Phase 3 Study of INCB123667 Plus Bevacizumab Versus Bevacizumab Alone as First-Line Maintenance Therapy in Ovarian Cancer Overexpressing Cyclin E1 (MAESTRA 3)
4 september 2026 uppdaterad av: Incyte Corporation
A Phase 3, Double-Blind, Randomized, Controlled Study of INCB123667 in Combination With Bevacizumab Versus Bevacizumab Alone as First-Line Maintenance Therapy in Participants With Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Overexpressing Cyclin E1 (MAESTRA 3)
The purpose of this study is to evaluate INCB123667 in Combination With Bevacizumab Versus Bevacizumab Alone as First-Line Maintenance Therapy in Participants With Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Overexpressing Cyclin E1.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
590
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Incyte Corporation Call Center (US)
- Telefonnummer: 1.855.463.3463
- E-post: medinfo@incyte.com
Studera Kontakt Backup
- Namn: Incyte Corporation Call Center (ex-US)
- Telefonnummer: +800 00027423
- E-post: eumedinfo@incyte.com
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
Inclusion Criteria:
- Newly diagnosed, histologically confirmed, FIGO Stage III or IV, high-grade serous, high-grade endometrioid, or clear cell ovarian, fallopian tube, or primary peritoneal cancer.
- Underwent debulking surgery prior to randomization (either PDS or IDS).
Completed first-line platinum-based chemotherapy in combination with bevacizumab prior to randomization.
- Received a minimum of 6 cycles (and no more than 8 cycles) of platinum-taxane chemotherapy.
- Received at least 2 infusions of bevacizumab concurrently with the last 2 to 3 cycles of chemotherapy.
- No clinical evidence of disease recurrence (ie, NED following surgery) or progression (ie, CR/PR/SD per RECIST v1.1) on completion of platinum-based chemotherapy.
- Tumor overexpresses cyclin E1.
- Has a local HRD (positive or negative) or BRCA test result available. Participants with BRCA wild-type must have a local HRD result based on a validated test.
- ECOG performance status of 0 or 1.
Exclusion Criteria:
- Ovarian, fallopian tube, or peritoneal cancer of nonepithelial origin or low-grade ovarian cancer.
- Deleterious tumor BRCA mutation per local test.
- Eligible for treatment with a PARPi as maintenance therapy.
- Known additional malignancy that progressed or requires active treatment, or history of other malignancy within 3 years prior to randomization.
- History of any clinically significant or uncontrolled cardiovascular disease within 6 months prior to randomization.
- Clinically significant gastrointestinal abnormality.
- History of thromboembolism and having been on therapeutic anticoagulation for less than 2 weeks prior to randomization.
- Current treatment with any strong CYP3A4/CYP3A5 inhibitor or inducer or treatment with a strong CYP3A4/CYP3A5 inhibitor or inducer within 5 half-lives or 28 days (whichever is shorter) prior to randomization.
Exclusionary Laboratory Values:
- Platelets: < 100 × 109/L
- Hemoglobin: < 9 g/dL or < 5.6 mmol/L
- ANC: < 1.5 × 109/L
- ALT: ≥ 2.5 × ULN or ≥ 5 × ULN for participants with liver metastases
- AST: ≥ 2.5 × ULN or ≥ 5 × ULN for participants with liver metastases
- Total bilirubin: ≥ 1.5 × ULN
- Albumin: < 2.5 g/dL
- Calculated CrCl: < 45 mL/min
- Protein in urine: Urine dipstick for proteinuria ≥ 2+
Other protocol-defined Inclusion/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: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Treatment Group A (TGA)
Bevacizumab plus INCB123667 at the protocol defined dose.
|
INCB123667 will be administered at the protocol defined dose.
Bevacizumab will be administered at the protocol defined dose.
|
|
Experimentell: Treatment Group B (TGB)
Bevacizumab plus matching placebo at the protocol defined dose.
|
Bevacizumab will be administered at the protocol defined dose.
