Track topics on Twitter Track topics that are important to you
This is an open-label, dose-escalation, non-randomized, phase I study in patients with histologically confirmed Stage III or IV melanoma and at least three metastatic cutaneous or subcutaneous lesions suitable for: intralesional (IL) injection (1 lesion), accessible for biopsy (1 lesion), and response evaluation by RECIST (v1.1) and modified RECIST (irRC) (1 lesion). The primary objective is to determine whether IL administration of BCG followed by intravenous (IV) infusion of ipilimumab is safe. Ipilimumab (YERVOY®) is the monoclonal anti-CTLA-4 antibody approved by the FDA and TGA as anticancer therapy for melanoma. Secondary objectives of the study are: a) clinical efficacy, to document whether this combination therapy induces tumour responses; and b) immunogenicity, to identify if the combination induces immune responses against the tumours. All patients will be included in the analysis of efficacy and immunogenicity.
Cohort 1 (9 patients with <10mm induration after tuberculin Purified Protein Derivative [PPD] test): Group 1 (3 patients) will receive one IL injection of 200 µl BCG containing 0.16 - 0.64 x 106 cfu followed by four IV infusions of 3 mg/kg ipilimumab every 3 weeks, starting on day 36. Group 2 (3 patients) and 3 (n=3) will receive 200 µl BCG containing 0.8 - 3.2 x 106 cfu and 4.0 -16.0 x 106 cfu, respectively, followed by the same ipilimumab regimen. Safety will be evaluated in this cohort.
Cohort 2 (up to 9 patients with ≥10mm induration after PPD test): Enrolment will start after the final patient in Cohort 1, Group 1 has reached study week 7. Then enrolment can proceed in parallel for Cohort 2 and Cohort 1 Groups 2 and 3. Patients will receive 0.16 -0.64 x 106 cfu BCG followed by four IV infusions of 3 mg/kg ipilimumab every 3 weeks, starting on day 36. Evaluation of safety in this cohort will be observational.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Bacillus Calmette-Guérin (BCG) vaccine, Ipilimumab
Austin Health, LICR Melbourne Austin Branch
Ludwig Institute for Cancer Research
Published on BioPortfolio: 2014-08-27T04:00:41-0400
The purpose of this study is to determine if treatment with the autologous cellular vaccine, Melaxin, in combination with Bacillus Calmette-Guerin (BCG) injections is effective in Stage I...
The primary purpose of this study is to demonstrate that the NEO-PV-01 vaccine, either with APX005M or ipilimumab, and nivolumab is safe for the treatment of patients with advanced or meta...
This study, with 20 patients participating, will examine the safety and tolerability for the ipilimumab/UV1 combination in patients with unresectable or metastatic malignant melanoma.
The purpose of this study is to determine whether giving Ipilimumab at a dose of 10mg/kg will extend the lives of subjects with unresectable or metastatic melanoma more than giving Ipilimu...
The goal of this clinical research study is to learn if combining Ipilimumab and Temozolomide can help to control metastatic melanoma. The safety of this drug combination will be studied....
Brain metastases are a common cause of disabling neurologic complications and death in patients with metastatic melanoma. Previous studies of nivolumab combined with ipilimumab in metastatic melanoma ...
Ipilimumab is a CTLA-4 monoclonal antibody that amplifies T-cell activation and response to melanoma. It is approved to treat unresectable or metastatic melanoma. Immune-related adverse events are com...
Immune checkpoint inhibitors are new therapeutic options for metastatic melanoma, but little data is available in organ transplant recipient populations. Six French patients, 3 men and 3 women, mean a...
Immunotherapy is a well-established treatment option in patients with metastatic melanoma. However, biomarkers that can be used to predict a response in these patients have not yet been found, putting...
Ipilimumab is a human monoclonal antibody that targets cytotoxic T-lymphocyte-associated antigen (CTLA-4) approved for treatment of metastatic melanoma. The most commonly reported side effects are imm...
An anti-CTLA-4 ANTIGEN monoclonal antibody initially indicated for the treatment of certain types of metastatic MELANOMA. Its mode of actions may include blocking of CTLA-4 mediated inhibition of CYTOTOXIC T LYMPHOCYTES, allowing for more efficient destruction of target tumor cells.
An unpigmented malignant melanoma. It is an anaplastic melanoma consisting of cells derived from melanoblasts but not forming melanin. (Dorland, 27th ed; Stedman, 25th ed)
A combined vaccine used to prevent infection with diphtheria and tetanus toxoid. This is used in place of DTP vaccine (DIPHTHERIA-TETANUS-PERTUSSIS VACCINE) when PERTUSSIS VACCINE is contraindicated.
A live vaccine containing attenuated poliovirus, types I, II, and III, grown in monkey kidney cell tissue culture, used for routine immunization of children against polio. This vaccine induces long-lasting intestinal and humoral immunity. Killed vaccine induces only humoral immunity. Oral poliovirus vaccine should not be administered to immunocompromised individuals or their household contacts. (Dorland, 28th ed)
Experimentally induced tumor that produces MELANIN in animals to provide a model for studying human MELANOMA.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
Melanoma is a highly malignant tumor of melanin-forming cells (melanocytes) There are most commonly found in the skin (resulting from sunlight exposure), but also in the eyes and mucous membranes. Metastasis to other regions of the body is also common....