- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07564141
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)
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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Antatt)
Fase
- Fase 3
Kontakter og plasseringer
Studiekontakt
- Navn: Genmab Trial Information
- Telefonnummer: +4570202728
- E-post: clinicaltrials@genmab.com
Studiesteder
-
-
Connecticut
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Danbury, Connecticut, Forente stater, 06810
- Rekruttering
- Danbury Hospital
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Wisconsin
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Waukesha, Wisconsin, Forente stater, 53188
- Rekruttering
- Prohealth Care Inc
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Arm 1: Rina-S ± Bevacizumab
Participants will receive Rina-S ± bevacizumab once every 3 weeks (Q3W).
|
IV infusjon
Intravenous (IV) infusion
Andre navn:
|
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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 infusjon
IV infusjon
IV infusjon
IV infusjon
IV infusion
|
Hva måler studien?
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 |
|---|---|
|
Total overlevelse (OS)
Tidsramme: Opptil ca 5 år
|
Opptil ca 5 år
|
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Varighet av respons (DOR) per RECIST v1.1
Tidsramme: Opptil ca 3 år
|
Opptil ca 3 år
|
|
Antall deltakere med bivirkninger av behandlingsopplevelse (TEAES)
Tidsramme: Opptil omtrent 3 år
|
Opptil omtrent 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
|
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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
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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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Study Official, Genmab
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Kjønnssykdommer
- Sykdommer i det endokrine systemet
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- Neoplasmer
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Kjønnssykdommer, kvinner
- Neoplasmer i endokrine kjertel
- Sykdommer i eggstokkene
- Adnexal sykdommer
- Genitale neoplasmer, kvinnelige
- Gonadal lidelser
- Neoplasmer i eggstokkene
- Aminosyrer, peptider og proteiner
- Proteiner
- Organiske kjemikalier
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Hydrokarboner
- Cycloparaffins
- Hydrokarboner, alicyklisk
- Hydrokarboner, syklisk
- Terpener
- Antistoffer, monoklonalt, humanisert
- Antistoffer, monoklonalt
- Antistoffer
- Immunoglobuliner
- Immunoproteiner
- Blodproteiner
- Serumglobuliner
- Globuliner
- Koordinasjonskomplekser
- Taxoider
- Cyclodecanes
- Diterpenes
- Deoxycytidine
- Cytidin
- Pyrimidin -nukleosider
- Pyrimidiner
- Bevacizumab
- Gemcitabin
- Karboplatin
- Paclitaxel
- 1-dodecylpyridoxal
Andre studie-ID-numre
- GCT1184-07
- 2025 (U.S. NIH-stipend/kontrakt: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- GOG-3143 (Annen identifikator: Other Identifier)
- ENGOT-ov103 (Annen identifikator: Other Identifier)
- GEICO-177-O (Annen identifikator: Other Identifier)
- APGOT-ov21 (Annen identifikator: Other Identifier)
- LACOG 0126-EVA (Annen identifikator: Other Identifier)
- 2025-524202-15-00 (Ctis)
- jRCT2021260025 (Registeridentifikator: Japan Registry for Clinical Trials (jRCT))
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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