A Phase 1 interventional study of CVA21 and Mitomycin C in Non-muscle Invasive Bladder Cancer, sponsored by Viralytics. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-27.
Sponsored by Viralytics · Phase 1, Interventional, and Treatment
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Among 20 studies in Non-Muscle Invasive Bladder Neoplasms with a site in United Kingdom — 8 open to participants now, 11 under way, 6 of them phase 3. Non-Muscle Invasive Bladder Neoplasms · United Kingdom.
Among the 20 studies in Non-Muscle Invasive Bladder Neoplasms with a site in United Kingdom, this one is the 16th largest by enrollment of the 17 interventional ones that give a count, is the only one that started in 2015, is one of 4 in phase 1, and was the 1st registered.
294 studies on the registry are indexed under Non-Muscle Invasive Bladder Neoplasms; 126 are open to participants now.
Browse Non-Muscle Invasive Bladder Neoplasms studies →8 of the 20 studies in Non-Muscle Invasive Bladder Neoplasms with a site in United Kingdom are open now. Recruiting first, the newest first:
Pfizer · Sites in United Kingdom, United States, France and 3 more countries
Ages 18+
Janssen Research & Development, LLC · Sites in United Kingdom, United States, Argentina and 12 more countries
Ages 18+
Merck Sharp & Dohme LLC · Sites in United Kingdom, United States, Argentina and 16 more countries
Ages 18+
Janssen Research & Development, LLC · Sites in United Kingdom, United States, Argentina and 17 more countries
Ages 18+
Eli Lilly and Company · Sites in United Kingdom, United States, Australia and 11 more countries
Ages 18+
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 92 Non-Muscle Invasive Bladder Neoplasms studies recruiting now, 77 (84%) set no upper age limit and 5 (5%) stop at 75 or younger; 2 take children under 18; 2 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.
20 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 8 · Phase 2 7 · Phase 3 6
First in 2015; this study’s year is marked. 1 started in 2015.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 16 is below the median of 62 across 231 interventional studies indexed under Non-Muscle Invasive Bladder Neoplasms.
Median enrollment 272 across the 17 interventional studies, 852 across the 3 observational. Of the 9 that completed or were terminated, 4 (44%) have results posted.
This tab as a report to print or save as PDF → With an account.
15 of 20 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 1 study filed under Non-Muscle Invasive Bladder Neoplasms — fewer than ten, so there is no comparison to draw.
2 of the studies in Non-Muscle Invasive Bladder Neoplasms with a site in United Kingdom that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04106115University College, LondonDURvalumab in Combination With S-488210/S-488211 vAccine in Non-muscle Invasive Bladder CancEr | 2027-03-30 |
| NCT05614739Eli Lilly and CompanyFORAGER-1: A Study of Vepugratinib (LY3866288; LOXO-435) in Participants With Cancer With a Change in a Gene Called FGFR3 | 2027-06 |
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Among the 20 studies in Non-Muscle Invasive Bladder Neoplasms with a site in United Kingdom, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The study consisted of 2 sequential parts. Part A assessed the safety and tolerability of CAVATAK administered via intravesical instillation in patients with non-muscle invasive bladder cancer scheduled to undergo TUR. Part B assessed the safety and tolerability of CAVATAK administered in sequential combination with low dose Mitomycin C in the same patient population.
This was a Phase I, two-part, open-label, dose-escalation study designed to evaluate CVA21 alone and in sequential combination with low-dose mitomycin C in patients with non-muscle invasive bladder cancer (NMIBC) who were candidates for and were planning to undergo TUR for treatment of their disease. This gave a relatively homogeneous study population and facilitated collection of resected tumour tissue for histological, pharmacodynamics (PD) and pharmacokinetic (PK) analyses.
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 scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CVA21 was administered by intravesical instillation at one of three (3) ascending dose levels or schedules.
