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유전성 BRCA 변이 동반 전이성 췌장암 환자에서 olaparib 단독요법 대비 면역항암제 pembrolizumab 병용요법의 효과를 비교하는 2상 임상시험

Testing the Addition of Pembrolizumab, an Immunotherapy Cancer Drug to Olaparib Alone as Therapy for Patients With Pancreatic Cancer That Has Spread With Inherited BRCA Mutations

안내

이 페이지는 자동 수집·AI 요약된 정보입니다. 의료 조언이 아니며, 치료 결정은 반드시 담당 의료진과 상의하세요. 응급 상황은 응급 가이드 또는 119.

항목 내용
등록번호 NCT04548752
상태 진행 중(모집 종료)
단계 2상
시험 약물/중재 Biopsy Procedure, Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Olaparib, Pembrolizumab
대상 질환 Metastatic Pancreatic Adenocarcinoma, Stage IV Pancreatic Cancer AJCC v8
스폰서 National Cancer Institute (NCI)
연령·성별 18 Years ~ 제한 없음 · ALL
목표 인원 68
시작 / 1차 완료 예정 2021-02-22 / 2025-07-16
국내 실시기관 없음
실시 국가 1개국, 기관 533곳 (United States)
결과 게시 아니오
최근 갱신 2026-10-07

시험 개요

이 연구는 체내 다른 부위로 전이되고 유전성(germline) BRCA1 또는 BRCA2 유전자 변이를 보유한 췌장선암 환자를 대상으로 하는 2상 임상시험입니다. 1차 백금 기반 항암화학요법을 16주 이상 투여받고 질병이 진행하지 않은 환자를 대상으로 표준 유지요법인 PARP 억제제 olaparib(올라파립) 단독 치료군과 olaparib에 면역관문억제제 pembrolizumab(펨브롤리주맙)을 추가한 병용 치료군을 무작위 배정하여 비교합니다. 두 치료법 간의 무진행 생존기간(PFS) 개선 효과와 안전성, 전체 생존기간(OS) 등을 확인하는 것이 목적입니다. 목표 환자 수는 68명이며 미국 NCI 주도로 진행 중입니다.

  • 유전성 BRCA1/2 변이를 가진 전이성 췌장선암 환자 68명을 대상으로 진행되는 2상 무작위 배정 임상시험입니다.
  • 1차 백금 기반 항암화학요법에 안정 병변 이상을 보인 환자에게 olaparib 단독 유지요법과 olaparib + pembrolizumab 병용 유지요법을 비교 평가합니다.
  • 주요 평가지표는 무진행 생존기간(PFS)이며 부차적으로 안전성, 전체 생존기간(OS), 객관적 반응률(ORR) 등을 평가합니다.

참여 조건 (AI 정리, 원문 확인 필요)

선정 기준: * 조직학적 또는 세포학적으로 확인된 췌장선암(pancreatic adenocarcinoma) 환자 * CLIA 인증 검사실에서 병원성 또는 병원성 추정으로 확인된 유전성(germline) BRCA1 또는 BRCA2 변이 보유 환자 * 전이성 병변이 있고 1차 백금 기반 항암화학요법(FOLFIRINOX, FOLFOX, gemcitabine+cisplatin 등)을 최소 16주 이상 투여받은 환자 * 등록 전 30일 이내 영상 검사(CT 또는 MRI)에서 1차 백금 항암제에 안정(stable) 또는 반응(responding)을 보인 환자 * 만 18세 이상이며 일상수행능력 평가 점수(Zubrod performance status) 0~1점인 환자 * 적절한 골수, 간, 신장 기능을 보유하고 경구 약물 복용이 가능한 환자

제외 기준: * 종양 조직에만 국한된 체세포(somatic) BRCA 변이 환자, 신경내분비종양, 세엽세포암, 선편평세포암 환자 * 이전에 면역관문억제제(anti-PD-1, anti-PD-L1, anti-PD-L2 등) 또는 PARP 억제제 치료를 받은 이력이 있는 환자 * olaparib 약물 또는 첨가제에 과민반응 병력이 있는 환자 * olaparib 투여 중 강력하거나 중등도의 CYP3A 억제제 또는 유도제 병용이 필요한 환자 * 무작위 배정 전 42일 이내에 생백신을 접종받았거나 치료 중 생백신 접종이 예정된 환자 * 면역결핍증 진단을 받았거나 치료 시작 전 7일 이내에 전신 스테로이드 등 면역억제 치료를 받은 환자

선정/제외 기준 원문 (영어)

Inclusion Criteria:

