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

April 12, 2024 updated by: Seagen Inc.

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 for certain solid tumors and what side effects (unwanted effects) may occur. There are seven parts to this study.

  • In Part A, the treatment will be given to participants every 3 weeks (3-week cycles).
  • In Part B, participants will receive tisotumab vedotin on Days 1, 8, and 15 every 4-week cycle.
  • In Part C, participants will receive tisotumab vedotin on Days 1 and 15 of every 4-week cycle.

  • In Part D, participants will be given treatment on Day 1 of every 3-week cycle. Participants in Part D will get tisotumab vedotin with either:

    • Pembrolizumab or,
    • Pembrolizumab and carboplatin, or
    • Pembrolizumab and cisplatin
  • In Part E, participants will receive tisotumab vedotin on Days 1 and 15 of every 4-week cycle.
  • In Part F, participants will receive tisotumab vedotin on Days 1, 15, and 29 of every 6-week cycle. Participants in Part F will get tisotumab vedotin with pembrolizumab.
  • In Part G, participants will receive tisotumab vedotin on Days 1, 15, and 29 of every 6-week cycle. Participants in Part G will get tisotumab vedotin with pembrolizumab and carboplatin.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 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 squamous cell carcinoma of the head and neck (SCCHN).

Study Type

Interventional

Enrollment (Estimated)

