About the study

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.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

1. Stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer, histologically diagnosed high-grade serous
2. 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.
3. Received ≤ 4 prior lines of anti-cancer therapy for ovarian cancer, including at least one platinum-based therapy
4. Evidence of progressive disease
5. 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.
6. Completed pre-treatment tumor biopsy and willing to undergo on-treatment tumor biopsy
7. ECOG 0-1
8. Live expectancy ≥ 6 months
9. Meet protocol-specified laboratory requirements Key

Exclusion criteria

1. Concurrent chemotherapy drugs, anti-cancer therapy or anti-neoplastic hormonal therapy, or radiotherapy
2. Prior receipt of survivin-based vaccines/therapy, immune checkpoint inhibitors, IDO inhibitor, or cell-based therapy
3. Non-epithelial tumor origin of the ovary, fallopian tube, or peritoneum
4. Clinical ascites
5. Concurrent second malignancy other than basal or squamous cell skin cancer, cervical carcinoma in situ, or Stage I or II caner in complete remission
6. GI condition that might limit absorption of oral agents
7. Recent history of thyroiditis
8. History of autoimmune disease requiring treatment within the last two years (except paraneoplastic syndrome, vitiligo, or diabetes)
9. History of bowel obstruction related to the disease
10. Presence of a serious acute infection or chronic infection
11. Uncontrolled concurrent illness or history of significant cardiac or pulmonary disfunction
12. Myocardial infarction or cerebrovascular event within past 6 months
13. Known central nervous system (CNS) or leptomeningeal metastasis (brain metastases)
14. Clinically significant illness or major surgery within past 28 days or anticipated need for major surgery during study treatment
15. Ongoing treatment with steroid therapy or other immunosuppressive
16. Receipt of live attenuated vaccines
17. Edema or lymphedema in the lower limbs > grade 2
18. Acute or chronic skin and/or microvascular disorders

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.