Study of DPX-Survivac Therapy in Patients With Recurrent Ovarian Cancer
Primary Purpose
Recurrent Epithelial Ovarian Cancer, Recurrent Fallopian Tube Cancer, Recurrent Peritoneal Cancer
Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
DPX-Survivac
Cyclophosphamide
Epacadostat (INCB024360)
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Epithelial Ovarian Cancer focused on measuring T cell activation, immunotherapy, ovarian, fallopian tube, peritoneal, cancer, recurrent, tumor, measurable
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
Sites / Locations
- Stanford University
- Georgia Cancer Center at Augusta University
- Lenox Hill Hospital
- Oregon Health & Sciences University, Knight Cancer Institute
- University of Pennsylvania
- Mary Crowley Cancer Research Center
- Tom Baker Cancer Centre
- Princess Margaret Hospital
- Centre Hospitalier de l'Université de Montréal (CHUM)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm 1
Arm 2
Arm Description
DPX-Survivac, Cyclophosphamide, Epacadostat (Phase 1 and initially Phase 2)
DPX-Survivac, Cyclophosphamide (in Phase 2 only)
Outcomes
Primary Outcome Measures
Safety as measured by adverse event reporting (CTCAE)
Objective Response Rate (Phase 2 only)
Evaluated using modified RECIST v1.1
Secondary Outcome Measures
Objective Response Rate (for each treatment group)
Evaluated using modified RECIST v1.1
Duration of Response
Cell mediated immunity as measured by the antigen specific response in peripheral blood
Evaluation of treatment-induced changes in tumor infiltrating lymphocytes
Time to Progression
Overall Survival
Full Information
NCT ID
NCT02785250
First Posted
May 18, 2016
Last Updated
June 16, 2021
Sponsor
ImmunoVaccine Technologies, Inc. (IMV Inc.)
Collaborators
Incyte Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02785250
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 2016 (undefined)
Primary Completion Date
October 2020 (Actual)
Study Completion Date
May 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ImmunoVaccine Technologies, Inc. (IMV Inc.)
Collaborators
Incyte Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Epithelial Ovarian Cancer, Recurrent Fallopian Tube Cancer, Recurrent Peritoneal Cancer
Keywords
T cell activation, immunotherapy, ovarian, fallopian tube, peritoneal, cancer, recurrent, tumor, measurable
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
DPX-Survivac, Cyclophosphamide, Epacadostat (Phase 1 and initially Phase 2)
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
DPX-Survivac, Cyclophosphamide (in Phase 2 only)
Intervention Type
Other
Intervention Name(s)
DPX-Survivac
Intervention Description
SubQ injection
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
PO BID
Intervention Type
Drug
Intervention Name(s)
Epacadostat (INCB024360)
Intervention Description
PO BID
Primary Outcome Measure Information:
Title
Safety as measured by adverse event reporting (CTCAE)
Time Frame
up to 13 months
Title
Objective Response Rate (Phase 2 only)
Description
Evaluated using modified RECIST v1.1
Time Frame
up to 13 months
Secondary Outcome Measure Information:
Title
Objective Response Rate (for each treatment group)
Description
Evaluated using modified RECIST v1.1
Time Frame
up to 13 months
Title
Duration of Response
Time Frame
up to 13 months
Title
Cell mediated immunity as measured by the antigen specific response in peripheral blood
Time Frame
bimonthly for up to 13 months
Title
Evaluation of treatment-induced changes in tumor infiltrating lymphocytes
Time Frame
at 8 to 10 weeks
Title
Time to Progression
Time Frame
up to 13 months
Title
Overall Survival
Time Frame
up to 13 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Georgia Cancer Center at Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10028
Country
United States
Facility Name
Oregon Health & Sciences University, Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Mary Crowley Cancer Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Centre Hospitalier de l'Université de Montréal (CHUM)
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
12. IPD Sharing Statement
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Study of DPX-Survivac Therapy in Patients With Recurrent Ovarian Cancer
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