Efficacy of DCVAC/OvCa Plus Standard of Care in Relapsed Platinum Resistant Epithelial Ovarian Carcinoma

SOTIO

Status and phase: Terminated; Phase 2

Conditions: Epithelial Ovarian Carcinoma

Treatments: Drug: Standard of Care (Paclitaxel or topotecan or doxorubicin); Biological: DCVAC/OvCa

Study type: Interventional

Funder types: Industry

Identifiers

NCT02107378

SOV03

Details and patient eligibility

About

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

Full 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).

Enrollment: 22 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

DCVAC/OvCa in parallel with chemo (SoC)

Experimental group

Description:

Combination therapy with DCVAC/OvCa and Standard of Care (SoC)

Treatment:

Biological: DCVAC/OvCa

Standard of Care (Chemotherapy)

Active Comparator group

Description:

Standard of Care as an Active Comparator (Paclitaxel or topotecan or doxorubicin is Standard of Care First Line Chemotherapy)

Treatment:

Drug: Standard of Care (Paclitaxel or topotecan or doxorubicin)