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Study to Assess the Efficacy and Safety of Rina-S With or Without Bevacizumab Compared to Investigator's Choice of Platinum-based Chemotherapy With or Without Bevacizumab as Second-line Treatment in Participants With Recurrent Platinum-sensitive Ovarian Cancer (RAINFOL™-07)

31 augusti 2026 uppdaterad av: Genmab

A Randomized, Open-label, Phase 3 Study of Rina-S ± Bevacizumab Versus Investigator's Choice of Platinum-Based Chemotherapy ± Bevacizumab as 2L Treatment in Participants With Recurrent Platinum-Sensitive Ovarian Cancer

This Phase 3 study will be conducted in different countries around the world with up to about 688 participants.

The purpose of this study is to evaluate how well Rina-S works against ovarian cancer in combination with or without bevacizumab and how it compares to an investigator's choice of platinum-based chemotherapy with or without bevacizumab.

Participants will receive either:

  • Rina-S monotherapy (by itself),
  • Rina-S plus bevacizumab,
  • investigator's choice chemotherapy (by itself) (standard of care), or
  • investigator's choice chemotherapy plus bevacizumab (standard of care).

No participants will be given placebo. Participants will participate in 1 of 2 arms.

The treatment duration will be different for every participant. If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open.

Participants will be asked to attend 1 to 3 visits at the study clinic for each cycle (duration of cycle is 3 or 4 weeks, depending on medication received). During visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity and imaging) to monitor whether the study treatment is safe and effective.

The overall study duration (including screening, treatment, and follow-up) will be different for every participant.

Studieöversikt

Detaljerad beskrivning

This is a global, open-label, randomized, Phase 3 study of Rina-S ± bevacizumab versus investigator's choice (IC) ± bevacizumab as second-line (2L) treatment in participants with recurrent platinum-sensitive ovarian cancer (PSOC).

Studietyp

Interventionell

Inskrivning (Beräknad)

688

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

    • Connecticut
      • Danbury, Connecticut, Förenta staterna, 06810
        • Rekrytering
        • Danbury Hospital
    • Wisconsin
      • Waukesha, Wisconsin, Förenta staterna, 53188
        • Rekrytering
        • Prohealth Care Inc

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Key Inclusion Criteria:

  • Participant must have histologically confirmed high-grade serous or endometrioid epithelial ovarian cancer (EOC), including primary peritoneal or fallopian tube cancer.
  • Participant must have documented recurrence or progression after first-line (1L) platinum-based chemotherapy regimen (carboplatin + paclitaxel ≥ 4 cycles) with or without bevacizumab and have platinum-sensitive disease defined as radiographic progression at least 6 months (ie, >183 days) after their last dose administration of platinum-based therapy.
  • Prior poly (ADP-ribose) polymerase inhibitor(s) (PARPi) maintenance therapy (alone or in combination with bevacizumab) is required for participants with breast cancer susceptibility gene (BRCA 1- and BRCA 2)-mutated (germline or somatic) or homologous recombination deficiency (HRD)-positive disease.
  • Participants must have measurable disease per RECIST v1.1 by investigator at baseline.
  • All participants must provide a tumor specimen.
  • Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at baseline.

Key Exclusion Criteria:

  • Participants with clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade/borderline ovarian tumors.
  • Participant has received previous therapy with other anti-angiogenetic agents different from bevacizumab or biosimilar.
  • Participant has received prior therapy with an antibody-drug conjugate (ADC) containing a topoisomerase-1 inhibitor.
  • Participant has received prior therapy with an ADC targeting folate receptor alpha (FRα).

Note: Other protocol-defined Inclusion and Exclusion criteria may apply.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Arm 1: Rina-S ± Bevacizumab
Participants will receive Rina-S ± bevacizumab once every 3 weeks (Q3W).
IV infusion
Intravenous (IV) infusion
Andra namn:
  • PRO1184
  • Rinatabart Sesutecan
  • GEN1184
Aktiv komparator: Arm 2: Investigator Choice of Chemotherapy ± Bevacizumab
Participants will receive carboplatin plus gemcitabine ± bevacizumab, carboplatin plus paclitaxel ± bevacizumab, or carboplatin plus pegylated liposomal doxorubicin (PLD) ± bevacizumab.
IV infusion
IV infusion
IV infusion
IV infusion
IV infusion

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1, as Determined by Blinded Independent Central Review (BICR)
Tidsram: Up to approximately 3 years
Up to approximately 3 years

Sekundära resultatmått

Resultatmått
Tidsram
Total överlevnad (OS)
Tidsram: Upp till cirka 5 år
Upp till cirka 5 år
Duration of Response (DOR) per RECIST v1.1
Tidsram: Upp till cirka 3 år
Upp till cirka 3 år
Antal deltagare med behandlings-emergente-händelser (TEAE)
Tidsram: Upp till cirka 3 år
Upp till cirka 3 år
PFS per RECIST v1.1, as Determined by Investigator
Tidsram: Up to approximately 3 years
Up to approximately 3 years
Objective Response Rate (ORR) per RECIST v1.1
Tidsram: Up to approximately 3 years
Up to approximately 3 years
Progression-free Survival on the Next Line of Therapy After the First Progression (PFS2)
Tidsram: Up to approximately 3 years
Up to approximately 3 years
Time to First Subsequent Therapy (TFST)
Tidsram: Up to approximately 3 years
Up to approximately 3 years
Cancer Antigen 125 (CA-125) Response per Gynecologic Cancer Intergroup (GCIG) Criteria
Tidsram: Up to approximately 3 years
Up to approximately 3 years
Overall Change from Baseline in Global Health Status (GHS)/Quality of Life (QoL) Score Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30)
Tidsram: Baseline up to approximately 3 years
Baseline up to approximately 3 years
Time to Deterioration (TTD) in the GHS/QoL Score Using the EORTC QLQ C30 Questionnaire
Tidsram: Up to approximately 3 years
Up to approximately 3 years

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Utredare

  • Studierektor: Study Official, Genmab

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

28 augusti 2026

Primärt slutförande (Beräknad)

1 december 2029

Avslutad studie (Beräknad)

1 november 2031

Studieregistreringsdatum

Först inskickad

27 april 2026

Först inskickad som uppfyllde QC-kriterierna

27 april 2026

Första postat (Faktisk)

4 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

31 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • GCT1184-07
  • 2025 (U.S.S. NIH-anslag/kontrakt: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • GOG-3143 (Annan identifierare: Other Identifier)
  • ENGOT-ov103 (Annan identifierare: Other Identifier)
  • GEICO-177-O (Annan identifierare: Other Identifier)
  • APGOT-ov21 (Annan identifierare: Other Identifier)
  • LACOG 0126-EVA (Annan identifierare: Other Identifier)
  • 2025-524202-15-00 (Ctis)
  • jRCT2021260025 (Registeridentifierare: Japan Registry for Clinical Trials (jRCT))

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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