Clinical trial NCT05243524: Maveropepimut-S (MVP-S) and Low-Dose CPA in Patients With Platinum-Resistant Ovarian Cancer
Official title: Phase 2b Single Arm Study of Maveropepimut-S and Low-Dose Cyclophosphamide in Subjects With Platinum-Resistant, Epithelial Ovarian Cancer.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Platinum-resistant Epithelial Ovarian Cancer
Keywords: T cell education
DPX-Survivac
Immunotherapy
Platinum-resistant (PROC)
High grade serous (HGSOC)
Lead sponsor: ImmunoVaccine Technologies, Inc. (IMV Inc.)
Sponsor class: INDUSTRY
First posted: 2022-02-17
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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).

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

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: up to 13 months
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: up to 13 months
measure: Duration of Response (DOR)
timeFrame: up to 23 months
measure: Disease Control Rate (DCR)
timeFrame: up to 13 months
measure: Time to Progression (TTP)
timeFrame: up to 23 months
measure: Progression Free Survival (PFS)
timeFrame: up to 23 months
measure: Progression Free Survival (6m PFS)
timeFrame: at 6 months
measure: Overall Survival (OS)
timeFrame: up to 23 months
measure: CA-125 Response
timeFrame: up to 13 months
measure: Frequency of adverse events
timeFrame: up to 13 months
Other outcomes:
measure: Cell mediated immune response
timeFrame: up to 13 months
measure: Changes in Tumor Micro-environment (TME)
timeFrame: up to 2 months
Locations:
city: Palo Alto
country: United States
facility: Stanford Health Care
state: California
city: Ocala
country: United States
facility: Ocala Oncology
state: Florida
city: Mineola
country: United States
facility: NYU Langone Hospital-Long Island
state: New York
city: New York
country: United States
facility: NYU Langone: Laura and Isaac Perlmutter Cancer Center
state: New York
city: Montréal
country: Canada
facility: CHUM - Centre hospitalier de l'Université de Montréal
state: Quebec
city: San Juan
country: Puerto Rico
facility: PanOncology Trials
Study officials:
References: