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

2026년 5월 18일 업데이트: 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).

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

150

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Cristina Suárez, Dr
  • 전화번호: +34 932543450
  • 이메일: csuarez@vhio.net

연구 장소

  • 스페인
    • Andalusia
      • Córdoba, Andalusia, 스페인, 14004
        • Hospital Universitario Reina Sofia
        • 연락하다:
        • 수석 연구원:
          • Mª José Méndez, Dr
    • Aragon
      • Zaragoza, Aragon, 스페인, 50009
        • Hospital Clínico Universitario Lozano Blesa
        • 연락하다:
        • 수석 연구원:
          • Julio Lambea, Dr
    • Cantabria
      • Santander, Cantabria, 스페인, 39008
        • Hospital Universitario Marqués de Valdecilla
        • 연락하다:
        • 수석 연구원:
          • Ignacio Durán, Dr
    • Catalonia
      • Barcelona, Catalonia, 스페인, 08036
        • Hospital Clinic de Barcelona
        • 연락하다:
        • 수석 연구원:
          • Oscar Reig, Dr
      • Barcelona, Catalonia, 스페인, 08035
        • Hospital Universitari Vall D Hebron
        • 연락하다:
        • 수석 연구원:
          • Cristina Suárez, Dr
      • L'Hospitalet de Llobregat, Catalonia, 스페인, 08908
        • Institut Catala D'oncologia
        • 연락하다:
        • 수석 연구원:
          • Mayra Lizbeth Orrillo, Dr
      • Sabadell, Catalonia, 스페인, 08208
        • Parc Taulí Hospital Universitari
        • 연락하다:
        • 수석 연구원:
          • Enrique Gallardo, Dr
    • Galicia
      • Lugo, Galicia, 스페인, 27003
        • Hospital Universitario Lucus Augusti
        • 연락하다:
        • 수석 연구원:
          • Sergio Vazquez, Dr
      • Ourense, Galicia, 스페인, 32005
        • Complejo Hospitalario Universitario de Ourense
        • 연락하다:
        • 수석 연구원:
          • Ovidio Fernandez, Dr
    • Madrid
      • Madrid, Madrid, 스페인, 28041
        • Hospital Universitario 12 de Octubre
        • 연락하다:
        • 수석 연구원:
          • Guillermo de Velasco, Dr
      • Madrid, Madrid, 스페인, 28034
        • Hospital Universitario Ramon y Cajal
        • 연락하다:
        • 수석 연구원:
          • Javier Molina, Dr
    • Navarre
      • Pamplona, Navarre, 스페인, 31008
        • Hospital Universitario de Navarra
        • 연락하다:
        • 수석 연구원:
          • Nuria Lainez, Dr
    • Principality of Asturias
      • Oviedo, Principality of Asturias, 스페인, 33011
        • Hospital Universitario Central de Asturias
        • 연락하다:
        • 수석 연구원:
          • Carlos Alvarez, Dr
    • Valencia
      • Valencia, Valencia, 스페인, 46026
        • Hospital Universitario y Politécnico La Fe
        • 연락하다:
        • 수석 연구원:
          • Regina Girones, Dr.

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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)
의약품: Neoadjuvant Pembrolizumab
400mg q6w of Pembrolizumab will be administered before nephrectomy in cohorts A and B
의약품: Belzutifan
120mg daily for 12w of Belzutifan will be administered before nephrectomy in Cohorts A and B
의약품: Lenvatinb
20mg daily for 12 weeks of lenvatinib will be administered before nephrectomy in Cohort A
실험적: Cohort B
Neoadjuvant therapy with Pembrolizumab (400mg q6w) + Belzutifan (120mg daily for 12w). Followed by nephrectomy and pembrolizumab (400mg q6w for 9 months)
의약품: Neoadjuvant Pembrolizumab
400mg q6w of Pembrolizumab will be administered before nephrectomy in cohorts A and B
의약품: Belzutifan
120mg daily for 12w of Belzutifan will be administered before nephrectomy in Cohorts A and B
활성 비교기: Cohort C
Nephrectomy folloewd by pembrolizumab (400mg q6w for 12 months)
의약품: Neoadjuvant Pembrolizumab
400mg q6w of Pembrolizumab will be administered before nephrectomy in cohorts A and B

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Response Rate
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Vall d'Hebron Institute of Oncology

수사관

  • 수석 연구원: Cristina Suárez, Dr, Hospital Vall d'hebrón

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 1일

기본 완료 (추정된)

2028년 1월 1일

연구 완료 (추정된)

2031년 6월 1일

연구 등록 날짜

최초 제출

2026년 5월 11일

QC 기준을 충족하는 최초 제출

2026년 5월 11일

처음 게시됨 (실제)

2026년 5월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 20일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 18일

마지막으로 확인됨

2025년 11월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

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

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다