- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 3
Kontakter och platser
Studiekontakt
- Namn: Genmab Trial Information
- Telefonnummer: +4570202728
- E-post: clinicaltrials@genmab.com
Studieorter
-
-
Connecticut
-
Danbury, Connecticut, Förenta staterna, 06810
- Rekrytering
- Danbury Hospital
-
-
Wisconsin
-
Waukesha, Wisconsin, Förenta staterna, 53188
- Rekrytering
- Prohealth Care Inc
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
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
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:
|
|
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
Sponsor
Utredare
- Studierektor: Study Official, Genmab
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Genitala sjukdomar
- Sjukdomar i det endokrina systemet
- Urogenitala neoplasmer
- Neoplasmer efter plats
- Neoplasmer
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Genitala sjukdomar, kvinnor
- Neoplasmer i endokrina körtel
- Ovariella sjukdomar
- Adnexala sjukdomar
- Genitala neoplasmer, hona
- Gonadal sjukdomar
- Ovariella neoplasmer
- Aminosyror, peptider och proteiner
- Proteiner
- Organiska kemikalier
- Heterocykliska föreningar, 1-ring
- Heterocykliska föreningar
- Kolväten
- Cykloparaffiner
- Kolväten, alicyklisk
- Kolväten, cykliska
- Terpener
- Antikroppar, monoklonal, humaniserad
- Antikroppar, monoklonal
- Antikroppar
- Immunglobuliner
- Immunoproteiner
- Blodproteiner
- Serumglobuliner
- Globuliner
- Koordinationskomplex
- Taxoids
- Cyklodekaner
- Gentare
- Deoxycytidin
- Cytidin
- Pyrimidin nukleosider
- Pyrimidiner
- Bevacizumab
- Gemcitabin
- Karboplatin
- Paklitaxel
- 1-dodecylpyridoxal
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)?
Läkemedels- och apparatinformation, studiedokument
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