  • Patients must have a histologic or cytologic diagnosis of pancreatic adenocarcinoma. Patients with neuroendocrine tumors, acinar cell and adenosquamous carcinomas are excluded. All disease must be assessed and documented on the Baseline Tumor Assessment Form
  • Patients must have one of the following mutations: germline mutation in BRCA 1 or 2 that was tested in a Clinical Laboratory Improvement Act (CLIA) certified lab defined as positive and/or deleterious (that is, pathogenic or likely pathogenic variant). (NOTE: Patients with tumor somatic mutations are not eligible)
  • Patients must have metastatic disease and received first line platinum-based chemotherapy (i.e. fluorouracil, irinotecan, leucovorin and oxaliplatin [FOLFIRINOX], leucovorin calcium, 5-fluorouracil, and oxaliplatin [FOLFOX], gemcitabine + nab-paclitaxel + cisplatin or gemcitabine + cisplatin)
  • Patients must have had a CT or MRI showing stable or responding disease on first line platinum-based chemotherapy within 30 days prior to registration
  • Patients with known human immunodeficiency virus (HIV)-infection are eligible providing they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within 6 months prior to registration
  • Patients with history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load within 30 days prior to registration
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment must have an undetectable HCV viral load within 30 days prior to registration
  • Patients must have received at least 16 weeks of first line platinum-based chemotherapy for metastatic disease. Patients may have also received one cycle of treatment (no more than 4 weeks) with gemcitabine + nab-paclitaxel while waiting for germline test results, prior to platinum-based therapy
  • Patients' last chemotherapy treatment must be within 30 days prior to registration
  • Patients must have resolved or stable =\< grade 1 toxicity from prior administration of another investigational drug and/or prior anti-cancer treatment, excluding neuropathy and alopecia
  • Patients must not have a known hypersensitivity to olaparib or any of the excipients of the product
  • Patients must not be planning to receive strong or moderate CYP3A inhibitors or inducers while on olaparib treatment. Patients receiving strong or moderate CYP3A inhibitors must discontinue use at least 2 weeks prior to receiving olaparib. Patients receiving strong or moderate CYP3A inducers must discontinue use at least 5 weeks prior to receiving olaparib. Medications should be checked using a frequently updated medical reference for a list of drugs to avoid
  • Patients must not have received live vaccines within 42 days prior to randomization and must not be planning to receive live virus or live bacterial vaccines while receiving study treatment and during the 30 day follow up period. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, shingles, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed. Coronavirus disease 2019 (COVID-19) messenger ribonucleic acid (mRNA) vaccine is allowed
  • Patients must not have had prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or any other immune checkpoint inhibitors
  • Patients must not have had prior therapy with PARP inhibitors
  • Patients must not have had a prior diagnosis of immunodeficiency or receiving systemic steroid therapy (defined as >= 10 mg prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
  • Zubrod performance status of 0-1
  • Patients must be >= 18 years old
  • Patients must have a complete medical history and physical exam within 28 days prior to registration
  • Absolute neutrophil count >= 1.5 x 10\^3/uL (within 14 days of registration)
  • Platelets >= 100 x 10\^3/uL (within 14 days of registration)
  • Total bilirubin =\< 1.5 institutional upper limit of normal (ULN) (within 14 days of registration)
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3 x institutional ULN (within 14 days of registration)
  • Albumin >= 3.0 g/dL (within 14 days of registration)
  • Hemoglobin >= 9.0 g/dL (within 14 days of registration)
  • Creatinine clearance (Cockcroft _Gault) > 50 mg/dL (within 14 days of registration)
  • Participants must have a serum creatinine =\< the institutional (I)ULN OR measured OR calculated creatinine clearance >= 50 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 14 days prior to registration
  • Patients must have CA19-9 obtained within 42 days prior to registration
  • Patients must be able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of the study medication
  • Participants with a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial provided it does not require concurrent therapy
  • Participants must not be pregnant or nursing due to the possibility of harm to the fetus or nursing infant from this treatment regimen. Women of childbearing potential must have a negative urine or serum pregnancy test within 28 days prior to registration. Women/men of reproductive potential must have agreed to use an effective contraceptive method for the course of the study through 6 months after the last dose of study medication. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures, he/she is responsible for beginning contraceptive measures. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
  • Patients must not have a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
  • Patients must not have an active infection requiring systemic therapy
  • Patients must not have active autoimmune disease that has required systemic treatment in 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
  • Patients must be offered the opportunity to participate in specimen banking of formalin-fixed paraffin-embedded (FFPE) tissue and whole blood. If a patient is unable to submit archival tissue, should the patient need to undergo a standard of care biopsy per National Comprehensive Cancer Network (NCCN) guidelines, patients must then be offered the opportunity to submit the fresh tumor tissue from that biopsy. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System
  • Patients must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. For participants with impaired decision making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Canada Industrial Relations Board (CIRB) regulations
  • As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

출처: ClinicalTrials.gov · 수집 2026-10-08 · 갱신 2026-10-08

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