Panoramica

Idoneità

Dettagli del Disegno

Bracci e Interventi

Misure di Esito

Siti dello Studio

Fonte: NCT07059845

Reclutamento in corso

FLORENZA: A Study to Assess Adverse Events and Change in Disease Activity of Multiple Treatment Combinations With Intravenous Mirvetuximab Soravtansine in Adult Participants With Ovarian Cancer

Interventistico

Fase 2

Icon Cancer Centre Wesley /ID# 277199

Sponsor: Abbvie

Ultimo Aggiornamento: 4 dicembre 2025
Avviso - Le informazioni provengono da registri pubblici e potrebbero non riflettere i cambiamenti in tempo reale presso il centro locale.

Ovarian cancer is a lethal disease with an estimated 310,000 new cases and 200,000 deaths experienced worldwide in 2020. The purpose of this study is to assess the adverse events and change in disease activity of mirvetuximab soravtansine with carboplatin, or bevacizumab (Bev), or bev alone in participants with ovarian cancer (OC). Participants must have confirmation of folate receptor alpha (FRa) positivity by the Ventana folate receptor 1 (FOLR1) Assay.

Mirvetuximab Soravtansine (MIRV) is an investigational drug for the treatment of OC. Participants will be assigned to 1 of 2 substudies and further into groups called treatment arms. In substudy 1, arms A-C, participants will receive 1 of 2 doses of MIRV with Bev, or Bev alone. In substudy 2, arms D and E, participants will receive 1 of 2 doses of MIRV with carboplatin, followed by MIRV alone. Approximately 320 participants will be enrolled in the study at 100 sites around the world.

Participants will receive intravenously (IV) infused MIRV with IV infused carboplatin, or IV infused Bev, or IV infused Bev alone. The total study duration will be approximately 40 months.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

Categoria di Trattamento

Anticorpi Monoclonali, Chemioterapia

Mutazioni richieste

FOLR1

Studio Iniziato

13 novembre 2025

Ultimo Aggiornamento dello Sponsor

4 dicembre 2025

Completamento Stimato

1 gennaio 2029

Contatto dello studio

Nome:ABBVIE CALL CENTER

Email:abbvieclinicaltrials@abbvie.com

Telefono:844-663-3742

Idoneità

Criteri di Inclusione

* Substudy 1 and 2: Confirmed high or medium folate receptor alpha (FRa) expression by Ventana folate receptor 1 (FOLR1) Assay.

* Substudy 1 and 2: Participants must have an Eastern Cooperative Oncology Group performance status of 0 or 1.

* Substudy 1: Participants must have a confirmed diagnosis of Federation of Gynecology and Obstetrics (FIGO) Stage III or IV high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.

* Substudy 1: Tumor must be confirmed HRD test negative (HRP), determined by a local homologous recombination deficient (HRD) test.

* Substudy 2: Participants must have a confirmed diagnosis of high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.

* Substudy 2: Participants must have relapsed after 1 or 2 prior lines of platinum-based chemotherapy.

* Substudy 2: Participants must have platinum-sensitive disease defined as radiographic progression greater than 6 months from the last dose of platinum-based chemotherapy.

* Substudy 2: Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (assessed by the investigator) at baseline.

Criteri di Esclusione

* Substudy 1: Participants with progressive disease (PD) while on triplet therapy or after the first day of their last triplet therapy cycle and before randomization.

* Substudy 1: Participants who receive an intervening dose of bevacizumab after the first day of their last triplet therapy cycle and before randomization.

* Substudy 1: Participants who received prior treatment with mirvetuximab soravtansine, any FRα-targeting agent, or any investigational agent.

* 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)

* Substudy 2: Participants who received prior treatment with mirvetuximab soravtansine or other FRα-targeting agents.

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Dettagli del Disegno

AllocazioneRandomized

Modello di InterventoParallel Assignment

MascheramentoNone (Open Label)

Numero da Arruolare320

Bracci e Interventi

Bracci

Interventi

Tipo: Experimental

Descrizione: Participants will receive dose A of MIRV with bevacizumab (Bev), as part of the approximately 40 month study duration.

