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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01213472




Registration number
NCT01213472
Ethics application status
Date submitted
1/10/2010
Date registered
4/10/2010

Titles & IDs
Public title
Evaluation of a New Anti-cancer Immunotherapy in Patients With Non-operable and Progressing Metastatic Cutaneous Melanoma
Scientific title
Study of GSK2241658A Antigen-Specific Cancer Immunotherapeutic in Patients With Unresectable and Progressive Metastatic Cutaneous Melanoma
Secondary ID [1] 0 0
2010-020663-20
Secondary ID [2] 0 0
112406
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 - GSK Biologicals' 2241658A Antigen-Specific Cancer Immunotherapeutic (ASCI)

Experimental: NY-ESO 1 Group - Patients with non-operable and progressing metastatic cutaneous melanoma, received up to 24 doses of GSK2241658A Cancer Immunotherapeutic, provided that at each tumor evaluation time point, the clinical criteria to continue the treatment were met, including patients having a clinical response.


Treatment: Other: GSK Biologicals' 2241658A Antigen-Specific Cancer Immunotherapeutic (ASCI)
Up to 24 intramuscular administrations
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Patients With Severe Toxicities During the Study Treatment Period
Timepoint [1] 0 0
During the study treatment period (maximum duration = 49 months).
Primary outcome [2] 0 0
Number of Patients With Severe Toxicities During the Follow-up Period
Timepoint [2] 0 0
During the one year follow-up period (i.e. from Month 49 until Month 61)
Primary outcome [3] 0 0
Number of Patients With the Best Overall Response in the Overall Population
Timepoint [3] 0 0
During the study treatment period (maximum duration = 49 months).
Secondary outcome [1] 0 0
Number of Patients With Best Overall Response Including Mixed Response (MxR) and Slow Progressive Disease (SPD) Criteria
Timepoint [1] 0 0
During the study treatment period (maximum duration = 49 months).
Secondary outcome [2] 0 0
Number of Patients With Objective Clinical Response (CR or PR) in the Population of Patients Who Present the Predictive Melanoma Antigen A3 (MAGE-A3) Gene Signature
Timepoint [2] 0 0
After 12, 22, 31 and 54 weeks of treatment.
Secondary outcome [3] 0 0
Number of Patients With Adverse Events (AEs) by Maximum Grade
Timepoint [3] 0 0
During the study treatment period (maximum duration = 49 months).
Secondary outcome [4] 0 0
Number of Patients With Adverse Events (AEs) That Are Causally Related to Treatment Administration by Maximum Grade
Timepoint [4] 0 0
During the study treatment period (maximum duration = 49 months).
Secondary outcome [5] 0 0
Number of Patients With Serious Adverse Events (SAEs) by Maximum Grade
Timepoint [5] 0 0
During the study treatment period (maximum duration = 49 months).
Secondary outcome [6] 0 0
Number of Patients With Serious Adverse Events (SAEs) That Are Causally Related to Treatment Administration by Maximum Grade
Timepoint [6] 0 0
During the study treatment period (maximum duration = 49 months).
Secondary outcome [7] 0 0
Time to Treatment Failure (TTF)
Timepoint [7] 0 0
From first treatment administration (i.e. at Week 0) until the last treatment administration (i.e. at Month 48)
Secondary outcome [8] 0 0
Progression-free Survival (PFS) Rate
Timepoint [8] 0 0
From first treatment administration (i.e. at Week 0) until the last tumor evaluation (i.e. at Month 49)
Secondary outcome [9] 0 0
Overall Survival (OS)
Timepoint [9] 0 0
From first treatment administration (i.e. at Week 0) until the last tumor evaluation (i.e. at Month 49)
Secondary outcome [10] 0 0
The Duration of Response for Patients With CR, PR or Stable Disease (SD) Status
Timepoint [10] 0 0
From first treatment administration (i.e. at Week 0) until the last tumor evaluation (i.e. at Month 49)
Secondary outcome [11] 0 0
Number of Patients With Progression-free Survival Events
Timepoint [11] 0 0
From first treatment administration (i.e. at Week 0) until the last tumor evaluation (i.e. at Month 49)
Secondary outcome [12] 0 0
Summary of Deaths Related to Progressive Disease of Cancer Under Study Reported After the Study Treatment, in the Period of Long-term Follow-up for Survival
Timepoint [12] 0 0
During the long-term Follow-Up period for progressive disease and survival [1 year after the study treatment end (at Month 49) or up to 5 years after the first study treatment administration, regardless of disease progression and study discontinuation.]
Secondary outcome [13] 0 0
Anti NY-ESO-1 Antibody Concentrations
Timepoint [13] 0 0
Before treatment (PRE), at 4 (W4), 8 (W8), 10 (W10), 12 (W12), 29 (W29), 51 (W51), 75 (W75), 99 (W99), 123 (W123) weeks of treatment and at the concluding visit, i.e. at Month 49 (POST)
Secondary outcome [14] 0 0
Humoral Response for Anti NY-ESO-1 Antibodies
Timepoint [14] 0 0
At 4 (W4), 8 (W8), 10 (W10), 12 (W12), 29 (W29), 51 (W51), 75 (W75), 99 (W99), 123 (W123) weeks of treatment and at the concluding visit, i.e. at Month 49 (POST)
Secondary outcome [15] 0 0
Cell Mediated Immune Response for Anti-NY-ESO-1 Antibodies (T-cell)
Timepoint [15] 0 0
Before treatment (PRE), at 4 (W4), 8 (W8), 10 (W10), 12 (W12), 29 (W29), 51 (W51), 75 (W75), 99 (W99), 123 (W123) weeks of treatment and at the concluding visit, i.e. at Month 49 (POST)

