Maveropepimut-S (MVP-S) and Low-Dose CPA in Patients With Platinum-Resistant Ovarian Cancer

Trial ID or NCT#

NCT05243524

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

Phase 2b Single Arm Study of Maveropepimut-S and Low-Dose Cyclophosphamide in Subjects With Platinum-Resistant, Epithelial Ovarian Cancer.

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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
    1. Key
Exclusion Criteria:
  1. * 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
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Investigator(s)

Oliver Dorigo, M.D., Ph.D.
Oliver Dorigo, M.D., Ph.D.
Gynecologic oncologist, Medical oncologist, Gynecologic oncologist
Mary Lake Polan Professor

Contact us to find out if this trial is right for you.

Contact

Alaina Poe
650-724-3308

View on ClinicalTrials.gov