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
3 other identifiers
interventional
350
7 countries
175
Brief Summary
This trial will study tisotumab vedotin to find out whether it is an effective treatment alone or with other anticancer drugs for certain solid tumors and what side effects (unwanted effects) may occur. There are seven parts to this study.
- In Part A, participants will receive tisotumab vedotin every 3 weeks (3-week cycles).
- In Part B, participants will receive tisotumab vedotin on Days 1, 8, and 15 every 4-week cycle.
- In Part C, participants will receive tisotumab vedotin on Days 1 and 15 of every 4-week cycle.
- In Part D, participants will be given treatment on Day 1 of every 3-week cycle.
- Participants in Part D will get tisotumab vedotin with either:
- Pembrolizumab or,
- Pembrolizumab and carboplatin, or
- Pembrolizumab and cisplatin
- In Part E, participants will receive tisotumab vedotin on Days 1 and 15 of every 4-week cycle.
- In Part F, participants will receive tisotumab vedotin on Days 1, 15, and 29 of every 6-week cycle. Participants in Part F will get tisotumab vedotin with pembrolizumab.
- In Part G, participants will receive tisotumab vedotin on Days 1, 15, and 29 of every 6-week cycle. Participants in Part G will get tisotumab vedotin with pembrolizumab and carboplatin. The objectives of the study have been achieved. Therefore, the study will transition to a long-term extension phase (LTEP).
- In LTEP, participants still receiving clinical benefit based on the investigator's assessment and remaining on treatment may continue receiving treatment.
- Participants will still receive tisotumab vedotin with either:
- Pembrolizumab or,
- Pembrolizumab and carboplatin, or
- Pembrolizumab and cisplatin
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2018
Longer than P75 for phase_2
175 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2018
CompletedFirst Posted
Study publicly available on registry
April 2, 2018
CompletedStudy Start
First participant enrolled
June 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
ExpectedJuly 22, 2026
July 1, 2026
7.7 years
March 8, 2018
July 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
Up to approximately 3 years
Secondary Outcomes (10)
Incidence of Adverse Events (AEs)
Up to approximately 3 years
Confirmed and Unconfirmed ORR
Up to approximately 3 years
Disease Control Rate (DCR)
Up to approximately 3 years
Duration of Response (DOR)
Up to approximately 3 years
Time to Response (TTR)
Up to approximately 1 year
- +5 more secondary outcomes
Study Arms (7)
Part A: Tisotumab Vedotin - Q3W Schedule
EXPERIMENTALTisotumab Vedotin on Day 1 of every 21-day cycle in participants with various solid tumors in 2L+
Part B: Tisotumab Vedotin - 3Q4W Schedule
EXPERIMENTALTisotumab Vedotin on Days 1, 8, and 15 of 28-day cycle in participants with various solid tumors in 2L+
Part C: Tisotumab Vedotin - 2Q4W Schedule
EXPERIMENTALTisotumab Vedotin on Days 1 and 15 of every 28-day cycle in participants with HNSCC or sqNSCLC in 2L+
Part D: Tisotumab Vedotin Combination Therapy - Q3W Schedule
EXPERIMENTALTisotumab 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
Part E: Tisotumab Vedotin - 2Q4W Schedule
EXPERIMENTALTisotumab Vedotin on Days 1 and 15 of every 28-day cycle in participants with HNSCC in the second- or third-line setting
Part F: Tisotumab Vedotin Combination Therapy - Q2W Schedule
EXPERIMENTALTisotumab 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
Part G: Tisotumab Vedotin Combination Therapy - Q2W Schedule
EXPERIMENTALTisotumab 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
Interventions
200mg or 400mg given by IV
AUC 5mg/mL per minute or AUC 3.3mg/mL per minute given by IV
Given into the vein (IV; intravenously)
Eligibility Criteria
You may qualify if:
- 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
- +11 more criteria
You may not qualify if:
- 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)
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genmabcollaborator
- Seagen, a wholly owned subsidiary of Pfizerlead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (175)
UCSD Medical Center - Encinitas
Encinitas, California, 92024, United States
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
La Jolla, California, 92037, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92037, United States
UCSD Koman Family Outpatient Pavilion
La Jolla, California, 92037, United States
UC San Diego/Moores Cancer Center
La Jolla, California, 92093, United States
UCSD Shiley Eye Institute
La Jolla, California, 92093, 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
UC San Diego Medical Center- Hillcrest
San Diego, California, 92103, United States
UC San Diego Health - Rancho Bernardo
San Diego, California, 92127, United States
Stanford Cancer Center South Bay
San Jose, California, 95124, United States
UCSD Medical Center - Vista
Vista, California, 92081, United States
Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
Eye Center of Northern Colorado
Fort Collins, Colorado, 80525, United States
Cancer Care & Hematology - Fort Collins
Fort Collins, Colorado, 80528, United States
Eye Center of Northern Colorado
Fort Collins, Colorado, 80528, United States
Cancer Care & Hematology - Greeley
Greeley, Colorado, 80634, United States
Cancer Care & Hematology - Loveland
Loveland, Colorado, 80538, United States
Simlow Cancer Hospitalat Yale-New Haven
New Haven, Connecticut, 06510, United States
