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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02785250
Recruitment Status : Active, not recruiting
First Posted : May 27, 2016
Last Update Posted : January 9, 2020
Sponsor:
Collaborator:
Incyte Corporation
Information provided by (Responsible Party):
ImmunoVaccine Technologies, Inc. (IMV Inc.)

Tracking Information
First Submitted Date  ICMJE May 18, 2016
First Posted Date  ICMJE May 27, 2016
Last Update Posted Date January 9, 2020
Study Start Date  ICMJE April 2016
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Study of DPX-Survivac Therapy in Patients With Recurrent Ovarian Cancer
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Recurrent Epithelial Ovarian Cancer
  • Recurrent Fallopian Tube Cancer
  • Recurrent Peritoneal Cancer
Intervention  ICMJE
  • Other: DPX-Survivac
    SubQ injection
  • Drug: Cyclophosphamide
    PO BID
  • Drug: Epacadostat (INCB024360)
    PO BID
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 19, 2018)
85
Original Estimated Enrollment  ICMJE
 (submitted: May 24, 2016)
32
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02785250
Other Study ID Numbers  ICMJE ONC-DPX-Survivac-06
DeCidE1 ( Other Identifier: Sponsor )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ImmunoVaccine Technologies, Inc. (IMV Inc.)
Study Sponsor  ICMJE ImmunoVaccine Technologies, Inc. (IMV Inc.)
Collaborators  ICMJE Incyte Corporation
Investigators  ICMJE Not Provided
PRS Account ImmunoVaccine Technologies, Inc. (IMV Inc.)
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP