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Phase 3 Study of INCB123667 Plus Bevacizumab Versus Bevacizumab Alone as First-Line Maintenance Therapy in Ovarian Cancer Overexpressing Cyclin E1 (MAESTRA 3)

1 oktober 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

590

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Incyte Corporation Call Center (US)
  • Telefoonnummer: 1.855.463.3463
  • E-mail: medinfo@incyte.com

Studie Contact Back-up

  • Naam: Incyte Corporation Call Center (ex-US)
  • Telefoonnummer: +800 00027423
  • E-mail: eumedinfo@incyte.com

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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, 1, or 2.

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Treatment Group A (TGA)

Bevacizumab plus INCB123667 at the protocol defined dose.
Geneesmiddel: INCB123667

INCB123667 will be administered at the protocol defined dose.

Geneesmiddel: Bevacizumab

Bevacizumab will be administered at the protocol defined dose.
Experimenteel: Treatment Group B (TGB)

Bevacizumab plus matching placebo at the protocol defined dose.
Geneesmiddel: Bevacizumab

Bevacizumab will be administered at the protocol defined dose.

Geneesmiddel: Placebo

Placebo will be administered at the protocol defined dose.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Progression-Free Survival (PFS) by BICR
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall Survival (OS)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Incyte Corporation

Onderzoekers

  • Studie directeur: Incyte Medical Monitor, Incyte Corporation

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 december 2026

Primaire voltooiing (Geschat)

1 mei 2032

Studie voltooiing (Geschat)

1 mei 2034

Studieregistratiedata

Eerst ingediend

26 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

26 augustus 2026

Eerst geplaatst (Werkelijk)

1 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

2 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

1 oktober 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • INCB123667-302
  • 2026-526071-30-00 (Register-ID: EU CT Number)
  • ENGOT-OV106 (Andere identificatie: ENGOT Study Number)
  • GOG-3146 (Andere identificatie: GOG Foundation)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

IPD-tijdsbestek voor delen

Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.

IPD-toegangscriteria voor delen

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 delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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