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

Platinum-resistant Epithelial Ovarian Cancer Clinical Trial

— AVALON  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05243524
• Other study ID #: P1606-SUR-O25
• Status: Terminated
• Phase: Phase 2
• Start date: August 5, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: September 2023
• Source: ImmunoVaccine Technologies, Inc. (IMV Inc.)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: August 31, 2023
• Est. primary completion date: July 24, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Neoplasms
• Platinum-resistant Epithelial Ovarian Cancer

Intervention

Other:
• Maveropepimut-S
SC injection on days 7, 28, then q8w

Drug:
• Cyclophosphamide 50mg
PO BID, one week on, one week off

Locations

Country	Name	City	State
Canada	CHUM - Centre hospitalier de l'Université de Montréal	Montréal	Quebec
Puerto Rico	PanOncology Trials	San Juan
United States	NYU Langone Hospital-Long Island	Mineola	New York
United States	NYU Langone: Laura and Isaac Perlmutter Cancer Center	New York	New York
United States	Ocala Oncology	Ocala	Florida
United States	Stanford Health Care	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
ImmunoVaccine Technologies, Inc. (IMV Inc.)

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cell mediated immune response	analysis of PBMC/plasma samples	up to 13 months
Other	Changes in Tumor Micro-environment (TME)	analysis of paired biopsies	up to 2 months
Primary	Objective Response Rate (ORR)	per RECIST v1.1 criteria	up to 13 months
Secondary	Objective Response Rate (ORR)	per iRECIST criteria	up to 13 months
Secondary	Duration of Response (DOR)		up to 23 months
Secondary	Disease Control Rate (DCR)		up to 13 months
Secondary	Time to Progression (TTP)		up to 23 months
Secondary	Progression Free Survival (PFS)		up to 23 months
Secondary	Progression Free Survival (6m PFS)		at 6 months
Secondary	Overall Survival (OS)		up to 23 months
Secondary	CA-125 Response	monthly measurements	up to 13 months
Secondary	Frequency of adverse events	graded using NCI CTCAE v5.0	up to 13 months