C/O Thomas Ferenez.RPh,BCOP,Smilow Cancer Hospital at Yale-New Haven
  • Florida
    • Gainesville, Florida, United States, 32610
      • UF Health Shands Hospital
    • Gainesville, Florida, United States, 32608
      • UF Health Shands Cancer Hospital
    • Gainesville, Florida, United States, 32608
      • UF Health Davis Cancer Pavilion and Shands Med Plaza
    • Gainesville, Florida, United States, 32605
      • Family Focus Eye Care - Gainesville
    • Lake City, Florida, United States, 32025
      • Family Focus Eye Care - Lake City
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center
    • Tampa, Florida, United States, 33612
      • Richard M Schulze Family Foundation Outpatient Center at McKinley Campus
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center McKinley Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
    • Atlanta, Georgia, United States, 30322
      • Winship Cancer Institute, Emory University
    • Atlanta, Georgia, United States, 30308
      • Emory University Hospital Midtown
    • Atlanta, Georgia, United States, 30322
      • The Emory Clinic
    • Atlanta, Georgia, United States, 30322
      • Investigational Drug Service, Emory University Clinic
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
    • Chicago, Illinois, United States, 60611
      • Northwestern Medical Group
    • Chicago, Illinois, United States, 60611
      • UChicago Medicine - River East
    • DeKalb, Illinois, United States, 60115
      • Northwestern Medicine Cancer Center Kishwaukee
    • DeKalb, Illinois, United States, 60115
      • Northwestern Medicine Kishwaukee Hospital
    • Evanston, Illinois, United States, 60208
      • Northwestern University
    • Flossmoor, Illinois, United States, 60422
      • Primary Healthcare Associates
    • Flossmoor, Illinois, United States, 60422
      • Ingalls Family Care Center (Infusion Center)
    • Geneva, Illinois, United States, 60134
      • Northwestern Medicine Cancer Center Delnor
    • Geneva, Illinois, United States, 60134
      • Northwestern Medicine Delnor Hospital
    • Harvey, Illinois, United States, 60426
      • Ingalls Memorial Hospital
    • Harvey, Illinois, United States, 60426
      • UChicago Medicine Ingalls Memorial
    • Harvey, Illinois, United States, 60426
      • Primary Healthcare Associates
    • New Lenox, Illinois, United States, 60451
      • University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
    • Orland Park, Illinois, United States, 60462
      • The University of Chicago Medicine Center for Advanced Care Orland Park
    • Tinley Park, Illinois, United States, 60477
      • UChicago Medicine at Ingalls - Tinley Park
    • Tinley Park, Illinois, United States, 60477
      • Primary Healthcare Associates
    • Warrenville, Illinois, United States, 60555
      • Northwestern Medicine Cancer Center Warrenville
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Community Health Network, Inc.
    • Indianapolis, Indiana, United States, 46219
      • Community Health Network, Inc.
    • Indianapolis, Indiana, United States, 46227
      • Community Health Network, Inc.
    • Indianapolis, Indiana, United States, 46256
      • Community Health Network, Inc.
