Trial · NCT02364713
MV-NIS or Investigator's Choice Chemotherapy in Treating Patients With Ovarian, Fallopian, or Peritoneal Cancer
NCT02364713, Phase 2, Terminated, Mayo Clinic; results first posted 2025-11-17
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. MV-NIS or Investigator's Choice Chemotherapy in Treating Patients With Ovarian, Fallopian, or Peritoneal Cancer. Trials, record NCT02364713. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02364713
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- MV-NIS or Investigator's Choice Chemotherapy in Treating Patients With Ovarian, Fallopian, or Peritoneal Cancer
- NCT number
- NCT02364713
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
Fallopian Tube Carcinosarcoma, Fallopian Tube Clear Cell Adenocarcinoma, Fallopian Tube Endometrioid Adenocarcinoma, Fallopian Tube Mucinous Adenocarcinoma, Fallopian Tube Serous Adenocarcinoma, Fallopian Tube Transitional Cell Carcinoma, Fallopian Tube Undifferentiated Carcinoma, Ovarian Carcinosarcoma, Ovarian Clear Cell Adenocarcinoma, Ovarian Endometrioid Adenocarcinoma, Ovarian Mucinous Adenocarcinoma, Ovarian Seromucinous Carcinoma, Ovarian Serous Adenocarcinoma, Ovarian Transitional Cell Carcinoma, Ovarian Undifferentiated Carcinoma, Platinum-Resistant Fallopian Tube Carcinoma, Platinum-Resistant Ovarian Carcinoma, Platinum-Resistant Primary Peritoneal Carcinoma, Primary Peritoneal Carcinosarcoma, Primary Peritoneal Clear Cell Adenocarcinoma, Primary Peritoneal Endometrioid Adenocarcinoma, Primary Peritoneal Serous Adenocarcinoma, Primary Peritoneal Transitional Cell Carcinoma, Primary Peritoneal Undifferentiated Carcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma
- Interventions
Bevacizumab, Gemcitabine Hydrochloride, Laboratory Biomarker Analysis, Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter, Paclitaxel, Pegylated Liposomal Doxorubicin Hydrochloride, Quality-of-Life Assessment, Topotecan Hydrochloride
- First posted
- 2015-02-18
- Last updated
- 2025-12-11
- Results first posted
- 2025-11-17
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | 5 years | Defined as the time from registration/randomization to death due to all causes. Will be a comparison of the oncolytic measles virus encoding thyroidal sodium iodide symporter versus investigator's choice chemotherapy using a one-sided log-rank test. |
| Secondary | Progression-free Survival | 11 months | Defined as the time from start of study therapy to the date of first observation of disease progression or death due to any cause (whichever comes first). The distribution of progression-free survival for both arms of the study will be estimated using the Kaplan-Meier method. |
| Secondary | Overall Survival | 12 months | Defined as the time from registration/randomization to death due to all causes. Overall survival at 12 months distributions both arms of the study will be estimated using the Kaplan-Meier method and be compared using a one-sided logrank test. |
| Secondary | Progression-free Survival | 6 months | Progression-free survival at 6 months distributions both arms of the study will be estimated using the Kaplan-Meier method. |
| Secondary | Objective Response Rate | 11 months | Objective response rate is defined to be a complete response or partial response noted as the objective status on 2 consecutive evaluations at least 4 weeks apart |
| Secondary | Incidence of Adverse Events Per Common Terminology Criteria for Adverse Events Version 4.0 | 12 months | Safety and tolerability of the oncolytic measles virus encoding thyroidal sodium iodide symporter as compared to standard therapy will be evaluated using all patients who have received any study treatment as well as summarizing those who have been included in the efficacy analyses. The overall adverse event rates for grade 3 or higher adverse events will be compared between arms. |
| Secondary | Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Ovarian Questionnaire | 5 years | Quality of life as measured by the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) questionnaire will be compared between treatment arms. The assessment will be scored according to the assessment scoring algorithm at each collection time. Scores at end of each cycle will be compared using Wilcoxon procedures. The FACT-O consist of 39 questions, each answered on a 5-point Likert scale ranging from 0 (Not at all) to 4 (Very much). Possible total scores range from 0-156, with higher scores indicating better quality of life. We will calculate the mean change from the start to the end of the study of patient total FACT-O point sum by arm. |
| Other | Time Course of Viral Gene Expression and Virus Elimination and Biodistribution of Virally Infected Cells Using Single-photon Emission Computerized Tomography/Computed Tomography Imaging | Up to course 2 | Descriptive statistics and simple scatter plots will form the basis of presentation of these data. Correlations between these laboratory values and other outcome measures will be carried out by standard parametric and nonparametric correlation procedures (Pearson's and Spearman's coefficients). |
| Other | Viremia, Viral Replication, and Viral Shedding/Persistence Following Intraperitoneal Administration Within the Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter Treatment Arm | Up to 5 years | Descriptive statistics and simple scatter plots will form the basis of presentation of these data. Correlations between these laboratory values and other outcome measures will be carried out by standard parametric and nonparametric correlation procedures (Pearson's and Spearman's coefficients). |
