Trial · NCT02288897
PV-10 vs Chemotherapy or Oncolytic Viral Therapy for Treatment of Locally Advanced Cutaneous Melanoma
NCT02288897, Phase 3, Terminated, Provectus Biopharmaceuticals, Inc.; results first posted 2022-01-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. PV-10 vs Chemotherapy or Oncolytic Viral Therapy for Treatment of Locally Advanced Cutaneous Melanoma. Trials, record NCT02288897. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02288897
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PV-10 vs Chemotherapy or Oncolytic Viral Therapy for Treatment of Locally Advanced Cutaneous Melanoma
- NCT number
- NCT02288897
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 20 participants, actual
- Lead sponsor
- Provectus Biopharmaceuticals, Inc.
- Conditions
- Cutaneous Melanoma
- Interventions
- PV-10 (10% rose bengal disodium), Dacarbazine, temozolomide or talimogene laherparepvec
- First posted
- 2014-11-11
- Last updated
- 2022-01-19
- Results first posted
- 2022-01-19
- Limitations and caveats
Planned accrual was 225 subjects. However, due to slow accrual during a period of rapid change in global drug development for cutaneous melanoma, the study was terminated early after 20 subjects initiated study treatment. Because the study was terminated prior to achievement of pre-specified efficacy thresholds, the planned central independent review was not conducted and the small number of subjects precluded formal analysis and scientifically meaningful interpretation of efficacy parameters.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | Assessed every 12 weeks until disease progression, withdrawal of consent, or study termination; progression detected between formal assessments was documented at the time of detection; median follow-up time for PFS was 26.6 weeks, maximum was 125.8 weeks. | PFS was estimated via Kaplan-Meier analysis using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. Subjects who did not have an event of progression or death were censored at their last assessment date. Assessment of progression was performed by the sponsor based on review of lesion measurement and clinical progression data reported by each investigator. Events signaling progression included increase in size and/or number of study lesions, onset of visceral metastatic disease, and death. For target lesions (assigned prior to randomization), complete response (CR) required disappearance of all target lesions; partial response (PR) required \>= 30% decrease in sum of the longest diameter (SLD) of all target lesions; progressive disease (PD) required \>=20% increase in SLD of target lesions. Non-target lesions were followed for CR, PD, or non-CR/non-PD status using equivalent thresholds. Progression occurred when PD was observed in either target or non-target lesion. |
| Secondary | Complete Response Rate (CRR) | 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. | CRR was assessed using RECIST v1.1 criteria, and required disappearance of all target and non-target lesions. |
| Secondary | Duration of Complete Response (DCR) | Assessed every 12 weeks until disease progression, withdrawal of consent, or study termination; median follow-up time for DCR was 26.7 weeks, maximum was 77.7 weeks. | DCR was estimated via Kaplan-Meier analysis for participants achieving a complete response, and was defined as the interval from first complete response to disease progression or death; responders who did not have an event of progression or death were censored at their last assessment date. Complete response was assessed using RECIST v1.1 criteria, and required disappearance of all target and non-target lesions. |
| Secondary | Overall Survival (OS) | Assessed every 12 weeks upon withdrawal from active study participation until death, withdrawal of consent, or study termination; median follow-up time for survival was 82.4 weeks, maximum was 167.0 weeks. | OS was documented at 12 week intervals commencing on withdrawal from active study participation. Documentation was made by subject clinic visit or other personal contact, telephonic contact, review of medical records, or other unequivocal evidence of survival status. OS was estimated via Kaplan-Meier analysis, and was defined as the interval from randomization to death; subjects who did not have an event of death were censored at their last assessment date. |
| Secondary | Number of Participants With Adverse Events | Assessed every 4 weeks until 28 days after last treatment; median duration of treatment was 11.8 and 9.5 weeks in each treatment group, respectively. | Safety and tolerability were assessed by monitoring the frequency, duration, severity and attribution of adverse events and evaluating changes in laboratory values and vital signs. |
| Other | Change in Domain Scores From Baseline Using the Patient Reported Skindex-16 Instrument | Assessed at baseline (Day 1 at start of study treatment) and at the end of each treatment cycle (every 4 or 6 weeks) until disease progression, withdrawal of consent, or study termination; median follow-up time was 26.6 weeks, maximum was 125.8 weeks. | In this exploratory endpoint, changes in Skindex-16 self-assessment scores were evaluated vs Day 1 baseline domain scores: symptom domain (items 1-4); emotional domain (items 5-11); and functioning domain (items 12-16). The Skindex-16 instrument solicits response to the extent of bother during the preceding week by 16 items (e.g., itching, hurting, worry, impact on daily activities), using a score from 0 (never bothered) to 6 (always bothered) for each item. Item scores are transformed to 0 to 100 scale, and domain scores are calculated as the average of the item scores comprising the domain. A lower domain score at baseline signifies lower impact of that domain; a decrease in domain score from baseline signifies improvement in that domain. Median baseline score and change from baseline over the study interval is presented for each domain. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) | Assessed every 12 weeks until disease progression, withdrawal of consent, or study termination; progression detected between formal assessments was documented at the time of detection; median follow-up time for PFS was 26.6 weeks, maximum was 125.8 weeks. | 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 PFS. | Months | MEDIAN |
