Status:
TERMINATED
Maveropepimut-S (MVP-S) and Low-Dose CPA in Patients With Platinum-Resistant Ovarian Cancer
Lead Sponsor:
ImmunoVaccine Technologies, Inc. (IMV Inc.)
Conditions:
Platinum-resistant Epithelial Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
A Simon two-stage statistical design to assess MVP-S in combination with low dose CPA in platinum-resistant epithelial ovarian cancer patients who have received no greater than 4 previous lines of ant...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
August 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2023
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT05243524
Start Date
August 5 2022
End Date
August 31 2023
Last Update
September 13 2023
Active Locations (6)
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1
Stanford Health Care
Palo Alto, California, United States, 94305
2
Ocala Oncology
Ocala, Florida, United States, 34474
3
NYU Langone Hospital-Long Island
Mineola, New York, United States, 11501
4
NYU Langone: Laura and Isaac Perlmutter Cancer Center
New York, New York, United States, 10016