Clinical trial • Phase III • Oncology

LY4170156 for Fallopian tube cancer | Peritoneal cancer | Ovarian cancer | Metastatic cancer

Phase III trial of LY4170156 for Fallopian tube cancer | Peritoneal cancer | Ovarian cancer | Metastatic cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Fallopian tube cancer | Peritoneal cancer | Ovarian cancer | Metastatic cancer
Trial Stage
Phase III
Drug Modality
ADC|Monoclonal antibody|Small molecule

Key dates

Initial CTIS Submission Date
21-01-2026
First CTIS Authorization Date
11-05-2026

Trial design

Part A control: investigator’s choice of chemotherapy or Mirvetuximab Soravtansine (MIRV). Part B control: investigator’s choice of platinum-based doublet chemotherapy plus bevacizumab. (Comparator agents listed in CTIS product list include carboplatin, paclitaxel, pegylated liposomal doxorubicin (doxorubicin), topotecan, gemcitabine, and mirvetuximab soravtansine; bevacizumab is used in combination in Part B.) Phase III trial in Hungary, Ireland, Italy and others.

Comparator
Part A control: investigator’s choice of chemotherapy or Mirvetuximab Soravtansine (MIRV). Part B control: investigator’s choice of platinum-based doublet chemotherapy plus bevacizumab. (Comparator agents listed in CTIS product list include carboplatin, paclitaxel, pegylated liposomal doxorubicin (doxorubicin), topotecan, gemcitabine, and mirvetuximab soravtansine; bevacizumab is used in combination in Part B.)
Target Sample Size
639

Eligibility

Recruits 639 No vulnerable population selected (isVulnerablePopulationSelected is false in CTIS). No specific vulnerable-population consent/assent handling is provided in the CTIS record..

Vulnerable Population
No vulnerable population selected (isVulnerablePopulationSelected is false in CTIS). No specific vulnerable-population consent/assent handling is provided in the CTIS record.

Inclusion criteria

  • {"criterion_text":"- Have ovarian, peritoneal, or fallopian tube cancer."}
  • {"criterion_text":"- Have adequate organ function and blood counts, as measured by blood tests"}
  • {"criterion_text":"- Be well enough to walk and do light work"}
  • {"criterion_text":"- (Part A): Have had their cancer return or worsen 6 months or less after their last platinum chemotherapy."}
  • {"criterion_text":"- (Part B): Have had their cancer return or worsen 6 months or more after the last platinum chemotherapy."}

Exclusion criteria

  • {"criterion_text":"- Have taken a special kind of medicine called an \"antibody-drug conjugate\" that has a topoisomerase inhibitor (DNA untangler) in it."}
  • {"criterion_text":"- (Part A): Have had their cancer return or worsen within the first 3 months after the last dose of the first treatment with platinum chemotherapy."}
  • {"criterion_text":"- (Part B): Have too much protein in the urine (called \"proteinuria\")."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Part A: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator\n- Part B: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded, independent, central review (BICR)","definition_or_measurement_approach":"Part A measured as PFS per RECIST v1.1 assessed by Investigator; Part B measured as PFS per RECIST v1.1 by blinded independent central review (BICR)."}

Recruitment

Digital Remote Recruitment
True, recruitment and participant engagement materials include digital/remote elements and eSource/eCOA platforms (vendors listed in third parties include Medable Inc. for eSource/eCOA, and documents reference Study Connect participant materials and video storyboard/online retention materials).
Planned Sample Size
639
Recruitment Window Months
65
Consent Approach
Informed consent is via subject information sheets and informed consent forms (main and prescreening versions) and optional consent addenda (e.g., optional biopsy, genetic research) provided per country. Country/language-specific ICFs are present in the document list (examples: English, Greek, Hungarian, Dutch, Italian, Polish, French, Norwegian, Czech, Romanian, and others as per country-specific ICF documents).

Methods

  • Country-specific recruitment materials and channels documented: flyers, posters, brochures (K2_Recruitment material files) for multiple countries (examples in document list for Ireland, Hungary, Netherlands, Poland, Belgium, Germany, Norway, Italy, Czechia, France).
  • Doctor referral letters / physician referral (K2 'Letter-Doctor-Referral' documents) to engage clinicians for patient identification.
  • Site-based recruitment and patient contact cards / visit cards / study guides (L2 and L1 documents listed per country) distributed at participating hospitals/clinics.
  • Retention and participant engagement materials including a CT video storyboard and postcard (document titles: CT Video-Storyboard, CT_Postcard) and digital participant connection materials (Study Connect).

Geography

Total Number Of Sites
62
Total Number Of Participants
387

Hungary

Earliest CTIS Part Ii Submission Date
13-03-2026
Latest Decision Or Authorization Date
15-05-2026
Processing Time Days
63
Number Of Sites
2
Number Of Participants
7

Sites

Site Name
Orszagos Onkologiai Intezet
Department Name
Nogyogyaszat
Contact Person Name
Andrea Bagameri
Contact Person Email
bagameristudy@gmail.com
Site Name
University Of Debrecen
Department Name
Szuleszeti es Nogyogyaszati Klinika
Contact Person Name
Robert Poka
Contact Person Email
pokar@med.unideb.hu

Ireland

Earliest CTIS Part Ii Submission Date
13-04-2026
Latest Decision Or Authorization Date
15-05-2026
Processing Time Days
32
Number Of Sites
3
Number Of Participants
13

Sites

Site Name
St Vincent's University Hospital
Department Name
Medical Oncology
Contact Person Name
Lynda McSorley
Contact Person Email
yndamcsorley@svhg.ie
Site Name
St James's Hospital
Department Name
Haematology Oncology Palliative Care (HOPe)
Contact Person Name
Karen Cadoo
Contact Person Email
KCadoo@stjames.ie
Site Name
Cork University Hospital
Department Name
Medical Oncology
Contact Person Name
Dearbhaile Collins
Contact Person Email
dearbhaile.collins@hse.ie

Italy

Earliest CTIS Part Ii Submission Date
16-03-2026
Latest Decision Or Authorization Date
12-05-2026
Processing Time Days
57
Number Of Sites
12
Number Of Participants
49

Sites

Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
SSD Oncologia Medica Zamagni
Contact Person Name
Claudio Zamagni
Contact Person Email
zamagniclaudio.sper@aosp.bo.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Ginecologia Oncologica
Contact Person Name
Anna Fagotti
Site Name
Azienda Ospedaliera Per L'Emergenza Cannizzaro
Department Name
Oncologia medica
Contact Person Name
Giuseppe Scandurra
Contact Person Email
giusy.scandurra@gmail.com
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Divisione Ginecologia Oncologica
Contact Person Name
Nicoletta Colombo
Contact Person Email
nicoletta.colombo@ieo.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Oncologia medica
Contact Person Name
Monika Ducceschi
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
S.C. Oncologia Sperimentale Uro-Genitale
Contact Person Name
Sabrina Cecere
Contact Person Email
s.cecere@istitutotumori.na.it
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
Oncologia medica
Contact Person Name
Claudia Casanova
Contact Person Email
casanova.claudia@libero.it
Site Name
Ospedale Vito Fazzi Lecce
Department Name
Medical Oncology University
Contact Person Name
Ugo De Giorgi
Contact Person Email
ugo.degiorgi@unisalento.it
Site Name
Azienda USL Toscana Centro
Department Name
SOC Oncologia Medica
Contact Person Name
Elena Zafarana
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
DH Oncologia
Contact Person Name
Cinzia Baldessari
Contact Person Email
baldessari.cinzia@aou.mo.it
Site Name
Azienda Unita' Sanitaria Locale Toscana Nord Ovest
Department Name
Oncology
Contact Person Name
Editta Baldini
Site Name
Humanitas Mirasole S.p.A.
Department Name
U.O. Ginecologia Oncologica Medica
Contact Person Name
Domenica Lorusso
Contact Person Email
domenica.lorusso@hunimed.eu

Netherlands

Earliest CTIS Part Ii Submission Date
06-05-2026
Latest Decision Or Authorization Date
11-05-2026
Processing Time Days
5
Number Of Sites
2
Number Of Participants
21

Sites

Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Medical Oncology
Contact Person Name
Ingrid Boere
Contact Person Email
i.boere@erasmusmc.nl
Site Name
Universitair Medisch Centrum Groningen
Department Name
Medical Oncology
Contact Person Name
An Reyners
Contact Person Email
a.k.l.reyners@umcg.nl

Norway

Earliest CTIS Part Ii Submission Date
06-05-2026
Latest Decision Or Authorization Date
11-05-2026
Processing Time Days
5
Number Of Sites
2
Number Of Participants
7

