Clinical trial • Phase II • Oncology

MIRVETUXIMAB SORAVTANSINE for Ovarian cancer

Phase II trial of MIRVETUXIMAB SORAVTANSINE for Ovarian cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Ovarian cancer
Trial Stage
Phase II
Drug Modality
ADC|Monoclonal antibody|Small molecule

Key dates

Initial CTIS Submission Date
18-09-2025
First CTIS Authorization Date
19-01-2026

Trial design

Randomised, open-label, mirvetuximab soravtansine in combination regimens (combinations include bevacizumab and carboplatin in some substudies); specific doses and schedules not specified in the part i summary.-controlled, adaptive Phase II trial across 38 sites in Belgium, Denmark, France and others.

Randomised
Yes
Open Label
Yes
Comparator
Mirvetuximab Soravtansine in combination regimens (combinations include bevacizumab and carboplatin in some substudies); specific doses and schedules not specified in the Part I summary.
Adaptive
True, dose-optimization master protocol to determine recommended Phase 3 dose (RP3D) in applicable substudies (dose optimization elements described in main objective).
Biomarker Stratified
True, biomarker: FRα (folate receptor alpha) positive
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
199

Eligibility

Recruits 199 No vulnerable populations selected (isVulnerablePopulationSelected: false). Informed consent obtained via subject information and informed consent forms (multiple ICF documents listed for different sub-studies and countries)..

Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected: false). Informed consent obtained via subject information and informed consent forms (multiple ICF documents listed for different sub-studies and countries).

Inclusion criteria

  • {"criterion_text":"- Substudy 1 and 2: Participants must have an Eastern Cooperative Oncology Group performance status of 0 or 1."}
  • {"criterion_text":"- Substudy 1: Participants must have a confirmed diagnosis of FIGO Stage III or IV high-grade serous ovarian, primary peritoneal, or fallopian tube cancer."}
  • {"criterion_text":"- Substudy 1: Tumor must be confirmed HRD test negative (HRP), determined by a local HRD test."}
  • {"criterion_text":"- Substudy 2: Participants must have a confirmed diagnosis of high-grade serous ovarian, primary peritoneal, or fallopian tube cancer."}
  • {"criterion_text":"- Substudy 2: Participants must have relapsed after 1 or 2 prior lines of platinum-based chemotherapy."}
  • {"criterion_text":"- Substudy 2: Participants must have platinum-sensitive disease defined as radiographic progression greater than 6 months from the last dose of platinum-based chemotherapy."}
  • {"criterion_text":"- Substudy 2: Participants must have measurable disease per RECIST v1.1 (assessed by the investigator) at baseline."}

Exclusion criteria

  • {"criterion_text":"- Substudy 1: Participants with PD while on triplet therapy or after the first day of their last triplet therapy cycle and before randomization."}
  • {"criterion_text":"- Substudy 1: Participants who receive an intervening dose of bevacizumab after the first day of their last triplet therapy cycle and before randomization."}
  • {"criterion_text":"- Substudy 2: More than 2 prior lines of chemotherapy. Lines of prior anticancer therapy are counted with the following considerations: • Neoadjuvant ± adjuvant therapies are considered 1 line of therapy if the neoadjuvant and adjuvant correspond to 1 fully predefined regimen; otherwise, they are counted as 2 prior regimens. • Maintenance therapy (e.g., bevacizumab, PARP inhibitor) will be considered part of the preceding line of therapy (i.e., not counted independently). • If a chemotherapeutic agent in a regimen is substituted with another during a course of treatment due to toxicity, it will be considered part of the proceeding line of therapy • Prior hormonal therapy will not be counted as a separate line of chemotherapy (it will be counted as part of the prior systemic therapy regimen)"}
  • {"criterion_text":"- Substudy 1 and 2: Participants who received prior treatment with mirvetuximab soravtansine or other FRα-targeting agents."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Substudy 1 and 2: Number of Participants with TEAEs (any grade, Grade ≥ 3)","definition_or_measurement_approach":"Treatment-emergent adverse events (TEAEs) counted by grade; Grade ≥3 specified."}
  • {"endpoint_text":"- Substudy 1 and 2: Number of Participants with TEAEs leading to discontinuation","definition_or_measurement_approach":"Number of participants experiencing TEAEs that lead to treatment discontinuation."}
  • {"endpoint_text":"- Substudy 1 and 2: Number of Participants with Ocular AEs (any grade, Grade ≥ 2)","definition_or_measurement_approach":"Number of participants with ocular adverse events, reported by grade; Grade ≥2 specified."}
  • {"endpoint_text":"- Substudy 1 and 2: Overall Response (OR) as assessed by the investigator per RECIST v1.1","definition_or_measurement_approach":"Overall response assessed by investigator using RECIST v1.1 criteria."}
  • {"endpoint_text":"- Substudy 1: Progression free survival (PFS) as assessed by the investigator per RECIST v1.1","definition_or_measurement_approach":"PFS assessed by investigator per RECIST v1.1 (time from baseline to progression or death)."}

