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A Phase I/IIa, Open-Label Bridging Safety and Pharmacodynamic Study of a New Formulation of 6 Month Extended Dosing With AGI - 101H Vaccine in the Treatment of Patients With Advanced Melanoma

Phase 1/Phase 2
18 Years
75 Years
Open (Enrolling)

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Trial Information

A Phase I/IIa, Open-Label Bridging Safety and Pharmacodynamic Study of a New Formulation of 6 Month Extended Dosing With AGI - 101H Vaccine in the Treatment of Patients With Advanced Melanoma

Total number of patients: 20 evaluable patients will be enrolled in the study.

Dosage: 5 x 107 live cells. No dose modification is planned.

Administration: Subcutaneous (s.c.)

Duration of treatment: Patients will receive treatment for up to 26 weeks. Progression at
any time point requiring systemic treatment with, for example with chemotherapy or cytokines
will lead to withdrawal of this patient from the study. All surviving patients of this
AGITAM trial will be offered the opportunity to transfer to a follow-up treatment protocol
with AGI - 101H. In this case treatment may continue every 4 - 8 weeks until progression or
death or withdrawal unless such therapy is contraindicated or patient does not wish to

Reference therapy: Not applicable.

Description of medicinal product: The drug substance, AGI-101H, is a whole cell, allogeneic
melanoma vaccine, representing a mixture (1:1 ratio) of two therapeutic genemodified human
melanoma cell lines, referred to as Mich1H6 and Mich2H6, which has been gamma-irradiated to
render the cells non-proliferative. There is no recommended International Non-proprietary
(INN) Name for the drug substance.

Methodology: In this open-label study of patients with advanced melanoma, one dose of AGI -
101H vaccine will be administered s.c.. 20 evaluable patients will be recruited. An
independent data monitoring committee (DMC) will review all safety data after the first 10
injections and then after another 10 injections (20 injections in total). Up to that second
DMC meeting all patients have to stay in the hospital for a 2 hours observation; after the
analysis of the 20 vaccinations the DMC will review the safety data and may recommend
reverting to normal outpatients setting.

Inclusion Criteria:

- Patients must have given signed informed consent for participation in the study prior
to any study-related procedures being performed and not part of normal medical care,
with the understanding that consent may be withdrawn by the patient at any time
without prejudice to their future medical care

- Age ≥18 years of age and ≤75 years of age

- Histologically confirmed, unresectable stage 3 or 4 measurable (RECIST criteria),
cutaneous melanoma or unknown primary with melanoma metastases

- Life expectancy of at least 30 weeks and an ECOG performance status of X 1

- Adequate renal and liver function as defined by serum creatinine and total bilirubin
levels no greater than 1.5 times the Investigational Site's upper normal laboratory

- Normal clotting

- The patient is willing and able to comply with the protocol for the duration of the
study, including 2 hours of follow up observation after the injections (until DMC
lifts it after analysis of the first 20 injections) during the course of the trial,
examinations and punch biopsies of the vaccination sites 48 hrs post vaccine 1 (week
0) and 8 (week14).

Exclusion Criteria:

- Any previous participation in another trial with the AGI - 101 vaccine

- Ocular or mucosal melanoma

- Pregnant or breast-feeding women, or women of childbearing potential unless effective
methods of contraception are used (lack of childbearing potential is met by being
post-menopausal, being surgically sterile, practicing contraception with an oral
contraceptive or other hormonal therapy [e.g. hormone implants], intra-uterine
device, diaphragm with spermicide or condom with spermicide, or being sexually

- Radiotherapy to target lesions or immunotherapy (including treatment with Interferon
or Interleukin-2 and systemic glucocorticosteroids) during the four weeks prior to
the start of study treatment.

- Any previous treatment with systemic chemotherapy for advanced melanoma

- Brain metastases

- Major surgery in the four weeks prior to the start of study treatment

- Patients who are poor medical risks due to a serious, uncontrolled medical disorder,
non-malignant systemic disease or active, uncontrolled infection. Examples include,
but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months)
myocardial infarction, uncontrolled major seizure disorder, spinal cord compression,
superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining
informed consent

- Patients who are known to be serologically positive for Hepatitis B (patients
vaccinated against Hepatitis B are accepted), Hepatitis C or HIV

- States causing significant immunosuppression (e.g. organ transplantation or

- Simultaneous participation in any other study involving investigational drugs or
having participated in a study less than 4 weeks prior to start of study treatment.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

The safety profile of AGI-101H

Outcome Time Frame:

9 months

Safety Issue:


Principal Investigator

Margaret Gralinska

Investigator Role:

Study Director

Investigator Affiliation:

AGIRx (Active Gene Interventions) Ltd


Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Study ID:

AGI - 101H/01-2007



Start Date:

June 2008

Completion Date:

March 2009

Related Keywords:

  • Melanoma
  • Melanoma