Sites

Site Name
Oslo Universitetssykehus HF
Department Name
Gynaecological Oncology
Contact Person Name
Kristina Lindemann
Contact Person Email
klinde@ous-hf.no
Site Name
Helse Stavanger HF
Department Name
Gynecology and Obstetrics
Contact Person Name
Elisabeth Berge Nilsen
Contact Person Email
elisabeth.berge.nilsen@sus.no

Poland

Earliest CTIS Part Ii Submission Date
10-04-2026
Latest Decision Or Authorization Date
15-05-2026
Processing Time Days
35
Number Of Sites
5
Number Of Participants
56

Sites

Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Kinika Ginekologii Onkologicznej I Endokrynologii Ginekologicznej
Contact Person Name
Dagmara Klasa-Mazurkiewicz
Contact Person Email
dklasa@gumed.edu.pl
Site Name
Wielkopolskie Centrum Onkologii Im. Marii Sklodowskiej-Curie
Department Name
Oddział Radioterapii i Onkologii Ginekologicznej
Contact Person Name
Bartosz Urbański
Contact Person Email
bartosz.urbanski@wco.pl
Site Name
Mazowiecki Szpital Wojewodzki w Siedlcach Sp. z o.o.
Department Name
Siedleckie Centrum Onkologii
Contact Person Name
Lubomir Bodnar
Contact Person Email
lbodnar@szpital.siedlce.pl
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Department Name
Poradnia Onkologiczna oraz Oddział Kliniczny Onkologii
Contact Person Name
Piotr Wysocki
Contact Person Email
piotr.wysocki@uj.edu.pl
Site Name
Uniwersytecki Szpital Kliniczny W Bialymstoku
Department Name
Uniwersyteckie Centrum Onkologii
Contact Person Name
Paweł Knapp
Contact Person Email
knapp@umb.edu.pl

Belgium

Earliest CTIS Part Ii Submission Date
15-04-2026
Latest Decision Or Authorization Date
12-05-2026
Processing Time Days
27
Number Of Sites
5
Number Of Participants
28

Sites

Site Name
Universitair Ziekenhuis Antwerpen
Department Name
Oncology
Contact Person Name
Laure-Anne Teuwen
Contact Person Email
laure-anne.teuwen@uza.be
Site Name
Az Maria Middelares Gent
Department Name
IKG
Contact Person Name
Christof Vulsteke
Site Name
AZ ST-JAN Brugge A.V.
Department Name
Oncology and /or Hematology
Contact Person Name
Eveline De Cuypere
Contact Person Email
eveline.decuypere@azsintjan.be
Site Name
UZ Leuven
Department Name
Gynecologic Oncology
Contact Person Name
Els Van Nieuwenhuysen
Site Name
Institut Jules Bordet
Department Name
Clinical Trial Conduct Unit (Completed) / Medicine Oncology (Incomplete)
Contact Person Name
Laura Polastro
Contact Person Email
laura.polastro@hubruxelles.be

Czechia

Earliest CTIS Part Ii Submission Date
29-04-2026
Latest Decision Or Authorization Date
12-05-2026
Processing Time Days
13
Number Of Sites
5
Number Of Participants
49

Sites

Site Name
Fakultni Nemocnice Brno
Department Name
Gynekologicko-porodnická klinika
Contact Person Name
Markéta Bednaříková
Contact Person Email
Bednarikova.Marketa@fnbrno.cz
Site Name
Nemocnice AGEL Novy Jicin a.s.
Department Name
Oddělení radioterapie a onkologie
Contact Person Name
Vojtěch Tlustý
Contact Person Email
vojtech.tlusty@nnj.agel.cz
Site Name
Krajska Nemocnice T Bati a.s.
Department Name
Onkologické oddělení
Contact Person Name
Markéta Pospíšková
Contact Person Email
pospiskova@bnzlin.cz
Site Name
University Hospital Olomouc
Department Name
Onkologická klinika
Contact Person Name
Bohuslav Melichar
Contact Person Email
bohuslav.melichar@fnol.cz
Site Name
Všeobecná fakultní nemocnice v Praze
Department Name
Gynekologicko porodnická klinika
Contact Person Name
David Cibula
Contact Person Email
dc@davidcibula.cz

