Malignant Melanoma Clinical Trial
Official title:
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 (VLA-007 CALM )
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).
This is a multicenter, open-label, 2-stage, single-arm efficacy and safety study.
Approximately 63 patients with histologically proven stage IIIc or stage IV melanoma who fail
to qualify for curative surgery and who bear one or more tumors that are accessible for
direct injections and at least one measurable lesion by RECIST 1.1 criteria will be
considered.
Prospective patients will attend the study center for initial screening within 28 days prior
to treatment with CVA21. They will have the nature of the study and its procedures and risks
fully explained. All patients must provide a written informed consent to participate in the
study.
The dose of CVA21 for this study is 3 x 108 TCID50 (about 4.5 x 106 TCID50/kg for a 70-kg
patient) by IT administration. Each patient will receive 4 separate CVA21 administrations in
the first 8 days on trial (Days 1, 3, 5 and 8), followed by a fifth dose 2 weeks later (Day
22) and further administrations at 3 weekly intervals (Days 43, 64, 85, 106 and 127, up to a
maximum of 10 sets of injections) or until confirmed disease progression or development of
excessive toxicity.
Disease status will be assessed by contrast-enhanced computerized tomography (CT) or magnetic
resonance imaging (MRI) scan and/or direct caliper measurement (and ultrasound assistance, if
necessary) and categorized by immune-related RECIST 1.1 criteria prior to commencing
treatment (baseline) and at Days 43, 85, 127 and 169 and 12-weekly intervals thereafter until
disease progression. At 2 years, intervals can increase to 6 months.
At 12 weeks post-commencement of treatment (Day 85), if a patient's disease status is classed
as progressive disease (but without rapid clinical deterioration) the patient may remain on
the trial for a further 6 weeks, when his/her disease status will be confirmed prior to the
scheduled treatment. If disease progression is confirmed, the patient will cease treatment
but will remain on the study and be observed for efficacy and safety until initiation of
treatment with non-CVA21 anticancer therapies. However, survival will be followed until
death. If stable disease or better (CR or PR) is observed at this time, the patient will
continue treatment as per the protocol. Complete and partial responses will be confirmed at
the next contrast-enhanced CT or MRI scan analysis.
Patients who have evidence of biologic activity, i.e., tumor inflammatory reaction and/or
stable disease or better, at 18 weeks (Day 127) are eligible to participate in the extension
trial in which they will continue to receive IT injections of CVA21 every 3 weeks up to a
total of 1 year of therapy from the first injection.
Throughout the trial, immunological responses to the tumor and CVA21 will be monitored.
After the full CVA21 injection schedule has been completed, patients will be followed at
12-weekly intervals beginning on Day 169 for a total of 12 months according to the schedule
for safety assessment and indefinitely for survival. Patients with progressive disease (but
without rapid clinical deterioration) at 6 months (Day 169) will have a further tumor
assessment 6 weeks later for confirmation or continuation of observation for duration of
disease control and all subjects will be followed for survival. Patients who are withdrawn
from treatment with CVA21 during the treatment phase must also be followed up every 6 weeks
for 12 weeks for safety and for survival.
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