| SECONDARY | Complete Response Rate (CRR) | 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. | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Complete Response (DCR) | Assessed every 12 weeks until disease progression, withdrawal of consent, or study termination; median follow-up time for DCR was 26.7 weeks, maximum was 77.7 weeks. | 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. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Assessed every 12 weeks upon withdrawal from active study participation until death, withdrawal of consent, or study termination; median follow-up time for survival was 82.4 weeks, maximum was 167.0 weeks. | Subjects were analyzed according to treatment group assignment at randomization. | Months | MEDIAN |
| SECONDARY | Number of Participants With Adverse Events | Assessed every 4 weeks until 28 days after last treatment; median duration of treatment was 11.8 and 9.5 weeks in each treatment group, respectively. | PV-10 safety population includes two subjects who received PV-10 upon crossover after progression on comparator. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Change in Domain Scores From Baseline Using the Patient Reported Skindex-16 Instrument | Assessed at baseline (Day 1 at start of study treatment) and at the end of each treatment cycle (every 4 or 6 weeks) until disease progression, withdrawal of consent, or study termination; median follow-up time was 26.6 weeks, maximum was 125.8 weeks. | Subjects receiving PV-10 upon crossover from comparator are included in the analysis population for PV-10 (after crossover).~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 Skindex data. | Scores on a Scale (0-100) | MEDIAN |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) | PV-10 | 6.1 | Full Range 1.5 to 28.9 | Months | |
| Progression-free Survival (PFS) | Chemotherapy or Oncolytic Viral Therapy | 8.6 | Full Range 1.8 to 14.4 | Months | |
| Complete Response Rate (CRR) | PV-10 | 3 | Participants | ||
| Complete Response Rate (CRR) | Chemotherapy or Oncolytic Viral Therapy | 2 | Participants | ||
| Duration of Complete Response (DCR) | PV-10 | NA | 95% Confidence Interval NA to NA | Months | |
| Duration of Complete Response (DCR) | Chemotherapy or Oncolytic Viral Therapy | NA | 95% Confidence Interval NA to NA | Months | |
| Overall Survival (OS) | PV-10 | NA | 95% Confidence Interval NA to NA | Months | |
| Overall Survival (OS) | Chemotherapy or Oncolytic Viral Therapy | NA | 95% Confidence Interval NA to NA | Months | |
| Number of Participants With Adverse Events | PV-10 | 14 | Participants | ||
| Number of Participants With Adverse Events | Chemotherapy or Oncolytic Viral Therapy | 8 | Participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PV-10 (10% Rose Bengal Disodium) | 12 | |
| Overall Study | STARTED | Chemotherapy or Oncolytic Viral Therapy (Dacarbazine, Temozolomide or Talimogene Laherparepvec) | 8 | |
| Overall Study | COMPLETED | PV-10 (10% Rose Bengal Disodium) | 12 | |
| Overall Study | COMPLETED | Chemotherapy or Oncolytic Viral Therapy (Dacarbazine, Temozolomide or Talimogene Laherparepvec) | 8 | |
| Overall Study | NOT COMPLETED | PV-10 (10% Rose Bengal Disodium) | 0 | |
| Overall Study | NOT COMPLETED | Chemotherapy or Oncolytic Viral Therapy (Dacarbazine, Temozolomide or Talimogene Laherparepvec) | 0 |
Source ClinicalTrials.gov
Adverse events66
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Injection site pain | General disorders | PV-10 | 12 | 14 | 12 |
| other | Injection site pain | General disorders | Chemotherapy or Oncolytic Viral Therapy | 1 | 8 | 1 |
| other | Injection sit oedema | General disorders | PV-10 | 7 | 14 | 7 |
| other | Injection sit oedema | General disorders | Chemotherapy or Oncolytic Viral Therapy | 0 | 8 | 0 |
| other | Injection site pruritus | General disorders | PV-10 | 7 | 14 | 7 |
| other | Injection site pruritus | General disorders | Chemotherapy or Oncolytic Viral Therapy | 0 | 8 | 0 |
| other | Injection site discharge | General disorders | PV-10 | 5 | 14 | 5 |
| other | Injection site discharge | General disorders | Chemotherapy or Oncolytic Viral Therapy | 1 | 8 | 1 |
| other | Injection site erythema | General disorders | PV-10 | 5 | 14 | 5 |
| other | Injection site erythema | General disorders | Chemotherapy or Oncolytic Viral Therapy | 0 | 8 | 0 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PV-10 | 0 | 14 |
| Total, all-cause mortality | Chemotherapy or Oncolytic Viral Therapy | 0 | 8 |
| Total, other adverse events | PV-10 | 13 | 14 |
| Total, other adverse events | Chemotherapy or Oncolytic Viral Therapy | 6 | 8 |
| Total, serious adverse events | PV-10 | 0 | 14 |
| Total, serious adverse events | Chemotherapy or Oncolytic Viral Therapy | 1 | 8 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| PV-10 vs Chemotherapy or Oncolytic Viral Therapy: Complete Response Rate (CRR) | Trial comparisons |
| PV-10 vs Chemotherapy or Oncolytic Viral Therapy: deaths from any cause | Trial comparisons |
| PV-10 vs Chemotherapy or Oncolytic Viral Therapy: Number of Participants With Adverse Events | Trial comparisons |
| PV-10 vs Chemotherapy or Oncolytic Viral Therapy: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02288897
GET https://conductscience.org/api/trials/v1/NCT02288897/results?page=2