Ovarian Cancer Clinical Trial

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

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.

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Full 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 anti-cancer therapy.

MVP-S, previously called DPX-Survivac, was recently evaluated in a small Phase 2 single arm study of ovarian cancer patients known as DeCidE1 (NCT02785250).

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Eligibility Criteria

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

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

73

Study ID:

NCT05243524

Recruitment Status:

Recruiting

Sponsor:

ImmunoVaccine Technologies, Inc. (IMV Inc.)

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There are 2 Locations for this study

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Ocala Oncology
Ocala Florida, 34474, United States More Info
Vippin Shetty
Contact
352-547-1954
[email protected]
Ketan Doshi, MD
Principal Investigator
NYU Langone Hospital-Long Island
Mineola New York, 11501, United States More Info
Kathryn Devlin, RN
Contact
516-663-1871
[email protected]
Eva Chalas, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

73

Study ID:

NCT05243524

Recruitment Status:

Recruiting

Sponsor:


ImmunoVaccine Technologies, Inc. (IMV Inc.)

How clear is this clinincal trial information?

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