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Pembrolizumab Plus Belzutifan With or Without Lenvatinib in Localized Renal Cell Carcinoma (Moonlanding)

2026年5月18日 更新者：Vall d'Hebron Institute of Oncology

A Randomized Phase 2 Trial of Neoadjuvant Pembrolizumab Plus Belzutifan With or Without Lenvatinib in Patients With Localized Renal Cell Carcinoma

This study is designed to evaluate the efficacy of belzutifan in combination with pembrolizumab with or without lenvatinib in the neoadjuvant setting, followed by adjuvant pembrolizumab versus adjuvant pembrolizumab alone, as treatment for participants with intermediate-high and high risk clear cell renal cell carcinoma (ccRCC).

調査の概要

状態

まだ募集していません

条件

介入・治療

研究の種類

介入

入学 (推定)

150

段階

  • フェーズ2

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：Cristina Suárez, Dr
  • 電話番号：+34 932543450
  • メール：csuarez@vhio.net

研究場所

  • スペイン
    • Andalusia
      • Córdoba、Andalusia、スペイン、14004
        • Hospital Universitario Reina Sofia
        • コンタクト：
          • Mª José Méndez, Dr
          • 電話番号：+34 957010380
          • メール：mjosemv@yahoo.es
        • 主任研究者：
          • Mª José Méndez, Dr
    • Aragon
      • Zaragoza、Aragon、スペイン、50009
        • Hospital Clínico Universitario Lozano Blesa
        • コンタクト：
        • 主任研究者：
          • Julio Lambea, Dr
    • Cantabria
      • Santander、Cantabria、スペイン、39008
        • Hospital Universitario Marqués de Valdecilla
        • コンタクト：
        • 主任研究者：
          • Ignacio Durán, Dr
    • Catalonia
      • Barcelona、Catalonia、スペイン、08036
        • Hospital Clinic de Barcelona
        • コンタクト：
        • 主任研究者：
          • Oscar Reig, Dr
      • Barcelona、Catalonia、スペイン、08035
        • Hospital Universitari Vall D Hebron
        • コンタクト：
          • Cristina Suárez, Dr
          • 電話番号：+34 932543450
          • メール：csuarez@vhio.net
        • 主任研究者：
          • Cristina Suárez, Dr
      • L'Hospitalet de Llobregat、Catalonia、スペイン、08908
        • Institut Catala D'oncologia
        • コンタクト：
        • 主任研究者：
          • Mayra Lizbeth Orrillo, Dr
      • Sabadell、Catalonia、スペイン、08208
        • Parc Taulí Hospital Universitari
        • コンタクト：
        • 主任研究者：
          • Enrique Gallardo, Dr
    • Galicia
      • Lugo、Galicia、スペイン、27003
        • Hospital Universitario Lucus Augusti
        • コンタクト：
        • 主任研究者：
          • Sergio Vazquez, Dr
      • Ourense、Galicia、スペイン、32005
        • Complejo Hospitalario Universitario de Ourense
        • コンタクト：
        • 主任研究者：
          • Ovidio Fernandez, Dr
    • Madrid
      • Madrid、Madrid、スペイン、28041
        • Hospital Universitario 12 de Octubre
        • コンタクト：
        • 主任研究者：
          • Guillermo de Velasco, Dr
      • Madrid、Madrid、スペイン、28034
        • Hospital Universitario Ramon y Cajal
        • コンタクト：
        • 主任研究者：
          • Javier Molina, Dr
    • Navarre
      • Pamplona、Navarre、スペイン、31008
        • Hospital Universitario de Navarra
        • コンタクト：
        • 主任研究者：
          • Nuria Lainez, Dr
    • Principality of Asturias
      • Oviedo、Principality of Asturias、スペイン、33011
        • Hospital Universitario Central de Asturias
        • コンタクト：
        • 主任研究者：
          • Carlos Alvarez, Dr
    • Valencia
      • Valencia、Valencia、スペイン、46026
        • Hospital Universitario y Politécnico La Fe
        • コンタクト：
        • 主任研究者：
          • Regina Girones, Dr.

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:

  • Male/female participants who are at least 18 years of age on the day of signing informed consent.

    2. Willing to provide written informed consent. They may also provide consent for Future Biomedical Research; however, the participant may participate in the main trial without participating in the Future Biomedical Research.

    3. Histologically confirmed diagnosis of RCC with a clear cell component with or without sarcomatoid features. Diagnosis is to be made by the investigator and does not require central histology review.

    4. Tumours must be T2 with grade 4, T3, T4, or any T with N1, M0 on radiographic imaging using TNM staging (8th edition)

    1. T2 is defined as a tumour >7cm but limited to the kidney; grade 4 is per the International Society of Urological Pathology (ISUP) grading.
    2. T3 is defined as tumour extension into major veins or perinephric tissues, but not into ipsilateral adrenal gland or beyond Gerota's fascia.
    3. T4 is defined as a tumour involving the ipsilateral adrenal gland or invading beyond Gerota's fascia.

    4. N1 is defined as metastatic involvement of regional lymph nodes. 5. Archival tumour tissue sample or newly obtained core, incisional, or excisional biopsy of a tumour lesion not previously irradiated has been provided. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.

      6. Have an Eastern Cooperation Oncology Group (ECOG) Performance Status of 0 to 1.

      Evaluation of ECOG is to be performed within 14 days prior to the first dose of study intervention.

      7. Have been considered suitable for curative intent surgery (partial or total nephrectomy), as evaluated by a surgeon. 8. Have adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 mm Hg.

