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

I

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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