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

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ClinicalTrials.gov Identifier: NCT02785250
Recruitment Status : Recruiting
First Posted : May 27, 2016
Last Update Posted : January 31, 2019
Sponsor:
Collaborator:
Incyte Corporation
Information provided by (Responsible Party):
ImmunoVaccine Technologies, Inc. (IMV Inc.)

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.

Condition or disease Intervention/treatment Phase
Recurrent Epithelial Ovarian Cancer Recurrent Fallopian Tube Cancer Recurrent Peritoneal Cancer Other: DPX-Survivac Drug: Cyclophosphamide Drug: Epacadostat (INCB024360) Phase 1 Phase 2

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : April 2016
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: Arm 1
DPX-Survivac, Cyclophosphamide, Epacadostat (Phase 1 and initially Phase 2)
Other: DPX-Survivac
SubQ injection

Drug: Cyclophosphamide
PO BID

Drug: Epacadostat (INCB024360)
PO BID

Experimental: Arm 2
DPX-Survivac, Cyclophosphamide (in Phase 2 only)
Other: DPX-Survivac
SubQ injection

Drug: Cyclophosphamide
PO BID




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


Secondary Outcome Measures :
  1. Objective Response Rate (for each treatment group) [ Time Frame: up to 13 months ]
    Evaluated using modified RECIST v1.1

  2. Duration of Response [ Time Frame: up to 13 months ]
  3. Cell mediated immunity as measured by the antigen specific response in peripheral blood [ Time Frame: bimonthly for up to 13 months ]
  4. Evaluation of treatment-induced changes in tumor infiltrating lymphocytes [ Time Frame: at 8 to 10 weeks ]
  5. Time to Progression [ Time Frame: up to 13 months ]
  6. Overall Survival [ Time Frame: up to 13 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02785250


Locations
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United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Alma Gonzalez    650-498-0624    agonlez@stanford.edu   
United States, Georgia
Georgia Cancer Center at Augusta University Recruiting
Augusta, Georgia, United States, 30912
Contact: Sandra Wall, BSN    706-721-4430    swall@augusta.edu   
United States, New York
Lenox Hill Hospital Recruiting
New York, New York, United States, 10028
Contact: Virgenimina Lugaro    212-434-6626    VLugaro@northwell.edu   
Contact: Jeannine Villella, MD       Jvillella@northwell.edu   
Principal Investigator: Jeannine Villella, MD         
United States, Oregon
Oregon Health & Sciences University, Knight Cancer Institute Recruiting
Portland, Oregon, United States, 97239
Contact: Knight Clinical Trials Information Line    503-494-1080    trials@ohsu.edu   
Principal Investigator: Tanja Pejovic, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Linda Crossette    215-662-2487    linda.crossette@pennmedicine.upenn.edu   
United States, Texas
Mary Crowley Cancer Research Center Recruiting
Dallas, Texas, United States, 75230
Contact: Referral Office    972-566-3000    referral@marycrowley.org   
Contact: James Strauss, MD    972-566-3000    JStrauss@MaryCrowley.Org   
Principal Investigator: James Strauss, MD         
Canada, Alberta
Tom Baker Cancer Centre Recruiting
Calgary, Alberta, Canada
Contact: Minna Gill, BSN    403-521-3149    minna.gill@ahs.ca   
Canada, Ontario
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Amit Oza, MD    416-946-2818    amit.oza@uhn.ca   
Contact: Angela Rodriguez       Angela.Rodriguez@uhn.ca   
Principal Investigator: Amit Oza, MD         
Sponsors and Collaborators
ImmunoVaccine Technologies, Inc. (IMV Inc.)
Incyte Corporation

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Responsible Party: ImmunoVaccine Technologies, Inc. (IMV Inc.)
ClinicalTrials.gov Identifier: NCT02785250     History of Changes
Other Study ID Numbers: ONC-DPX-Survivac-06
DeCidE1 ( Other Identifier: Sponsor )
First Posted: May 27, 2016    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Keywords provided by ImmunoVaccine Technologies, Inc. (IMV Inc.):
T cell activation
immunotherapy
ovarian
fallopian tube
peritoneal
cancer
recurrent
tumor
measurable
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Fallopian Tube Diseases
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists