Clinical trial · Interventional
Maveropepimut-S (MVP-S) and Low-Dose CPA in Patients With Platinum-Resistant Ovarian Cancer
Phase 2b Single Arm Study of Maveropepimut-S and Low-Dose Cyclophosphamide in Subjects With Platinum-Resistant, Epithelial Ovarian Cancer.
NCT05243524CI-TRIAL-00069515AVALONterminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Closure of IMV operations
Summary
Brief summary (as posted)
Phase 2, single arm, study to assess the efficacy and safety of maveropepimut-S (MVP-S) and low-dose cyclophosphamide (CPA) in subjects with recurrent, platinum resistant ovarian cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Platinum-resistant Epithelial Ovarian Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide 50mg | Drug | Cyclophosphamide | ALIAS |
| Maveropepimut-S | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MVP-S + CPA
- description
- All subjects will receive two doses of maveropepimut-S (q3w) followed by up to six doses (q8w) plus low-dose cyclophosphamide on a repeating cycle of one week on/one week off.
- interventionNames
- Other: Maveropepimut-S
- Drug: Cyclophosphamide 50mg
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- up to 13 months
- description
- per RECIST v1.1 criteria
Secondary outcomes (9)
- measure
- Objective Response Rate (ORR)
- timeFrame
- up to 13 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer, histologically diagnosed high-grade serous * Platinum-resistant disease (relapsing within 3-6 months after completion of initial platinum-based treatment). Patients progressing at any time on or after ≥ 2nd platinum-based therapy are eligible. * Received ≤ 4 prior lines of anti-cancer therapy for ovarian cancer, including at least one platinum-based therapy * Evidence of progressive disease * Measurable disease (RECIST v1.1) with at least one non-target lesion accessible by image-guided biopsy. No single lesion may be larger than 4 cm in diameter. * Completed pre-treatment tumor biopsy and willing to undergo on-treatment tumor biopsy * ECOG 0-1 * Live expectancy ≥ 6 months * Meet protocol-specified laboratory requirements Key Exclusion Criteria: * Concurrent chemotherapy drugs, anti-cancer therapy or anti-neoplastic hormonal therapy, or radiotherapy * Prior receipt of survivin-based vaccines/therapy, immune checkpoint inhibitors, IDO inhibitor, or cell-based therapy * Non-epithelial tumor origin of the ovary, fallopian tube, or peritoneum * Clinical ascites * Concurrent second malignancy other than basal or squamous cell skin cancer, cervical carcinoma in situ, or Stage I or II caner in complete remission * GI condition that might limit absorption of oral agents * Recent history of thyroiditis * History of autoimmune disease requiring treatment within the last two years (except paraneoplastic syndrome, vitiligo, or diabetes) * History of bowel obstruction related to the disease * Presence of a serious acute infection or chronic infection * Uncontrolled concurrent illness or history of significant cardiac or pulmonary disfunction * Myocardial infarction or cerebrovascular event within past 6 months * Known central nervous system (CNS) or leptomeningeal metastasis (brain metastases) * Clinically significant illness or major surgery within past 28 days or anticipated need for major surgery during study treatment * Ongoing treatment with steroid therapy or other immunosuppressive * Receipt of live attenuated vaccines * Edema or lymphedema in the lower limbs \> grade 2 * Acute or chronic skin and/or microvascular disorders
References
Publications (0)
Data not yet available
No reference posted for this study.