Phase II Study DCVAC/OvCa Plus Carboplatin Gemcitabine Relapsed Platinum (Pt)-Sensitive Epithelial Ovarian Carcinoma

Ovarian Neoplasms Clinical Trial

Official title:

A Randomized, Open-label, Parallel Group, Multi-center Phase II Clinical Trial DCVAC/OvCa Added to Standard Chemotherapy in Women With Relapsed Platinum Sensitive Epithelial Ovarian Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02107950
• Other study ID #: SOV02
• Secondary ID: 2013-001323-38
• Status: Completed
• Phase: Phase 2
• Start date: November 2013
• Est. completion date: May 17, 2017

Study information

• Verified date: January 2016
• Source: Sotio a.s.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether DCVAC/OvCa added to chemotherapy (carboplatin and gemcitabine as second line chemotherapy) may result in prolongation of progression free survival (PFS).

Description:

The purpose of this study is to determine whether DCVAC/OvCa added to Standard of Care chemotherapy (carboplatin and gemcitabine as second line chemotherapy) may result in prolongation of progression free survival (PFS).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: May 17, 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Females 18 years old and older

• Patients with histologically confirmed, International Federation of Gynecology and Obstetrics (FIGO) stage III or IV epithelial ovarian, primary peritoneal or fallopian tube carcinoma (serous, endometrioid or mucinous), who had complete remission after first line platinum (Pt)-based chemotherapy and are selected to receive second line Standard of Care chemotherapy

• Radiologically confirmed relapse after >6 months of remission (Platinum-sensitive patients), found up to 4 weeks prior study entry.

• The patient must have at least one measureable target lesion as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria to be eligible for enrolment in the study

Exclusion Criteria:

• FIGO I,II epithelial ovarian cancer

• FIGO III, IV clear cells epithelial ovarian cancer

• Non-epithelial ovarian cancer

• Borderline tumors (tumors of low malignant potential)

• Prior or current systemic anti-cancer therapy for ovarian cancer [for example chemotherapy, monoclonal antibody therapy , tyrosine kinase inhibitor therapy, vascular endothelial growth factor (VEGF) therapy or hormonal therapy] except first line Platinum-based chemotherapy (with or without bevacizumab)

• Previous radiotherapy to the abdomen and pelvis

• Malignancy other than epithelial ovarian cancer, except those that have been in clinical remission (CR) for a minimum of 3 years, and except carcinoma in-situ of the cervix or non-melanoma skin carcinomas

Related Conditions & MeSH terms

• Hypersensitivity
• Neoplasms, Glandular and Epithelial
• Ovarian Cancer (OvCa)
• Ovarian Epithelial Cancer
• Ovarian Neoplasms

Intervention

Biological:
• DCVAC/OvCa in parallel with chemotherapy
DCVAC/OvCa is the experimental therapy added on to Carboplatin and Gemcitabine

Drug:
• Standard of Care
Carboplatin and Gemcitabine is Standard of Care First Line Chemotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sotio a.s.

Countries where clinical trial is conducted

Czechia,  Germany,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine median progression free survival		72 Week
Secondary	Overall survival (all causes)		56, 64, 72 weeks
Secondary	Objective Response Rate		8, 16, 24, 32, 40, 48, 56. 64. 72 weeks
Secondary	Biological Progression Free Interval		6, 12, 18, 24, 36, 42, 48, 56, 64, 72 weeks
Secondary	Immunological Response		24, 48, 72 weeks
Secondary	Frequency of adverse events		8, 16, 24, 32, 40, 48, 56. 64. 72 weeks