Comparison · NCT02288897-b37e29ae
PV-10 vs Chemotherapy or Oncolytic Viral Therapy: Complete Response Rate (CRR)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. PV-10 vs Chemotherapy or Oncolytic Viral Therapy: Complete Response Rate (CRR). Trial comparisons, record NCT02288897-b37e29ae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02288897-b37e29ae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.333 | 0.121 | 0.646 | wilson | |
| Risk in group 2 | 0.333 | 0.0968 | 0.7 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.424 | 0.392 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.232 | 4.31 | log | |
| Odds ratio, group 1 over group 2 | 1 | 0.112 | 8.95 | log | |
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | PV-10 | Subjects received intralesional PV-10 to all Study Lesions on study Day 1. PV-10 should be re-administered at 28-day intervals until complete response, disease progression or study termination. | 3 | 9 | OG000 |
| Group 2 | Chemotherapy or Oncolytic Viral Therapy | Subjects received (a) dacarbazine (intravenously at 850 m/m2) or temozolomide (orally at 200 mg/m2 daily for 5 consecutive days), administered at consecutive 28-day intervals, or (b) intralesional talimogene laherparepvec administered on an initial 21 interval followed by consecutive 14 day intervals, until complete response, disease progression or study termination. | 2 | 6 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Complete Response Rate (CRR)
- Description
- CRR was assessed using RECIST v1.1 criteria, and required disappearance of all target and non-target lesions.
- Time frame
- Assessed every 12 weeks until disease progression, withdrawal of consent, or study termination; median follow-up time for CRR was 26.6 weeks, maximum was 125.8 weeks.
- Population
Subjects receiving PV-10 upon crossover from comparator are not included in the analysis population.~Response data from one study center were censored due to resignation of the principal investigator.~Because the study was terminated prior to achievement of pre-specified efficacy thresholds (i.e., out of a planned 225 subjects only 20 initiated study treatment), the small number of subjects enrolled precludes scientifically meaningful interpretation of CRR.
Source ClinicalTrials.gov
Trial
- Title
- PV-10 vs Chemotherapy or Oncolytic Viral Therapy for Treatment of Locally Advanced Cutaneous Melanoma
- NCT number
- NCT02288897
- Phases
- PHASE3
- Conditions
- Cutaneous Melanoma
- Interventions
- PV-10 (10% rose bengal disodium), Dacarbazine, temozolomide or talimogene laherparepvec
- Lead sponsor
- Provectus Biopharmaceuticals, Inc.
- Results first posted
- 2022-01-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02288897?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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