Pilot Phase II, Open Label, Multicenter, Efficacy and Safety Study of 852A Administered Intravenously to Subjects with Unresectable Metastatic Cutaneous Melanoma - 852A-IV-NA-LI-04-MC-M

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-003910-41-DE

Enrollment

Registered

2005-02-25

Start date

2005-04-28

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Unresectable metastatic cutaneous melanoma Stage III (local and regional metastasis) and Stage IV

Interventions

Product Name: 852A injectable solution Pharmaceutical Form: Solution for injection Current Sponsor code: 852A Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Most important inclusion criteria: Subjects have: -histological evidence of melanoma -advanced melanoma not responding to a first line of chemotherapy -Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 -a life expectancy of greater than or equal to 6 months Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Most important exclusion criteria: Subjects are excluded who have: - had prior immunotherapy for stage IV melanoma (including but not limited to: Interferons, IL-2, TNF alpha and melanoma vaccines) within 6 weeks of the first dose of 852A - stage IV disease which has previously progressed during treatment with interferon alone or combined interferon and monochemotherapy -brain metastases with the exception of brain metastases completely excised or successfully controlled with stereotactic radiosurgery

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the antitumor activity of 852A intravenous bolus injection administered 3x/week for 12 weeks.;Secondary Objective: · To assess the safety of the dosage regimen over 12 weeks · To obtain preliminary data regarding the safety and long term efficacy of 852A in subjects treated with the drug for more than 12 weeks · To explore immunological signs of TLR7 activation;Primary end point(s): Overall tumor response based on assessments of target and nontarget lesions according to the RECIST criteria described in section 6.2.1 of the protocol.	—

Measure

Time frame

Main Objective: To assess the antitumor activity of 852A intravenous bolus injection administered 3x/week for 12 weeks.;Secondary Objective: · To assess the safety of the dosage regimen over 12 weeks · To obtain preliminary data regarding the safety and long term efficacy of 852A in subjects treated with the drug for more than 12 weeks · To explore immunological signs of TLR7 activation;Primary end point(s): Overall tumor response based on assessments of target and nontarget lesions according to the RECIST criteria described in section 6.2.1 of the protocol.

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Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026