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

Immunovaccine

Status and phase: Terminated; Phase 2

Conditions: Platinum-resistant Epithelial Ovarian Cancer

Treatments: Other: Maveropepimut-S; Drug: Cyclophosphamide 50mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT05243524

P1606-SUR-O25

Details and patient eligibility

About

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.

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).

Enrollment: 16 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

MVP-S + CPA

Experimental group

Description:

All subjects will receive two doses of maveropepimut-S (q3w) followed by up to six doses (q8w) plus low-dose cyclophosphamide on a repeating cycle of one week on/one week off.

Treatment:

Drug: Cyclophosphamide 50mg

Other: Maveropepimut-S