Secondary endpoints

  • {"endpoint_text":"- Substudy 1 and 2: CA-125 response per Gynecologic Cancer Intergroup (GCIG) Criteria","definition_or_measurement_approach":"CA-125 response evaluated according to GCIG criteria."}
  • {"endpoint_text":"- Substudy 1 and 2: Duration of Response (DOR) as assessed by the investigator per RECIST v1.1","definition_or_measurement_approach":"Duration of response per RECIST v1.1 assessed by investigator (time from first documented response to progression)."}
  • {"endpoint_text":"- Substudy 1 and 2: Number of Participants with Peripheral neuropathy AEs (any grade, Grade ≥ 2)","definition_or_measurement_approach":"Number of participants with peripheral neuropathy adverse events, by grade; Grade ≥2 specified."}
  • {"endpoint_text":"- Substudy 1 and 2: Number of Participants with Pneumonitis/ Interstitial Lung Disease (ILD) (any grade)","definition_or_measurement_approach":"Number of participants with pneumonitis/ILD adverse events (any grade)."}
  • {"endpoint_text":"- Substudy 2: PFS as assessed by the investigator per RECIST v1.1","definition_or_measurement_approach":"Progression-free survival assessed by investigator per RECIST v1.1."}

Recruitment

Planned Sample Size
199
Recruitment Window Months
36
Consent Approach
Informed consent obtained using subject information and informed consent forms. Multiple ICF documents are provided (prescreen, main ICF, optional ICFs, pregnancy-related ICFs) and country-specific ICFs are listed for Belgium, Denmark, France, Spain and Czechia. Documents available in multiple languages (English, French, Dutch, Danish, Spanish, Czech) as indicated by the published ICF filenames.

Methods

  • Country-specific recruitment arrangements documents (Recruitment and ICF Procedures) listed for Belgium, Denmark, France, Spain, Czechia.
  • Recruitment brochures (K2) / recruitment brochures public (country-specific).
  • Doctor-to-Patient letters (country- and sub-study-specific) to inform potential participants.

Geography

Total Number Of Sites
38
Total Number Of Participants
121

Belgium

Earliest CTIS Part Ii Submission Date
05-01-2026
Latest Decision Or Authorization Date
19-01-2026
Processing Time Days
14
Number Of Sites
5
Number Of Participants
16

Sites

Site Name
Centre hospitalier universitaire de Liege
Department Name
Medical Oncology
Contact Person Name
Christine Gennigens
Site Name
Az Maria Middelares Gent
Department Name
Medical Oncology
Contact Person Name
Christof Vulsteke
Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Medical Oncology
Contact Person Name
Stéphanie Henry
Site Name
UZ Leuven
Department Name
Gynaecological Oncology
Contact Person Name
Toon Van Gorp
Contact Person Email
toon.vangorp@uzleuven.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Oncology
Contact Person Name
Jean-Francois Baurain

Denmark

Earliest CTIS Part Ii Submission Date
08-01-2026
Latest Decision Or Authorization Date
20-01-2026
Processing Time Days
12
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
Odense University Hospital
Department Name
Oncology
Contact Person Name
Trine Lembrecht Jørgensen
Contact Person Email
trine.joergensen@rsyd.dk
Site Name
Aalborg University Hospital
Department Name
Department of Oncology
Contact Person Name
Charlotte Haslund
Contact Person Email
cah@rn.dk
Site Name
Region Hovedstaden
Department Name
Oncology
Contact Person Name
Trine Zeeberg Iversen

France

Earliest CTIS Part Ii Submission Date
19-12-2025
Latest Decision Or Authorization Date
23-01-2026
Processing Time Days
35
Number Of Sites
13
Number Of Participants
41

Sites

Site Name
Centre Leon Berard
Department Name
Département d’oncologie médicale
Contact Person Name
Olivia Le Saux
Site Name
Centr Georges Francois Leclerc
Department Name
Département d’oncologie médicale
Contact Person Name
Jean David Fumet
Contact Person Email
jdfumet@cgfl.fr
Site Name
Institut Bergonie
Department Name
Département d’oncologie médicale
Contact Person Name
Coriolan Lebreton
Site Name
Centre Antoine Lacassagne
Department Name
Département d’oncologie médicale
Contact Person Name
Philippe Follana
Site Name
Institut Gustave Roussy
Department Name
Département d’oncologie médicale
Contact Person Name
Alexandra Leary
Site Name
Oncopole Claudius Regaud
Department Name
Département d’oncologie médicale
Contact Person Name
Laurence Gladieff
Site Name
Sainte Catherine Institut Du Cancer Avignon-Provence
Department Name
Unité fonctionnelle cancers du sein et gynécologiques
Contact Person Name
Julien Grenier
Contact Person Email
j.grenier@isc84.org
Site Name
Groupe Hospitalier Saint Vincent
Department Name
Département d’oncologie
Contact Person Name
Youssef Tazi
Contact Person Email
ytazi@solcrr.org
Site Name
Institut Godinot
Department Name
Département d’oncologie médicale
Contact Person Name
Pierre Martin
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Département d’oncologie
Contact Person Name
Elise Deluche
Contact Person Email
elise.deluche@chu-limoges.fr
Site Name
Centre Francois Baclesse
Department Name
Départements de gynécologie et d'urologie
Contact Person Name
Florence Joly
Contact Person Email
f.joly@baclesse.unicancer.fr
Site Name
Hopital Prive Des Cotes D'armor
Department Name
Département d'oncologie
Contact Person Name
Anne-Claire Hardy-Bessard
Contact Person Email
ac.hardy@cario-sante.fr
Site Name
Institut Curie
Department Name
Département d’oncologie médicale
Contact Person Name
Antoine Vasseur
Contact Person Email
antonie.vasseur@curie.fr

