Platinum-resistant Epithelial Ovarian Cancer
Conditions
Keywords
T cell education, DPX-Survivac, Immunotherapy, Platinum-resistant (PROC), High grade serous (HGSOC)
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).
Interventions
OTHERMaveropepimut-S
SC injection on days 7, 28, then q8w
PO BID, one week on, one week off
Sponsors
ImmunoVaccine Technologies, Inc. (IMV Inc.)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | up to 13 months | per RECIST v1.1 criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | up to 13 months | per iRECIST criteria |
| Duration of Response (DOR) | up to 23 months | — |
| Disease Control Rate (DCR) | up to 13 months | — |
| Time to Progression (TTP) | up to 23 months | — |
| Progression Free Survival (PFS) | up to 23 months | — |
| CA-125 Response | up to 13 months | monthly measurements |
| Frequency of adverse events | up to 13 months | graded using NCI CTCAE v5.0 |
| Progression Free Survival (6m PFS) | at 6 months | — |
| Overall Survival (OS) | up to 23 months | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cell mediated immune response | up to 13 months | analysis of PBMC/plasma samples |
| Changes in Tumor Micro-environment (TME) | up to 2 months | analysis of paired biopsies |
Countries
Canada, Puerto Rico, United States
Outcome results
None listed