Yale-New Haven Hospital- Yale Cancer Center
New Haven, Connecticut, 06510, United States
C/O Thomas Ferenez.RPh,BCOP,Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut, 06511, United States
Family Focus Eye Care - Gainesville
Gainesville, Florida, 32605, 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
Family Focus Eye Care - Lake City
Lake City, Florida, 32025, United States
Moffitt Cancer Center McKinley Hospital
Tampa, Florida, 33612, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Richard M Schulze Family Foundation Outpatient Center at McKinley Campus
Tampa, Florida, 33612, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Investigational Drug Service, Emory University Clinic
Atlanta, Georgia, 30322, United States
The Emory Clinic
Atlanta, Georgia, 30322, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322, United States
Northwestern Medical Group
Chicago, Illinois, 60611, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
UChicago Medicine - River East
Chicago, Illinois, 60611, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115, United States
Northwestern Medicine Kishwaukee Hospital
DeKalb, Illinois, 60115, United States
Northwestern University
Evanston, Illinois, 60208, United States
Ingalls Family Care Center (Infusion Center)
Flossmoor, Illinois, 60422, United States
Primary Healthcare Associates
Flossmoor, Illinois, 60422, United States
UChicago Medicine at Ingalls - Flossmoor
Flossmoor, Illinois, 60422, United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134, United States
Northwestern Medicine Delnor Hospital
Geneva, Illinois, 60134, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
Primary Healthcare Associates
Harvey, Illinois, 60426, United States
UChicago Medicine Ingalls Memorial
Harvey, Illinois, 60426, United States
University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
New Lenox, Illinois, 60451, United States
The University of Chicago Medicine Center for Advanced Care Orland Park
Orland Park, Illinois, 60462, United States
Primary Healthcare Associates
Tinley Park, Illinois, 60477, United States
UChicago Medicine at Ingalls - Tinley Park
Tinley Park, Illinois, 60477, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555, United States
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
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 Kansas Cancer Center
Westwood, Kansas, 66205, United States
Norton Cancer Institute Pharmacy
Louisville, Kentucky, 40202, United States
Norton Cancer Institute, Downtown
Louisville, Kentucky, 40202, United States
Norton Hospital
Louisville, Kentucky, 40202, United States
The Eye Care Institute
Louisville, Kentucky, 40206, United States
Norton Audubon Hospital
Louisville, Kentucky, 40217, United States
Norton Cancer Institute, Audubon Hospital Campus
Louisville, Kentucky, 40217, United States
Norton Brownsboro Hospital
Louisville, Kentucky, 40241, United States
Norton Cancer Institute, Brownsboro Hospital Campus
Louisville, Kentucky, 40241, 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
Massachusetts Eye and Ear Infirmary(MEEI)
Boston, Massachusetts, 02114, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Ophthalmic Consultants of Boston Inc (OCB)
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Karmanos Cancer Institute Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Oncology Research, HealthPartners Institute
Saint Louis Park, Minnesota, 55426, United States
Park Nicollet Frauenshuh Cancer Center
Saint Louis Park, Minnesota, 55426, 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
Siteman Cancer Center - North County
Florissant, Missouri, 63031, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
Washington University - Investigational Drug Service Pharmacy
St Louis, Missouri, 63110, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Siteman Cancer Center - South County
St Louis, Missouri, 63129, United States
MSK Basking Ridge.
Basking Ridge, New Jersey, 07920, United States
MSK Monmouth
Middletown, New Jersey, 07748, United States
MSK Bergen
Montvale, New Jersey, 07645, United States
MSK Commack.
Commack, New York, 11725, United States
MSK Westchester.
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
New York, New York, 10021, United States
MSK Nassau.
Uniondale, New York, 11553, United States
North Carolina Basnight Cancer Hospital Infusion Pharmacy
Chapel Hill, North Carolina, 27514, United States
UNC Hospitals, The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Duke Cancer Center
Durham, North Carolina, 27710, United States
Investigational Chemotherapy Service
Durham, North Carolina, 27710, United States
Duke Raleigh Hospital
Raleigh, North Carolina, 27609, United States
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
OHSU Knight Cancer Institute, Beaverton
Beaverton, Oregon, 97006, 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, East Portland
Portland, Oregon, 97216, United States
OHSU Center for Health and Healing 2
Portland, Oregon, 97239, United States
OHSU Center for Health and Healing
Portland, Oregon, 97239, United States
Oregon Health and Science University Research Pharmacy Services
Portland, Oregon, 97239, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
OHSU Knight Cancer Institute, Tualatin
Tualatin, Oregon, 97062, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
The Miriam Hospital
Providence, Rhode Island, 02906, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410, United States
Renovatio Clinical.
