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

SOTIO

Status and phase: Completed; Phase 2

Conditions: Ovarian Neoplasms; Ovarian Cancer (OvCa); Ovarian Epithelial Cancer

Treatments: Biological: DCVAC/OvCa in parallel with chemotherapy; Drug: Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT02107950

2013-001323-38 (EudraCT Number)

SOV02

Details and patient eligibility

About

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).

Full 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).

Enrollment: 71 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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71 participants in 2 patient groups

DCVAC/OvCa in parallel with chemotherapy

Experimental group

Description:

Combination therapy with DCVAC/OvCa and Standard of Care

Treatment:

Biological: DCVAC/OvCa in parallel with chemotherapy

Standard of Care

Active Comparator group

Description:

Standard of Care carboplatin and gemcitabine

Treatment:

Drug: Standard of Care