Denmark

Earliest CTIS Part Ii Submission Date
30-04-2026
Latest Decision Or Authorization Date
11-05-2026
Processing Time Days
11
Number Of Sites
2
Number Of Participants
21

Sites

Site Name
Lillebaelt Hospital
Department Name
Oncology
Contact Person Name
Caroline Brenner Thomsen
Site Name
Rigshospitalet
Department Name
Oncology
Contact Person Name
Trine Jakobi Nøttrup

France

Earliest CTIS Part Ii Submission Date
09-04-2026
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
34
Number Of Sites
11
Number Of Participants
77

Sites

Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Oncology and Hematology
Contact Person Name
Lauriane EBERST
Contact Person Email
l.eberst@icans.eu
Site Name
Centre Hospitalier de la Côte Basque
Department Name
Oncology
Contact Person Name
Thomas GRELLETY
Contact Person Email
tgrellety@ch-cotebasque.fr
Site Name
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Department Name
Oncology
Contact Person Name
Coriolan LEBRETON
Site Name
Centre Oscar Lambret
Department Name
Oncology
Contact Person Name
Mathilde SAINT-GHISLAIN
Contact Person Email
m-saintghislain@o-lambret.fr
Site Name
Institut de Cancérologie de l'Ouest
Department Name
Oncology
Contact Person Name
Paule AUGEREAU
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
Oncology
Contact Person Name
Stanislas QUESADA
Site Name
Hôpitaux Universitaires Paris Centre-Hôpital Cochin
Department Name
Service d'Oncologie Medicale
Contact Person Name
Jerôme ALEXANDRE
Contact Person Email
jerome.alexandre@aphp.fr
Site Name
Groupe Hospitalier Diaconesses Croix Saint Simon
Department Name
URCEC
Contact Person Name
Antoine ANGELERGUES
Contact Person Email
aangelergues@hopital-dcss.org
Site Name
Centre Léon Bérard
Department Name
Oncology
Contact Person Name
Isabelle-Laure RAY-COQUARD
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Oncologie
Contact Person Name
Elise DELUCHE
Contact Person Email
elise.deluche@chu-limoges.fr
Site Name
CHRU de Brest
Department Name
Institut de cancérologie et d'Hématologie
Contact Person Name
Laura DEIANA
Contact Person Email
laura.deiana@chu-brest.fr

Germany

Earliest CTIS Part Ii Submission Date
30-04-2026
Latest Decision Or Authorization Date
12-05-2026
Processing Time Days
12
Number Of Sites
9
Number Of Participants
39

Sites

Site Name
Technische Universitaet Dresden
Department Name
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
Contact Person Name
Pauline Wimberger
Site Name
Universitaetsklinikum Aachen AöR
Department Name
Frauenklinik
Contact Person Name
Elmar Stickeler
Contact Person Email
estickeler@ukaachen.de
Site Name
Charité Campus Virchow-Klinikum
Department Name
Charité Campus Virchow-Klinikum
Contact Person Name
Elena Braicu
Contact Person Email
elena.braicu@charite.de
Site Name
Universitaetsklinikum Koeln AöR
Department Name
Klinik und Poliklinik für Frauenheilkunde und Gynäkologische Onkologie
Contact Person Name
Florin Andrei Taran
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Klinik für Gynäkologie und Geburtshilfe
Contact Person Name
Peter Fasching
Site Name
KEM I Evang. Kliniken Essen-Mitte gGmbH
Department Name
Klinik für Gynäkologie und Gynäkologische Onkologie
Contact Person Name
Sabrina Kaiser
Contact Person Email
sa.kaiser@kem-med.com
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Gynaecological oncology
Contact Person Name
Eva-Katharina Egger
Contact Person Email
eva-katharina.egger@ukbonn.de
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Klinik für Frauenheilkunde & Geburtshilfe
Contact Person Name
Tanja Fehm
Site Name
Universitaetsklinikum Schleswig-Holstein Campus Kiel
Department Name
Klinik für Gynäkologie und Geburtshilfe, Studienzentrale
Contact Person Name
Marion Tina van Mackelenbergh

Greece

Earliest CTIS Part Ii Submission Date
24-02-2026
Latest Decision Or Authorization Date
11-05-2026
Processing Time Days
76
Number Of Sites
4
Number Of Participants
20

