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New treatment option for Prostate Cancer
Official title First-in-human Study of OVM-200 as a Therapeutic Cancer Vaccine
ClinicalTrials.gov ID: NCT05104515
What this study is testing
What is OVM-200?
OVM-200 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- OVM-200 will be tested in humans for the first time in Study OVM-200-100. Up to 52 patients aged 18-75 with prostate, lung or ovarian cancer will be enrolled in the Study to find out if OVM-200 is safe to continue studying it in patients with cancer.
- Phase 1: an early, usually small safety study
- Time commitment: about 6 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 1\. Histologically confirmed metastatic or locally advanced inoperable NSCLC, ovarian cancer, or prostate cancer that have already received at least...
- 2\. Are not receiving active cancer treatment other than supportive therapies or androgen deprivation therapies for prostate cancer, which may be...
- 3\. At least 1 measurable lesion that can be accurately assessed at baseline by computed tomography (CT)/magnetic resonance imaging (MRI) and is...
- 4\. Age ≥ 18 years and ≤ 75 years. 5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Section 7.2.6).
- 6\. Predicted life expectancy ≥ 3 months. 7. Adequate bone marrow, renal, and hepatic function.
You likely can't join if
- Known history or evidence of significant immunodeficiency due to underlying illness. Patients with a condition requiring systemic treatment with...
- Patients with a history of or active, known, or suspected autoimmune disease or a syndrome that requires systemic or immunosuppressive agents...
- Prior therapy with an anticancer vaccine; anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody; or any other antibody or drug...
- Administration of an investigational drug in the 28 days or 6 half-lives (whichever is longer) before the first dose of study drug.
- Major surgery or treatment with any chemotherapy, or radiation therapy for cancer in the 28 days before the first dose of study drug.
- Active infection requiring antibiotics or physician monitoring, or recurrent fevers (\> 38.0°C) associated with a clinical diagnosis of active...
See the full eligibility criteria
- 1\. Histologically confirmed metastatic or locally advanced inoperable NSCLC, ovarian cancer, or prostate cancer that have already received at least 1 line of approved cancer therapy and either: exhausted current...
- 2\. Are not receiving active cancer treatment other than supportive therapies or androgen deprivation therapies for prostate cancer, which may be continued, and, in the opinion of the investigator, are not anticipated...
- 3\. At least 1 measurable lesion that can be accurately assessed at baseline by computed tomography (CT)/magnetic resonance imaging (MRI) and is suitable for repeated assessment (NSCLC only).
- 4\. Age ≥ 18 years and ≤ 75 years. 5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Section 7.2.6).
- 6\. Predicted life expectancy ≥ 3 months. 7. Adequate bone marrow, renal, and hepatic function.
- Known history or evidence of significant immunodeficiency due to underlying illness. Patients with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisolone equivalent) or other...
- Patients with a history of or active, known, or suspected autoimmune disease or a syndrome that requires systemic or immunosuppressive agents. Patients with vitiligo, type I diabetes mellitus, residual hypothyroidism...
- Prior therapy with an anticancer vaccine; anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody; or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways...
- Administration of an investigational drug in the 28 days or 6 half-lives (whichever is longer) before the first dose of study drug.
- Major surgery or treatment with any chemotherapy, or radiation therapy for cancer in the 28 days before the first dose of study drug.
- Active infection requiring antibiotics or physician monitoring, or recurrent fevers (\> 38.0°C) associated with a clinical diagnosis of active infection.
- Active viral disease, positive test for hepatitis B virus using hepatitis B surface antigen test, or positive test for hepatitis C virus (HCV) using HCV ribonucleic acid or HCV antibody test indicating acute or chronic...
- Receipt of any vaccine within 28 days before the first dose of study drug.
- Other prior malignancy within the previous 3 years, except for local or organ-confined early stage cancer that has been definitively treated with curative intent and does not require ongoing treatment, has no evidence...
- Symptomatic brain metastases or any leptomeningeal metastasis.
- Any serious or uncontrolled medical disorder (including cardiovascular, respiratory, renal, or autoimmune disease) that, in the opinion of the investigator or the medical monitor, may increase the risk associated with...
- History of allergic reaction or hypersensitivity to any component of the OVM-200 therapeutic vaccine or adjuvant.
The study team makes the final eligibility decision.
Where it's taking place
- London, London, United Kingdom
- London, United Kingdom
- Manchester, United Kingdom
- Oxford, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, London, United Kingdom; London, United Kingdom; Manchester, United Kingdom; Oxford, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.