CPG 7909 Injection in Melanoma

Study Overview
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Brief Summary
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To determine the safety, tolerability and effects of CPG 7909 (the study drug) when given with chemotherapy to patients with melanoma.

Official Title
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ProMune™ (CPG 7909 Injection) With or Without Chemotherapy for the Treatment of Stage III b/c or IV Melanoma: A Randomized, Multi-Center, Open Label, Parallel Group, Active-Controlled, Phase II/III Study

Conditions
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Carcinoma, Melanoma

Intervention / Treatment
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* Drug: CPG 7909 Injection
* Drug: dacarbazine
* Drug: Chemotherapy
* Drug: CPG 7909 Injection
* Drug: CPG 7909 Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed melanoma that is metastatic. Measurable disease according to the RECIST criteria. Karnofsky Performance Status of > 70. Exclusion Criteria: Prior treatment with anti-neoplastic biologic or chemotherapy for recurrent or metastatic disease (except one course of adjuvant immunotherapy and/or adjuvant chemotherapy other than DTIC). Suspected or known CNS metastases.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPG 7909 Injection plus chemotherapy<br>CPG 7909 Injection plus DTIC | Drug: CPG 7909 Injection<br>* CPG 7909 Injection administered subcutaneously at a dose of 40 mg weekly.<br>* Other names: ProMune, PF-3512676;Drug: dacarbazine<br>* dacarbazine 850mg/m2 in three-week cycles until disease progression<br>* Other names: DTIC;|
| Active Comparator: Chemotherapy alone<br>dacarbazine | Drug: Chemotherapy<br>* Chemotherapy in three-week cycles until disease progression: dacarbazine 850mg/m2<br>* Other names: DTIC;|
| Experimental: CPG 7909 Injection 10 mg<br> | Drug: CPG 7909 Injection<br>* CPG 7909 Injection administered subcutaneously at a dose of 10 mg weekly.<br>* Other names: ProMune, PF-03512676;|
| Experimental: CPG 7909 Injection 40 mg<br> | Drug: CPG 7909 Injection<br>* CPG 7909 Injection administered subcutaneously at a dose of 40 mg weekly.<br>* Other names: ProMune, PF-03512676;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase II: Assess the anti-neoplastic activity, as determined by overall response rate (complete plus partial responses) according to the RECIST criteria. |  | indeterminate | 
| Phase III: Evaluate and compare the survival time of the two treatment groups, as selected in Phase II. |  | Indeterminate | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase III: Assess the overall response rate |  | indeterminate | 
| Asses the degree of clinical benefit defined as the proportion of patients experiencing complete and partial responses as well as stable disease. |  | indeterminate | 
| Determine the duration of response. |  | indeterminate | 
| Determine the time to progression |  | indeterminate | 
| Assess the pharmacokinetic profile and immunopharmacodynamic response to CPG 7909 Injection alone or in combination with DTIC, or DTIC alone (immunopharmacodynamic response only). |  | indeterminate | 
| Describe the tolerability of CPG 7909 Injection alone, CPG 7909 Injection in combination with DTIC vs. DTIC alone |  | indeterminate | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunotherapy, skin cancer