Symbiotic-GYN-18: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Advanced or Recurrent MMR-proficient Endometrial Cancer
AN INTERVENTIONAL PHASE 3, OPEN LABEL, RANDOMIZED STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS PEMBROLIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN ADULT PARTICIPANTS WITH ADVANCED OR RECURRENT MISMATCH REPAIR PROFICIENT ENDOMETRIAL CANCER
This study is being conducted to assess whether the study medicine PF 08634404, given in combination with chemotherapy, improves outcomes compared with another medicine called pembrolizumab plus chemotherapy. Chemotherapy is a type of cancer treatment that uses medicines to destroy cancer cells or stop them from growing.
Our bodies have a built-in DNA "spell-checker," called the mismatch repair (MMR) system, that fixes genetic mistakes. In most endometrial cancers, this system works normally, and these cancers are called MMR-proficient (pMMR). However, pMMR tumors are harder for the immune system to recognize and attack. When endometrial cancer has spread beyond the uterus or comes back after previous treatment, it is called advanced or recurrent endometrial cancer. This study is for adults with mismatch repair-pMMR advanced or recurrent endometrial cancer.
Participants must meet key criteria, including:
- Women who are 18 years or older, and not pregnant at the time of joining the study
- pMMR endometrial cancer only
- Measurable Stage III disease, Stage IV disease (with or without measurable disease) per FIGO staging, a system doctors use to describe how far cancer has spread in the body, or recurrent (with or without measurable disease) endometrial cancer
- Has not received chemotherapy except for chemotherapy given after the main surgery and more than 6 months before relapse
- Be in good enough health to receive study treatment. Approximately 600 adult women will be enrolled. Each participant will be randomly assigned (like a flip of the coin) to one of two treatment groups, with about half in each group. The study is open, meaning both the doctors and participants know what treatment is being given. Participants will receive their assigned treatment through intravenous infusions (medicine is given directly into a vein). The treatment will be given in cycles.
Experimental Group will receive new study medicine called PF-08634404 plus chemotherapy. It will be followed by PF 08634404 alone for up to 2 years (35 cycles).
Control Group will receive an approved medicine called pembrolizumab plus chemotherapy. It will be followed by pembrolizumab alone for up to 2 years (20 cycles).
The study will include regular visits for:
- Participants will have regular visits to the study site for treatment, health checks, and tests.
- After stopping treatment, participants will come for a final visit within a month to check their health and review any reactions.
- Follow-up will continue every 12 weeks by phone or in person or by reviewing health records. This helps check health and any new treatments.
- Tests will be done every 9 weeks during the first 104 weeks to see how the cancer is responding. After that, tests will be done every 12 weeks.
調査の概要
状態
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Pfizer CT.gov Call Center
- 電話番号：1-800-718-1021
- メール：ClinicalTrials.gov_Inquiries@pfizer.com
研究場所
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Saitama
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Hidaka、Saitama、日本、350-1298
- Saitama Medical University International Medical Center
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参加基準
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
説明
Inclusion Criteria:
- Women ≥18 years of age who are confirmed not pregnant at screening.
- Histologically or cytologically confirmed endometrial cancer that is recurrent or advanced; carcinosarcomas are eligible but pure sarcomas are excluded.
- Newly diagnosed FIGO Stage III disease with measurable disease per RECIST v1.1, newly diagnosed FIGO Stage IV disease with or without measurable disease, or recurrent disease with or without measurable disease for which curative treatment with surgery and/or radiotherapy is unlikely.
- For participants with recurrent disease, prior adjuvant systemic anti-cancer therapy is allowed if relapse occurred more than 6 months after the last dose.
- Must provide tumor tissue for prospective central assessment of MMR and p53 status.
- Proficient mismatch repair (pMMR) endometrial cancer as determined by central testing.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Life expectancy of at least 12 weeks.
- Adequate organ function as defined in the protocol.
Exclusion Criteria:
- Prior systemic therapy for first-line advanced or recurrent endometrial cancer.
- Prior immunotherapy or anti-angiogenic therapy.
- Deficient mismatch repair (dMMR) endometrial cancer by central testing.
- Active or untreated central nervous system (CNS) metastases; participants with previously treated and clinically stable brain metastases may be eligible if not requiring steroids and without evidence of progression.
- Clinically significant risk of bleeding or fistula, including a history of severe bleeding disorders.
- History of another malignancy within 3 years, except for cancers with negligible risk of recurrence or death.
- History of allogeneic organ or hematopoietic stem cell transplantation; active autoimmune disease requiring systemic treatment within the past 2 years; or history of immunodeficiency
- Interstitial lung disease, pneumonitis, or clinically significant pulmonary disease
- Uncontrolled or significant cardiovascular, metabolic, renal, hepatic, or vascular disease
- Active or uncontrolled infection.
