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피세라푸스 알파, 펨브롤리주맙 및 정위적 체부 방사선 요법(SBRT)의 두경부 편평세포암종(HNSCC) 치료

2026년 11월 1일 업데이트: Washington University School of Medicine

Ficerafusp Alfa, Pembrolizumab 및 SBRT의 신보조제 병용 요법에 대한 국소 진행성 두경부 편평 세포 암종(HNSCC) 치료 1/2상 임상 시험

The study is an open-label phase I/II clinical trial. The study will enroll patients to receive neoadjuvant SBRT plus 1 or 2 doses of neoadjuvant pembrolizumab with concurrent ficerafusp alfa (4 doses) prior to definitive surgical resection for high-risk, locoregionally advanced HPV-negative head and neck squamous cell carcinoma (HNSCC). Approximately 6 weeks after end of SBRT, patients will undergo standard of care (SOC) surgical resection followed by SOC adjuvant chemoradiation per National Comprehensive Cancer Network (NCCN) guidelines. Adjuvant therapy is not part of this study and therefore is not dictated by study protocol.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

45

단계

  • 2 단계
  • 1단계

연락처 및 위치

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

연구 연락처

연구 연락처 백업

  • 이름: Sidharth Puram, MD, PhD
  • 전화번호: 314-362-9700
  • 이메일: sidpuram@wustl.edu

연구 장소

  • 미국
    • Missouri
      • St Louis, Missouri, 미국, 63110
        • Washington University School of Medicine
        • 부수사관:
          • Peter Oppelt, MD
        • 부수사관:
          • Esther Lu, PhD
        • 부수사관:
          • Jesse Zaretsky, MD, PhD
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Sana Karam, MD, PhD
        • 수석 연구원:
          • Sidharth Puram, MD, PhD
        • 부수사관:
          • Douglas R Adkins, MD
        • 부수사관:
          • Anthony J Apicelli, MD, PhD
        • 부수사관:
          • Christine Auberle, MD
        • 부수사관:
          • Jennifer De Los Santos, MD
        • 부수사관:
          • Hiram Gay, MD
        • 부수사관:
          • Lannis Hall, MD, MPH
        • 부수사관:
          • Yao Hao, PhD
        • 부수사관:
          • R Alex Harbison, MD, MS
        • 부수사관:
          • Ryan S Jackson, MD
        • 부수사관:
          • Brendan J Knapp, MD
        • 부수사관:
          • Daniel Miller, MD, PhD
        • 부수사관:
          • Patrick Pipkorn, MD
        • 부수사관:
          • Nikhil Rammohan, MD, PhD
        • 부수사관:
          • Jason T Rich, MD
        • 부수사관:
          • Robert D Siegel, MD
        • 부수사관:
          • Wade L Thorstad, MD
        • 부수사관:
          • Gregory R Vlacich, MD, PhD
        • 부수사관:
          • Paul Zolkind, MD

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

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Newly diagnosed histologically or cytologically confirmed locally advanced, OPC HPV-negative head and neck squamous cell carcinoma (OPSCC) or HNSCC arising from oral cavity, larynx, or hypopharynx.

  • Baseline resectable disease per the judgment of the treating surgical oncologist.

  • Clinical stage III, IVA, or IVB disease as defined using the 8th (2017) edition of the tumor, node, metastasis (TNM) staging system by the American Joint Committee on Cancer (AJCC) and the Union for International Cancer Control (UICC):

    • T1-2, N1-3 or
    • T3, any N or
    • T4, any N

  • Documented tumor PD-L1 CPS ≥ 1 (by PD-L1 IHC pharmDx assay), determined locally.

  • Willing to provide blood and newly obtained core or excisional biopsy of tumor lesion pre-treatment and at the time of surgery for pathologic and correlative analyses.

  • Age 18 years or older at the time of informed consent.

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

  • Adequate organ and marrow function as defined below:

    • Absolute neutrophil count ≥ 1.5 K/cumm
    • Platelets ≥ 100 K/cumm
    • Hemoglobin ≥ 9 g/dL (without PRBC transfusion in the prior 7 days)
    • Total serum bilirubin ≤ 1.5 x IULN (except for subjects with documented diagnosis of Gilbert syndrome). For subjects with a documented diagnosis of Gilbert's syndrome, total bilirubin must be ≤ 3.0 × ULN, provided that direct bilirubin is within normal limits
    • AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN
    • Creatinine clearance (measured or calculated via the Cockcroft-Gault equation or per institutional standards) ≥ 30 mL/min
    • PT/INR or aPTT ≤ 1.5 x IULN (except for subjects receiving anticoagulant therapy)

  • The effects of pembrolizumab and ficerafusp alfa on the developing human fetus are unknown. For this reason, people of childbearing potential and people able to father a child must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 120 days (women) or 90 days (men) after completion of study treatment.

  • Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.

Exclusion Criteria:

  • Currently receiving any other investigational agents.
  • Prior history of grade ≥ 2 intolerance or hypersensitivity reactions to other murine proteins, or the active substances of ficerafusp alfa, pembrolizumab, or any of their excipients.
  • At higher risk of bleeding, including known bleeding diathesis or current active major bleeding, or recent major bleeding episode (within 4 weeks prior to enrollment).
  • Any of the following within 6 months prior to starting study treatment: ST-elevation myocardial infarction, severe/unstable angina, uncontrolled cardiac ventricular arrhythmia, coronary/peripheral artery bypass graft or stent, cerebrovascular accident/stroke less than 6 months prior to enrollment, or congestive heart failure. Subjects with deep vein thrombosis who are hemodynamically stable can enroll if they are on a stable dose of anticoagulants for at least 3 months.
  • Active autoimmune disease requiring systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Active systemic infection requiring either hospitalization or parenteral anti-infective therapy within 2 weeks before first dose of study treatment.
  • Chronic hepatitis B virus (HBV) infection with active disease meeting the criteria for anti-HBV therapy but not on a suppressive antiviral therapy prior to initiation of study treatment. HBV testing not required in the absence of known history of infection. Note: Subjects who are hepatitis B surface antigen positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization. These subjects should remain on antiviral therapy throughout the study treatment period and follow local guidelines for HBV antiviral therapy post completion of study treatment.
  • Known history of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible provided they completed curative antiviral therapy at least 4 weeks prior to initiation of study treatment. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection.
  • Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies) with viral load >0 or CD4<350. HIV testing is not required in the absence of known history of infection.
  • Receipt of any organ transplantation, including autologous and allogeneic stem cell transplantation, except for transplants that do not require immunosuppression.
  • Known to be diagnosed and/or treated for any other additional malignancy within 2 years prior to randomization with the exception of the following: curatively treated basal cell carcinoma or squamous cell carcinoma of the skin, and curatively resected in situ cervical cancer, and curatively resected in situ breast cancer, and low-risk early stage prostate cancer defined as follows: Stage T1c or T2a with a Gleason score ≤ 6 and prostatic-specific antigen < 10 ng/mL either treated with definitive intent or untreated in active surveillance that has been stable for the past year prior to study entry. Other exceptions may be considered with the PI's consultation. The time requirement for no malignancy for 2 years does not apply to the cancer for which a subject is enrolled in the study.
  • Any condition requiring systemic treatment with either corticosteroids (>10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 7 days prior to the first dose of study treatment, except for topical, intranasal, intrabronchial, or ocular steroids. Corticosteroid use as premedication for allergic reactions (e.g., intravenous contrast), or as a prophylactic management of AEs related to the therapies specified in the protocol is allowed. The use of physiologic doses of corticosteroids may be approved after consultation with the principle-Investigator.
  • Use of a live or live attenuated vaccine within 4 weeks prior to Screening. Note: Administration of killed, recombinant, or inactivated vaccines is allowed.
  • Pregnant or breastfeeding. People of childbearing potential must have a negative pregnancy test at screening and within 7 days of first dose of study treatment.

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: 무작위화되지 않음
  • 중재 모델: 순차적 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Phase 1 Dose Level 1: Dose De-Escalation Neoadjuvant SBRT and pembrolizumab plus ficerafusp alfa

Treatment during the Phase 1 Level 1 consists of Stereotactic Body Radiotherapy (SBRT) at 8 Gy x 3 fractions over one week (given on Days 1, 3, and 5), 2 doses of neoadjuvant pembrolizumab at 200 mg (given on D1 and D22), and 4 weekly doses of ficerafusp alfa at 750 mg (given on D1, D8, D15, and D22). Six weeks after end of SBRT, patients will undergo standard of care (SOC) surgical resection, or biopsy for patients who do not undergo resection, followed by standard of care (SOC) adjuvant chemoradiation per National Comprehensive Cancer Network (NCCN) guidelines.
방사능: Hypofractionated Stereotactic Body Radiotherapy (SBRT)

1-3 fractions given over 1 week as assigned in phase I and as determined to be the maximum tolerated dose (MTD) in phase II

생물학적: Pembrolizumab

200 mg intravenously (IV) given on Day 1 or Days 1 and 22 as assigned in phase I and as determined to be the maximum tolerated dose (MTD) in phase II.

