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

Immunovaccine

Status and phase: Completed; Phase 1

Conditions: Epithelial Ovarian Cancer; Peritoneal Cancer; Fallopian Tube Cancer

Treatments: Drug: Cyclophosphamide; Biological: DPX-Survivac(Aqueous); Biological: DPX-Survivac

Study type: Interventional

Funder types: Industry

Identifiers

NCT03332576

ONC-DPX-Survivac-03

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

37 participants in 5 patient groups

Cohort 1

Experimental group

Description:

6 Doses DPX-Survivac (2 prime q3w, 4 boost q8w) Low dose cyclophosphamide

Treatment:

Biological: DPX-Survivac

Drug: Cyclophosphamide

Cohort 2

Experimental group

Description:

6 Doses DPX-Survivac (2 prime q3w, 4 boost q8w) Low dose cyclophosphamide

Treatment:

Biological: DPX-Survivac

Drug: Cyclophosphamide

Cohort 3

Experimental group

Description:

3 Doses DPX-Survivac (1 prime, 2 boost q8w) Low dose cyclophosphamide

Treatment:

Biological: DPX-Survivac

Drug: Cyclophosphamide

Cohort 4

Experimental group

Description:

5 Doses DPX-Survivac (2 prime q6w, 3 boost q6w) Low dose cyclophosphamide

Treatment:

Biological: DPX-Survivac

Drug: Cyclophosphamide

Cohort 5

Experimental group

Description:

5 Doses DPX-Survivac/DPX-Survivac(Aqueous) (2 prime q4w, 3 boost q4w) Low dose cyclophosphamide

Treatment:

Biological: DPX-Survivac

Biological: DPX-Survivac(Aqueous)

Drug: Cyclophosphamide