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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01149343




Registration number
NCT01149343
Ethics application status
Date submitted
22/06/2010
Date registered
23/06/2010

Titles & IDs
Public title
Evaluation of a New Vaccine Treatment for Patients With Metastatic Skin Cancer
Scientific title
Study of GSK2302025A Antigen-Specific Cancer Immunotherapeutic in Patients With Metastatic Melanoma
Secondary ID [1] 0 0
2009-016636-13
Secondary ID [2] 0 0
113173
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Immunotherapeutic GSK2302025A, different formulations

Experimental: GSK2302025A Cohort 1 - Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.

Experimental: GSK2302025A Cohort 2 - Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.

Experimental: GSK2302025A Cohort 3 - Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.

Experimental: GSK2302025A Cohort 4 - In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.


Treatment: Other: Immunotherapeutic GSK2302025A, different formulations
Intramuscular administration
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Patients With Dose-limiting Toxicity (Phase I)
Timepoint [1] 0 0
During the study treatment (up to Year 4), for all patients
Primary outcome [2] 0 0
Percentage of Patients With Anti-PReferentially Expressed Antigen of MElanoma (Anti-PRAME) Humoral Immune Response (Phase I)
Timepoint [2] 0 0
After the administration of dose 4, at Week 8
Primary outcome [3] 0 0
Number of Patients With Best Overall Response to Study Treatment (Phase II)
Timepoint [3] 0 0
During the entire study period - up to Year 4 + 1 month post last study treatment administration
Secondary outcome [1] 0 0
Number of Patients With Any Unsolicited Adverse Events (AEs), by Maximum Grading
Timepoint [1] 0 0
During the entire study period - up to Year 4 + 1 month post last study treatment administration
Secondary outcome [2] 0 0
Number of Patients With Serious Adverse Events (SAEs), by Maximum Grading
Timepoint [2] 0 0
During the entire study period - up to Year 4 + 1 month post last study treatment administration
Secondary outcome [3] 0 0
Number of Patients With Laboratory Abnormalities Versus Baseline, by Maximum Grading
Timepoint [3] 0 0
During the entire study period - up to Year 4 + 1 month post last study treatment administration
Secondary outcome [4] 0 0
Number of Patients With Laboratory Abnormal Results Versus Baseline, by Maximum Grading
Timepoint [4] 0 0
During the entire study period - up to Year 4 + 1 month post last study treatment administration
Secondary outcome [5] 0 0
Number of Patients With Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
Timepoint [5] 0 0
During the entire study period - up to Year 4 + 1 month post last study treatment administration
Secondary outcome [6] 0 0
Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
Timepoint [6] 0 0
During the entire study period - up to Year 4 + 1 month post last study treatment administration
Secondary outcome [7] 0 0
Number of Patients With Lab Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
Timepoint [7] 0 0
During the entire study period - up to Year 4 + 1 month post last study treatment administration
Secondary outcome [8] 0 0
Number of Patients With Abnormal Hematological and Biochemical Results Versus Baseline, by Maximum Grading
Timepoint [8] 0 0
During the entire study period - up to Year 4 + 1 month post last study treatment administration
Secondary outcome [9] 0 0
Number of Patients With Abnormal Hematological and Biochemical Laboratory Results Versus Baseline, by Maximum Grading
Timepoint [9] 0 0
During the entire study period - up to Year 4 + 1 month post last study treatment administration
Secondary outcome [10] 0 0
Percentage of Patients With Anti-PRAME Cellular (T-cell) Response (Phase I)
Timepoint [10] 0 0
Up to Data Lock Point at Week 8
Secondary outcome [11] 0 0
Number of Patients With Anti-PRAME Humoral Immune Response (Phase I & II)
Timepoint [11] 0 0
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
Secondary outcome [12] 0 0
Number of Patients With Stable Disease (SD), Progressive Disease (PD), Mixed Response (MR) (Phase I & II)
Timepoint [12] 0 0
At 30 days after the last treatment administration for each patient (Week 199)
Secondary outcome [13] 0 0
Number of Patients With Best Overall Response, Including Mixed Response (MxR) and Slow Progressive Disease (SPD) Criteria (Phase I & II)
Timepoint [13] 0 0
At 30 days after the last treatment administration for each patient (Week 199)
Secondary outcome [14] 0 0
Anti-Protein D Humoral Response (Phase I & II)
Timepoint [14] 0 0
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
Secondary outcome [15] 0 0
Anti-Cytosine Phosphate Guanosine Oligodeoxynucleotide (CpG) Humoral Response (Phase I & II)
Timepoint [15] 0 0
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
Secondary outcome [16] 0 0
Time to Treatment Failure, Progression Free Survival and Overall Survival (Phase I & II)
Timepoint [16] 0 0
Up to concluding visit, at Week 199
Secondary outcome [17] 0 0
Duration of Response for Patients With CR, PR and SD or SD/PR Status (Phase II)
Timepoint [17] 0 0
Up to concluding visit, at Week 199

Eligibility
Key inclusion 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.

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:

* 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/07/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/12/2016
Sample size
Target
Accrual to date
Final
107
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Czechia
State/province [1] 0 0
Brno
Country [2] 0 0
Czechia
State/province [2] 0 0
Hradec Kralove
Country [3] 0 0
Czechia
State/province [3] 0 0
Praha 2
Country [4] 0 0
France
State/province [4] 0 0
Bordeaux
Country [5] 0 0
France
State/province [5] 0 0
Lille
Country [6] 0 0
France
State/province [6] 0 0
Marseille cedex 5
Country [7] 0 0
France
State/province [7] 0 0
Nantes
Country [8] 0 0
France
State/province [8] 0 0
Reims
Country [9] 0 0
France
State/province [9] 0 0
Rennes
Country [10] 0 0
France
State/province [10] 0 0
Vandoeuvre les Nancy
Country [11] 0 0
Germany
State/province [11] 0 0
Baden-Wuerttemberg
Country [12] 0 0
Germany
State/province [12] 0 0
Bayern
Country [13] 0 0
Germany
State/province [13] 0 0
Niedersachsen
Country [14] 0 0
Germany
State/province [14] 0 0
Nordrhein-Westfalen
Country [15] 0 0
Germany
State/province [15] 0 0
Rheinland-Pfalz
Country [16] 0 0
Germany
State/province [16] 0 0
Saarland
Country [17] 0 0
Germany
State/province [17] 0 0
Schleswig-Holstein
Country [18] 0 0
Germany
State/province [18] 0 0
Thueringen
Country [19] 0 0
Germany
State/province [19] 0 0
Berlin
Country [20] 0 0
Italy
State/province [20] 0 0
Campania
Country [21] 0 0
Italy
State/province [21] 0 0
Emilia-Romagna
Country [22] 0 0
Italy
State/province [22] 0 0
Liguria
Country [23] 0 0
Italy
State/province [23] 0 0
Lombardia
Country [24] 0 0
Poland
State/province [24] 0 0
Gdansk
Country [25] 0 0
Poland
State/province [25] 0 0
Poznan
Country [26] 0 0
Poland
State/province [26] 0 0
Slupsk
Country [27] 0 0
Russian Federation
State/province [27] 0 0
Chelyabinsk
Country [28] 0 0
Russian Federation
State/province [28] 0 0
Moscow
Country [29] 0 0
Russian Federation
State/province [29] 0 0
Pyatigorsk
Country [30] 0 0
Russian Federation
State/province [30] 0 0
St. Petersburg

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01149343