Placebo will be administered at the protocol defined dose.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Progression-Free Survival (PFS) by BICR
Tidsram: Up to approximately 5 years
|
Defined as the time from randomization until the first documented disease progression or disease recurrence as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first.
|
Up to approximately 5 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Overall Survival (OS)
Tidsram: Up to approximately 7 years
|
Defined as the time from randomization until death due to any cause.
|
Up to approximately 7 years
|
|
Progression-Free Survival (PFS) by investigator
Tidsram: Up to approximately 5 years
|
Defined as the time from randomization until the first documented disease progression or disease recurrence as assessed by the investigator per RECIST v1.1, or death due to any cause, whichever occurs first.
|
Up to approximately 5 years
|
|
Progression-Free Survival on the First Subsequent Therapy (PFS2)
Tidsram: Up to approximately 7 years
|
Defined as the time from randomization until radiologic or clinical disease progression on the first subsequent therapy as assessed by the investigator, or death due to any cause, whichever occurs first.
|
Up to approximately 7 years
|
|
Second Progression-Free Survival (PFS)
Tidsram: Up to approximately 7 years
|
Defined as the time from the start of the first subsequent therapy until radiologic or clinical disease progression as assessed by the investigator.
|
Up to approximately 7 years
|
|
Time to First Subsequent Therapy (TFST)
Tidsram: Up to approximately 7 years
|
Defined as the time from randomization until the start of the first subsequent therapy, or death due to any cause, whichever occurs first.
|
Up to approximately 7 years
|
|
Time to Second Subsequent Therapy (TSST)
Tidsram: Up to approximately 7 years
|
Defined as the time from randomization until the start of the second subsequent therapy, or death due to any cause, whichever occurs first.
|
Up to approximately 7 years
|
|
Treatment Emergent Adverse Events (TEAEs)
Tidsram: Up to approximately 13 months
|
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug until 30 days after the last dose of study drug or the start of new anticancer therapy, whichever occurs first.
|
Up to approximately 13 months
|
|
TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment
Tidsram: Up to approximately 13 months
|
TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment.
|
Up to approximately 13 months
|
|
Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core 30 (C30) at each postbaseline visit
Tidsram: Up to approximately 5 years
|
The EORTC QLQ-C30 is a validated, self-administered questionnaire developed to assess the quality of life in patients with cancer.
It consists of 30 questions divided into several subscales, including 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), a global health status/QoL scale, and a number of single-item measures that assess additional symptoms such as dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties.
|
Up to approximately 5 years
|
|
Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) -Ovarian Cancer 28 (OV28) score at each postbaseline visit
Tidsram: Up to approximately 5 years
|
The EORTC QLQ-OV28 is a validated, self-administered questionnaire developed as a supplementary module to the core QLQ-C30, specifically designed to assess HRQoL in participants with ovarian cancer.
It contains 28 questions across several subscales, including 5 symptom scales (abdominal/gastrointestinal, peripheral neuropathy, hormonal/menopausal, chemotherapy side effects, and attitudes towards disease/treatment), 2 functional scales (body image and sexual functioning), and a number of single-item measures addressing issues such as other abdominal symptoms and hair loss.
|
Up to approximately 5 years
|
|
Change from baseline in EQ-5D-5L score at each postbaseline visit
Tidsram: Up to approximately 5 years
|
The EQ-5D-5L is a validated, self-reported instrument for assessing HRQoL across 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Each dimension has 5 response levels of severity, ranging from no problems to extreme problems.
The questionnaire also includes a visual analog scale for self-rated overall health on a scale from 0 (worst imaginable health) to 100 (best imaginable health).
|
Up to approximately 5 years
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Incyte Medical Monitor, Incyte Corporation
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
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 (Beräknad)
1 december 2026
Primärt slutförande (Beräknad)
1 maj 2032
Avslutad studie (Beräknad)
1 maj 2034
Studieregistreringsdatum
Först inskickad
26 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
26 augusti 2026
Första postat (Faktisk)
1 september 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
9 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
4 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Nyckelord
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
- Antikroppar, monoklonal, humaniserad
- Antikroppar, monoklonal
- Antikroppar
- Immunglobuliner
- Immunoproteiner
- Blodproteiner
- Serumglobuliner
- Globuliner
- Bevacizumab
Andra studie-ID-nummer
- INCB123667-302
- 2026-526071-30-00 (Registeridentifierare: EU CT Number)
- ENGOT-OV106 (Annan identifierare: ENGOT Study Number)
- GOG-3146 (Annan identifierare: GOG Foundation)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
Incyte shares data with qualified external researchers after a research proposal is submitted.
These requests are reviewed and approved by a review panel on the basis of scientific merit.
All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Tidsram för IPD-delning
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Kriterier för IPD Sharing Access
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com
website.
For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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