Biological: CVA21
Mitomycin C (MMC) was administered at 10 mg by intravesical instillation on Day 1. Four hours after instillation of MMC, CVA21 was administered by intravesical instillation of one of 2 ascending dose levels or schedules. Subjects received a second instillation of CVA21 alone on Day 2 without pretreatment with MMC.
Biological: CVA21 · Drug: Mitomycin C
CAVATAK is a purified preparation of CVA21
Also known as: CAVATAK, Coxsackievirus A21
Chemotherapy
Incidence of Dose-limiting Toxicities Treatment-related Adverse Events.
Number of Participants with Treatment-emergent adverse events. The events for each cohort of dose of CVA21 only are pooled for the analysis.
Time frame: 30 days from last dose
9 patients were enrolled into VLA012A and 6 patients into VLA012B and data presented for these 15 patients. One patient was enrolled, but not treated due to difficulties in placing the urinary catheter.
| Milestone | A1 - CVA21 1x10^8 TCID50 | CVA21/Mitomycin C | A2 - CVA21 3x10^8 TCID50. | A3 - CVA21 3x10^8 TCID50 x2 |
|---|---|---|---|---|
| Started | 4 | 6 | 3 | 3 |
| Completed | 3 | 6 | 3 | 3 |
| Not completed | 1 | 0 | 0 | 0 |
| Withdrew: Difficulties with urinary catheter | 1 | 0 | 0 | 0 |
Number of Participants with Treatment-emergent adverse events. The events for each cohort of dose of CVA21 only are pooled for the analysis.
| Participants | CVA21 | CVA21/Mitomycin C |
|---|---|---|
| Incidence of Dose-limiting Toxicities Treatment-related Adverse Events. | 9 | 6 |
Collected over 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CVA21 | 0/9 (0%) | 1/9 (11.1%) | 9/9 (100%) |
| CVA21/Mitomycin C | 0/6 (0%) | 0/6 (0%) | 6/6 (100%) |
| Event | CVA21 | CVA21/Mitomycin C |
|---|---|---|
| E. Coli urinary tract infectionInfections and infestations | 1/9 | 0/6 |
| Event | CVA21 | CVA21/Mitomycin C |
|---|---|---|
| HematuriaRenal and urinary disorders | 5/9 | 4/6 |
| DysuriaRenal and urinary disorders | 5/9 | 1/6 |
| PollakiuriaRenal and urinary disorders | 3/9 | 1/6 |
| HyperglycaemiaMetabolism and nutrition disorders | 3/9 | 1/6 |
| Urinary tract infection enterococcalInfections and infestations | 2/9 | 1/6 |
| Escherichia urinary tract infectionInfections and infestations | 2/9 | 0/6 |
| Blood urea increasedInvestigations | 2/9 | 0/6 |
| Blood uric acid increasedInvestigations | 2/9 | 0/6 |
| FatigueGeneral disorders | 2/9 | 0/6 |
| Decreased appetiteMetabolism and nutrition disorders | 2/9 | 0/6 |
Received at least one dose of treatment.
| Age, Continuous(years) | CVA21 | CVA21/MitomycinC | Total |
|---|---|---|---|
| Mean | 67 ± 11.6 | 62.7 ± 8.3 | 65 ± 9.4 |
| Sex: Female, Male(Participants) | CVA21 | CVA21/MitomycinC | Total |
|---|---|---|---|
| Female | 2 | 1 | 3 |
| Male | 7 | 5 | 12 |
| Ethnicity (NIH/OMB)(Participants) | CVA21 | CVA21/MitomycinC | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 9 | 6 | 15 |
| Unknown or Not Reported | 0 | 0 | 0 |
Ran from Jan 2015 to primary completion in Mar 2016, 13 months.
Results were first posted in Jun 2019, 3 years 3 months after primary completion.
Of 24 phase 1 interventional studies under Non-Muscle Invasive Bladder Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 61. This study's 13 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Gebasaxturev
Non-Muscle Invasive Bladder Neoplasms →
Viralytics