Informations générales (source: ClinicalTrials.gov)
A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) Versus Treatment of Investigator's Choice (IC) in Patients With Platinum Resistant Ovarian Cancer
Interventional
Phase 3
Genmab (Voir sur ClinicalTrials)
février 2025
mai 2028
13 mai 2026
This phase 3 study will be conducted in different countries all over the world.
The purpose of this study is to compare how well Rina-S works against platinum-resistant
ovarian cancer compared to chemotherapy drugs that are already approved and used for
platinum-resistant ovarian cancer.
Treatment in this study could be Rina-S or it could be 1 of 4 indicated chemotherapy
agents that are considered standard medical care. There is an equal (50:50) chance of
getting Rina-S or an approved chemotherapy agent as treatment in this study. No one will
know what treatment they are assigned to until the first dose.
All participants will receive active drug; no one will be given placebo.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Kaissa OUALI | 12/05/2026 15:55:06 | Contacter | ||
Critères
Femme
- Participants must have histologically or cytologically confirmed high grade serous
or endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian
tube cancer.
- Participants may be enrolled regardless of FRα expression level.
- Participants must have received 1 to 4 prior lines of therapy. Participants must
have progressed radiographically on or after their most recent line of therapy.
- Participants must have received prior treatment with the following therapies:
- Platinum chemotherapy
- Prior bevacizumab (or biosimilar) treatment is required, if labeled and
available as standard of care per institutional guidelines, unless the
participant has a documented contraindication or unless the participant is not
eligible for treatment with bevacizumab (or biosimilar) due to
precautions/intolerance
- Participants with known or suspected deleterious germline or somatic breast
cancer gene (BRCA) mutations and who achieved a complete or partial response to
platinum-based chemotherapy must have been treated with a poly ADP-ribose
polymerase (PARP) inhibitor as maintenance treatment unless the participant is
not eligible for treatment with PARP inhibitor
- Mirvetuximab soravtansine, if:
- Mirvetuximab soravtansine is available in the enrollment region, and
- The participant is eligible based on positive FRα expression per Food and
Drug Administration (FDA)-approved (or local equivalent) test, and
- The participant does not have a documented medical exception, including
chronic corneal disorders, history of corneal transplantation, or active
ocular conditions requiring ongoing treatment/monitoring, such as
uncontrolled glaucoma, wet age-related macular degeneration requiring
intravitreal injections, active diabetic retinopathy with macular edema,
macular degeneration, presence of papilledema, and /or monocular vision.
- Participants must have platinum-resistant disease:
- Participants who have only had 1 line of platinum-based therapy must have
received at least 4 cycles of platinum therapy, and must have either had a
response (CR or PR) or had non-measurable disease at the start of adjuvant
platinum-based therapy, and then progressed between > 91 days and ≤ 183 days
after the date of the last dose of platinum.
- Participants who have received 2 to 4 lines of platinum-based therapy must have
progressed on or within 183 days after the date of the last dose of platinum.
Key Exclusion Criteria:
- Prior therapy with an antibody-drug conjugate containing a topoisomerase 1
inhibitor.
- Have primary platinum-refractory disease, defined as ovarian cancer that did not
respond (CR or PR) to or progressed ≤ 91 days after the last dose of a first-line
platinum-containing regimen.
- History of another malignancy within 3 years before the first dose of study drug, or
any evidence of residual disease from a previously diagnosed malignancy. Exceptions
are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS
≥90%), including, but not limited to, adequately treated carcinoma in situ of the
cervix, non-melanoma skin carcinoma, ductal carcinoma in situ, or Stage I uterine
cancer.
- Known active central nervous system metastases or carcinomatous meningitis.
Participants with previously treated brain metastases may participate provided they
are clinically stable for at least 4 weeks prior to study entry after brain
metastasis treatment, they have no new or enlarging brain metastases, and are off
corticosteroids and anticonvulsants prescribed for symptoms associated with brain
metastases for at least 7 days prior to the first dose of study drug. Participants
with suspected brain metastases at screening should undergo a computed tomography
(CT)/magnetic resonance imaging (MRI) of the brain prior to study entry.
- Hospitalization or clinical symptoms due to gastrointestinal obstruction within the
past 91 days or radiographic evidence of gastrointestinal obstruction at the time of
screening. Enrollment of participants who currently require parenteral nutrition
must be discussed with the study medical monitor to determine eligibility.
- Ascites requiring frequent paracentesis (more often than approximately every 4
weeks) for symptomatic management. Enrollment of participants with an indwelling
peritoneal catheter must be discussed with the medical monitor to determine
eligibility.
NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.