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

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 Phase

Phase 1/Phase 2

Study Type

Interventional

Primary Outcome

Safety as measured by adverse event reporting (CTCAE)

Secondary Outcome

 Objective Response Rate (for each treatment group)

Condition

Recurrent Epithelial Ovarian Cancer

Intervention

DPX-Survivac

Study Arms / Comparison Groups

 Arm 1

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Other

Estimated Enrollment

Start Date

April 2016

Completion Date

December 2020

Primary Completion Date

February 2020

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

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

Canada

Location Countries

Canada

Administrative Informations

NCT ID

NCT02785250

Organization ID

ONC-DPX-Survivac-06

Secondary IDs

DeCidE1

Responsible Party

Sponsor

Study Sponsor

ImmunoVaccine Technologies, Inc. (IMV Inc.)

Collaborators

 Incyte Corporation

Study Sponsor

, ,

Verification Date

January 2019