Overview

This trial has been terminated.

Condition epithelial ovarian carcinoma
Treatments dcvac/ovca, standard of care (paclitaxel or topotecan or doxorubicin)
Phase phase 2
Sponsor Sotio a.s.
Start date January 2014
End date August 2016
Trial size 22 participants
Trial identifier NCT02107378, SOV03

Summary

The purpose of this study is to determine whether DCVAC/OvCa added to chemotherapy may result in prolongation of Overall Survival (OS).

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 (SoC)
dcvac/ovca
DCVAC/OvCa is the experimental therapy added on to Paclitaxel or topotecan or doxorubicin
(Active Comparator)
Standard of Care as an Active Comparator (Paclitaxel or topotecan or doxorubicin is Standard of Care First Line Chemotherapy)
standard of care (paclitaxel or topotecan or doxorubicin) Paclitaxel
Paclitaxel or topotecan or doxorubicin is Standard of Care First Line Chemotherapy

Primary Outcomes

Measure
Overall survival (all cause mortality)
time frame: 72 weeks

Secondary Outcomes

Measure
Progression Free Survival
time frame: 72 weeks
Objective Response Rate
time frame: 0, 8, 16, ,24, 32, 40, 48, 56, 64, 72 weeks
Biological Progression Free Interval
time frame: 0, 8, 16, 24, 32, 40, 48, 56, 64, 72 weeks
Immunological Response
time frame: 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 weeks
Frequency of Adverse Events
time frame: 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 56, 64, 72 weeks
Evaluation of Quality of Life via Functional Assessment of Cancer Therapy-Ovarian
time frame: 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 56, 64, 72 weeks

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Females 18 years or older - 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 have undergone initial surgery or interval debulking surgery but have not reached complete remission of more than 6 months after first line platinum based chemotherapy, for one of the following reasons - Patients are platinum-refractory (no response) - Complete remission was not reached (partial responders) - Relapse within ≤6 months of remission (Platinum-resistant) - Platinum-based chemotherapy failure should have been confirmed by computerized tomography (CT)/magnetic resonance imaging (MRI) scan (Platinum-resistant) or by finding described as 'did not reach complete clinical remission' (Platinum-refractory or Platinum-partial response) Patients must have at least one measureable target lesion as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria - Eastern Cooperative Oncology Group (ECOG) Performance status 0−2 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 - Clinically significant cardiovascular disease - Active autoimmune disease requiring treatment - History of severe forms of primary immune deficiencies - Systemic immunosuppressive therapy for any reason

Additional Information

Official title A Randomized, Open-label, Parallel Group, Multi-center Phase II Clinical Trial Evaluating Effect of Addition of DCVAC/OvCa to Standard Chemotherapy in Women With Relapsed Platinum (Pt)-Resistant Epithelial Ovarian Carcinoma
Description The purpose of this study is to determine whether DCVAC/OvCa added to Standard of Care chemotherapy may result in prolongation of Overall Survival (OS).
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Sotio a.s..