An Extension Protocol to Evaluate the Efficacy and Safety of Extended Use Treatment with OncoVEX GM-CSF or GM-CSF for Eligible Melanoma Patients Participating in Study 005/05

Phase 1

• Conditions: nresectable Stage IIIb, IIIc and IV Melanoma

• Registration Number: EUCTR2010-021070-11-GB
• Lead Sponsor: BioVex Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-08-17
• Study Completion: 2014-08-08
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 31

Inclusion Criteria

1. Previously participated in protocol 005/05 and:
a. received the maximum number of OncoVEXGM-CSF treatment injections or cycles of GM-CSF allowable for that patient on study 005/05, or
b. new lesion(s) appeared after 12 months from randomization after previous resolution of all disease while on study 005/05. New injectable lesions must have appeared within = 12 months from the End of Treatment visit on the 005/05 study.
2. In the opinion of the investigator further treatment is warranted (e.g., those patients who do not have PDr).
3. Performance status (ECOG) 0 or 1.
4. For patients randomized to OncoVEXGM-CSF only: Injectable disease (i.e. suitable for direct injection or through the use of ultrasound guidance) defined as at least 1 injectable cutaneous, subcutaneous or nodal melanoma lesion. There is no minimum size for injection.
5. Must not have received additional anti-tumor therapies for melanoma after end of treatment on Study 005/05 and prior to enrollment into Study 005/05E. Note: Patients who received radiation therapy for palliation or underwent surgical resection of melanoma tumor since end of treatment on Study 005/05 will not be excluded.
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

Patients will be excluded if they have:
1.Prior CTCAE grade 3 or 4 toxicity related to 005/05 study treatment of any organ system (with the exception of injection site reactions, fever and vomiting).
2.History of Grade 3 fatigue lasting > 1 week while on 005/05 study treatment.
3.History of Grade 3 arthralgia/myalgias while on 005/05 study treatment.
4.History of = Grade 2 autoimmune reactions, allergic reactions or urticaria or other treatment-related non-hematological toxicities while on study treatment that required a dose delay or discontinuation of therapy.
5.PDr while participating in study 005/05
6.Patient requested to be withdrawn from study 005/05 or was unable to comply with the demands of the 005/05 trial.
7.At the discretion of the investigator, patient was withdrawn from the 005/05 trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified