Phase I Endovenous Administration of Oncolytic Adenovirus ICOVIR-5 in Patients With Advanced or Metastatic Melanoma

Phase I Clinical Trial of Endovenous Administration of Conditionally Replicative Adenovirus ICOVIR-5 in Patients With Locally Advanced or Metastatic Melanoma

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01864759

Enrollment

Registered

2013-05-30

Start date

2013-01-11

Completion date

2017-04-26

Last updated

2017-08-29

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

Conditions

Locally Advanced or Metastatic Melanoma

Keywords

melanoma, oncolytic, adenovirus, virotherapy, locally advanced, metastatic

Brief summary

The investigators will evaluate the safety of a single endovenous infusion of ICOVIR5 in adults with locally advanced and metastatic melanoma. ICOVIR5 consists in a conditionally replicative or oncolytic adenovirus.

Interventions

BIOLOGICALICOVIR-5

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Malignant melanoma advanced or metastatic. * Other than 18 years * Karnofsky index \> 60 % * Life expectancy \> 3 months * ALT/AST \<=2.5 times the upper normal limit * Creatinine clearance \>= 50 ml/min. * Bilirubin \<25 umol/l * Alkaline phosphatase \<= 2.5 time upper normal limit * Normal bone marrow function: Neutrophils \>=1.5 E9/L, platelets \>= 1E11/L, hemoglobin \>= 100 g/l, Normal prothrombin time and thromboplastin time, * HIV negative * Measurable disease * Signed informed consent.

Exclusion criteria

* Geographical, social or psychological conditions that may impair the protocol compliance. * Active infections or other severe medical status. * History of liver disease. * Other or concomitant treatments for melanoma or investigational product. * Previous participation in studies with adenovirus. * Virus diseases diagnosed two weeks before inclusion. * Immunosuppressive concomitant treatments * Concomitant malignant haematological disease. * Patients having family members with immunodeficient status or disease * Patients with Li Fraumeni syndrome or germinal retinoblastoma gene defects.

Design outcomes

Primary

Measure	Time frame	Description
Maximum tolerated dose	4 weeks	The highest dose where less than two out of three or six patients suffered dose limiting toxicity.

Secondary

Measure	Time frame
Recommended dose	4 weeks
Anti-tumour activity	4 weeks

Other

Measure	Time frame	Description
Viral pharmacokinetics	1 day	Viremia at 0 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours and 24 hours after endovenous injection.
Viral pharmacodynamics	5 days	Virus presence in tumors at day 5 post-administration.

Countries

Spain

Outcome results

None listed

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