Maveropepimut-S (MVP-S) and Low-Dose CPA in Patients With Platinum-Resistant Ovarian Cancer (NCT05243524) | Clinical Trial Compass
TerminatedPhase 2
Maveropepimut-S (MVP-S) and Low-Dose CPA in Patients With Platinum-Resistant Ovarian Cancer
Stopped: Closure of IMV operations
United States, Canada16 participantsStarted 2022-08-05
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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 ye…
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: up to 13 months
Trial details
NCT IDNCT05243524
SponsorImmunoVaccine Technologies, Inc. (IMV Inc.)