      9. Have adequate organ function as defined in the following table (Table 7). Specimens must be collected within 14 days prior to the start of study intervention.

      10.Participants agree to the contraception guidelines outlined in section 5.1.3.2.

      11.Participants who are HBsAg positive are eligible if they have received hepatitis B virus (HBV) anti-viral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.

      Note: Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention.

      Hepatitis B screening tests are not required unless:

      Known history of HBV infection As mandated by local health authority 12.Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.

      Note: Participants must have completed curative anti-viral therapy at least 4 weeks prior to randomization.

      Hepatitis C screening tests are not required unless:

      Known history of HCV infection As mandated by local health authority 13.HIV-infected participants must have well-controlled HIV on antiretroviral therapy (ART), defined as:

    1. Participants on ART must have a CD4+ T-cell count ≥350 cells/mm3 at the time of screening.
    2. Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 or the lower limit of quantification (LLOQ) (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening
    3. It is advised that participants must not have had any AIDS-defining opportunistic infections within the past 12 months.
    4. Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry (Day 1) and agree to continue ART throughout the stud

Exclusion Criteria:

  • 1. Has evidence of metastatic disease on screening imaging. 2. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137).

    3. Has received prior systemic anti-cancer therapy including investigational agents within 3 years prior to randomization.

    4. Known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded.

Participants with low-risk early-stage prostate cancer either treated with definitive intent or untreated in active surveillance with stable disease are not excluded.

5. Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed. COVID-19 and influenza vaccinations are allowed provided they are not live vaccines 6. Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.

7. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug 8. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients, and/or lenvatinib, and/or belzutifan.

9. Has active autoimmune disease that has required immunosuppressive systemic treatment in the past 2 years except replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid).

10.Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease11.Has any of the following:

  1. A pulse oximeter reading <92% at rest, or
  2. Requires intermittent supplemental oxygen, or
  3. Requires chronic supplemental oxygen. 12.Has an active infection requiring systemic intravenous therapy. 13.Has moderate to severe hepatic impairment (Child-Pugh B or C). 14.Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection.

Note: Hepatitis B and C screening tests are not required unless:

  1. Known history of HBV and HCV infection
  2. As mandated by local health authority

15.Has urine protein ≥1 g/24 hours.

  1. Note: Participants with proteinuria ≥2+ (≥100 mg/dL) on urine dipstick testing (urinalysis) will undergo 24-hour urine collection for quantitative assessment of proteinuria.

  2. Note: Urine dipstick is the preferred method for testing urinary protein, however, urinalysis may be used if the use of urine dipsticks is not feasible.

    16.Has had major surgery within 3 weeks prior to first dose of study interventions.

    Note: Adequate wound healing after major surgery must be assessed clinically, independent of time elapsed for eligibility 17.Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.

    18.Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

    19.Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.

    20.Has had an allogenic tissue/solid organ transplant. 21.Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula22.Has a left ventricular ejection fraction (LVEF) below the institutional (or local laboratory) normal range, as determined by multigated acquisition (MUGA) or echocardiogram (ECHO).

    23.Prolongation of QTcF interval to >480 ms. 24.Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability. Note: Medically controlled arrhythmia would be permitted.

    25.Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.

    26.Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib 27.Is currently receiving either strong (phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort)

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：クロスオーバー割り当て
  • 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
実験的：Cohort A
Neoadjuvant therapy with Pembrolizumab (400mg q6w) + Lenvatinib (20mg daily for 12w) + Belzutifan (120mg daily for 12w). Followed by nephrectomy and pembrolizumab (400mg q6w for 9 months)
薬：Neoadjuvant Pembrolizumab
400mg q6w of Pembrolizumab will be administered before nephrectomy in cohorts A and B
薬：Belzutifan
120mg daily for 12w of Belzutifan will be administered before nephrectomy in Cohorts A and B
薬：Lenvatinb
20mg daily for 12 weeks of lenvatinib will be administered before nephrectomy in Cohort A
実験的：Cohort B
Neoadjuvant therapy with Pembrolizumab (400mg q6w) + Belzutifan (120mg daily for 12w). Followed by nephrectomy and pembrolizumab (400mg q6w for 9 months)
薬：Neoadjuvant Pembrolizumab
400mg q6w of Pembrolizumab will be administered before nephrectomy in cohorts A and B
薬：Belzutifan
120mg daily for 12w of Belzutifan will be administered before nephrectomy in Cohorts A and B
アクティブコンパレータ：Cohort C
Nephrectomy folloewd by pembrolizumab (400mg q6w for 12 months)
薬：Neoadjuvant Pembrolizumab
400mg q6w of Pembrolizumab will be administered before nephrectomy in cohorts A and B

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
Response Rate
時間枠：At 12 weeks from start of treatment
Radiographic response defined as a decrease of initial tumour size ≥30% from baseline to week 12 CT scan
At 12 weeks from start of treatment

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

Vall d'Hebron Institute of Oncology

捜査官

  • 主任研究者：Cristina Suárez, Dr、Hospital Vall d'hebrón

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6月1日

一次修了 (推定)

2028年1月1日

研究の完了 (推定)

2031年6月1日

試験登録日

最初に提出

2026年5月11日

QC基準を満たした最初の提出物

2026年5月11日

最初の投稿 (実際)

2026年5月18日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月20日

QC基準を満たした最後の更新が送信されました

2026年5月18日

最終確認日

2025年11月1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

  • VHIO24002
  • 2024-519673-18-00 (Ctis)

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?

未定

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

いいえ

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。

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