| Other | Humoral and Cellular Immune Responses to Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter | Up to 5 years | Descriptive statistics and simple scatter plots will form the basis of presentation of these data. Correlations between these laboratory values and other outcome measures will be carried out by standard parametric and nonparametric correlation procedures (Pearson's and Spearman's coefficients). |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | 5 years | All eligible and treated patients | Months | MEDIAN |
| SECONDARY | Progression-free Survival | 11 months | All eligible and treated patients | Months | MEDIAN |
| SECONDARY | Overall Survival | 12 months | All eligible and treated patients | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-free Survival | 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Objective Response Rate | 11 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Incidence of Adverse Events Per Common Terminology Criteria for Adverse Events Version 4.0 | 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Ovarian Questionnaire | 5 years | change in score | MEAN | |
| OTHER_PRE_SPECIFIED | Time Course of Viral Gene Expression and Virus Elimination and Biodistribution of Virally Infected Cells Using Single-photon Emission Computerized Tomography/Computed Tomography Imaging | Up to course 2 | |||
| OTHER_PRE_SPECIFIED | Viremia, Viral Replication, and Viral Shedding/Persistence Following Intraperitoneal Administration Within the Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter Treatment Arm | Up to 5 years | |||
| OTHER_PRE_SPECIFIED | Humoral and Cellular Immune Responses to Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter | Up to 5 years |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Arm A (MV-NIS) | 11.2 | 95% Confidence Interval 3.5 to NA | Months | |
| Overall Survival | Arm B (DOXIL, GEM, TOPA, TAXOL) | 14.2 | 95% Confidence Interval 10.6 to NA | Months | |
| Progression-free Survival | Arm A (MV-NIS) | 1.8 | 95% Confidence Interval 1.7 to NA | Months | |
| Progression-free Survival | Arm B (DOXIL, GEM, TOPA, TAXOL) | 4.1 | 95% Confidence Interval 1.8 to NA | Months | |
| Overall Survival | Arm A (MV-NIS) | 4 | Participants | ||
| Overall Survival | Arm B (DOXIL, GEM, TOPA, TAXOL) | 2 | Participants | ||
| Progression-free Survival | Arm A (MV-NIS) | 5 | Participants | ||
| Progression-free Survival | Arm B (DOXIL, GEM, TOPA, TAXOL) | 4 | Participants | ||
| Objective Response Rate | Arm A (MV-NIS) | 0 | Participants | ||
| Objective Response Rate | Arm B (DOXIL, GEM, TOPA, TAXOL) | 0 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (MV-NIS) | 10 | |
| Overall Study | STARTED | Arm B (DOXIL, GEM, TOPA, TAXOL) | 7 | |
| Overall Study | COMPLETED | Arm A (MV-NIS) | 8 | |
| Overall Study | COMPLETED | Arm B (DOXIL, GEM, TOPA, TAXOL) | 5 | |
| Overall Study | NOT COMPLETED | Arm A (MV-NIS) | 2 | |
| Overall Study | NOT COMPLETED | Arm B (DOXIL, GEM, TOPA, TAXOL) | 2 |
Source ClinicalTrials.gov
Adverse events88
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 | Anemia | Blood and lymphatic system disorders | Arm A (MV-NIS) | 2 | 9 | 2 |
| other | Anemia | Blood and lymphatic system disorders | Arm B (DOXIL, GEM, TOPA, TAXOL) | 0 | 5 | 0 |
| other | Hypothyroidism | Endocrine disorders | Arm A (MV-NIS) | 1 | 9 | 1 |
| other | Hypothyroidism | Endocrine disorders | Arm B (DOXIL, GEM, TOPA, TAXOL) | 0 | 5 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Arm A (MV-NIS) | 1 | 9 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Arm B (DOXIL, GEM, TOPA, TAXOL) | 0 | 5 | 0 |
| other | Diarrhea | Gastrointestinal disorders | Arm A (MV-NIS) | 3 | 9 | 6 |
| other | Diarrhea | Gastrointestinal disorders | Arm B (DOXIL, GEM, TOPA, TAXOL) | 0 | 5 | 0 |
| other | Flatulence | Gastrointestinal disorders | Arm A (MV-NIS) | 1 | 9 | 1 |
| other | Flatulence | Gastrointestinal disorders | Arm B (DOXIL, GEM, TOPA, TAXOL) | 0 | 5 | 0 |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A (MV-NIS) | 8 | 10 |
| Total, all-cause mortality | Arm B (DOXIL, GEM, TOPA, TAXOL) | 5 | 7 |
| Total, other adverse events | Arm A (MV-NIS) | 8 | 9 |
| Total, other adverse events | Arm B (DOXIL, GEM, TOPA, TAXOL) | 4 | 5 |
| Total, serious adverse events | Arm A (MV-NIS) | 6 | 9 |
| Total, serious adverse events | Arm B (DOXIL, GEM, TOPA, TAXOL) | 2 | 5 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA015083 | Mayo Clinic Comprehensive Cancer Center Support Grant | WILLMAN, CHERYL LYNN | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A (MV-NIS) vs Arm B (DOXIL, GEM, TOPA, TAXOL): Overall Survival | Trial comparisons |
| Arm A (MV-NIS) vs Arm B (DOXIL, GEM, TOPA, TAXOL): Objective Response Rate | Trial comparisons |
| Arm A (MV-NIS) vs Arm B (DOXIL, GEM, TOPA, TAXOL): Progression-free Survival | Trial comparisons |
| Arm A (MV-NIS) vs Arm B (DOXIL, GEM, TOPA, TAXOL): deaths from any cause | Trial comparisons |
| Arm A (MV-NIS) vs Arm B (DOXIL, GEM, TOPA, TAXOL): Incidence of Adverse Events Per Common Terminology Criteria for Adverse Events Version 4.0 | Trial comparisons |
| Arm A (MV-NIS) vs Arm B (DOXIL, GEM, TOPA, TAXOL): 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/NCT02364713
GET https://conductscience.org/api/trials/v1/NCT02364713/events?page=2