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An Extension Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer in China (RAINFOL-02)

7 septembre 2026 mis à jour par: Genmab

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

The purpose of this Chinese extension 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.

This study is an extension study of the protocol GCT1184-02 (NCT06619236).

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

82

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Chine
      • Changchun, Chine
        • Recrutement
        • The First Hospital of Jilin University
      • Changsha, Chine
        • Recrutement
        • Hunan Cancer Hospital
      • Chengdu, Chine
        • Recrutement
        • West China Second University Hospital, Sichuan University
      • Chongqing, Chine
        • Recrutement
        • Chongqing University Cancer Hospital - Chongqing Cancer Hospital
      • Guangzhou, Chine
        • Recrutement
        • Sun Yat-sen University Cancer Center
      • Guangzhou, Chine
        • Recrutement
        • Sun Yat-sen Memorial Hospital
      • Hangzhou, Chine
        • Recrutement
        • Zhejiang Cancer Hospital
      • Harbin, Chine
        • Recrutement
        • Harbin Medical University Cancer Hospital
      • Jinan, Chine
        • Recrutement
        • Shandong First Medical University Affiliated Tumor Hospital
      • Nanjing, Chine
        • Recrutement
        • Nanjing Drum Tower Hospital (The Affiliated Hospital of Nanjing University Medical School)
      • Shanghai, Chine
        • Recrutement
        • Obstetrics & Gynecology Hospital of Fudan University
      • Shanghai, Chine
        • Recrutement
        • Fudan University Shanghai Cancer Hospital
      • Shenyang, Chine
        • Recrutement
        • Liaoning Cancer Hospital
      • Taiyuan, Chine
        • Recrutement
        • Shanxi Cancer Hospital
      • Tianjin, Chine
        • Recrutement
        • Tianjin Medical University Cancer Institute & Hospital
      • Xi'an, Chine
        • Recrutement
        • The First Affiliated Hospital of Xi'an Jiaotong University
      • Zhengzhou, Chine
        • Recrutement
        • Henan Cancer Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Key Inclusion Criteria:

  • 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, 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 a protocol defined number of 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.
  • Participant has clinically significant ascites/pleural effusion. Enrollment of participants with an indwelling catheter flush/drain is not allowed. Note: Clinically significant is defined as (1) symptomatic, or (2) requires therapeutic paracentesis/thoracentesis within 8 weeks of the first dose, or (3) recurrent ascites/pleural effusion that necessitates multiple paracentesis/thoracocentesis procedures more often than approximately every 4 weeks.

NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Choix de l'enquêteur
Médicament: Paclitaxel
Perfusion IV
Médicament: Gemcitabine
Perfusion IV
Médicament: Doxorubicine liposomale pégylée (PLD)
Perfusion IV
Médicament: Topotécan
Perfusion IV
Expérimental: Rina-S
Médicament: Rina-S
Perfusion intraveineuse (IV)
Autres noms:
  • PRO1184
  • Rinatabart Sésutécan
  • GEN1184

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Progression-Free Survival (PFS)
Délai: Up to approximately 16 months
PFS is defined as the time from the date of randomization to the date of the first documented progression or death (PD) due to any cause, whichever occurs first based on response evaluation criteria in solid tumors (RECIST) version 1.1 as assessed by the investigator.
Up to approximately 16 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Overall Survival (OS)
Délai: Up to approximately 25 months
OS is defined as the time from date of randomization to date of death due to any cause.
Up to approximately 25 months
Objective Response Rate (ORR)
Délai: Up to approximately 25 months
ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) based on RECIST v1.1 as assessed by the investigator.
Up to approximately 25 months
PFS as Determined by BICR
Délai: Up to approximately 16 months
PFS is defined as the time from the date of randomization to the date of the first documented progression or death (PD) due to any cause, whichever occurs first based on RECIST version 1.1 as determined by BICR.
Up to approximately 16 months
ORR as Determined by BICR
Délai: Up to approximately 25 months
ORR is defined as the percentage of participants with BOR of CR or PR based on RECIST v1.1 as determined by BICR.
Up to approximately 25 months
Duration of Response (DOR)
Délai: Up to approximately 25 months
DOR is defined as the time from the onset date of response to the date of the first documented progression or death due to any cause based on RECIST v1.1 as assessed by the investigator and by blinded independent central review (BICR).
Up to approximately 25 months
Percentage of Participants Who Achieved Cancer Antigen-125 (CA-125) Response per Gynecologic Cancer Intergroup (GCIG) Criteria
Délai: Up to approximately 25 months
A CA-125 response per the GCIG criteria is defined as a ≥ 50% reduction in CA-125 levels from baseline.
Up to approximately 25 months
Time to Second Disease Progression or Death From any Cause (PFS2)
Délai: Up to approximately 25 months
PFS2 is defined as the time from randomization to the date of the second PD (i.e., the first PD reported in subsequent anti-cancer therapies, or long-term follow up) or death.
Up to approximately 25 months
Overall Change From Baseline in Global Health Status/Quality of Life (GHS/Qol)
Délai: Baseline, up to approximately 25 months
Overall change from baseline in GHS/Qol score (items 29 and 30) will be calculated using the European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC-QLQ-C30) questionnaire. The score ranges from 0 to 100. A high scale score represents a higher response level.
Baseline, up to approximately 25 months
Time to Deterioration (TTD) in the GHS/Qol Score
Délai: Up to approximately 25 months
TTD in the GHS/Qol score is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) in GHS/QoL score. A longer TTD indicates a better outcome.
Up to approximately 25 months
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Délai: Up to approximately 25 months
Up to approximately 25 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Genmab

Les enquêteurs

  • Directeur d'études: Study Official, Genmab

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

26 juin 2026

Achèvement primaire (Estimé)

1 septembre 2027

Achèvement de l'étude (Estimé)

1 décembre 2028

Dates d'inscription aux études

Première soumission

18 mai 2026

Première soumission répondant aux critères de contrôle qualité

18 mai 2026

Première publication (Réel)

22 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • GCT1184-02 Extension Study
  • CTR20253987 (Identificateur de registre: ChinaDrugTrials.org.cn)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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