Eligibility
Key inclusion criteria
* Male or female patient with histologically proven, measurable metastatic cutaneous melanoma, and with documented progressive disease within the 12 weeks before the first administration of study treatment.
* Written informed consent for NY-ESO-1 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.
* Patient is >= 18 years of age at the time of signature of the informed consent.
* The patient's tumor shows expression of NY-ESO-1, as determined by real-time quantitative reverse transcription polymerase chain reaction (RT-PCR) analysis or any updated technique on fresh tissue sample(s).
* Eastern Cooperative Oncology Group performance status of 0 or 1.
* The patient has normal organ functions as shown by all of the following:

* Hemoglobin = 12 g/dL
* Absolute leukocytes count = 3.0 x 1000000000/L
* Absolute lymphocytes count = 1.0 x 1000000000/L
* Platelets = 100 x 1000000000/L
* Serum creatinine = Upper Limit of Normal (ULN)
* Serum total bilirubin = 1.5 x ULN (except for patients with Gilbert's syndrome for whom the limit is 2 x ULN)
* Lactate dehydrogenase = ULN
* Aspartate aminotransferase = 2 × ULN
* Alanine aminotransferase = 2 × ULN

These tests must be done no more than 3 weeks before the first ASCI administration.

* Female patients of non-childbearing potential may be enrolled in the study.
* Female patient of childbearing potential may be enrolled in the study, if the patient:

* has practiced adequate contraception for 30 days prior to first ASCI administration, and
* has a negative pregnancy test at the specified study visits, and
* has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the ASCI administration series.
* In the view of the investigator, the patient can and will comply with the requirements of this protocol.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* The patient has at any time received systemic chemotherapy, biochemotherapy, small molecules or nti-CTLA-4 monoclonal antibody for metastatic disease.
* The patient is scheduled to receive any other anticancer treatments than those specified in the protocol, including but not limited to (bio-) chemotherapeutic, immunomodulating agents and radiotherapy.
* The patient received any cancer immunotherapy containing a NY-ESO-1 antigen or any cancer immunotherapy for his/her metastatic disease.
* The patient requires concomitant treatment with systemic corticosteroids, or any other immunosuppressive agents.
* Use of any investigational or non-registered product other than the ASCI within 30 days preceding the first ASCI administration, or planned use during the study period.
* The patient has (had) previous or concomitant malignancies at other sites, 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 an autoimmune disease such as, but not limited to, multiple sclerosis, lupus, and inflammatory bowel disease. Patients with vitiligo are not excluded.
* The patient has a family history of congenital or hereditary immunodeficiency.
* The patient is known to be positive for the Human Immunodeficiency Virus.
* The patient has an uncontrolled bleeding disorder.
* The patient has a family history of congenital or hereditary immunodeficiency.
* The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the trial procedures.
* The patient has concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
* For female patients: the patient is pregnant or lactating.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Single group
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
31/01/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/04/2018
Sample size
Target
Accrual to date
Final
33
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
GSK Investigational Site - North Sydney
Recruitment hospital [2] 0 0
GSK Investigational Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
2060 - North Sydney
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
France
State/province [2] 0 0
Marseille Cedex 5
Country [3] 0 0
France
State/province [3] 0 0
Montpellier cedex 5
Country [4] 0 0
France
State/province [4] 0 0
Nantes Cedex 1
Country [5] 0 0
France
State/province [5] 0 0
Paris
Country [6] 0 0
Germany
State/province [6] 0 0
Baden-Wuerttemberg
Country [7] 0 0
Germany
State/province [7] 0 0
Niedersachsen
Country [8] 0 0
Germany
State/province [8] 0 0
Schleswig-Holstein
Country [9] 0 0
Italy
State/province [9] 0 0
Liguria
Country [10] 0 0
Italy
State/province [10] 0 0
Lombardia
Country [11] 0 0
Italy
State/province [11] 0 0
Toscana
Country [12] 0 0
Netherlands
State/province [12] 0 0
Amsterdam
Country [13] 0 0
Netherlands
State/province [13] 0 0
Maastricht
Country [14] 0 0
Netherlands
State/province [14] 0 0
Rotterdam
Country [15] 0 0
Switzerland
State/province [15] 0 0
Genève
Country [16] 0 0
Switzerland
State/province [16] 0 0
Zürich
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Chelmsford
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Leicester
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Southampton

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
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD for this study will be made available via the Clinical Study Data Request site.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
Available to whom?
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://clinicalstudydatarequest.com


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01213472