692

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Recruiting
        • University of Alberta / Cross Cancer Institute
        • Principal Investigator:
          • Neil Chua
  • France
    • Other
      • Besancon, Other, France, 25030
        • Recruiting
        • Hospitalier Jean Minjoz
        • Principal Investigator:
          • Christophe Borg
      • LYON cedex 08, Other, France, 69008
        • Completed
        • Centre Léon Bérard
      • Marseille Cedex 20, Other, France, 13915
        • Recruiting
        • APHM Hôpital Nord
        • Principal Investigator:
          • Sebastien Salas
      • Nantes Cedex 2, Other, France, 44277
        • Recruiting
        • Hopital prive du Confluent
        • Principal Investigator:
          • Claude El Kouri, MD
      • Suresnes, Other, France, 92150
        • Recruiting
        • Hopital FOCH
        • Principal Investigator:
          • Jaafar Bennouna
      • Villejuif Cedex, Other, France, 94805
        • Recruiting
        • Institut Gustave Roussy
        • Principal Investigator:
          • Caroline Even
  • Germany
    • Other
      • Bochum, Other, Germany, 44791
        • Completed
        • Ruhr-Uni. Bochum, St. Josef-Hospital
      • Halle, Other, Germany, 06120
        • Completed
        • Universitätsklinikum Halle-Universitätsklinik und Poliklinik
      • Karlsruhe, Other, Germany, 76137
        • Recruiting
        • Vincentius-Diakonissen-Kliniken gAG
        • Principal Investigator:
          • Christian Meyer
  • Italy
    • Other
      • Brescia, Other, Italy, 25123
        • Recruiting
        • Azienda Ospedaliera Spedali Civili di Brescia
        • Principal Investigator:
          • Alfredo Berruti
      • Catanzaro, Other, Italy, 88100
        • Recruiting
        • Azienda Ospedaliero Universitaria (AOU) Master Domin U.O. Oncologia Medica Traslazzionale
        • Principal Investigator:
          • Pierfrancesco Tassone, MD
      • Milano, Other, Italy, 20141
        • Recruiting
        • Istituto Europeo Di Oncologia
        • Principal Investigator:
          • Giuseppe Curigliano
      • Napoli, Other, Italy, 80131
        • Recruiting
        • Seconda Università degli Studi di Napoli, AOU
        • Principal Investigator:
          • Fortunato Ciardiello
      • Pistoia, Other, Italy, 51100
        • Recruiting
        • Azienda USL Toscana Centro
        • Principal Investigator:
          • Mauro Iannopollo, MD
      • Ravenna, Other, Italy, 48121
        • Recruiting
        • Oncologia Medica, Ospedale Civile S. Maria delle Croci
        • Principal Investigator:
          • Claudia Casanova
      • Roma, Other, Italy, 00128
        • Completed
        • PU Campus Bio-medico di Roma
  • Puerto Rico
      • Rio Piedras, Puerto Rico, 00935
        • Recruiting
        • Pan American Center for Oncology Trials, LLC
        • Principal Investigator:
          • Maria Garcia Pallas, MD
  • Spain
    • Other
      • Badalona, Other, Spain, 08916
        • Recruiting
        • Hospital Universitari Germans Trias i Pujol
        • Principal Investigator:
          • Beatriz Cirauqui
      • Barcelona, Other, Spain, 08023
        • Recruiting
        • Hospital Quironsalud Barcelona Instituto Oncologico Baselga
        • Principal Investigator:
          • Alejandro Martinez
      • Barcelona, Other, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Principal Investigator:
          • Irene Brana
      • Madrid, Other, Spain, 28050
        • Completed
        • HM Centro Integral Oncologico Clara Campal
      • Madrid, Other, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramon y Cajal Servicio de Oncologia Medica Oficina de Ensayos Clinicos
        • Principal Investigator:
          • Teresa Alonso Gordoa
      • Manresa, Other, Spain, 08243
        • Recruiting
        • Althaia Xarxa Assistencial Manresa
        • Principal Investigator:
          • Silvia Catot Tort, MD
      • Palma de Mallorca, Other, Spain, 07198
        • Recruiting
        • Son LLatzer University Hospital
        • Principal Investigator:
          • Juan Coves Sarto
  • United Kingdom
    • Other
      • London, Other, United Kingdom, SE1 9RT
        • Completed
        • Guys and St Thomas Hospital
  • United States
    • California
      • Sacramento, California, United States, 95817
        • Completed
        • University of California Davis
      • San Jose, California, United States, 95124
        • Recruiting
        • Stanford Cancer Center / Blood and Marrow Transplant Program
        • Principal Investigator:
          • Heather Wakelee, M.D.
        • Contact:
    • Colorado
      • Fort Collins, Colorado, United States, 80528
        • Recruiting
        • Poudre Valley Health System (PVHS)
        • Contact:
        • Principal Investigator:
          • Steven R Schuster
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Completed
        • Yale Cancer Center
    • Florida
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • Shands Cancer Center / University of Florida
        • Contact:
        • Principal Investigator:
          • Thomas George
      • Tampa, Florida, United States, 33612
        • Recruiting
        • H. Lee Moffitt Cancer Center and Research Institute
        • Contact:
        • Principal Investigator:
          • Christine Chung
    • Georgia
      • Athens, Georgia, United States, 30607
        • Completed
        • University Cancer & Blood Center, LLC
      • Atlanta, Georgia, United States, 30322
        • Completed
        • Winship Cancer Institute / Emory University School of Medicine
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Medical Center
        • Contact:
        • Principal Investigator:
          • Ari Rosenberg, MD
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern Memorial Hospital
        • Principal Investigator:
          • Jochen Lorch, MD
        • Contact:
      • DeKalb, Illinois, United States, 60115
        • Recruiting
        • Northwestern Medicine Cancer Center Kishwaukee / Kishwaukee Cancer Center
        • Principal Investigator:
          • Jochen Lorch, MD
      • Geneva, Illinois, United States, 60134
        • Recruiting
        • Northwestern Medicine Cancer Center Delnor
        • Principal Investigator:
          • Jochen Lorch, MD
      • Harvey, Illinois, United States, 60426
        • Completed
        • Ingalls Cancer Care / Ingalls Memorial Hospital
      • Warrenville, Illinois, United States, 60555
        • Recruiting
        • Northwestern Medicine Cancer Center Warrenville
        • Principal Investigator:
          • Jochen Lorch, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Recruiting
        • Community Health Network
        • Contact:
        • Principal Investigator:
          • Bert H O'Neil
    • Kansas
      • Fairway, Kansas, United States, 66205
        • Completed
        • University of Kansas Cancer Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins Hospital
        • Contact:
        • Principal Investigator:
          • Tanguy Y Seiwert
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Completed
        • Dana Farber Cancer Institute
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Karmanos Cancer Institute / Wayne State University
        • Principal Investigator:
          • Ammar Sukari
        • Contact:
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55426
        • Completed
        • HealthPartners Institute
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University in St Louis
        • Principal Investigator:
          • Douglas Adkins, MD
        • Contact:
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Principal Investigator:
          • Lara Dunn, MD
        • Contact:
      • New York, New York, United States, 10065
        • Completed
        • Weill Cornell Medicine
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • UNC Lineberger Comprehensive Cancer Center / University of North Carolina
        • Principal Investigator:
          • Shetal Patel
        • Contact:
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest Baptist Medical Center / Wake Forest University
        • Principal Investigator:
          • Lowell L Hart
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97239-3098
        • Recruiting
        • Oregon Health and Science University
        • Principal Investigator:
          • Jeremy Cetnar
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania / Perelman Center for Advanced Medicine
        • Contact:
        • Principal Investigator:
          • Lova Sun
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Rhode Island Hospital
        • Contact:
        • Principal Investigator:
          • Howard Safran
    • Texas
      • Dallas, Texas, United States, 75246
        • Completed
        • Texas Oncology - Fort Worth
      • Houston, Texas, United States, 77030-4095
        • Recruiting
        • MD Anderson Cancer Center / University of Texas
        • Principal Investigator:
          • Neal S. Akhave
        • Contact:
      • Lubbock, Texas, United States, 79410
        • Recruiting
        • Joe Arrington Cancer Research and Treatment Center
        • Principal Investigator:
          • Isaac Tafur
        • Contact:
      • The Woodlands, Texas, United States, 77380
        • Completed
        • Renovatio Clinical
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Completed
        • University of Virginia
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington
        • Principal Investigator:
          • Cristina P Rodriguez
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 SCCHN 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.
    • SCCHN (closed to enrollment): Participants with SCCHN in Part C must have received prior therapy with a platinum-based regimen and/or a checkpoint inhibitor (CPI), if eligible, and must have experienced disease progression following such therapy. Participants should have received no more than 3 systemic lines of therapy in the recurrent or metastatic setting.

