Clinical trial · Interventional
Open Label Immunotherapy of Myoma
Open Label Phase II Clinical Trial of Myoma Immunotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Myoma of the uterus or uterine fibroids are benign tumors that appears in the myometrium or the muscular layer of the uterus. It is one of the most common diseases in pre-climax women, reaching 12-25% of all gynecological diseases. There is an opinion that the true prevalence of myoma is much larger and reaches up to 80%, i.e., practically every second woman has it, often without knowing about. For the treatment of MM, surgical removal of the nodes or removal of the uterus is used. In addition, GnRH-agonist therapy is practiced, as well as embolization to block blood flow in the tumor. We propose to evaluate the immunotherapy approach in an open label Phase II study in 20 women with myoma, for whom no alternative therapy is available.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fibroid Uterus | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
| Fibroma | Fibroma | ONTOLOGY_EXACT | 0.98 |
| Leiomyoma | Leiomyoma | ONTOLOGY_EXACT | 0.98 |
| Myoma;Uterus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| V3-Myoma | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm receiving V3-Myoma
- description
- A single oral pill of V3-Myoma therapeutic vaccine containing pooled antigens circulating in peripheral blood and within myoma tissues
- interventionNames
- Biological: V3-Myoma
Primary outcomes (1)
- measure
- Change in tumor size compared to baseline
- timeFrame
- Once monthly for three months
- description
- This parameter will be evaluated by pelvic examination and transvaginal ultrasonography
Secondary outcomes (3)
- measure
- Changes in bleeding pattern at and between menstruations
- timeFrame
- During and between periods for three months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: diagnosed myoma with single or multiple tumors presence of typical clinical symptoms associated with myoma - Exclusion Criteria: other gynecological diseases not related to myoma hysterectomy \-
References
Publications (0)
Data not yet available