Spain

Earliest CTIS Part Ii Submission Date
23-12-2025
Latest Decision Or Authorization Date
23-01-2026
Processing Time Days
31
Number Of Sites
12
Number Of Participants
39

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Contact Person Name
David García Illescas
Contact Person Email
dgillescas@vhio.net
Site Name
Clinica Universidad De Navarra
Department Name
Oncology
Contact Person Name
Antonio Gonzalez Martin
Contact Person Email
agonzalezma@unav.es
Site Name
Complexo Hospitalario Universitario A Coruña (CHUAC)
Department Name
Oncology
Contact Person Name
Maria Quindos Varela
Contact Person Email
maria.quindos.varela@sergas.es
Site Name
Hospital Universitario Donostia
Department Name
Oncology
Contact Person Name
Miren Karmele Mujika
Contact Person Email
mkmujika@onkologikoa.org
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncology
Contact Person Name
Purificación García Estevez
Contact Person Email
puriestevez@gmail.com
Site Name
Institut Catala D'oncologia
Department Name
Oncology
Contact Person Name
Maria Pilar Barretina Ginesta
Contact Person Email
mpbarretina@iconcologia.net
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Oncology
Contact Person Name
Ignacio Romero
Contact Person Email
iromero@fivo.org
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Oncology
Contact Person Name
Ana De Juan Ferre
Contact Person Email
anade.juan@scsalud.es
Site Name
Hospital Clinic De Barcelona
Department Name
Oncology
Contact Person Name
Lydia Gaba
Contact Person Email
lgaba@clinic.cat
Site Name
Hospital Clinico San Carlos
Department Name
Oncology
Contact Person Name
Antonio Casado Herraez
Contact Person Email
antoniocasado6@gmail.com
Site Name
Complejo Hospitalario Universitario Insular Materno Infantil
Department Name
Oncology
Contact Person Name
Avinash Ramchandani Vaswani
Contact Person Email
avirv87@hotmail.com
Site Name
Hospital Clinico Universitario Lozano Blesa
Department Name
Oncology
Contact Person Name
Alfonso Yubero
Contact Person Email
ayuberoe@salud.aragon.es

Czechia

Earliest CTIS Part Ii Submission Date
19-12-2025
Latest Decision Or Authorization Date
13-02-2026
Processing Time Days
56
Number Of Sites
5
Number Of Participants
16

Sites

Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
Oncology
Contact Person Name
David Cibula
Contact Person Email
dc@davidcibula.cz
Site Name
Fakultni Nemocnice Ostrava
Department Name
Gynekologicko-porodnicka klinika, Onkogynekologické oddéleni
Contact Person Name
Jan Kümmel
Contact Person Email
jan.kummel@fno.cz
Site Name
Masarykuv Onkologicky Ustav
Department Name
Oncology
Contact Person Name
Maria Zvarikova
Contact Person Email
maria.zvarikova2@mou.cz
Site Name
Fakultni Nemocnice Motol A Homolka
Department Name
Department of Oncology
Contact Person Name
Anna Nohejlova Medkova
Contact Person Email
anna.nohejlova@fnmotol.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
Porodnicka a gynekologicka klinika/ Department of Obstetrics and Gynecology
Contact Person Name
Munachiso Ndukwe
Contact Person Email
molie.mo@gmail.com

Sponsor

Primary sponsor

Full Name
AbbVie Deutschland GmbH & Co. KG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Contract research organisations

Name
Iqvia Biotech LLC
Responsibilities
sponsorDuties code: 3

Third parties

  • {"country":"United States","full_name":"Iqvia Biotech LLC","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Ventana (Roche Tissue Diagnostics)","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp","duties_or_roles":"sponsorDuties codes: 15 (Supply lab kits); 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
Mirvetuximab Soravtansine
Active Substance
MIRVETUXIMAB SORAVTANSINE
Modality
ADC
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Investigational Product Name
BEVACIZUMAB
Active Substance
BEVACIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Investigational Product Name
CARBOPLATIN
Active Substance
CARBOPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Combination Treatment
Yes

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