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

• ClinicalTrials.gov Identifier: NCT02785250
• Recruitment Status: Active, not recruiting
• First Posted: May 27, 2016
• Last Update Posted: June 18, 2021
• Sponsor: ImmunoVaccine Technologies, Inc. (IMV Inc.)
• Collaborator: Incyte Corporation
• Information provided by (Responsible Party): ImmunoVaccine Technologies, Inc. (IMV Inc.)

Tracking Information

• First Submitted Date: May 18, 2016
• First Posted Date: May 27, 2016
• Last Update Posted Date: June 18, 2021
• Study Start Date: April 2016
• Actual Primary Completion Date: October 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 29, 2019)

• Safety as measured by adverse event reporting (CTCAE) [ Time Frame: up to 13 months ]
• Objective Response Rate (Phase 2 only) [ Time Frame: up to 13 months ]
  Evaluated using modified RECIST v1.1

Original Primary Outcome Measures (submitted: May 24, 2016)

• Safety as measured by adverse event reporting (CTCAE) [ Time Frame: up to 13 months ]
• Cell mediated immunity as measured by the antigen specific response in peripheral blood [ Time Frame: bimonthly for up to 13 months ]
• Evaluation of treatment-induced changes in tumor infiltrating lymphocytes [ Time Frame: at 8 to 10 weeks ]

Current Secondary Outcome Measures (submitted: January 29, 2019)

• Objective Response Rate (for each treatment group) [ Time Frame: up to 13 months ]
  Evaluated using modified RECIST v1.1
• Duration of Response [ Time Frame: up to 13 months ]
• Cell mediated immunity as measured by the antigen specific response in peripheral blood [ Time Frame: bimonthly for up to 13 months ]
• Evaluation of treatment-induced changes in tumor infiltrating lymphocytes [ Time Frame: at 8 to 10 weeks ]
• Time to Progression [ Time Frame: up to 13 months ]
• Overall Survival [ Time Frame: up to 13 months ]

Original Secondary Outcome Measures (submitted: May 24, 2016)

• Objective Response Rate [ Time Frame: up to 13 months ]
  Evaluated using modified RECIST v1.1
• Duration of Response [ Time Frame: up to 13 months ]
• Time to Progression [ Time Frame: up to 13 months ]
• Overall Survival [ Time Frame: up to 13 months ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of DPX-Survivac Therapy in Patients With Recurrent Ovarian Cancer
• 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
• 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).

• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Recurrent Epithelial Ovarian Cancer
• Recurrent Fallopian Tube Cancer
• Recurrent Peritoneal Cancer

Intervention

• Other: DPX-Survivac
  SubQ injection
• Drug: Cyclophosphamide
  PO BID
• Drug: Epacadostat (INCB024360)
  PO BID

Study Arms

• Experimental: Arm 1
  DPX-Survivac, Cyclophosphamide, Epacadostat (Phase 1 and initially Phase 2)
  Interventions:

  • Other: DPX-Survivac
  • Drug: Cyclophosphamide
  • Drug: Epacadostat (INCB024360)
• Experimental: Arm 2
  DPX-Survivac, Cyclophosphamide (in Phase 2 only)
  Interventions:

  • Other: DPX-Survivac
  • Drug: Cyclophosphamide

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: September 19, 2018): 85
• Original Estimated Enrollment (submitted: May 24, 2016): 32
• Estimated Study Completion Date: May 2025
• Actual Primary Completion Date: October 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, United States

Administrative Information

• NCT Number: NCT02785250
• Other Study ID Numbers: ONC-DPX-Survivac-06; DeCidE1 ( Other Identifier: Sponsor )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: ImmunoVaccine Technologies, Inc. (IMV Inc.)
• Original Responsible Party: Same as current
• Current Study Sponsor: ImmunoVaccine Technologies, Inc. (IMV Inc.)
• Original Study Sponsor: Same as current
• Collaborators: Incyte Corporation
• Investigators: Not Provided
• PRS Account: ImmunoVaccine Technologies, Inc. (IMV Inc.)
• Verification Date: June 2021