A Study of Safety and Clinical Activity of Immunotherapy Plus Chemotherapy in Metastatic Melanoma Patients

Melanoma Clinical Trial

Official title:

Study of GSK2132231A Antigen-Specific Cancer Immunotherapeutic in Association With Chemotherapy in Patients With Unresectable and Progressive Metastatic Cutaneous Melanoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00849875
• Other study ID #: 111714
• Status: Terminated
• Phase: Phase 2
• First received: February 2, 2009
• Last updated: September 24, 2015
• Start date: May 2009
• Est. completion date: November 2014

Study information

• Verified date: March 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Agence Fédérale des Médicaments et des Produits de la SantéFrance: Agence Française de Sécurité Sanitaire des Produits de Santé
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical trial is to find out how successfully, patients with progressive metastatic cutaneous melanoma, are able to develop an immune response to injections with the immunotherapeutic product GSK1572932A when given in combination with dacarbazine and evaluate the safety of this combination.

Description:

This Protocol Posting has been updated following amendment 3, dated 16 October 2009. The sections impacted are :

• Enrollment, number of subjects

• Outcome measures

• Exclusion criteria

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female patient with histologically proven, measurable metastatic cutaneous melanoma

2. Written informed consent has been obtained from the patient before the performance of any protocol-specific procedure.

3. Patient is >= 18 years of age at the time of signature of the Informed Consent.

4. The patient's tumor shows expression of MAGE-A3 antigen, detected by Reverse-Transcription Polymerase Chain Reaction (RT-PCR).

5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

6. The patient has normal organ functions.

7. 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 all the study treatment period and for 2 months after completion of the treatment administration series.

8. In the view of the investigator, the patient can and will comply with the requirements of the protocol.

Exclusion Criteria:

1. The patient has at any time received systemic (bio)-chemotherapy.

2. The patient is scheduled to receive any other anticancer treatments than those specified in the protocol, including but not limited to (bio)-chemotherapy, immunomodulating agents and radiotherapy.

3. The patient requires concomitant treatment with systemic corticosteroids, or any other immunosuppressive agents.

4. The patient received any cancer immunotherapeutic containing a MAGE-A3 antigen or any cancer immunotherapeutic for his/her metastatic disease.

5. The patient has received any investigational or non-registered drug or vaccine other than the study medication within the 30 days preceding the first dose of study treatment, or plans to receive such a drug during the study period.

6. 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.

7. History of allergic disease or reactions likely to be exacerbated by any component of the study investigational product.

8. 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.

9. The patient has a family history of congenital or hereditary immunodeficiency.

10. The patient is known to be positive for the Human Immunodeficiency Virus (HIV).

11. The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the trial procedures.

12. 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.

13. For female patients: the patient is pregnant or lactating.

14. The patient has an uncontrolled bleeding disorder.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma

Intervention

Biological:
• Immunotherapeutic GSK2132231A
Intramuscular administration

Drug:
• Dacarbazine
Intravenous administration Chemotherapy

Locations

Country	Name	City	State
Belgium	GSK Investigational Site	Brussel
Belgium	GSK Investigational Site	Brussels
Belgium	GSK Investigational Site	Bruxelles
Belgium	GSK Investigational Site	Liège
Belgium	GSK Investigational Site	Roeselare
Belgium	GSK Investigational Site	Yvoir
France	GSK Investigational Site	Caen
France	GSK Investigational Site	Lille
France	GSK Investigational Site	Marseille Cedex 5
France	GSK Investigational Site	Nantes
France	GSK Investigational Site	Paris
France	GSK Investigational Site	Paris Cedex 10
France	GSK Investigational Site	Reims
France	GSK Investigational Site	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The occurrence of treatment related adverse events of Grade 3 or 4		After the concluding visit of the last patient	No
Primary	Occurrence of serious adverse events (SAEs)		After the concluding visit/contact of the last patient	No
Primary	Evaluation of immunogenicity		At regular intervals during the treatment period (9 assessments per patient) and after the concluding visit of the last patient	No
Secondary	The rate of objective response (complete and partial)		After the concluding visit of the last patient	No
Secondary	The rate of stable disease		After the concluding visit/contact of the last patient	No
Secondary	The rate of mixed response		After the concluding visit/contact of the last patient	No
Secondary	Time to study treatment failure		After the concluding visit/contact of the last patient	No
Secondary	Progression free survival time		After the concluding visit/contact of the last patient	No
Secondary	Progression free survival time after initial Slow Progressive Disease		After the concluding visit/contact of the last patient	No
Secondary	Occurrence of any adverse events (including abnormal laboratory values for haematology and biochemistry)		After the concluding visit of the last patient	No
Secondary	Overall survival		After the concluding visit / contact of the last patient	No