  • Part E

    • Participants with SCCHN must have experienced disease progression on or after their most recent systemic therapy. Participants should have received no more than 1 or 2 systemic lines of therapy in the recurrent/metastatic setting as specified below. Participants must have received a platinum-based regimen and a PD-(L)1 inhibitor.

  • Parts D, F, and G

    • Part D is closed to enrollment. Part F and Part G will enroll only participants with SCCHN.
    • Participants with SCCHN must have received no previous systemic therapy in the recurrent or metastatic disease setting.

    • Part D only

      • Participants with NSCLC must have histologically or cytologically documented squamous cell NSCLC and must have received no previous systemic therapy for metastatic disease or radiation therapy to the lung that is > 30 Gy within 6 months of the first dose of study treatment.
      • PD-L1 biomarker expression as determined by a PD-L1 IHC assay should be available

    • Part F only

      • Participants must have CPS ≥1 by local PD-L1 IHC assay to be eligible for enrollment. Participants must be able to submit a tissue sample for retrospective PD-L1 testing. Tissue may be fresh biopsy or archival, collected within 2 years of Cycle 1 Day 1.

    • Part G only

      • Non-EU eligibility criteria: No CPS requirement for the cohort evaluating tisotumab vedotin in combination with pembrolizumab and carboplatin.
      • EU-specific eligibility criteria: Participants must have a CPS ≥1 by local PD-L1 IHC assay.
      • Participants must be able to submit a tissue sample for retrospective PD-L1 testing. Tissue may be fresh biopsy or archival, collected within 2 years of Cycle 1 Day 1.
  • Baseline measurable disease as measured by RECIST v1. 1.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.

