Phase 3 Study of INCB123667 Plus Bevacizumab Versus Bevacizumab Alone as First-Line Maintenance Therapy in Ovarian Cancer Overexpressing Cyclin E1 (MAESTRA 3)
2026年9月4日 更新者：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.
調査の概要
研究の種類
介入
入学 (推定)
590
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Incyte Corporation Call Center (US)
- 電話番号：1.855.463.3463
- メール：medinfo@incyte.com
研究連絡先のバックアップ
- 名前：Incyte Corporation Call Center (ex-US)
- 電話番号：+800 00027423
- メール：eumedinfo@incyte.com
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
実験的：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Progression-Free Survival (PFS) by BICR
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overall Survival (OS)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディディレクター：Incyte Medical Monitor、Incyte Corporation
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年12月1日
一次修了 (推定)
2032年5月1日
研究の完了 (推定)
2034年5月1日
試験登録日
最初に提出
2026年8月26日
QC基準を満たした最初の提出物
2026年8月26日
最初の投稿 (実際)
2026年9月1日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月9日
QC基準を満たした最後の更新が送信されました
2026年9月4日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- INCB123667-302
- 2026-526071-30-00 (レジストリ識別子：EU CT Number)
- ENGOT-OV106 (その他の識別子：ENGOT Study Number)
- GOG-3146 (その他の識別子：GOG Foundation)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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 共有時間枠
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
IPD 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。