- Recent major surgery or severe trauma within protocol-defined washout periods.
研究計画
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：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：PF-08634404 plus Chemotherapy
PF-08634404 plus Chemotherapy, followed by PF-08634404 maintenance therapy
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Solution for IV infusion
Solution for IV infusion
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アクティブコンパレータ：Pembrolizumab plus Chemotherapy
Pembrolizumab plus Chemotherapy, followed by Pembrolizumab maintenance therapy
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Solution for IV infusion
Solution for IV infusion
他の名前：
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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 |
|---|---|---|
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Progression-Free Survival (PFS) using RECIST v1.1 as assessed by Blinded Independent Central Review (BICR)
時間枠：Approximately 36 months
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PFS by BICR is defined as the time from the date of randomization to the date of first documented disease progression per RECIST v1.1 as assessed by BICR, or death due to any cause, whichever occurs first.
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Approximately 36 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Overall Survival (OS)
時間枠：Approximately 56 months
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OS is defined as the time from the date of randomization to the date of death due to any cause.
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Approximately 56 months
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PFS using RECIST v1.1 as assessed by investigator
時間枠：Approximately 36 months
|
PFS by investigator is defined as the time from the date of randomization to the date of first documented disease progression per RECIST v1.1 as assessed by investigator, or death due to any cause, whichever occurs first.
PFS by investigator will be analyzed with the same methodology as for PFS by BICR.
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Approximately 36 months
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Objective Response Rate (ORR) as assessed by BICR and investigator
時間枠：Approximately 56 months
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Proportion of participants with confirmed Complete Response (CR) or Partial Response (PR) per RECIST v1.1, assessed by BICR and by investigator
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Approximately 56 months
|
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Duration of Response (DoR) as assessed by BICR and investigator
時間枠：Approximately 56 months
|
Time from first documented CR or PR to disease progression or death, per RECIST v1.1, assessed by BICR and by investigator
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Approximately 56 months
|
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Number of participants with treatment-emergent adverse events
時間枠：Through end of the study and up to approximately 56 months
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AEs as characterized by type, frequency, intensity as graded by NCI CTCAE version 5.0, timing, seriousness, and relationship to study intervention(s)
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Through end of the study and up to approximately 56 months
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Number of participants with laboratory abnormalities
時間枠：Through end of the study and up to approximately 56 months
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Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing.
For laboratory tests without CTCAE grade definitions, results will be categorized as normal, high, low, or not done and be listed.
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Through end of the study and up to approximately 56 months
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Serum concentrations of PF-08634404
時間枠：Through end of the study and up to approximately 56 months
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Pre-dose and post-dose serum concentrations of PF-08634404
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Through end of the study and up to approximately 56 months
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Incidence of ADA against PF-08634404
時間枠：Through end of the study and up to approximately 56 months
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Incidence of anti-drug antibodies (ADA) to PF-08634404
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Through end of the study and up to approximately 56 months
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Change from baseline in the global health status/quality of life (QoL) and physical functioning scale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
時間枠：Baseline, up to approximately 56 months
|
The EORTC QLQ-C30 is a questionnaire for quantitative measure of health-related quality of life pertinent to participants with a broad range of cancers who are participating in international clinical trials. The core instrument is a 30-item questionnaire consisting of the following:
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Baseline, up to approximately 56 months
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Change from baseline in the back pain/pelvis pain, GI symptoms, and urological symptoms scales of the EORTC QLQ EN24
時間枠：Baseline, up to approximately 56 months
|
The Endometrial Cancer Module (EORTC QLQ-EN24) is a disease-specific measure that is supplemental to the EORTC QLQ-C30 to capture patient's experiences with endometrial cancer-specific symptoms and impacts. The recall period is the past week. The 24-item questionnaire consists of the following:
Higher scores for functional scales represent high level of functioning, while higher scores for symptoms scales represent higher levels of symptoms/problems. |
Baseline, up to approximately 56 months
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Time to definitive deterioration in the global health status/QoL and physical functioning scale of the EORTC QLQ-C30.
時間枠：Approximately 56 months
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The European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30), is a validated 30-item self-administered core questionnaire designed to assess HRQoL, functioning, and symptoms in all cancer patients or survivors. Time to deterioration is defined as time from baseline (defined as day 1 of cycle 1 before first application of maintenance therapy) to the date of the first clinically meaningful deterioration i.e. a decrease by ≥10 points for the functional scales and an increase by ≥ 10 points for the symptom scales or death in:
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Approximately 56 months
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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Pfizer CT.gov Call Center、Pfizer
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- C6461018
- 2026-525584-40-00 (レジストリ識別子：CTIS (EU))
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- ENGOT-en37 (その他の識別子：APGOT)
- APGOT-EN6 (その他の識別子：APGOT)
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?
IPD プランの説明
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
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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