다른 이름들:
  • 키트루다
의약품: Ficerafusp alfa

750mg intravenously (IV) on Days 1, 8, 15, and 22.

다른 이름들:
  • BCA101
실험적: Phase 1 Dose Level -1: Dose De-Escalation Neoadjuvant SBRT and pembrolizumab plus ficerafusp alfa

Treatment during the Phase 1 Level -1 consists of Stereotactic Body Radiotherapy (SBRT) at 8 Gy x 3 fractions over one week (given on Days 1, 3, and 5), 1 dose of neoadjuvant pembrolizumab at 200 mg (given on D1), and 4 weekly doses of ficerafusp alfa at 750 mg (given on D1, D8, D15, and D22). Six weeks after end of SBRT, patients will undergo standard of care (SOC) surgical resection, or biopsy for patients who do not undergo resection, followed by standard of care (SOC) adjuvant chemoradiation per National Comprehensive Cancer Network (NCCN) guidelines.
방사능: Hypofractionated Stereotactic Body Radiotherapy (SBRT)

1-3 fractions given over 1 week as assigned in phase I and as determined to be the maximum tolerated dose (MTD) in phase II

생물학적: Pembrolizumab

200 mg intravenously (IV) given on Day 1 or Days 1 and 22 as assigned in phase I and as determined to be the maximum tolerated dose (MTD) in phase II.

다른 이름들:
  • 키트루다
의약품: Ficerafusp alfa

750mg intravenously (IV) on Days 1, 8, 15, and 22.

다른 이름들:
  • BCA101
실험적: Phase 1 Dose Level -2: Dose De-Escalation Neoadjuvant SBRT and pembrolizumab plus ficerafusp alfa

Treatment during the Phase 1 Level -2 consists of Stereotactic Body Radiotherapy (SBRT) at 8 Gy x 3 fractions over one week (given on Days 1 and 4), 1 dose of neoadjuvant pembrolizumab at 200 mg (given on D1), and 4 weekly doses of ficerafusp alfa at 750 mg (given on D1, D8, D15, and D22). Six weeks after end of SBRT, patients will undergo standard of care (SOC) surgical resection, or biopsy for patients who do not undergo resection, followed by standard of care (SOC) adjuvant chemoradiation per National Comprehensive Cancer Network (NCCN) guidelines.
방사능: Hypofractionated Stereotactic Body Radiotherapy (SBRT)

1-3 fractions given over 1 week as assigned in phase I and as determined to be the maximum tolerated dose (MTD) in phase II

생물학적: Pembrolizumab

200 mg intravenously (IV) given on Day 1 or Days 1 and 22 as assigned in phase I and as determined to be the maximum tolerated dose (MTD) in phase II.

다른 이름들:
  • 키트루다
의약품: Ficerafusp alfa

750mg intravenously (IV) on Days 1, 8, 15, and 22.

다른 이름들:
  • BCA101
실험적: Phase 1 Dose Level -3: Dose De-Escalation Neoadjuvant SBRT and pembrolizumab plus ficerafusp alfa

Treatment during the Phase 1 Level -3 consists of Stereotactic Body Radiotherapy (SBRT) at 8 Gy x 3 fractions over one week (given on Day 1), 1 dose of neoadjuvant pembrolizumab at 200 mg (given on D1), and 4 weekly doses of ficerafusp alfa at 750 mg (given on D1, D8, D15, and D22). Six weeks after end of SBRT, patients will undergo standard of care (SOC) surgical resection, or biopsy for patients who do not undergo resection, followed by standard of care (SOC) adjuvant chemoradiation per National Comprehensive Cancer Network (NCCN) guidelines.
방사능: Hypofractionated Stereotactic Body Radiotherapy (SBRT)

1-3 fractions given over 1 week as assigned in phase I and as determined to be the maximum tolerated dose (MTD) in phase II

생물학적: Pembrolizumab

200 mg intravenously (IV) given on Day 1 or Days 1 and 22 as assigned in phase I and as determined to be the maximum tolerated dose (MTD) in phase II.

다른 이름들:
  • 키트루다
의약품: Ficerafusp alfa

750mg intravenously (IV) on Days 1, 8, 15, and 22.

