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

Recurrent Fallopian Tube Cancer Clinical Trial

Official title:

A Phase 1b/2 Study of an Immunotherapeutic Vaccine, DPX-Survivac With Low Dose Cyclophosphamide and Epacadostat (INCB024360) in Patients With Recurrent Ovarian Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02785250
• Other study ID #: ONC-DPX-Survivac-06
• Secondary ID: DeCidE1
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: April 2016
• Est. completion date: May 2025

Study information

• Verified date: June 2021
• Source: ImmunoVaccine Technologies, Inc. (IMV Inc.)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 85
• Est. completion date: May 2025
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Fallopian Tube Neoplasms
• Ovarian Neoplasms
• Recurrent Epithelial Ovarian Cancer
• Recurrent Fallopian Tube Cancer
• Recurrent Peritoneal Cancer

Intervention

Other:
• DPX-Survivac
SubQ injection

Drug:
• Cyclophosphamide
PO BID
• Epacadostat (INCB024360)
PO BID

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	Centre Hospitalier de l'Université de Montréal (CHUM)	Montréal	Quebec
Canada	Princess Margaret Hospital	Toronto	Ontario
United States	Georgia Cancer Center at Augusta University	Augusta	Georgia
United States	Mary Crowley Cancer Research Center	Dallas	Texas
United States	Lenox Hill Hospital	New York	New York
United States	Stanford University	Palo Alto	California
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Oregon Health & Sciences University, Knight Cancer Institute	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
ImmunoVaccine Technologies, Inc. (IMV Inc.)	Incyte Corporation

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety as measured by adverse event reporting (CTCAE)		up to 13 months
Primary	Objective Response Rate (Phase 2 only)	Evaluated using modified RECIST v1.1	up to 13 months
Secondary	Objective Response Rate (for each treatment group)	Evaluated using modified RECIST v1.1	up to 13 months
Secondary	Duration of Response		up to 13 months
Secondary	Cell mediated immunity as measured by the antigen specific response in peripheral blood		bimonthly for up to 13 months
Secondary	Evaluation of treatment-induced changes in tumor infiltrating lymphocytes		at 8 to 10 weeks
Secondary	Time to Progression		up to 13 months
Secondary	Overall Survival		up to 13 months