Phase 2
N=24
Study of GSK2132231A Antigen-Specific Cancer Immunotherapeutic in Patients With Inoperable Metastatic Cutaneous Melanoma
Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT00896480 ↗Enrolled (actual)
24
Serious AEs
8.3%
Results posted
Sep 2019
Primary outcome: Primary: Number of Patients With Objective Tumor Response (OR) to GSK2132231A Study Treatment — 2; 0; 0; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Immunotherapeutic GSK2132231A (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Objective Tumor Response (OR) to GSK2132231A Study Treatment |
2; 0; 0; 1; 1; 0 | — |
| PRIMARY Number of Patients With Mixed Response (MR) to GSK2132231A |
2; 0; 0; 1; 1; 0 | — |
| PRIMARY Time to Treatment Failure (TTF), by Gene Signature |
14.8; 2.3; 2.4 | — |
| PRIMARY Anti-MAGE-A3 Antibody Concentrations |
13.9; 15.3; 13.8; 13.9; 16.8; 14.2 | — |
| PRIMARY Number of Seroconverted Patients for Anti-MAGE-A3 |
1; 1; 1; 1; 1; 1 | — |
| PRIMARY Number of Patients With Treatment Response for Anti-MAGE-A3 Antibodies |
0; 0; 0; 0; 1; 0 | — |
| PRIMARY Geometric Mean Titers of Anti-MAGE-A3 Specific CD4+ and CD8+ T-cells Concentrations After Immunization |
1.05; 1.01; 3.36; 1; 5.35; 1 | — |
| PRIMARY Number of Patients With CD4+ and CD8+ T Cell Frequency ≥ 1.24 Cut-off |
1; 1; 15; 0; 11; 0 | — |
| PRIMARY Number of Patients With a Cellular Response (Anti-MAGE-A3 Specific CD4+ and CD8+ T-cells Concentrations After Immunization) |
5; 0; 8; 0; 4; 0 | — |
| PRIMARY Number of Patients Reported With Antigen Specific Cancer Immunotherapeutics (ASCI)-Related grade3/4 Adverse Events (AEs) According to the Common Terminology Criteria (CTCAE) Version 3.0. |
0; 0 | — |
| PRIMARY Number of Patients Reported With Serious Adverse Events (SAEs) |
2 | — |
| PRIMARY Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade |
20; 3; 0; 1; 0; 0 | — |
| PRIMARY Number of Patients With Abnormal Aspartate Aminotransferase (AST) Values by Maximum Grade |
19; 5; 0; 0; 0; 0 | — |
| PRIMARY Number of Patients With Abnormal Alkaline Phosphatase (ALK) Values by Maximum Grade |
0; 0; 0; 0; 0; 1 | — |
| PRIMARY Number of Patients With Abnormal Bilirubine (BIL) Values by Maximum Grade |
24; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade |
20; 2; 0; 0; 0; 1 | — |
| PRIMARY Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade |
0; 1; 0; 0; 0; 0 | — |
| PRIMARY Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade |
14; 9; 0; 0; 0; 0 | — |
| PRIMARY Number of Patients With Abnormal Hypercalcemia (HCA) Values by Maximum Grade |
3; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade |
2; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Patients With Abnormal Hypernatremia (HNA) Values by Maximum Grade |
2; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Patients With Abnormal Hypoalbuminemia (hAL) Values by Maximum Grade |
1; 1; 0; 0; 0; 0 | — |
| PRIMARY Number of Patients With Abnormal Hypocalcemia (hCA) Values by Maximum Grade |
3; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Patients With Abnormal Hypokalemia (hKA) Values by Maximum Grade |
2; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Patients With Abnormal Hyponatremia (hNA) Values by Maximum Grade |
2; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade |
21; 2; 0; 0; 0; 0 | — |
| PRIMARY Number of Patients With Abnormal Lymphopenia (LYM) Values by Maximum Grade |
17; 0; 3; 0; 0; 0 | — |
| PRIMARY Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade |
21; 2; 1; 0; 0; 0 | — |
| PRIMARY Number of Patients With Abnormal Platelets (PLT) Values by Maximum Grade |
24; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade |
24; 6; 15; 3; 0; 0 | — |
| PRIMARY Number of Patients With Any AE(s) and With AEs by Maximum Grade, Related to Treatment Administration |
23; 11; 12; 0; 0; 0 | — |
| PRIMARY Number of Patients With Any Serious Adverse Events (SAEs) and With SAEs by Maximum Grade |
2; 0; 1; 1; 0; 0 | — |
| PRIMARY Number of Patients With Any Serious Adverse Events (SAEs) and With SAEs by Maximum Grade, Related to Treatment Administration |
0; 0; 0; 0; 0; 0 | — |
Summary
The clinical objective of this clinical trial is to examine the clinical activity in terms of tumor response and time to treatment failure of the immunotherapeutic product GSK2132231A when given to patients with unresectable and progressive metastatic cutaneous melanoma. The safety of the treatment will also be assessed just as its immunogenicity in terms of the humoral and cellular immune response induced by the GSK2132231A immunotherapeutic. Translational research objectives are to assess the effects of the study treatment in terms of various biological variables.
Eligibility Criteria
Inclusion Criteria
- The patient (male or female) has histologically proven, measurable metastatic cutaneous melanoma in one of the following stages according to the American Joint Committee on Cancer classification of 2002:
- Stage III in transit, or
- Stage III unresectable, or
- Stage IV M1a.
- There has been documented progression of the patient's disease within the 12 weeks before the first administration of study treatment.
- The patient presents at screening with at least 3 tumor lesions of diameter >= 0.5 mm.
- Written informed consent has been obtained from the patient before the performance of any protocol-specific procedure.
- The patient is >= 18 years of age at the time of signature of informed consent.
- The patient's tumor shows expression of MAGE-A3 gene in at least one of the two tumor biopsies performed at baseline.
- The patient's ECOG performance status is 0 or 1.
- The patient has normal organ functions, as assessed by standard laboratory criteria.
- If the patient is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to administration of study treatment, have a negative pregnancy test and continue such precautions during the entire study treatment period and for 2 months after completion of the treatment injection series.
- In the view of the investigator, the patient can and will comply with the requirements of the protocol.
Exclusion Criteria
- The patient has at any time received systemic (bio)-chemotherapy
- The patient is scheduled to receive any anti-cancer specific treatment, including radiotherapy, immunotherapy, chemotherapy and immunomodulating agents.
- The patient requires concomitant treatment with systemic corticosteroids, or any other immunosuppressive agents.
- The patient has received any cancer immunotherapeutic containing a MAGE A3 antigen or any cancer immunotherapeutic for his/her metastatic disease.
- Use of any investigational or non-registered product (drug or vaccine) other than the study treatment within the 30 days preceding the first dose of study treatment, or planned use during the study period.
- The patient has (or has had) previous or concomitant malignancies at other sites, except effectively treated malignancy that is considered by the investigator highly likely to have been cured.
- History of allergic disease or reactions likely to be exacerbated by any component of the study investigational product.
- The patient has an autoimmune disease such as, but not limited to, neuroinflammatory autoimmune diseases, systemic lupus erythematosus, and inflammatory bowel disease
- The patient has a family history of congenital or hereditary immunodeficiency.
- The patient is known to be positive for the human immunodeficiency virus (HIV).
- The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the study 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.
Data sourced from ClinicalTrials.gov (NCT00896480). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.