Education and Training

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

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.

Stanford is currently not accepting patients for this trial.

Intervention(s):

  • other: Maveropepimut-S
  • drug: Cyclophosphamide 50mg

Eligibility


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Alaina Poe
650-724-3308
Not Recruiting