  • Kansas
    • Fairway, Kansas, United States, 66205
      • The University of Kansas Clinical Research Center
    • Fairway, Kansas, United States, 66205
      • The University of Kansas Cancer Center ,Investigational Drug Services
    • Westwood, Kansas, United States, 66205
      • The University of Kansas Cancer Center
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Norton Hospital
    • Louisville, Kentucky, United States, 40206
      • The Eye Care Institute
    • Louisville, Kentucky, United States, 40217
      • Norton Cancer Institute, Audubon Hospital Campus
    • Louisville, Kentucky, United States, 40241
      • Norton Brownsboro Hospital
    • Louisville, Kentucky, United States, 40241
      • Norton Cancer Institute, Brownsboro Hospital Campus
    • Louisville, Kentucky, United States, 40202
      • Norton Cancer Institute, Downtown
    • Louisville, Kentucky, United States, 40217
      • Norton Audubon Hospital
    • Louisville, Kentucky, United States, 40202
      • Norton Cancer Institute Pharmacy
  • Maryland
    • Baltimore, Maryland, United States, 21231
      • John Hopkins Sidney Kimmel Comprehensive Cancer Center
    • Baltimore, Maryland, United States, 21287
      • John Hopkins Sidney Kimmel Comprehensive Cancer Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital Cancer Center
    • Boston, Massachusetts, United States, 02114
      • Ophthalmic Consultants of Boston Inc (OCB)
    • Boston, Massachusetts, United States, 02114
      • Massachusetts Eye and Ear Infirmary(MEEI)
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Institute
    • Farmington Hills, Michigan, United States, 48334
      • Karmanos Cancer Institute Weisberg Cancer Treatment Center
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Rochester
    • Saint Louis Park, Minnesota, United States, 55426
      • Park Nicollet Frauenshuh Cancer Center
    • Saint Louis Park, Minnesota, United States, 55426
      • Oncology Research, HealthPartners Institute
  • Missouri
    • City of Saint Peters, Missouri, United States, 63376
      • Siteman Cancer Center - St. Peters
    • Creve Coeur, Missouri, United States, 63141
      • Siteman Cancer Center - West County
    • Florissant, Missouri, United States, 63031
      • Siteman Cancer Center - North County
    • St Louis, Missouri, United States, 63110
      • Barnes-Jewish Hospital
    • St Louis, Missouri, United States, 63110
      • Washington University School of Medicine
    • St Louis, Missouri, United States, 63129
      • Siteman Cancer Center - South County
    • St Louis, Missouri, United States, 63110
      • Washington University - Investigational Drug Service Pharmacy
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • MSK Basking Ridge.
    • Middletown, New Jersey, United States, 07748
      • MSK Monmouth
    • Montvale, New Jersey, United States, 07645
      • MSK Bergen
  • New York
    • Commack, New York, United States, 11725
      • MSK Commack.
    • Harrison, New York, United States, 10604
      • MSK Westchester.
    • New York, New York, United States, 10021
      • Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
    • Uniondale, New York, United States, 11553
      • MSK Nassau.
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • The University of North Carolina at Chapel Hill
    • Chapel Hill, North Carolina, United States, 27514
      • UNC Hospitals, The University of North Carolina at Chapel Hill
    • Chapel Hill, North Carolina, United States, 27514
      • North Carolina Basnight Cancer Hospital Infusion Pharmacy
    • Durham, North Carolina, United States, 27710
      • Duke Cancer Center
    • Durham, North Carolina, United States, 27710
      • Investigational Chemotherapy Service
    • Raleigh, North Carolina, United States, 27609
      • Duke Raleigh Hospital
    • Winston-Salem, North Carolina, United States, 27157
      • Atrium Health Wake Forest Baptist
    • Winston-Salem, North Carolina, United States, 27157
      • Atrium Health Wake Forest Baptist Health
  • Oregon
    • Beaverton, Oregon, United States, 97006
      • OHSU Knight Cancer Institute, Beaverton
    • Gresham, Oregon, United States, 97030
      • OHSU Knight Cancer Institute, Gresham
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
    • Portland, Oregon, United States, 97239
      • OHSU Center for Health and Healing 2
    • Portland, Oregon, United States, 97239
      • OHSU Center for Health and Healing
    • Portland, Oregon, United States, 97210
      • OHSU Knight Cancer Institute, Northwest Portland
    • Portland, Oregon, United States, 97216
      • OHSU Knight Cancer Institute, East Portland
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University Research Pharmacy Services
    • Tualatin, Oregon, United States, 97062
      • OHSU Knight Cancer Institute, Tualatin
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • The Miriam Hospital
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas MD Anderson Cancer Center
    • Lubbock, Texas, United States, 79410
      • Joe Arrington Cancer Research and Treatment Center
    • The Woodlands, Texas, United States, 77380
      • Renovatio Clinical.
