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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)
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.
Studie Overzicht
Toestand
Gedetailleerde beschrijving
Studietype
Inschrijving (Geschat)
Fase
- Fase 3
Contacten en locaties
Studiecontact
- Naam: Genmab Trial Information
- Telefoonnummer: +4570202728
- E-mail: clinicaltrials@genmab.com
Studie Locaties
-
-
Connecticut
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Danbury, Connecticut, Verenigde Staten, 06810
- Werving
- Danbury Hospital
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Wisconsin
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Waukesha, Wisconsin, Verenigde Staten, 53188
- Werving
- Prohealth Care Inc
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Arm 1: Rina-S ± Bevacizumab
Participants will receive Rina-S ± bevacizumab once every 3 weeks (Q3W).
|
IV infusie
Intravenous (IV) infusion
Andere namen:
|
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Actieve vergelijker: 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 infusie
IV infusie
IV infusie
IV infusie
IV infusion
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1, as Determined by Blinded Independent Central Review (BICR)
Tijdsspanne: Up to approximately 3 years
|
Up to approximately 3 years
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Algehele overleving (OS)
Tijdsspanne: Tot ongeveer 5 jaar
|
Tot ongeveer 5 jaar
|
|
Duur van de respons (DOR) volgens RECIST v1.1
Tijdsspanne: Tot ongeveer 3 jaar
|
Tot ongeveer 3 jaar
|
|
Aantal deelnemers met bijwerkingen voor behandelingsopkomst (TEEAS)
Tijdsspanne: Tot ongeveer 3 jaar
|
Tot ongeveer 3 jaar
|
|
PFS per RECIST v1.1, as Determined by Investigator
Tijdsspanne: Up to approximately 3 years
|
Up to approximately 3 years
|
|
Objective Response Rate (ORR) per RECIST v1.1
Tijdsspanne: Up to approximately 3 years
|
Up to approximately 3 years
|
|
Progression-free Survival on the Next Line of Therapy After the First Progression (PFS2)
Tijdsspanne: Up to approximately 3 years
|
Up to approximately 3 years
|
|
Time to First Subsequent Therapy (TFST)
Tijdsspanne: Up to approximately 3 years
|
Up to approximately 3 years
|
|
Cancer Antigen 125 (CA-125) Response per Gynecologic Cancer Intergroup (GCIG) Criteria
Tijdsspanne: 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)
Tijdsspanne: Baseline up to approximately 3 years
|
Baseline up to approximately 3 years
|
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Time to Deterioration (TTD) in the GHS/QoL Score Using the EORTC QLQ C30 Questionnaire
Tijdsspanne: Up to approximately 3 years
|
Up to approximately 3 years
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Study Official, Genmab
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Urogenitale ziekten
- Genitale ziekten
- Endocriene systeemziekten
- Urogenitale neoplasmata
- Neoplasmata per site
- Neoplasmata
- Vrouwelijke urogenitale ziekten
- Vrouwelijke urogenitale ziekten en zwangerschapscomplicaties
- Genitale ziekten, vrouw
- Endocriene klierneoplasmata
- Ovariële ziekten
- Adnexale ziekten
- Genitale neoplasmata, vrouwelijk
- Gonadale aandoeningen
- Ovariumneoplasmata
- Aminozuren, peptiden en eiwitten
- Eiwitten
- Organische chemicaliën
- Heterocyclische verbindingen, 1-ring
- Heterocyclische verbindingen
- Koolwaterstoffen
- Cycloparaffins
- Koolwaterstoffen, alicyclisch
- Koolwaterstoffen, cyclisch
- Terpenen
- Antilichamen, monoklonaal, gehumaniseerd
- Antilichamen, monoklonaal
- Antilichamen
- Immunoglobulinen
- Immunoproteïnen
- Bloedeiwitten
- Serum -globulines
- Globulines
- Coördinatiecomplexen
- Taxoids
- Cyclodecanes
- Diterpenen
- Deoxycytidine
- Cytidine
- Pyrimidine -nucleosiden
- Pyrimidines
- Bevacizumab
- Gemcitabine
- Carboplatine
- Paclitaxel
- 1-dodecylpyridoxal
Andere studie-ID-nummers
- GCT1184-07
- 2025 (Subsidie/contract van de Amerikaanse NIH: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- GOG-3143 (Andere identificatie: Other Identifier)
- ENGOT-ov103 (Andere identificatie: Other Identifier)
- GEICO-177-O (Andere identificatie: Other Identifier)
- APGOT-ov21 (Andere identificatie: Other Identifier)
- LACOG 0126-EVA (Andere identificatie: Other Identifier)
- 2025-524202-15-00 (Ctis)
- jRCT2021260025 (Register-ID: Japan Registry for Clinical Trials (jRCT))
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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