Interventi:

Bevacizumab
Carboplatin
Mirvetuximab Soravtansine

Misure di Esito

Misure di Esito Primarie

Substudy 1 and 2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) (any grade, Grade >= 3)Up to Approximately 40 Months

TEAEs defined as any adverse event (AE) with the onset after the first dose of study drug until 30 days after the last dose of the study drug.

Substudy 1 and 2: Number of Participants with TEAEs Leading to DiscontinuationUp to Approximately 40 Months

TEAEs defined as any adverse event (AE) with the onset after the first dose of study drug until 30 days after the last dose of the study drug.

Substudy 1 and 2: Number of Participants with Ocular Adverse Events (AEs) (any grade, Grade >= 2)Up to Approximately 40 Months

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

Substudy 1 and 2: Overall Response (OR) as Assessed by the Investigator per RECIST v1.1Up to Approximately 40 Months

OR is defined as achieving a best overall response of confirmed complete response (CR) or confirmed partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Substudy 1: Progression free survival (PFS) as Assessed by the Investigator per RECIST v1.1Up to Approximately 40 Months

PFS is defined as the time from the date of randomization to the first occurrence of radiographic progression based on RECIST version 1.1 or death from any cause, whichever occurs first.

Misure di Esito Secondarie

Substudy 1 and 2: CA-125 Response per Gynecologic Cancer Intergroup (GCIG) CriteriaUp to Approximately 40 Months

CA-125 response per GCIG Criteria.

Substudy 1 and 2: Duration of Response (DOR) as Assessed by the Investigator per RECIST v1.1Up to Approximately 40 Months

DoR is defined for confirmed responders as the time from the participants' initial response (CR or PR) to the first occurrence of radiographic progression per RECIST v1.1 or death from any cause.

Substudy 1 and 2: Number of Participants with Peripheral Neuropathy AEs (any grade, Grade ≥ 2)Up to Approximately 40 Months

Substudy 1 and 2: Number of Participants with Pneumonitis/ Interstitial Lung Disease (ILD) (any grade)Up to Approximately 40 Months

ILD is defined by ILD standardized MedDRA query (SMQ) (broad) per investigator and determined per adjudication.

Substudy 2: PFS as Assessed by the Investigator per RECIST v1.1Up to Approximately 40 Months

PFS is defined as the time from the date of randomization to the first occurrence of radiographic progression based on RECIST version 1.1 or death from any cause, whichever occurs first.

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Siti dello Studio

Questo studio ha 10 siti

Icon Cancer Centre Wesley /ID# 277199

Auchenflower, Queensland, AU

In fase di reclutamento

Auchenflower, Queensland, 4066 AU

Icon Cancer Centre Wesley /ID# 277199

In fase di reclutamento

Adelaide, South Australia, 5065 AU

Burnside War Memorial Hospital /ID# 277602

In fase di reclutamento

Hobart, Tasmania, 7000 AU

Icon Cancer Centre Hobart /ID# 277688

In fase di reclutamento

Seoul, Seoul Teugbyeolsi, 06351 KR

Samsung Medical Center /ID# 276261

In fase di reclutamento

Clayton, Victoria, 3168 AU

Monash Health - Monash Medical Centre /ID# 276984

In fase di reclutamento

Seoul, Seoul Teugbyeolsi, 03080 KR

Seoul National University Hospital /ID# 276182

In fase di reclutamento

Seoul, Seoul Teugbyeolsi, 03722 KR

Yonsei University Health System Severance Hospital /ID# 276266

In fase di reclutamento

Kogarah, New South Wales, 2217 AU

St. George Private Hospital /ID# 276570

In fase di reclutamento

Seoul, Seoul Teugbyeolsi, 08308 KR

Korea University Guro Hospital /ID# 276194

In fase di reclutamento

Melbourne, Victoria, 3084 AU

Austin Hospital /ID# 276534

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