A Phase 2 interventional study of CVA21 in Melanoma, sponsored by Viralytics. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-09.
Sponsored by Viralytics · Phase 2, Interventional, and Treatment
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Among 2,048 studies in Melanoma with a site in United States — 243 open to participants now, 439 under way, 32 of them phase 3. Melanoma · United States.
Among the 2,048 studies in Melanoma with a site in United States, this one is the 1,300th largest by enrollment of the 1,748 interventional ones that give a count, is one of 78 that started in 2012, is one of 612 in phase 2, and was the 828th registered.
3,372 studies on the registry are indexed under Melanoma; 580 are open to participants now.
Browse Melanoma studies →243 of the 2,048 studies in Melanoma with a site in United States are open now. Recruiting first, the newest first:
Children's Oncology Group · Sites in United States
Ages up to 25
John Kirkwood · Sites in United States
Ages 18+
University of Wisconsin, Madison · Sites in United States
Ages 18+
H. Lee Moffitt Cancer Center and Research Institute · Sites in United States
Ages 18+ · Healthy volunteers
University of Colorado, Denver · Sites in United States
Ages 55+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 468 Melanoma studies recruiting now, 381 (81%) set no upper age limit and 49 (10%) stop at 75 or younger; 47 take children under 18; 29 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
2,048 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 934 · Phase 2 907 · Phase 3 115 · Phase 4 11
First in 1991; this study’s year is marked. 78 started in 2012.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 16 is below the median of 40 across 2,650 interventional studies indexed under Melanoma.
Median enrollment 37 across the 1,748 interventional studies, 156 across the 212 observational. Of the 1,481 that completed or were terminated, 598 (40%) have results posted.
This tab as a report to print or save as PDF → With an account.
799 of 2,048 have an industry lead sponsor. The 10 most frequent:
Viralytics is the lead sponsor of 11 studies on the registry; none are open to participants now.
Viralytics has 7 studies filed under Melanoma — fewer than ten, so there is no comparison to draw.
141 of the studies in Melanoma with a site in United States that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05608291Phase 3Regeneron PharmaceuticalsA Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery | 2027-01-15 |
| NCT05987332Phase 3IDEAYA BiosciencesIDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma | 2027-01-15 |
| NCT06246916Phase 3Regeneron PharmaceuticalsA Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head) | 2027-03-22 |
| NCT01223248Phase 3Memorial Sloan Kettering Cancer CenterRandomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy | 2027-10 |
| NCT06112314Phase 3Immunocore LtdIMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301) | 2027-10-16 |
Add all 141 to your calendar (.ics) → With an account.
Among the 2,048 studies in Melanoma with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is an extended use study for patients who have received 10 doses of CAVATAK™ in the VLA 007 trial. There may be patients who have benefitted from the study drug and who might benefit from further treatment. In order to accommodate those patients further treatment to complete 48 weeks of CVA21 intratumoral injections will be made available.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dose of CAVATAK up to 3 x 10⁸ TCID50 for an additional 9 treatments at 3-week intervals
Biological: CVA21
Safety
Participants with Grade 3 or Higher Adverse Events
Time frame: 12 months
Subjects were recruited from medical clinics from 03 July 2012 to 29 July 2015 (last subject enrolled in VLA-008).
| Milestone | CVA21 |
|---|---|
| Started | 16 |
| Completed | 16 |
| Not completed | 0 |
Participants with Grade 3 or Higher Adverse Events
| participants | CVA21 |
|---|---|
| Safety | 16 |
Collected over 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CVA21 | 1/16 (6.3%) | 2/16 (12.5%) | 13/16 (81.3%) |
| Event | CVA21 |
|---|---|
| Cardiac arrestCardiac disorders | 1/16 |
| Motor DysfunctionNervous system disorders | 1/16 |
| Event | CVA21 |
|---|---|
| FatigueGeneral disorders | 3/16 |
| PainGeneral disorders | 3/16 |
| NauseaGastrointestinal disorders | 3/16 |
| DizzinessNervous system disorders | 3/16 |
| CoughRespiratory, thoracic and mediastinal disorders | 3/16 |
| Sinus congestionRespiratory, thoracic and mediastinal disorders | 3/16 |
| ChillsGeneral disorders | 2/16 |
| Influenza like illnessGeneral disorders | 2/16 |
| DiarrhoeaGastrointestinal disorders | 2/16 |
| VomitingGastrointestinal disorders | 2/16 |
| Age, Continuous(years) | CVA21 |
|---|---|
| Mean | 68.1 ± 12.8 |
| Sex: Female, Male(Participants) | CVA21 |
|---|---|
| Female | 4 |
| Male | 12 |
| Region of Enrollment(Participants) | CVA21 |
|---|---|
| United States | 16 |
Ran from Jul 2012 to primary completion in Apr 2016, 45 months.
Results were first posted in Apr 2018, 2 years after primary completion.
Of 106 industry-sponsored phase 2 interventional studies under Melanoma, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 60. This study's 45 months is above that.
Counting every sponsor, half of 384 studies reached it within 53 months; a quarter within 32 and three quarters within 90.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Gebasaxturev
Viralytics