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A Phase 2 Study of the Efficacy and Safety of Intratumoral CAVATAK™ (Coxsackievirus A21, CVA21) in Patients With Stage IIIc and Stage IV Malignant Melanoma to Extend Dosing for up to 48 Weeks Total


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Melanoma

Thank you

Trial Information

A Phase 2 Study of the Efficacy and Safety of Intratumoral CAVATAK™ (Coxsackievirus A21, CVA21) in Patients With Stage IIIc and Stage IV Malignant Melanoma to Extend Dosing for up to 48 Weeks Total


Inclusion Criteria:



- 1. Patients must have reached Week 24 of the core protocol in immune-related complete
response (irCR), immune-related partial response (irPR), immune-related stable
disease (irSD), or immune-related progressive disease (irPD) (unconfirmed) with
evidence of tumor inflammatory reaction.

- 2. If patient is in irPD (unconfirmed) status, they must not have had a decrease in
their Karnofsky Performances Scale (KPS) score > 10 points and to be judged to not
have "rapid clinical deterioration" by the investigator since the subject's last
tumor measurement leading to irPD assessment.

- 3. Patients must start treatment in the extension protocol within 8 weeks of their
last injection administered in the core protocol.

- 4. Patient is able and willing to provide written informed consent to participate in
the study.

- 5. Fertile males and females must agree to the use of an adequate form of
contraception, e.g., condoms for males.

Exclusion Criteria:

- 1. Tumors to be injected lying in mucosal regions or close to an airway, major blood
vessel or spinal cord that, in the opinion of the Investigators, could cause
occlusion or compression in the case of tumor swelling or erosion into a major vessel
in the case of necrosis.

- 2. If lesions are too small to be visualized or palpable for accurate injection.

- 3. Currently in status of irPD (confirmed) or irPD (unconfirmed) without evidence of
tumor inflammatory response, or with rapid clinical deterioration, or with a decrease
of 10 points or more on their KPS score since their last assessment before irPD
(unconfirmed) assessment.

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

To assess the clinical efficacy of intratumoral (IT) CVA21 when given beyond 18 weeks using immune-related Progression-Free Survival (irPFS)

Principal Investigator

Jose Lutzky, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mount Sinai School of Medicine

Authority:

United States: Food and Drug Administration

Study ID:

VLA 008

NCT ID:

NCT01636882

Start Date:

June 2012

Completion Date:

Related Keywords:

  • Melanoma
  • Melanoma

Name

Location

Huntsman Cancer InstituteSalt Lake City, Utah  84112