Evaluation of a New Anti-cancer Immunotherapy in Patients With Non-operable and Progressing Metastatic Cutaneous Melanoma

NCT ID: NCT01213472

Last Updated: 2019-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2018-04-17

Brief Summary

The purpose of this study is to investigate the safety, immunogenicity and clinical activity of GSK2241658A antigen-specific cancer immunotherapeutic (ASCI) for the treatment of patients with non-operable and progressing metastatic cutaneous melanoma.

Detailed Description

In this study, patients were to receive a maximum of 24 doses of recNY-ESO-1 + AS15 ASCI according four cycles over a period of four years. An active follow-phase (up to five years after registration into the study) was planned for all patients.

As of Amendment 3, there will no longer be an active follow-up of patients after discontinuation or completion of the treatment. The study will end 30 days after the last dose will be administered.

In addition, no more biological samples will be collected for protocol research purposes. For each biological sample already collected in the scope of this study and not tested yet, testing will not be performed by default, except if a scientific rationale remains relevant.

Blood sampling for safety monitoring as per protocol will continue.

Conditions

Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

GSK Biologicals' 2241658A Antigen-Specific Cancer Immunotherapeutic (ASCI)

Intervention Type: BIOLOGICAL

Up to 24 intramuscular administrations

Interventions

GSK Biologicals' 2241658A Antigen-Specific Cancer Immunotherapeutic (ASCI)

Up to 24 intramuscular administrations

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

North Sydney, New South Wales, Australia

GSK Investigational Site

Woolloongabba, Queensland, Australia

GSK Investigational Site

Graz, , Austria

GSK Investigational Site

Marseille, , France

GSK Investigational Site

Montpellier, , France

GSK Investigational Site

Nantes, , France

GSK Investigational Site

Paris, , France

GSK Investigational Site

Freiburg im Breisgau, Baden-Wurttemberg, Germany

GSK Investigational Site

Heidelberg, Baden-Wurttemberg, Germany

GSK Investigational Site

Hanover, Lower Saxony, Germany

GSK Investigational Site

Lübeck, Schleswig-Holstein, Germany

GSK Investigational Site

Genoa, Liguria, Italy

GSK Investigational Site

Milan, Lombardy, Italy

GSK Investigational Site

Milan, Lombardy, Italy

GSK Investigational Site

Milan, Lombardy, Italy

GSK Investigational Site

Siena, Tuscany, Italy

GSK Investigational Site

Amsterdam, , Netherlands

GSK Investigational Site

Maastricht, , Netherlands

GSK Investigational Site

Rotterdam, , Netherlands

GSK Investigational Site

Geneva, , Switzerland

GSK Investigational Site

Zurich, , Switzerland

GSK Investigational Site

Chelmsford, , United Kingdom

GSK Investigational Site

Leicester, , United Kingdom

GSK Investigational Site

Southampton, , United Kingdom

Countries

Australia; Austria; France; Germany; Italy; Netherlands; Switzerland; United Kingdom

References

American Joint Committee on Cancer. 2002. Cancer staging manual. Sixth edition. Springer editions.

Reference Type: BACKGROUND

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2010-020663-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

112406

Identifier Type: -

Identifier Source: org_study_id