Exclusion Criteria:

  • Participants with primary neuroendocrine or sarcomatoid histologies. For SCCHN, participants may not have a primary site of nasopharynx or salivary gland.
  • Active bleeding conditions
  • Ocular surface disease at the time of enrollment (Note: cataract is not considered active ocular surface disease for this protocol)
  • Other cancer: known past or current malignancy other than inclusion diagnosis.
  • Uncontrolled tumor-related pain
  • Inflammatory lung disease. Participants with pulmonary disease are allowed if systemic steroids and long-term oxygen are not required
  • Peripheral neuropathy greater than or equal to Grade 2
  • Active brain metastasis
  • 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A: Tisotumab Vedotin - Q3W Schedule
Tisotumab Vedotin every 3 weeks
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
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.
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 C: Tisotumab Vedotin - 2Q4W Schedule
Tisotumab Vedotin on Days 1 and 15 of every 28-day cycle in participants with SCCHN or sqNSCLC
Drug: tisotumab vedotin
Given into the vein (IV; intravenously)
Other Names:
  • TIVDAK
Experimental: Part E: Tisotumab Vedotin - 2Q4W Schedule
Tisotumab Vedotin on Days 1 and 15 of every 28-day cycle in participants with SCCHN 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.
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.
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, F, and G)
Time Frame: Up to approximately 3 years
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
Confirmed ORR per blinded independent central review (BICR) (Part E)
Time Frame: Up to approximately 1 year
Proportion of patients who achieve a confirmed CR or PR according to RECIST v1.1 as assessed by BICR
Up to approximately 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events (AEs)
Time Frame: Up to approximately 3 years
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
Time Frame: Up to approximately 3 years
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 Frame: Up to approximately 4 years
Time from the start of study treatment to date of death due to any cause
Up to approximately 4 years
Cmax
Time Frame: Through 30-37 days following the last dose; up to approximately 3 years
Maximum observed plasma concentration
Through 30-37 days following the last dose; up to approximately 3 years
Ctrough
Time Frame: Through 30-37 days following the last dose; up to approximately 3 years
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)
Time Frame: Through 30-37 days following the last dose; up to approximately 3 years
Through 30-37 days following the last dose; up to approximately 3 years
Confirmed and Unconfirmed ORR per BICR (Part E)
Time Frame: Up to approximately 1 year
Proportion of patients who achieve a CR or PR according to RECIST v1.1 as assessed by BICR
Up to approximately 1 year
Disease Control Rate (DCR)
Time Frame: Up to approximately 3 years
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
DCR per BICR (Part E)
Time Frame: Up to approximately 1 year
Proportion of patients who achieve a confirmed CR or PR according to RECIST v1.1 as assessed by BICR, or meet the stable disease (SD) criteria at least once after start of study treatment at a minimum interval of 12 weeks
Up to approximately 1 year
Duration of Response (DOR)
Time Frame: Up to approximately 3 years
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
DOR per BICR (Part E)
Time Frame: Up to approximately 3 years
Time from the first documentation of objective response to the first documentation of PD or death due to any cause, whichever comes first, as assessed by BICR
Up to approximately 3 years
Time to Response (TTR)
Time Frame: Up to approximately 1 year
Time from the start of study treatment to the first documentation of objective response, as assessed by investigator
Up to approximately 1 year
TTR per BICR (Part E)
Time Frame: Up to approximately 1 year
Time from the start of study treatment to the first documentation of objective response, as assessed by BICR
Up to approximately 1 year
Progression-free survival (PFS)
Time Frame: Up to approximately 3 years
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
PFS per BICR (Part E)
Time Frame: Up to approximately 3 years
Time from the start of study treatment to the first documentation of PD according to RECIST v1.1 or death due to any cause, whichever comes first, as assessed by BICR
Up to approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seagen Inc.

Collaborators

Merck Sharp & Dohme LLC
Genmab

Investigators

  • Study Director: Kristi Schmidt, MD, Seagen Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2018

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

November 30, 2026

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 16, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGNTV-001
  • 2017-005076-26 (EudraCT Number)
  • KEYNOTE-E02 (Other Identifier: Merck Sharp & Dohme LLC)
  • MK-3475-E02 (Other Identifier: Merck Sharp & Dohme LLC)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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