Phase I/II Study of GSK2302025A Antigen-Specific Cancer Immunotherapeutic in Patients With Metastatic Melanoma
1. 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.
Phase II segment: All melanoma patients with measurable, unresectable stage III
melanoma including in-transit metastasis (with (N3) or without (N2c) nodal
metastasis) and stage IV M1a melanoma. The patient should have documented progressive
disease within 12 weeks of registration into the trial. Patients with resected stage
IV and with stage IV M1b or M1c disease cannot be included.
2. 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.
3. The patient is >= 18 years old at the time of signing the first informed consent
4. The patient's tumor shows expression of the PRAME antigen as determined by RT-PCR
analysis or any updated technique on fresh tissue sample.
5. Eastern Cooperative Oncology Group performance status of 0 or 1.
6. The patient has adequate bone marrow reserve, renal, adrenal and hepatic function as
assessed by standard laboratory criteria.
7. 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.
8. Female patients of childbearing potential may be enrolled in the study, if the
- has practiced adequate contraception for 30 days prior to the study product
- has a negative pregnancy test on the day of administration, and
- has agreed to continue adequate contraception during the entire treatment period
and for 2 months after the completion of the study product administration
9. In the view of the investigator, the patient can and will comply with all the
requirements of the protocol.
1. The patient has at any time received systemic chemotherapy, (bio)-chemotherapy or
CTLA-4 monoclonal antibodies for metastatic disease.
2. The patient is scheduled to receive any other anticancer treatment, including but not
limited to (bio)-chemotherapeutic or immunomodulating agents and radiotherapy.
3. The patient has received any cancer immunotherapy containing the PRAME antigen or any
cancer immunotherapy for his/her metastatic disease.
4. The patient requires concomitant treatment (more than 7 consecutive days) with
systemic corticosteroids or any other immunosuppressive agents.
5. 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
6. 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.
7. The patient has an allergy to any component of the study investigational product or
has a history of previous allergic reactions to vaccinations.
8. The patient has a history of confirmed adrenal dysfunction.
9. The patient has an autoimmune disease such as, but not limited to, multiple
sclerosis, lupus, and inflammatory bowel disease.
10. The patient is known to be positive for the human immunodeficiency virus (HIV).
11. The patient has an uncontrolled bleeding disorder.
12. The patient has a family history of congenital or hereditary immunodeficiency.
13. The patient has psychiatric or addictive disorders that may compromise his/her
ability to give informed consent or to comply with the trial procedures.
14. The patient has other concurrent severe medical problems, unrelated to the
malignancy, that would significantly limit full compliance with the study or expose
the patient to unacceptable risk.
15. For female patients: the patient is pregnant or lactating.