Last reviewed · How we verify

NCT02068794

MV-NIS Infected Mesenchymal Stem Cells in Treating Recurrent Ovarian, Primary Peritoneal or Fallopian Tube Cancer

Active, enrolled Phase 1, PHASE2 Results posted Last updated 18 November 2025
What this trial tests

Phase 1, PHASE2 trial testing Laboratory Biomarker Analysis in Fallopian Tube Clear Cell Adenocarcinoma in 34 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
25 April 2014
Primary endpoint
15 March 2024
1 September 2026

Quick facts

Lead sponsorMayo Clinic
PhasePhase 1, PHASE2
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment34
Start date25 April 2014
Primary completion15 March 2024
Estimated completion1 September 2026
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Mayo Clinic

Who can join

18 and older, any sex, with Fallopian Tube Clear Cell Adenocarcinoma or Fallopian Tube Endometrioid Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Count of Participants That Experience a DLT Primary · 28 days

Maximum tolerated dose will be defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients (at least 2 of a maximum of 6 new patients).

GroupValue95% CI
Phase I Dose Level 00
Phase I Dose Level 10
Overall Survival at 12 Months Primary · 12 months

The proportion of patients that were followed and alive at 12 months post registration.

GroupValue95% CI
Phase I and II (Dose Level 1)0.692
4 Month Progression Free Survival Rate Secondary · 4 months

Defined as the proportion of patients alive and progression free at 4 months.

GroupValue95% CI
Phase I and II (Dose Level 1)0.769

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were followed for 8 months and mortality was followed for 5 years.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Phase I Dose Level 0
Serious: 0/4 (0%)
Deaths: 4/4
Phase I Dose Level 1
Serious: 0/7 (0%)
Deaths: 5/7
Phase II (Dose Level 1)
Serious: 4/23 (17%)
Deaths: 14/23

Serious adverse events (3 terms)

ReactionSystemPhase I Dose Level 0Phase I Dose Level 1Phase II (Dose Level 1)
Small intestinal obstructionGastrointestinal disorders
Infections and infestations - Oth specInfections and infestations
Hip fractureInjury, poisoning and procedural complications
Other adverse events (23 terms — click to expand)

ReactionSystemPhase I Dose Level 0Phase I Dose Level 1Phase II (Dose Level 1)
Abdominal painGastrointestinal disorders
DiarrheaGastrointestinal disorders
DyspneaRespiratory, thoracic and mediastinal disorders
FlatulenceGastrointestinal disorders
NauseaGastrointestinal disorders
FeverGeneral disorders
Platelet count decreasedInvestigations
White blood cell decreasedInvestigations
VomitingGastrointestinal disorders
ChillsGeneral disorders
Lymphocyte count decreasedInvestigations
Neutrophil count decreasedInvestigations
FatigueGeneral disorders
Activated partial throm time prolongedInvestigations
Alkaline phosphatase increasedInvestigations
ConstipationGastrointestinal disorders
AnorexiaMetabolism and nutrition disorders
DehydrationMetabolism and nutrition disorders
HyponatremiaMetabolism and nutrition disorders
MyalgiaMusculoskeletal and connective tissue disorders
AlopeciaSkin and subcutaneous tissue disorders
Rash maculo-papularSkin and subcutaneous tissue disorders
HypertensionVascular disorders

Most-reported serious reactions: Small intestinal obstruction, Infections and infestations - Oth spec, Hip fracture.

Data from ClinicalTrials.gov NCT02068794 adverse events section.

Sponsor's own description

This phase I/II trial studies the side effects and best dose of oncolytic measles virus encoding thyroidal sodium iodide symporter (MV-NIS) infected mesenchymal stem cells and to see how well it works in treating patients with ovarian, primary peritoneal or fallopian tube cancer that has come back. Mesenchymal stem cells may be able to carry tumor-killing substances directly to ovarian, primary peritoneal and fallopian tube cancer cells.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Shattering barriers toward clinically meaningful MSC therapies.
    Levy O, Kuai R, Siren EMJ, Bhere D, et al · · 2020 · cited 501× · PMID 32832666 · DOI 10.1126/sciadv.aba6884
  2. Challenges and advances in clinical applications of mesenchymal stromal cells.
    Zhou T, Yuan Z, Weng J, Pei D, et al · · 2021 · cited 489× · PMID 33579329 · DOI 10.1186/s13045-021-01037-x
  3. Intratumoral microbiota: roles in cancer initiation, development and therapeutic efficacy.
    Yang L, Li A, Wang Y, Zhang Y. · · 2023 · cited 299× · PMID 36646684 · DOI 10.1038/s41392-022-01304-4
  4. Stromal cells in the tumor microenvironment: accomplices of tumor progression?
    Zhao Y, Shen M, Wu L, Yang H, et al · · 2023 · cited 271× · PMID 37666813 · DOI 10.1038/s41419-023-06110-6
  5. Engineering the next generation of cell-based therapeutics.
    Bashor CJ, Hilton IB, Bandukwala H, Smith DM, et al · · 2022 · cited 271× · PMID 35637318 · DOI 10.1038/s41573-022-00476-6
  6. Mesenchymal stem/stromal cells in cancer therapy.
    Lan T, Luo M, Wei X. · · 2021 · cited 251× · PMID 34789315 · DOI 10.1186/s13045-021-01208-w
  7. Therapeutic Potential of Mesenchymal Stem Cells for Cancer Therapy.
    Hmadcha A, Martin-Montalvo A, Gauthier BR, Soria B, et al · · 2020 · cited 241× · PMID 32117924 · DOI 10.3389/fbioe.2020.00043
  8. Concise Review: Cancer Cells, Cancer Stem Cells, and Mesenchymal Stem Cells: Influence in Cancer Development.
    Papaccio F, Paino F, Regad T, Papaccio G, et al · · 2017 · cited 222× · PMID 29072369 · DOI 10.1002/sctm.17-0138

Verify or expand the search:

Other trials of Laboratory Biomarker Analysis

Trials testing the same drug.

Other recruiting trials for Fallopian Tube Clear Cell Adenocarcinoma

Currently open trials in the same condition.

Other Mayo Clinic trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02068794.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing