Overview

This trial is active, not recruiting.

Conditions ovarian neoplasms, ovarian cancer (ovca), ovarian epithelial cancer
Treatments dcvac/ovca in parallel with chemotherapy, standard of care
Phase phase 2
Sponsor Sotio a.s.
Start date November 2013
End date November 2016
Trial size 60 participants
Trial identifier NCT02107950, 2013-001323-38, SOV02

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Combination therapy with DCVAC/OvCa and Standard of Care
dcvac/ovca in parallel with chemotherapy DCVAC/OvCa
DCVAC/OvCa is the experimental therapy added on to Carboplatin and Gemcitabine
(Active Comparator)
Standard of Care carboplatin and gemcitabine
standard of care Carboplatin and Gemcitabine
Carboplatin and Gemcitabine is Standard of Care First Line Chemotherapy

Primary Outcomes

Measure
Determine median progression free survival
time frame: 72 Week

Secondary Outcomes

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

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

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
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).
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Sotio a.s..