CompletedPhase 2

Study of GSK2132231A Antigen-Specific Cancer Immunotherapeutic in Patients With Inoperable Metastatic Cutaneous Melanoma

Belgium, France24 participantsStarted 2009-05-19

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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:
✓. 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.

Exclusion criteria

What they're measuring

Number of Patients With Objective Tumor Response (OR) to GSK2132231A Study Treatment

Timeframe: From Pre-treatment (up to 4 weeks before first treatment) to study end (Year 4), each patient being censored out of the analysis at 1st report of disease progression in assessed lesions

Number of Patients With Mixed Response (MR) to GSK2132231A

Timeframe: From Pre-treatment (up to 4 weeks before first treatment) to study end (Year 4), each patient being censored out of the analysis at 1st report of disease progression in assessed lesions

Time to Treatment Failure (TTF), by Gene Signature

Timeframe: From Pre-treatment (up to 4 weeks before first treatment) to study end (Year 4), each patient being censored out of the analysis at 1st report of disease progression or death

Anti-MAGE-A3 Antibody Concentrations

Timeframe: From Pre-treatment (up to 4 weeks before first treatment) to Concluding visit (CCL: at Week 196 + 30 to 37 days for patients completing the treatment, 1 month after the last Dose administered for patients withdrawn from study treatment before completion)

Number of Seroconverted Patients for Anti-MAGE-A3

Trial details

NCT IDNCT00896480

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-11-03

Results submitted2017-09-28

View on ClinicalTrials.gov More Melanoma trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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:
✓. 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.

Exclusion criteria

What they're measuring

Number of Patients With Objective Tumor Response (OR) to GSK2132231A Study Treatment

Timeframe: From Pre-treatment (up to 4 weeks before first treatment) to study end (Year 4), each patient being censored out of the analysis at 1st report of disease progression in assessed lesions

Number of Patients With Mixed Response (MR) to GSK2132231A

Timeframe: From Pre-treatment (up to 4 weeks before first treatment) to study end (Year 4), each patient being censored out of the analysis at 1st report of disease progression in assessed lesions

Time to Treatment Failure (TTF), by Gene Signature

Timeframe: From Pre-treatment (up to 4 weeks before first treatment) to study end (Year 4), each patient being censored out of the analysis at 1st report of disease progression or death

Anti-MAGE-A3 Antibody Concentrations

Number of Seroconverted Patients for Anti-MAGE-A3