Ovarian Cancer Clinical Trial

Study of DPX-Survivac Therapy in Patients With Recurrent Ovarian Cancer

Summary

T cell activating therapy DPX-Survivac, low dose oral cyclophosphamide, and IDO1 inhibitor epacadostat will be tested together for the first time in patients with recurrent ovarian, fallopian tube, or peritoneal cancer to determine the safety and potential immune-modulating activity of the combination of these agents.

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Full Description

The Phase 1b component is a multicenter, non-randomized, open label, uncontrolled, safety and effectiveness study to identify the recommended Phase 2 dose (R2PD) of epacadostat in combination with DPX-Survivac and cyclophosphamide.

The Phase 2 component was initially a multicenter, randomized, open-label study to evaluate the safety and effectiveness of DPX-Survivac + cyclophosphamide with or without the RP2D of epacadostat. The design of the study has been amended to a single arm study in which up to 16 evaluable subjects will be enrolled to received DPX-Survivac plus intermittent low dose cyclophosphamide (i.e. treatment arm 2).

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Eligibility Criteria

Key Inclusion Criteria:

Histologically confirmed, stage IIc-IV epithelial ovarian, fallopian tube or peritoneal cancer
Platinum-resistant or -sensitive subjects after completing first-line treatment (debulking surgery and adjuvant or neoadjuvant treatment with standard of care treatment such as carboplatin and paclitaxel). Subjects may have had any number of subsequent lines of chemotherapy.
Must have evidence of progressive disease with either biochemical (i.e. rising CA-125) and/or radiologic progression
Must have measurable disease by RECIST v1.1, a successful pre-treatment tumor biopsy, and be willing to undergo tumor biopsy during treatment
Ambulatory with an ECOG 0-1
Life expectancy ≥ 6 months
Meet protocol-specified laboratory requirements

Key Exclusion Criteria:

Eligible for otherwise curative treatment or undergoing concurrent therapy
Prior receipt of survivin based vaccines or immune checkpoint inhibitors (e.g. anti-CTLA-4, anti-PD-1, anti-PD-L1, or any other antibody or drug specifically targeting T cell co-stimulation) or an IDO inhibitor
Concurrent second malignancy other than non-melanoma skin cancer, cervical carcinoma in situ, or controlled bladder cancer
Clinical ascites
Any single lesion greater than or equal to 4 cm (per RECIST v1.1)
Malignant bowel obstruction
History of autoimmune disease requiring treatment within the last two years (except vitiligo or diabetes)
Recent history of thyroiditis
Presence of a serious acute infection or chronic infection
Active central nervous system (CNS) or leptomeningeal metastasis (brain metastases)
GI condition that might limit absorption of oral agents
Other serious intercurrent chronic or acute illness, including myocardial infarction or cerebrovascular event within 6 months
Ongoing treatment with steroid therapy or other immunosuppressive
Receipt of monoamine oxidase inhibitors (MAOIs) or UGT1A9 inhibitors
Receipt of live attenuated vaccines
Acute or chronic skin and/or microvascular disorders
Edema or lymphedema in the lower limbs > grade 2

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

85

Study ID:

NCT02785250

Recruitment Status:

Active, not recruiting

Sponsor:

ImmunoVaccine Technologies, Inc. (IMV Inc.)

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There are 8 Locations for this study

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Stanford University
Palo Alto California, 94304, United States
Georgia Cancer Center at Augusta University
Augusta Georgia, 30912, United States
Lenox Hill Hospital
New York New York, 10028, United States
Oregon Health & Sciences University, Knight Cancer Institute
Portland Oregon, 97239, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Mary Crowley Cancer Research Center
Dallas Texas, 75230, United States
Tom Baker Cancer Centre
Calgary Alberta, , Canada
Princess Margaret Hospital
Toronto Ontario, M5G 2, Canada
Centre Hospitalier de l'Université de Montréal (CHUM)
Montréal Quebec, H2X 3, Canada

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

85

Study ID:

NCT02785250

Recruitment Status:

Active, not recruiting

Sponsor:


ImmunoVaccine Technologies, Inc. (IMV Inc.)

How clear is this clinincal trial information?

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