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临床试验/EUCTR2018-004321-86-DE
EUCTR2018-004321-86-DE进行中（未招募）1 期

First-in-human, dose titration and expansion trial to evaluate safety, immunogenicity and preliminary efficacy of W_pro1 (BNT112) monotherapyand in combination with cemiplimab in patients with prostate cancer. - PRO-MERIT (Prostate Cancer Messenger RNA Immunotherapy)

BioNTech SE0 个研究点目标入组 115 人开始时间: 2019年10月10日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
发起方
BioNTech SE
入组人数
115
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Male

入选标准

  • •Main INCLUSION criteria for ALL patients
  • •Patient must be male and aged = 18 years
  • •Patient must have histologically confirmed prostate adenocarcinoma.
  • •Patients or their legally authorized representative (if applicable) must sign an informed consent form (ICF) indicating that they understand the purpose of the procedures required for the trial and are willing to participate.
  • •Patient must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1
  • •Patient must have adequate organ and bone marrow function.
  • •Patients who are sexually active with a woman of childbearing potential must agree to use a condom with spermicidal foam/gel/film/cream/suppository in addition to at least one form of highly effective contraception used by the patient or their partner (for details, see Section 10.4) during the trial starting after signing the ICF and for 90 days after receiving the last dose of BNT112 OR for 6 months after receiving the last dose of cemiplimab.
  • •Patients should not donate sperm during the trial starting after signing the ICF and for 90 days after receiving the last dose of BNT112 OR for 6 months after receiving the last dose of cemiplimab.
  • •Main SPECIFIC INCLUSION criteria for mCRPC patients (Part 1 and Part 2 Arms 1A and 1B)
  • •Patients must have histologically confirmed mCRPC and have progressed after at least 2 but no more than 3 lines of life-prolonging systemic therapy (e.g., abiraterone or enzalutamide, docetaxel, cabazitaxel) or cannot tolerate or have refused any of these therapies. These lines of therapy include life-prolonging therapies administered in the metastatic hormone-sensitive setting.
  • •Prior surgical or chemical castration with a serum testosterone < 1.7 nmol/L (50 ng/dL).
  • •Patients must have documented mCRPC progression within 6 months prior to screening (assuming no subsequent change in treatments), as determined by the investigator, by means of 1 or more of the following:
  • •- PSA progression as defined by a minimum of 2 rising PSA levels with an interval of =1 week between each assessment where the PSA value at screening should be > 2 ng/mL.
  • •- Two rises out of 3 PSA sequential tests separated by at least 1 week also satisfies the criteria for baseline progression providing a new nadir is not established (i.e., upward trend)
  • •- Radiographic disease progression in soft tissue based on modified Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) with or without PSA progression.
  • •- Radiographic disease progression in soft tissue based on modified Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) with or without PSA progression.
  • •- Radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on bone scan with or without PSA progression.
  • •Patients must have adequate liver function
  • •Patients must agree to provide an archival pre-treatment formalin-fixed, paraffin-embedded tumor sample if available.
  • •Main SPECIFIC INCLUSION criteria for newly diagnosed LPC patients (Part 2 Arms 2 and 3)
  • •Treatment-naïve patients with LPC (i.e., N0, M0). According to risk levels of the European Association of Urology Guidelines on Prostate Cancer (2018)24 and in line with the U.S. National Comprehensive Cancer Network (NCCN 2020), patients must have at least one of the following:
  • •- PSA > 20 ng/mL or
  • •- Gleason Score > 7 or
  • •- Localized stage =cT2c, N0, M0 according to tumor, node, metastasis (TNM) c

排除标准

  • •Main exclusion criteria for ALL patients
  • •Patient has uncontrolled intercurrent illness, including but not limited to:
  • •- Ongoing or active infection which requires systemic treatment with antibiotics or corticoid therapy within 14 days before the first dose of IMP.
  • •- Symptomatic congestive heart failure (NYHA Grade III or IV), myocardial infarction within 3 months before screening, unstable angina pectoris, or cardiac arrhythmia.
  • •- Known recent history (in the past 5 years) or presence of significant pulmonary conditions.
  • •- Uncontrolled hypertension defined as systolic blood pressure = 160 mmHg and/or diastolic blood pressure = 100 mmHg, despite optimal medical management.
  • •- Known primary immunodeficiencies, either cellular or combined T- and B-cell immunodeficiencies.
  • •- Ongoing or recent evidence (within the past year) of significant autoimmune disease that required treatment with systemic immunosuppressive treatments which may suggest risk for immune-related AEs.
  • •- Non-healing wound, skin ulcer (of any grade), or bone fracture.
  • •- Patients with prior allogeneic stem cell or solid organ transplantation.
  • •- Patients with the risk factors for bowel perforation.
  • •- Patients with uncontrolled Type 1 diabetes mellitus.
  • •- Patients with uncontrolled adrenal insufficiency.
  • •- Any other disease, metabolic dysfunction, physical examination finding and/or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or may render the patient at high-risk for treatment of complications.
  • •Patients with a known history or current malignancy other than the inclusion diagnosis.
  • •Patients who have had a splenectomy.
  • •Patients who have had a major surgery (e.g., requiring general anesthesia) within 4 weeks before screening, or have not have fully recovered from surgery, or have a surgery planned during the time of trial participation, except for the radical prostatectomy planned for patients in Part 2 Arms 2 and 3.
  • •Patients with a known history of any of the following:
  • •a. HIV 1 or 2
  • •b. Hepatitis B
  • •c. Hepatitis C
  • •Patients with a known allergy, hypersensitivity, or intolerance to BNT112 or its excipients (all patients in Parts 1 and 2), cemiplimab or its excipients (patients in Part 2 Arm 1A, Arm 1B switch-over patients, and Arm 2 only), or to ADT (e.g., goserelin)or its excipients (patients in Part 2 Arms 2 and 3 only).
  • •Patients with any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient or that could prevent, limit, or confound the protocol-specified assessments.
  • •In situations where trial patients are not legally competent to provide consent (e.g. mentally incapacitated), these patients are not allowed to enter the trial.
  • •Prior/Concomitant Therapy
  • •Patients who have received or currently receive the following therapy/treatment:
  • •a. Chronic systemic immunosuppressive corticosteroid treatment (prednisone >5 mg daily PO or IV, or equivalent) during the trial.
  • •b. Prior treatment with other immune modulating agents under conditions set in the Protocol.
  • •c. Prior treatment with live attenuated vaccines within 4 weeks before the first dose of IMP and during treatment with IMP.
  • •d. Prior treatment with an investigational drug within 4 weeks or 5 half-lives of the agent (whichever is longer) before the planned first dose of IMP.
  • •e. Therapeutic PO or IV antibiotics within 14 days pri

研究者

发起方
BioNTech SE

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