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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01213472
First received: October 1, 2010
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

This study is investigating 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.


Condition Intervention Phase
Melanoma
Biological: GSK Biologicals' 2241658A Antigen-Specific Cancer Immunotherapeutic (ASCI)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of GSK2241658A Antigen-Specific Cancer Immunotherapeutic in Patients With Unresectable and Progressive Metastatic Cutaneous Melanoma

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of severe toxicities. [ Time Frame: On continuous basis during the study treatment period (49 months) and active follow-up period (one year). ] [ Designated as safety issue: No ]
  • The induction of objective clinical response (Complete Response (CR) or Partial Response (PR)) in the overall population. Week 12 [ Time Frame: After 12 weeks of treatment. ] [ Designated as safety issue: No ]
  • The induction of objective clinical response (Complete Response (CR) or Partial Response (PR)) in the overall population. Week 22 [ Time Frame: After 22 weeks of treatment. ] [ Designated as safety issue: No ]
  • The induction of objective clinical response (Complete Response (CR) or Partial Response (PR)) in the overall population. Week 31 [ Time Frame: After 31 weeks of treatment. ] [ Designated as safety issue: No ]
  • The induction of objective clinical response (Complete Response (CR) or Partial Response (PR)) in the overall population. Week 54 [ Time Frame: After 54 weeks of treatment. ] [ Designated as safety issue: No ]
  • The induction of objective clinical response (Complete Response (CR) or Partial Response (PR)) in the overall population. 1 Year 6 Months [ Time Frame: After 1 year and six months of treatment. ] [ Designated as safety issue: No ]
  • The induction of objective clinical response (Complete Response (CR) or Partial Response (PR)) in the overall population. 2 Years [ Time Frame: After 2 years of treatment. ] [ Designated as safety issue: No ]
  • The induction of objective clinical response (Complete Response (CR) or Partial Response (PR)) in the overall population. 2 Years 6 Months [ Time Frame: After 2 years and six months of treatment. ] [ Designated as safety issue: No ]
  • The induction of objective clinical response (Complete Response (CR) or Partial Response (PR)) in the overall population. 3 Years [ Time Frame: After 3 years of treatment. ] [ Designated as safety issue: No ]
  • The induction of objective clinical response (Complete Response (CR) or Partial Response (PR)) in the overall population. 3 Years 6 Months [ Time Frame: After 3 years and six months of treatment. ] [ Designated as safety issue: No ]
  • The induction of objective clinical response (Complete Response (CR) or Partial Response (PR)) in the overall population. 4 Years 1 Month [ Time Frame: After 4 years and 1 month of treatment. ] [ Designated as safety issue: No ]
  • The induction of objective clinical response (Complete Response (CR) or Partial Response (PR)) in the overall population. 4 Years 7 Months [ Time Frame: After 4 years and 7 months of treatment. ] [ Designated as safety issue: No ]
  • The induction of objective clinical response (Complete Response (CR) or Partial Response (PR)) in the overall population. 5 Years 1 Month [ Time Frame: After 5 years and 1 months of treatment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of objective clinical response (CR or PR) in the population of patients who present the predictive Melanoma Antigen A3 (MAGE-A3) gene signature. [ Time Frame: After 12, 22, 31 and 54 weeks of treatment and subsequently after 1 year and six months, 2 years, 2 years and six months, 3 years, 3 years and six months, 4 years and one month, 4 years and 7 months, and 5 years and 1 month. ] [ Designated as safety issue: No ]
  • Occurrence of adverse events (AEs) and serious adverse events (SAEs). [ Time Frame: On continuous basis during the study treatment period and ending 30 days after the last study treatment administration (49 months). ] [ Designated as safety issue: No ]
  • Immunogenicity of the NY-ESO-1 ASCI treatment. [ Time Frame: At start of treatment, after 4, 8, 10, 12, 30 and 52 weeks of treatment and after 1 year and six months, 2 yrs, 2 yrs and six months, 3 yrs, 3 yrs and six months, 4 yrs and one month, 4 yrs and four months, 4 yrs and 7 months, and 5 yrs and 1 month. ] [ Designated as safety issue: No ]
  • In the overall population and in the population of patients presenting the predictive MAGE-A3 gene signature: Occurrence of stable disease (SD). [ Time Frame: Throughout the study treatment period (49 months) and follow-up period. ] [ Designated as safety issue: No ]
  • In the overall population and in the population of patients presenting the predictive MAGE-A3 gene signature: Occurrence of mixed response (MR). [ Time Frame: Throughout the study treatment period (49 months) and follow-up period. ] [ Designated as safety issue: No ]
  • In the overall population and in the population of patients presenting the predictive MAGE-A3 gene signature: Time to Treatment Failure (TTF). [ Time Frame: Throughout the study treatment period (49 months) and follow-up period. ] [ Designated as safety issue: No ]
  • In the overall population and in the population of patients presenting the predictive MAGE-A3 gene signature: Progression-free survival (PFS). [ Time Frame: Throughout the study treatment period (49 months) and follow-up period. ] [ Designated as safety issue: No ]
  • In the overall population and in the population of patients presenting the predictive MAGE-A3 gene signature: Overall survival (OS). [ Time Frame: Throughout the study treatment period (49 months) and follow-up period. ] [ Designated as safety issue: No ]
  • In the overall population and in the population of patients presenting the predictive MAGE-A3 gene signature: The duration of response for patients with CR, PR or Stable Disease (SD) status. [ Time Frame: Throughout the study treatment period (49 months) and follow-up period. ] [ Designated as safety issue: No ]

