Evaluation of a New Vaccine Treatment for Patients With Metastatic Skin Cancer (NCT01149343) | Clinical Trial Compass
CompletedPhase 1
Evaluation of a New Vaccine Treatment for Patients With Metastatic Skin Cancer
Czechia, France107 participantsStarted 2010-07-02
Plain-language summary
The purpose of this clinical study is to examine the safety, immunogenicity and clinical activity of the immunotherapeutic product GSK2302025A (also referred to as recPRAME + AS15 Antigen-Specific Cancer Immunotherapeutic \[ASCI\]) administered as a first line treatment in patients with unresectable and progressive metastatic cutaneous melanoma.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female patient with histologically proven cutaneous melanoma. Phase I segment: All melanoma patients with stage IV M1b and stage IV M1c including completely resected stage IV patients but with the exception of stage IV M1c disease with serum lactate dehydrogenase \> 1.5 x Upper Limit of Normal or with involvement of the Central Nervous System.
✓. Written informed consent for PRAME expression screening and gene profiling on resected tumor tissue and for the complete study has been obtained from the patient prior to shipment of the sample for expression testing and prior to the performance of any other protocol-specific procedure.
✓. The patient is \>= 18 years old at the time of signing the first informed consent form.
✓. The patient's tumor shows expression of the PRAME antigen as determined by RT-PCR analysis or any updated technique on fresh tissue sample.
✓. Eastern Cooperative Oncology Group performance status of 0 or 1.
✓. The patient has adequate bone marrow reserve, renal, adrenal and hepatic function as assessed by standard laboratory criteria.
✓. Female patients of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause.
✓. Female patients of childbearing potential may be enrolled in the study, if the patient:
Exclusion criteria
✕. The patient has at any time received systemic chemotherapy, (bio)-chemotherapy or CTLA-4 monoclonal antibodies for metastatic disease.
What they're measuring
1
Number of Patients With Dose-limiting Toxicity (Phase I)
Timeframe: During the study treatment (up to Year 4), for all patients
2
Percentage of Patients With Anti-PReferentially Expressed Antigen of MElanoma (Anti-PRAME) Humoral Immune Response (Phase I)
Timeframe: After the administration of dose 4, at Week 8
3
Number of Patients With Best Overall Response to Study Treatment (Phase II)
Timeframe: During the entire study period - up to Year 4 + 1 month post last study treatment administration
✕. The patient is scheduled to receive any other anticancer treatment, including but not limited to (bio)-chemotherapeutic or immunomodulating agents and radiotherapy.
✕. The patient has received any cancer immunotherapy containing the PRAME antigen or any cancer immunotherapy for his/her metastatic disease.
✕. The patient requires concomitant treatment (more than 7 consecutive days) with systemic corticosteroids or any other immunosuppressive agents.
✕. Use of any investigational or non-registered product (drug or vaccine) other than the study product within the 30 days preceding the first ASCI dose injection or planned use during the study period
✕. The patient has (had) previous or concomitant malignancies at other sites (including carcinoma in situ), except effectively treated non-melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for over 5 years and is highly likely to have been cured.
✕. The patient has an allergy to any component of the study investigational product or has a history of previous allergic reactions to vaccinations.
✕. The patient has a history of confirmed adrenal dysfunction.