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

Phase 2

Completed

• Conditions: Ovarian Epithelial Cancer; Ovarian Neoplasms; Ovarian Cancer (OvCa)
• Interventions: Biological: DCVAC/OvCa in parallel with chemotherapy; Drug: Standard of Care

• Registration Number: NCT02107950
• Lead Sponsor: SOTIO a.s.

Brief 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).

Detailed 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).

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-04-04
• Study First Submitted QC: 2014-04-04
• Study First Posted: 2014-04-08
• Status Verified: 2016-01
• Primary Completion: 2016-11
• Study Completion: 2017-05-17
• Last Update Submitted: 2018-08-13
• Last Update Posted: 2018-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DCVAC/OvCa in parallel with chemotherapy	DCVAC/OvCa in parallel with chemotherapy	Combination therapy with DCVAC/OvCa and Standard of Care
Standard of Care	Standard of Care	Standard of Care carboplatin and gemcitabine

Primary Outcome Measures

Name	Time	Method
Determine median progression free survival	72 Week

Secondary Outcome Measures

Name	Time	Method
Immunological Response	24, 48, 72 weeks
Frequency of adverse events	8, 16, 24, 32, 40, 48, 56. 64. 72 weeks
Overall survival (all causes)	56, 64, 72 weeks
Objective Response Rate	8, 16, 24, 32, 40, 48, 56. 64. 72 weeks
Biological Progression Free Interval	6, 12, 18, 24, 36, 42, 48, 56, 64, 72 weeks