First in human evaluation of the W_pro1 cancer vaccine in patients that have been diagnosed with metastatic prostate cancer that is resistant to androgen depletion therapy, and in patients with newly diagnosed localized prostate cancer (LPC) before the surgical removal of the prostate. LPC patients will additionally be treated with hormonal treatment (Goserelin Acetate). All patients will be treated with either W_pro1 alone or with W_pro1 and an immune system modulating agent (Cemiplimab).
- Conditions
- Male adults with prostate cancer, both mCRPC (Arms 1A & 1B) and LPC (ARms 2&3) patients, will be treated with W_pro1 alone or in combination with cemiplimab. LPC patients will also receive neo-adjuvant goserelin acetate therapy addition to W_pro1 with or without Cemiplimab.MedDRA version: 20.0Level: LLTClassification code 10007113Term: Cancer of prostateSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-004321-86-GB
- Lead Sponsor
- BioNTech SE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- 130
Main INCLUSION criteria for ALL patients
• Patient must be a male and aged = 18 years of age.
• Patient must have histologically confirmed prostate adenocarcinoma.
• Patients or their legally authorized representative (if applicable, except Germany) 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.
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
Main SPECIFIC INCLUSION criteria for newly diagnosed LPC patients (Part 2 Arms 2 and 3)
• Treatment naïve patient with high-risk LPC (i.e. N0, M0) defined according to European Association of Urology Guidelines on Prostate Cancer (2018)). Patients must have at least 1 of the following:
- PSA > 20 ng/mL or
- Gleason Score > 7 or
- Localized stage = cT2b, N0, M0 according to tumor, node, metastasis (TNM) classification
• Patients who intend to have and are suitable for a radical prostatectomy.
• Patients must have adequate liver function
• Patients must agree to provide tumor sample(s) from pre-treatment diagnostic biopsy and planned post-treatment surgery.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 85
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45
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 (Grade III or IV as classified by the New York Heart Association), 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 adverse events (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 following risk factors for bowel perforation (e.g., history of acute diverticulitis or intra-abdominal abscess in the last 3 years; history of gastrointestinal obstruction or abdominal carcinomatosis).
- 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 (testing not required):
a. HIV 1 or 2
b. Hepatitis B
c. Hepatitis C
• Patients with a known allergy, hypersensitivity, or intolerance to
W_pro1 or its excipients (all patients in Parts 1 and 2), cemiplimab or its excipients (patients in Part 2 Arm 2 only), or to ADT (e.g., goserelin)or its excipients (patients in Part 2 Arms 2 and 3 only).
Prior/Concomitant Therapy
•Patients who have received or currently receive the following therapy/medication:
a. Chronic systemic immunosuppressive corticosteroid treatment (prednisone >5 mg daily orally (PO) or IV, or equivalent) during the trial.
b. Prior treatment with other immune modulating agents for any non-cancer disease within 4 weeks or 5 half-lives of the agent (whichever is shorter) before the first dose of IMP.
c. Prior treatment with live attenuated vaccines within 4 weeks before the first dose of IMP during treatment, and for 3 months after the last dose of W_pro1.
d. Prior treatment with an investigational drug (including investigational vaccines) within 4 weeks or 5 half-lives of the agent (whichever is shorter) before the planned first dose of IMP.
e. Therapeutic PO or IV antibiotics within 14 days prior to enrolment.
f. Concurrent use of he
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method