The Woodlands, Texas, 77380, United States
Cancer Center IDS Pharmacy
Charlottesville, Virginia, 22903, United States
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, 22903, United States
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
UVA Health System; Attention: GI Team
Charlottesville, Virginia, 22908, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
CHRU de Besançon- Hopital Jean Minjoz
Besançon, Doubs, 25030, France
Laboratoire Oriade Noviale Medipole
Bourgoin, 38300, France
Laboratoire Oriade Noviale Tixier
Bourgoin, 38300, France
The Centre Léon Bérard
Lyon, 69373, France
Lbmms Du Chu de Lyon
Lyon, 69424 CEDEX 03, France
CEPCM/CHU Timone, Batiment 3 -1er etage
Marseille, 13005, France
Hopital prive du Confluent S.A.S.
Nantes, 44277, France
L'hôpital Privé du Confluent - Pharmacie
Nantes, 44277, France
Synlab Bourgogne Pont de Vaux
Pont-de-Vaux, 01190, France
Laboratoire Cerballiance Portes Les Valence
Portes-lès-Valence, 26800, France
Hôpital Foch Pharmacie - Essais Cliniques
Suresnes, 92150, France
Hôpital Foch
Suresnes, 92150, France
LBM UNIBIO Jean Herve Lebras
Tain-l'Hermitage, 26600, France
Laboratoire Trevoux-Dyomedea Neolab
Trévoux, 01600, France
Gustave Roussy
Villejuif, 94805, France
Vincentius-Diakonissen-Klinken Gag Augenklinik
Karlsruhe, 76135, Germany
Vincentius-Diakonissen-Kliniken gAG Medizinische Klinik 2
Karlsruhe, 76137, Germany
Vincentius-Diakonissen-Klinken Gag Radiologisches Institut
Karlsruhe, 76137, Germany
Vincentius-Diakonissen-Klinken Gag Zentralapotheke
Karlsruhe, 76137, Germany
IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori- IRST S.r.l
Meldola (Fc), Emilia-Romagna, 47014, Italy
Oncologia Medica, Ospedale Civile S. Maria delle Croci
Ravenna, Emilia-Romagna, 48121, Italy
IRST IRCCS - Farmacia Oncologica
Meldola (FC), Forli-cesena, 47014, Italy
UOC Oncologia Medica
Rome, Lazio, 00128, Italy
U.O. Oncologia
Brescia, Lombardy, 25123, Italy
Istituto Europeo di Oncologia
Milan, MI, 20141, Italy
Ospedale Cervesi di Cattolica-AUSL Romagna
Cattolica, RN, 47841, Italy
Ospedale degli Infermi -AUSL Romagna
Rimini, RN, 47923, Italy
PO Ospedale degli Infermi Faenza, AUSL Romagna
Faenza, 48018, Italy
Ospedale Umberto I di Lugo, AUSL della Romagna, SSR Emilia-Romagna
Lugo, 48022, Italy
AOU Università degli studi della Campania Luigi Vanvitelli, Policlinico di Napoli
Naples, 80131, Italy
Azienda Ospedaliera Universitaria - Universita della Campania Luigi Vanvitelli
Naples, 80131, Italy
Ospedale S.Jacopo di Pistoia, AUSL Toscana centro, SST
Pistoia, 51100, Italy
Farmacia Oncologica c/o Ospedale S.Maria delle Croci-AUSL Romagna
Ravenna, 48121, Italy
Institut Catala D 'Oncologia-Hospital Germans Trias I Pujol,Servicio de Oncologia Medica
Barcelona, Badalona, 08916, Spain
ALTHAIA, Xarxa Assistencial Universitaria de Manresa.
Manresa, Barcelona, 08243, Spain
Hospital Quironsalud Barcelona Instituto Oncologico Baselga
Barcelona, Catalonia, 08023, Spain
Hospital Quiron Salud Barcelona Plaza
Barcelona, 08023, Spain
Vall d'Hebron University Hospital
Barcelona, 08023, Spain
Hospital Universitario Dexeus - Grupo Quirónsalud
Barcelona, 08028, Spain
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
Institut Catala d'Oncologia (ICO BADALONA)
Barcelona, 08908, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Clinical Research Facility - Clinical Research Facility
London, London, CITY of, SE1 9RT, United Kingdom
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
Pharmacy Stores (CCR5916) - The Royal Marsden
Sutton, Surrey, SM2 5PT, United Kingdom
The Royal Marsden NHS Foundation Trust (RM).
London, SW3 6JJ, United Kingdom
Royal Marsden Hospital NHS Foundation Trust - HNTU
Sutton, SM2 5PT, United Kingdom
The Royal Marsden NHS Foundation trust (RM)
Sutton, SM2 5PT, United Kingdom
Related Publications (1)
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.
PMID: 41044356DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2018
First Posted
April 2, 2018
Study Start
June 25, 2018
Primary Completion
March 20, 2026
Study Completion (Estimated)
March 31, 2027
Last Updated
July 22, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
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.