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Health System
    • Charlottesville, Virginia, United States, 22903
      • Cancer Center IDS Pharmacy
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia Comprehensive Cancer Center
    • Charlottesville, Virginia, United States, 22908
      • UVA Health System; Attention: GI Team
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutchinson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A: Tisotumab Vedotin - Q3W Schedule; Tisotumab Vedotin on Day 1 of every 21-day cycle in participants with various solid tumors in 2L+	Drug: tisotumab vedotin; Given into the vein (IV; intravenously); Other Names: TIVDAK
Experimental: Part B: Tisotumab Vedotin - 3Q4W Schedule; Tisotumab Vedotin on Days 1, 8, and 15 of 28-day cycle in participants with various solid tumors in 2L+	Drug: tisotumab vedotin; Given into the vein (IV; intravenously); Other Names: TIVDAK
Experimental: Part C: Tisotumab Vedotin - 2Q4W Schedule; Tisotumab Vedotin on Days 1 and 15 of every 28-day cycle in participants with HNSCC or sqNSCLC in 2L+	Drug: tisotumab vedotin; Given into the vein (IV; intravenously); Other Names: TIVDAK
Experimental: Part D: Tisotumab Vedotin Combination Therapy - Q3W Schedule; Tisotumab 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	Drug: tisotumab vedotin; Given into the vein (IV; intravenously); Other Names: TIVDAK; Drug: cisplatin; 100mg/m^2 given by IV; Drug: pembrolizumab; 200mg or 400mg given by IV; Other Names: KEYTRUDA®; Drug: carboplatin; AUC 5mg/mL per minute or AUC 3.3mg/mL per minute given by IV
Experimental: Part E: Tisotumab Vedotin - 2Q4W Schedule; Tisotumab Vedotin on Days 1 and 15 of every 28-day cycle in participants with HNSCC in the second- or third-line setting	Drug: tisotumab vedotin; Given into the vein (IV; intravenously); Other Names: TIVDAK
Experimental: Part F: Tisotumab Vedotin Combination Therapy - Q2W Schedule; Tisotumab 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	Drug: tisotumab vedotin; Given into the vein (IV; intravenously); Other Names: TIVDAK; Drug: pembrolizumab; 200mg or 400mg given by IV; Other Names: KEYTRUDA®
Experimental: Part G: Tisotumab Vedotin Combination Therapy - Q2W Schedule; Tisotumab 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	Drug: tisotumab vedotin; Given into the vein (IV; intravenously); Other Names: TIVDAK; Drug: pembrolizumab; 200mg or 400mg given by IV; Other Names: KEYTRUDA®; Drug: carboplatin; AUC 5mg/mL per minute or AUC 3.3mg/mL per minute given by IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to approximately 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Overall Survival (OS)	Time from the start of study treatment to date of death due to any cause	Up to approximately 4 years
Cmax	Maximum observed plasma concentration	Through 30-37 days following the last dose; up to approximately 3 years
Ctrough	Observed plasma concentration at the end of the dosing interval	Through 30-37 days following the last dose; up to approximately 3 years
Incidence of anti-therapeutic antibodies (ATAs)		Through 30-37 days following the last dose; up to approximately 3 years
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
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
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
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

Collaborators and Investigators

• Sponsor: Seagen, a wholly owned subsidiary of Pfizer
• Collaborators: Merck Sharp & Dohme LLC; Genmab
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

General 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2018
• Primary Completion (Actual): March 20, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: March 8, 2018
• First Submitted That Met QC Criteria: March 26, 2018
• First Posted (Actual): April 2, 2018

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: NSCLC; Colorectal cancer; HNSCC; Pancreatic cancer; Seattle Genetics; Head and neck cancer; CRC; sqNSCLC
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Intestinal Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Lung Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Colonic Diseases; Lung Neoplasms; Carcinoma; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Colorectal Neoplasms; Pancreatic Neoplasms; Carcinoma, Non-Small-Cell Lung; Head and Neck Neoplasms; Organic Chemicals; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Coordination Complexes; Platinum Compounds; Carboplatin; Cisplatin; pembrolizumab; tisotumab vedotin
• Other Study ID Numbers: SGNTV-001; 2023-503812-34-00 (Registry Identifier: CTIS (EU)); C5721001; innovaTV 207 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No