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

NCT ID: NCT02785250

Last Updated: 2021-06-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2025-05-31

Brief 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.

Detailed 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).

Conditions

Recurrent Epithelial Ovarian Cancer; Recurrent Fallopian Tube Cancer; Recurrent Peritoneal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

DPX-Survivac, Cyclophosphamide, Epacadostat (Phase 1 and initially Phase 2)

Group Type: EXPERIMENTAL

DPX-Survivac

Intervention Type: OTHER

SubQ injection

Cyclophosphamide

Intervention Type: DRUG

PO BID

Epacadostat (INCB024360)

Intervention Type: DRUG

PO BID

Arm 2

DPX-Survivac, Cyclophosphamide (in Phase 2 only)

Group Type: EXPERIMENTAL

DPX-Survivac

Intervention Type: OTHER

SubQ injection

Cyclophosphamide

Intervention Type: DRUG

PO BID

Interventions

DPX-Survivac

SubQ injection

Intervention Type: OTHER

Cyclophosphamide

PO BID

Intervention Type: DRUG

Epacadostat (INCB024360)

PO BID

Intervention Type: DRUG

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: collaborator

ImmunoVaccine Technologies, Inc. (IMV Inc.)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Stanford University

Palo Alto, California, United States

Georgia Cancer Center at Augusta University

Augusta, Georgia, United States

Lenox Hill Hospital

New York, New York, United States

Oregon Health & Sciences University, Knight Cancer Institute

Portland, Oregon, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Mary Crowley Cancer Research Center

Dallas, Texas, United States

Tom Baker Cancer Centre

Calgary, Alberta, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

Countries

United States; Canada

Other Identifiers

DeCidE1

Identifier Type: OTHER

Identifier Source: secondary_id

ONC-DPX-Survivac-06

Identifier Type: -

Identifier Source: org_study_id