Estimated Enrollment: 34
Study Start Date: January 2011
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NY-ESO 1 Group
Patients will receive up to 24 doses of GSK2241658A Cancer Immunotherapeutic
Biological: GSK Biologicals' 2241658A Antigen-Specific Cancer Immunotherapeutic (ASCI)
Up to 24 intramuscular administrations

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01213472

  Hide Study Locations
Locations
United States, Florida
GSK Investigational Site
Tampa, Florida, United States, 33612
United States, Michigan
GSK Investigational Site
Detroit, Michigan, United States, 48202
GSK Investigational Site
Grand Rapids, Michigan, United States, 49503
United States, New York
GSK Investigational Site
New York, New York, United States, 10016
United States, Oregon
GSK Investigational Site
Portland, Oregon, United States, 97213
United States, Texas
GSK Investigational Site
Dallas, Texas, United States, 75230
Australia, New South Wales
GSK Investigational Site
North Sydney, New South Wales, Australia, 2060
Australia, Queensland
GSK Investigational Site
Woolloongabba, Queensland, Australia, 4102
Australia, Victoria
GSK Investigational Site
Heidelberg, Victoria, Australia, 3084
Austria
GSK Investigational Site
Graz, Austria, A-8036
France
GSK Investigational Site
Marseille Cedex 5, France, 13385
GSK Investigational Site
Montpellier cedex 5, France, 34295
GSK Investigational Site
Nantes Cedex 1, France, 44093
GSK Investigational Site
Paris, France, 75006
Germany
GSK Investigational Site
Freiburg, Baden-Wuerttemberg, Germany, 79104
GSK Investigational Site
Heidelberg, Baden-Wuerttemberg, Germany, 69120
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68167
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45122
GSK Investigational Site
Luebeck, Schleswig-Holstein, Germany, 23538
GSK Investigational Site
Gera, Thueringen, Germany, 07548
Italy
GSK Investigational Site
Modena, Emilia-Romagna, Italy, 41124
GSK Investigational Site
Genova, Liguria, Italy, 16132
GSK Investigational Site
Milano, Lombardia, Italy, 20133
GSK Investigational Site
Milano, Lombardia, Italy, 20141
GSK Investigational Site
Milano, Lombardia, Italy, 20132
GSK Investigational Site
Siena, Toscana, Italy, 53100
Netherlands
GSK Investigational Site
Amsterdam, Netherlands, 1081 HV
GSK Investigational Site
Maastricht, Netherlands, 6229 HX
GSK Investigational Site
Rotterdam, Netherlands, 3075 EA
Switzerland
GSK Investigational Site
Genève, Switzerland, 1211
GSK Investigational Site
Zürich, Switzerland, 8091
United Kingdom
GSK Investigational Site
Chelmsford, United Kingdom, CM1 7ET
GSK Investigational Site
Leicester, United Kingdom, LE1 5WW
GSK Investigational Site
London, United Kingdom, SE1 9RT
GSK Investigational Site
London, United Kingdom, SW17 0RE
GSK Investigational Site
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01213472     History of Changes
Other Study ID Numbers: 112406, 2010-020663-20
Study First Received: October 1, 2010
Last Updated: July 24, 2014
Health Authority: Netherlands: Minister van VWS Medische Technologie
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Canada: Therapeutic Products Directorate Health Products and Food Branch
Switerland: Swissmedic Schweizerisches Heilmittelinstitut
Australia: Therapeutic Goods Administration
Italy: Segreteria Commissione per l'ammissibilità alla sperimentazione clinica di Fase I Istituto Superiore di Sanità

Keywords provided by GlaxoSmithKline:
ASCI
melanoma
tumor antigen
unresectable
progressive
NY-ESO-1
adult
cancer-testis antigen
Immunotherapy

Additional relevant MeSH terms:
Melanoma
Skin Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on July 29, 2014