다른 이름들:
  • BCA101
실험적: Phase 2: Maximum Tolerable Dose (MTD) Neoadjuvant SBRT and pembrolizumab plus ficerafusp alfa

Treatment consists of SBRT beginning on D1 at the dose and number of fractions established in phase I, neoadjuvant pembrolizumab 200 mg at the number of doses established in phase I, and 4 weekly doses of ficerafusp alfa 750 mg (given on D1, D8, D15, and D22). Six weeks after end of SBRT, patients will undergo standard of care (SOC) surgical resection, or biopsy for patients who do not undergo resection, followed by standard of care (SOC) adjuvant chemoradiation per National Comprehensive Cancer Network (NCCN) guidelines.
방사능: Hypofractionated Stereotactic Body Radiotherapy (SBRT)

1-3 fractions given over 1 week as assigned in phase I and as determined to be the maximum tolerated dose (MTD) in phase II

생물학적: Pembrolizumab

200 mg intravenously (IV) given on Day 1 or Days 1 and 22 as assigned in phase I and as determined to be the maximum tolerated dose (MTD) in phase II.

다른 이름들:
  • 키트루다
의약품: Ficerafusp alfa

750mg intravenously (IV) on Days 1, 8, 15, and 22.

다른 이름들:
  • BCA101

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Phase I only: Maximum tolerated dose (MTD) of SBRT in combination with pembrolizumab plus ficerafusp alfa
기간: From start of treatment until date of surgery (total estimated time of 7 weeks)

The maximum tolerated dose (MTD) is defined as the highest dose level at which 0 or 1 patients of a cohort experience dose-limiting toxicity during the dose limiting toxicity (DLT) window. DLTs are defined in the protocol.
From start of treatment until date of surgery (total estimated time of 7 weeks)
Phase II only: Rate of pathologic complete response (pCR)
기간: At the time of surgery (estimated to be week 7)

Response will be defined according to the systematic pTR system. pTR is defined as the presence of tumor cell necrosis and keratinous debris with giant cell/histiocytic reaction, quantified as a percentage of the overall tumor bed (area pathologic response/area pathologic response plus viable tumor). pCR is defined as follows: 100% of sample characterized by tumor necrosis, keratinous debris, and/or giant cells/histiocytes
At the time of surgery (estimated to be week 7)

2차 결과 측정

결과 측정
측정값 설명
기간
2상만: 임상에서 병리학적 병기 하향 조정률(및 필요한 경우 수술 계획 변경 범위)
기간: 수술 시점 (예상 7주차)
수술 시점 (예상 7주차)
Phase II only: Number and types of Adverse Events (AEs)
기간: From start of treatment through 5 years after completion of treatment (estimated to be 5 years and 2 months)

As defined by CTCAE v5.0.
From start of treatment through 5 years after completion of treatment (estimated to be 5 years and 2 months)
Phase II only: Pathological response rate (PRR)
기간: At time of surgery (estimated to be week 7)

PRR is categorized as pCR, mPR, and others (pTR-0, pTR-1, pTR-2). Simon's two-stage optimal design will be used for a rate of pCR in phase II.

Response will be defined according to the systematic pTR system. pTR is defined as the presence of tumor cell necrosis and keratinous debris with giant cell/histiocytic reaction, quantified as a percentage of the overall tumor bed (area pathologic response/area pathologic response plus viable tumor). pTR is defined as follows: pTR-0: < 10% of sample characterized by tumor necrosis, keratinous debris, and/or giant cells/histiocytes, pTR-1: 10-49%, pTR-2: 50-89%, pTR-3: 90-99% (also referred to as mPR), and pTR-4: 100% (also referred to as pCR).
At time of surgery (estimated to be week 7)
Phase II only: Event-free survival (EFS)
기간: From start of treatment through 5 years after completion of treatment (estimated to be 5 years and 2 months)

EFS is defined as the time from the first date of treatment to the date of disease progression or death, whichever occurs first.
From start of treatment through 5 years after completion of treatment (estimated to be 5 years and 2 months)
Phase II only: Overall survival (OS)
기간: From start of treatment through 5 years after completion of treatment (estimated to be 5 years and 2 months)

OS is defined as the time from the first date of treatment to the date of death. Alive patients are censored at the last follow-up otherwise.
From start of treatment through 5 years after completion of treatment (estimated to be 5 years and 2 months)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Washington University School of Medicine

협력자

Bicara Therapeutics

수사관

  • 수석 연구원: Sana Karam, MD, PhD, Washington University School of Medicine
  • 수석 연구원: Sidharth Puram, MD, PhD, Washington University School of Medicine

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

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 11월 30일

기본 완료 (추정된)

2029년 1월 31일

연구 완료 (추정된)

2034년 1월 31일

연구 등록 날짜

최초 제출

2026년 4월 20일

QC 기준을 충족하는 최초 제출

2026년 4월 20일

처음 게시됨 (실제)

2026년 4월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 1일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 202604179

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

예

미국에서 제조되어 미국에서 수출되는 제품

예

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