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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)

1. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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).

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

688

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arm 1: Rina-S ± Bevacizumab
Participants will receive Rina-S ± bevacizumab once every 3 weeks (Q3W).
Medicin: Bevacizumab
IV infusion
Biologisk: Rina-S
Intravenous (IV) infusion
Andre navne:
  • 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.
Medicin: Bevacizumab
IV infusion
Medicin: Paclitaxel
IV infusion
Medicin: Gemcitabin
IV infusion
Medicin: Carboplatin
IV infusion
Medicin: PLD
IV infusion

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Tidsramme
Samlet overlevelse (OS)
Tidsramme: Op til cirka 5 år
Op til cirka 5 år
Varighed af svar (DOR) pr. RECIST v1.1
Tidsramme: Op til cirka 3 år
Op til cirka 3 år
Antal deltagere med bivirkninger af behandlingsfremstilling (TEAE'er)
Tidsramme: Op til cirka 3 år
Op til cirka 3 år
PFS per RECIST v1.1, as Determined by Investigator
Tidsramme: Up to approximately 3 years
Up to approximately 3 years
Objective Response Rate (ORR) per RECIST v1.1
Tidsramme: Up to approximately 3 years
Up to approximately 3 years
Progression-free Survival on the Next Line of Therapy After the First Progression (PFS2)
Tidsramme: Up to approximately 3 years
Up to approximately 3 years
Time to First Subsequent Therapy (TFST)
Tidsramme: Up to approximately 3 years
Up to approximately 3 years
Cancer Antigen 125 (CA-125) Response per Gynecologic Cancer Intergroup (GCIG) Criteria
Tidsramme: 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)
Tidsramme: 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
Tidsramme: Up to approximately 3 years
Up to approximately 3 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Genmab

Efterforskere

  • Studieleder: Study Official, Genmab

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. december 2029

Studieafslutning (Anslået)

1. november 2031

Datoer for studieregistrering

Først indsendt

27. april 2026

Først indsendt, der opfyldte QC-kriterier

27. april 2026

Først opslået (Faktiske)

4. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GCT1184-07
  • 2025-524202-15 (Anden identifikator: EU CT No.)
  • GOG-3143 (Anden identifikator: Other Identifier)
  • ENGOT-ov103 (Anden identifikator: Other Identifier)
  • GEICO-177-O (Anden identifikator: Other Identifier)
  • APGOT-ov21 (Anden identifikator: Other Identifier)
  • LACOG 0126-EVA (Anden identifikator: Other Identifier)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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