Evaluation of a new vaccine treatment for patients with metastatic skin cancer
Trial overview
Number of patients with dose-limiting toxicity (Phase I)
Timeframe: During the study treatment (up to Year 4), for all patients
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
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
Number of patients with any unsolicited adverse events (AEs), by maximum grading
Timeframe: During the entire study period - up to Year 4 + 1 month post last study treatment administration
Number of patients with Serious Adverse Events (SAEs), by maximum grading
Timeframe: During the entire study period - up to Year 4 + 1 month post last study treatment administration
Number of patients with laboratory abnormalities versus baseline, by maximum grading
Timeframe: During the entire study period - up to Year 4 + 1 month post last study treatment administration
Number of patients with laboratory abnormal results versus baseline, by maximum grading
Timeframe: During the entire study period - up to Year 4 + 1 month post last study treatment administration
Number of patients with hematological and biochemical abnormalities versus baseline, by maximum grading
Timeframe: During the entire study period - up to Year 4 + 1 month post last study treatment administration
Number of patients with laboratory hematological and biochemical abnormalities versus baseline, by maximum grading
Timeframe: During the entire study period - up to Year 4 + 1 month post last study treatment administration
Number of patients with lab hematological and biochemical abnormalities versus baseline, by maximum grading
Timeframe: During the entire study period - up to Year 4 + 1 month post last study treatment administration
Number of patients with abnormal hematological and biochemical results versus baseline, by maximum grading
Timeframe: During the entire study period - up to Year 4 + 1 month post last study treatment administration
Number of patients with abnormal hematological and biochemical laboratory results versus baseline, by maximum grading
Timeframe: During the entire study period - up to Year 4 + 1 month post last study treatment administration
Percentage of patients with anti-PRAME cellular (T-cell) response (Phase I)
Timeframe: Up to Data Lock Point at Week 8
Number of patients with anti-PRAME humoral immune response (Phase I & II)
Timeframe: At Weeks 0, 4, 8, 10, 12, 29, 51, 75, 99, 123, 147 and conclusion visit at 30 days post last treatment administration (Week 199) for each patient
Number of patients with stable disease (SD), progressive disease (PD), mixed response (MR) (Phase I & II)
Timeframe: At 30 days after the last treatment administration for each patient (Week 199)
Number of patients with best overall response, including Mixed Response (MxR) and Slow Progressive Disease (SPD) criteria (Phase I & II)
Timeframe: At 30 days after the last treatment administration for each patient (Week 199)
Anti-Protein D humoral response (Phase I & II)
Timeframe: At Week 0, 4, 8, 12, 29, 51, 75, 99, 123, 147, 30 days after the last treatment administration for each patient (Week 199), with follow-up, 3, 6, 9 and 12 months after concluding visit
Anti-Cytosine Phosphate Guanosine oligodeoxynucleotide (CpG) humoral response (Phase I & II)
Timeframe: At Week 0, 4, 8, 12, 29, 51, 75, 99, 123, 147, 30 days after the last treatment administration for each patient (Week 199), with follow-up, 3, 6, 9 and 12 months after concluding visit
Time to treatment failure, progression free survival and overall survival (Phase I & II)
Timeframe: Up to concluding visit, at Week 199
Duration of response for patients with CR, PR and SD or SD/PR status (Phase II)
Timeframe: Up to concluding visit, at Week 199
Participation criteria
- 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.
- 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.
- has practiced adequate contraception for 30 days prior to the study product administration, and
- 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 series. 9. In the view of the investigator, the patient can and will comply with all the requirements of the protocol.
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 form. 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 patient:
- 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.
Trial location(s)
Study documents
No study documents available.
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.