CPG 7909 Injection in Melanoma

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00070642

Enrollment

184

Registered

2003-10-08

Start date

2003-12-31

Completion date

2005-12-31

Last updated

2009-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Melanoma

Keywords

Immunotherapy, skin cancer

Brief summary

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

Interventions

DRUGCPG 7909 Injection

CPG 7909 Injection administered subcutaneously at a dose of 40 mg weekly.

DRUGdacarbazine

dacarbazine 850mg/m2 in three-week cycles until disease progression

DRUGChemotherapy

Chemotherapy in three-week cycles until disease progression: dacarbazine 850mg/m2

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	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

Measure	Time frame
Determine the duration of response.	indeterminate
Determine the time to progression	indeterminate
Phase III: Assess the overall response rate	indeterminate
Describe the tolerability of CPG 7909 Injection alone, CPG 7909 Injection in combination with DTIC vs. DTIC alone	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
Asses the degree of clinical benefit defined as the proportion of patients experiencing complete and partial responses as well as stable disease.	indeterminate

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026