Phase 1b Study of a Cancer Vaccine to Treat Patients With Advanced Stage Ovarian, Fallopian or Peritoneal Cancer

Phase 1

Completed

• Conditions: Epithelial Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer
• Interventions: Biological: DPX-Survivac; Drug: Cyclophosphamide; Biological: DPX-Survivac(Aqueous)

• Registration Number: NCT03332576
• Lead Sponsor: ImmunoVaccine Technologies, Inc. (IMV Inc.)

Brief Summary

As a follow-on study to NCT01416038, this study is designed to identify the optimal dosage of immunotherapeutic survivin vaccine DPX-Survivac and low dose oral cyclophosphamide. The combination treatment is being evaluated in a non-randomized, multi-cohort study as post-chemotherapy treatment for patients with late-stage ovarian, fallopian tube, or peritoneal cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-23
• Primary Completion: 2016-09-08
• Study First Submitted: 2017-11-02
• Study First Submitted QC: 2017-11-02
• Study First Posted: 2017-11-06
• Study Completion: 2019-09-09
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-16
• Last Update Posted: 2021-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 37

Inclusion Criteria

• Histologically confirmed stage IIc-IV epithelial ovarian, fallopian tube or peritoneal cancer
• Complete or partial response following standard of care surgery and first line chemotherapy
• May have one disease recurrence with complete or partial response or stable disease following standard of care second line care treatment
• Previous investigational biologic therapy allowed, must be more than 56 days prior to first injection
• Previous treatment with bisphosphonate allowed, must be completed 14 days prior to first injection
• Ambulatory with an ECOG 0-1
• Life expectancy > 6 months
• Meet protocol-specified lab requirements
• Provide informed consent and have ability to comply with protocol requirements

Key

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Exclusion Criteria

• Concurrent chemotherapy, radiation therapy, immunotherapy are excluded (washout periods as specified in protocol)
• Prior receipt of survivin based vaccines
• Participation in prior therapeutic adjuvant ovarian cancer studies, except for platinum-based adjuvant studies
• Progressive disease (rising CA-125 acceptable)
• More than one course of chemotherapy for recurrent disease
• Concurrent bevacizumab as maintenance therapy
• Concurrent second malignancy other than non-melanoma skin cancer, cervical carcinoma in situ, or controlled bladder cancer
• History of autoimmune disease
• Recent history of thyroiditis
• Presence of a serious acute infection or chronic infection
• Brain metastases
• Other serious intercurrent chronic or acute illness
• Ongoing treatment with steroid therapy or other immunosuppressive
• Acute or chronic skin disorders

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 1	DPX-Survivac	6 Doses DPX-Survivac (2 prime q3w, 4 boost q8w) Low dose cyclophosphamide
Cohort 1	Cyclophosphamide	6 Doses DPX-Survivac (2 prime q3w, 4 boost q8w) Low dose cyclophosphamide
Cohort 2	DPX-Survivac	6 Doses DPX-Survivac (2 prime q3w, 4 boost q8w) Low dose cyclophosphamide
Cohort 2	Cyclophosphamide	6 Doses DPX-Survivac (2 prime q3w, 4 boost q8w) Low dose cyclophosphamide
Cohort 3	DPX-Survivac	3 Doses DPX-Survivac (1 prime, 2 boost q8w) Low dose cyclophosphamide
Cohort 3	Cyclophosphamide	3 Doses DPX-Survivac (1 prime, 2 boost q8w) Low dose cyclophosphamide
Cohort 4	DPX-Survivac	5 Doses DPX-Survivac (2 prime q6w, 3 boost q6w) Low dose cyclophosphamide
Cohort 4	Cyclophosphamide	5 Doses DPX-Survivac (2 prime q6w, 3 boost q6w) Low dose cyclophosphamide
Cohort 5	DPX-Survivac	5 Doses DPX-Survivac/DPX-Survivac(Aqueous) (2 prime q4w, 3 boost q4w) Low dose cyclophosphamide
Cohort 5	DPX-Survivac(Aqueous)	5 Doses DPX-Survivac/DPX-Survivac(Aqueous) (2 prime q4w, 3 boost q4w) Low dose cyclophosphamide
Cohort 5	Cyclophosphamide	5 Doses DPX-Survivac/DPX-Survivac(Aqueous) (2 prime q4w, 3 boost q4w) Low dose cyclophosphamide

Primary Outcome Measures

Name	Time	Method
Safety as measured by adverse event reporting (CTCAE)	up to 11 months

Secondary Outcome Measures

Name	Time	Method
Cell mediated immunity as measured by the antigen specific response in peripheral blood	up to 11 months
Impact on residual tumour	up to 11 months	Evaluated by standard of care radiology and CA-125

Trial Locations

Locations (3)

Princess Margaret Cancer Centre; 🇨🇦 Toronto, Ontario, Canada

Winthrop University Hospital; 🇺🇸 Mineola, New York, United States

Lenox Hill Hospital; 🇺🇸 New York, New York, United States