Clinical Trials /

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

NCT02785250

Description:

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.

Related Conditions:
  • Fallopian Tube Carcinoma
  • Malignant Peritoneal Neoplasm
  • Ovarian Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: ONC-DPX-Survivac-06
  • SECONDARY ID: DeCidE1
  • NCT ID: NCT02785250

Conditions

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

Interventions

DrugSynonymsArms
CyclophosphamideArm 1
Epacadostat (INCB024360)Arm 1

Purpose

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).
    

Trial Arms

NameTypeDescriptionInterventions
Arm 1ExperimentalDPX-Survivac, Cyclophosphamide, Epacadostat (Phase 1 and initially Phase 2)
  • Cyclophosphamide
  • Epacadostat (INCB024360)
Arm 2ExperimentalDPX-Survivac, Cyclophosphamide (in Phase 2 only)
  • Cyclophosphamide

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

          -  The sum of baseline target lesions, measured by RECIST v1.1, must be less than 5 cm.

          -  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 or metastatic pleural fluid

          -  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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety as measured by adverse event reporting (CTCAE)
Time Frame:up to 13 months
Safety Issue:
Description:Evaluated using modified RECIST v1.1

Secondary Outcome Measures

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

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:ImmunoVaccine Technologies, Inc. (IMV Inc.)

Trial Keywords

  • T cell activation
  • immunotherapy
  • ovarian
  • fallopian tube
  • peritoneal
  • cancer
  • recurrent
  • tumor
  • measurable

Last Updated

January 29, 2019