Informations générales (source: ClinicalTrials.gov)
A Phase 2, Open-Label, Randomized, Master Protocol Dose Optimization Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations With Mirvetuximab Soravtansine in Subjects With Ovarian Cancer
Interventional
Phase 2
AbbVie (Voir sur ClinicalTrials)
novembre 2025
janvier 2029
10 juin 2026
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 3 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. In substudy 3, arms F and G,
participants will receive one of two doses of MIRV with BEV and carboplatin, followed by
MIRV with BEV. Approximately 400 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 carboplatin and 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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Alexandra LEARY | 05/06/2026 07:15:06 | Contacter | ||
Critères
Femme
Substudy 1
- Participants must be willing to provide an archival tumor tissue block or slides or
must undergo a procedure to obtain a new tumor biopsy using a low-risk, medically
routine procedure for immunohistochemistry (IHC) confirmation of FRα expression as
defined by the central VENTANA FOLR1 (FOLR1-2.1) assay. Tumors must have
FRα-expression in >= 50% of viable tumor cells with >= 2+ staining intensity.
- Participants must have an Eastern Cooperative Oncology Group performance status of 0
or 1.
- 1L participants must have a confirmed diagnosis of Federation of Gynecology and
Obstetrics (FIGO) Stage III or IV high-grade serous epithelial ovarian, primary
peritoneal, or fallopian tube cancer.
2L participants must have platinum-sensitive high-grade serous epithelial ovarian,
primary peritoneal, or fallopian tube cancer. Participants must have
platinum-sensitive disease defined as radiographic progression greater than 183 days
from the last dose of most recent platinumbased chemotherapy. Note: Progression
should be calculated from the date of the last administered dose of platinum therapy
to the date of the radiographic imaging showing progression.
- Participant has a local homologous recombination deficient (HRD) or breast cancer
susceptibility gene (BRCA) test result available. Participants with BRCA wild-type
will need to have a local HRD test result available.
Substudy 2
- Participants must be willing to provide an archival tumor tissue block or slides or
must undergo a procedure to obtain a new tumor biopsy using a low-risk, medically
routine procedure for immunohistochemistry (IHC) confirmation of FRα expression as
defined by the central VENTANA FOLR1 (FOLR1-2.1) assay. Tumors must have
FRα-expression in >= 50% of viable tumor cells with >= 2+ staining intensity.
- Participants must have an Eastern Cooperative Oncology Group performance status of 0
or 1.
- Participants must have a confirmed diagnosis of high-grade serous ovarian, primary
peritoneal, or fallopian tube cancer.
- Participants must have relapsed after 1 or 2 prior lines of platinum-based
chemotherapy.
- Participants must have platinum-sensitive disease defined as radiographic
progression greater than 183 days from the last dose of platinum-based chemotherapy.
- Participants must have measurable disease per Response Evaluation Criteria in Solid
Tumors (RECIST) v1.1 (assessed by the investigator) at baseline.
Substudy 3
- Participants must be willing to provide an archival tumor tissue block or slides or
must undergo a procedure to obtain a new tumor biopsy using a low-risk, medically
routine procedure for immunohistochemistry (IHC) confirmation of FRα expression as
defined by the central VENTANA FOLR1 (FOLR1-2.1) assay. Tumors must have
FRα-expression in >= 50% of viable tumor cells with >= 2+ staining intensity.
- Participants must have an Eastern Cooperative Oncology Group performance status of 0
or 1.
- Participants must have a confirmed diagnosis of high-grade serous ovarian, primary
peritoneal, or fallopian tube cancer.
- Participants must have relapsed after 1 or 2 prior lines of platinum-based
chemotherapy.
- Participants must have platinum-sensitive disease defined as radiographic
progression greater than 183 days from the last dose of platinum-based chemotherapy.
- Participants must have measurable disease per Response Evaluation Criteria in Solid
Tumors (RECIST) v1.1 (assessed by the investigator) at baseline.
Exclusion Criteria:
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.
- Participants who receive an intervening dose of bevacizumab after the first day of
their last triplet therapy cycle and before randomization.
- Participants who received prior treatment with mirvetuximab soravtansine (MIRV), any
FRα-targeting agent, or Poly(ADP-ribose) polymerase inhibitor (PARPi).
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, PARPi) 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 same
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)
- Participants who received prior treatment with mirvetuximab soravtansine or other
FRα-targeting agents.
Substudy 3
- 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, PARPi) 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 same
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)
- Participants who received prior treatment with mirvetuximab soravtansine or other
FRα-targeting agents.