Sites

Site Name
General Oncological Hospital Of Kifissia Agioi Anargyroi
Department Name
Department of Medical Oncology
Contact Person Name
Roubini Zakopoulou
Contact Person Email
rzakopoul@gmail.com
Site Name
General Hospital Of Athens Alexandra
Department Name
Oncology Department, University Clinic of Therapeutics
Contact Person Name
Michalis Liontos
Contact Person Email
mliontos@gmail.com
Site Name
General Hospital Of Messinia
Department Name
Oncology Department
Contact Person Name
Sofia Stamatopoulou
Contact Person Email
stamatopouloudoubali@yahoo.gr
Site Name
Areteio Hospital
Department Name
Oncology Unit, 2nd Surgical Department
Contact Person Name
Flora Zagouri
Contact Person Email
florazagour@yahoo.co.uk

Sponsor

Primary sponsor

Full Name
Eli Lilly & Co.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Icon Clinical Research LLC
Responsibilities
Laboratory & Diagnostics:Imaging
Name
IQVIA Limited
Responsibilities
Study Development/Conduct: Site Monitoring
Name
PPD Global Central Labs
Responsibilities
Laboratory & Diagnostics: Central Lab Regional
Name
Kcas LLC
Responsibilities
Laboratory & Diagnostics: Bioanalytical Sample Analysis
Name
Pharmaceutical Product Development LLC
Responsibilities
Laboratory & Diagnostics: Central Lab & Project Management
Name
Medable Inc.
Responsibilities
Data Management: eSource, Ecoa

Third parties

  • {"country":"United States","full_name":"Icon Clinical Research LLC","duties_or_roles":"Laboratory & Diagnostics:Imaging","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"Pharmaserve Lilly S.A.C.I.","duties_or_roles":"Codes: 1, 12, 15 (includes 'Negotiation and Execution of Clinical Trial Agreements with the participating sites, make study payments based on invoices'), 2, 5","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Study Development/Conduct: Site Monitoring","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"Laboratory & Diagnostics: Central Lab Regional","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Kcas LLC","duties_or_roles":"Laboratory & Diagnostics: Bioanalytical Sample Analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Cleveland Clinic Foundation","duties_or_roles":"Study Development/Conduct : Adjudication","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Copyright Licensing and Translations of Scales / Questionnaires / Diaries","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"Data Management/eDC Data Management / Data Validation/ Data Review/Queries Data Management / Data Reporting / Analytics","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"Laboratory & Diagnostics: Central Lab & Project Management","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medable Inc.","duties_or_roles":"Data Management: eSource, Ecoa","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
LY4170156
Active Substance
LY4170156
Modality
ADC
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
No marketing authorisation (marketingAuthNumber is '-')
Investigational Product Name
MIRVETUXIMAB SORAVTANSINE
Active Substance
Mirvetuximab soravtansine
Modality
ADC
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
No marketing authorisation (marketingAuthNumber is '-')
Maximum Dose
6 mg/kg
Investigational Product Name
BEVACIZUMAB
Active Substance
Bevacizumab
Modality
Monoclonal antibody
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
No marketing authorisation recorded in product entry (marketingAuthNumber is '-')
Maximum Dose
15 mg/kg
Investigational Product Name
PACLITAXEL
Active Substance
Paclitaxel
Modality
Small molecule
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
No marketing authorisation recorded in product entry (marketingAuthNumber is '-')
Maximum Dose
175 mg/m2
Investigational Product Name
CARBOPLATIN
Active Substance
Carboplatin
Modality
Small molecule
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
No marketing authorisation recorded in product entry (marketingAuthNumber is '-')
Maximum Dose
900 mg/m2
Investigational Product Name
GEMCITABINE
Active Substance
Gemcitabine hydrochloride
Modality
Small molecule
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
No marketing authorisation recorded in product entry (marketingAuthNumber is '-')
Maximum Dose
1000 mg/m2
Investigational Product Name
DOXORUBICIN HYDROCHLORIDE
Active Substance
Doxorubicin hydrochloride
Modality
Small molecule
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
No marketing authorisation recorded in product entry (marketingAuthNumber is '-')
Maximum Dose
40 mg/m2
Investigational Product Name
TOPOTECAN
Active Substance
Topotecan
Modality
Small molecule
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
No marketing authorisation recorded in product entry (marketingAuthNumber is '-')
Maximum Dose
4 mg/m2
Combination Treatment
Yes

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