A Study of Intratumoral CAVATAK™ in Patients With Stage IIIc and Stage IV Malignant Melanoma (VLA-007 CALM )

Completed · Phase 2

Conditions studied: Malignant Melanoma

In brief

The purpose of this study is to assess the clinical efficacy of Intratumoral (IT) CVA21 in terms of immune-related Progression-Free Survival (irPFS) at 6 months as monitored via immune-related Response Criteria \[irRECIST 1.1\] (revised Response Evaluation Criteria In Solid Tumors \[RECIST\] 1.1).

Key facts

Study ID

NCT01227551

Run by

Viralytics

People needed

57

Starts

2011-12-29

Expected to finish

2016-04-06

Last updated by the study team

2019-07-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient with histologically proven stage IIIc or stage IV melanoma who fails to qualify for curative surgery and who bears one or more tumors that are accessible for direct injection
• Patient must have had no more than one previous systemic regimen for management of melanoma; however, adjuvant chemotherapy administered 6 months or longer before entering the trial does not count as a line of treatment
• Absence of circulating serum neutralizing antibodies to CVA21 (titer < 1:16)
• At least one tumor 0.5 to 10 cm in the longest diameter must be suitable for injection and at least one tumor must be equal to or greater than 1 cm and qualified to be a target lesion for RECIST 1.1 criteria
• Patient must have adequate hematologic, hepatic and renal function, defined as:
• Absolute neutrophil count (ANC) > 1.5 x 10\^9/L, platelets > 100 x 10\^9/L
• Bilirubin < 1.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST) < 2.5 x ULN
• Serum creatinine < 1.5 x ULN; if > 1.5 x ULN, it must be confirmed that creatinine clearance > 30 mL/minute
• Serum lactate dehydrogenase (LDH) levels < or = 1.5 x ULN
• Male or female age 18 years or older
• Performance status (Eastern Cooperative Oncology Group [ECOG]) 0 or 1
• Estimated life expectancy of more than 6 months
• Recovered from prior therapy with at least 4 weeks since the last exposure to chemotherapy or radiotherapy
• Patient is able and willing to provide written informed consent to participate in the study
• Fertile males and females must agree to the use of an adequate form of contraception, e.g., condoms for males. A negative pregnancy test is required in female patients of childbearing potential.

You may not qualify if…

• Mucosal or ocular primary tumors
• Bone metastases
• Greater than 3 visceral metastases
• Any visceral metastases > 10 cm
• Serum anti-CVA21 neutralizing titer of > 1:16 at baseline
• Presence of any central nervous system (CNS) tumor that has not been stable for at least 3 months off corticosteroids and confirmed by imaging
• 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 into a major vessel in the case of necrosis
• Only measurable tumor had prior local radiotherapy without subsequent nodule progression
• Patient has received chemotherapy within the last 4 weeks prior to first injection
• ECOG score greater than 1
• Estimated life expectancy of less than 6 months
• Pregnancy or breastfeeding
• Primary or secondary immunodeficiency, including immunosuppressive disease, and immunosuppressive doses of corticosteroids (e.g., prednisolone > 7.5 mg per day) or other immunosuppressive medications including cyclosporine, azathioprine, interferons within the past 4 weeks prior to screening
• Positive serology for human immunodeficiency virus (HIV), hepatitis B or C
• Full dose anticoagulation or a history of bleeding diathesis or poorly controlled bleeding in the last month prior to screening
• Previous splenectomy
• Presence of uncontrolled infection
• Presence of unstable neurological disease
• Any uncontrolled medical condition that, in the opinion of the investigator, is likely to place the patient at unacceptable risk during the study or reduce his/her ability to complete the study
• Participation in another study requiring administration of an investigational drug or biological agent within the last 4 weeks prior to screening
• Any other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
• Participation in any previous melanoma immunotherapy trial within 1 month prior to entry to this trial or any trial of any other investigational agent within the last month prior to entry to this trial
• Active infections or serious general medical conditions
• Patients with previous malignancies should only be permitted if they have been in a continued state of "no evidence of disease" for at least 5 years with the exception of adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of the breast, and basal cell/squamous cell skin cancer
• Known allergy to treatment medication or its excipients and/or to the contrast medium

Where it is running

• Moores UCSD Cancer Center — La Jolla, California, United States
• St Mary's Medical Center — San Francisco, California, United States
• Mount Sinai Medical Center — Miami Beach, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Oncology Specialists, SC — Niles, Illinois, United States
• Investigative Clinical Research of Indiana — Indianapolis, Indiana, United States
• Atlantic Melanoma Center — Morristown, New Jersey, United States
• Providence Cancer Center — Portland, Oregon, United States
• Mary Crowley Cancer Research Centers — Dallas, Texas, United States
• Huntsman Cancer Institute — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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