DCVAC/OvCa After Standard-of-care Chemotherapy in Women With Relapse of Platinum-sensitive Epithelial Ovarian Cancer

NCT03657966 | Completed Phase 2 DMC

• 2 other identifiers: SOV062017-002196-26
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this trial is to investigate if maintenance DCVAC/OvCa after second-line chemotherapy of carboplatin/gemcitabine or carboplatin/paclitaxel improves efficacy outcomes in women with FIGO stage III and IV epithelial ovarian carcinoma who experienced relapse more than 6 months after complete remission of first line platinum-based chemotherapy (platinum sensitive ovarian cancer)

Conditions

Ovarian Cancer Recurrent

Keywords

Immunotherapy; Platinum-sensitive; Biologic; Vaccine; Ovarian cancer; Fallopian Tube cancer; Primary peritoneal cancer; dendritic cells; chemotherapy; leukapheresis; FIGO III; FIGO IV

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival by modifications to the RECIST 1.1

  PFS as defined as the time from the first dose of Standard-of-Care (SoC) therapy administerd until tumor progression or death from any cause

  Assessed from enrollment up to 104 weeks

Secondary Outcomes (7)

• Overall survival

  Assessed from enrolment through study completion approximately 5 years

• Biological progression-free interval

  CA-125 assessed every 6 weeks up to 104 weeks

• Objective Response rate

  Response is assessed every 8 weeks up to 104 weeks

• Immunologic Response

  Blood samples collected 5 times throughout the study from enrolment up to 104 weeks

• Incidence of Treatment-emergent adverse events [safety and tolerability]

  Screening through 30 days after completion of treatment

Study Arms (1)

Standard of care chemotherapy + DCVAC/Ov

EXPERIMENTAL

Standard-of-care carboplatin/gemcitabine or carboplatin/paclitaxel followed by DCVAC/OvCa

Biological: DCVAC/OvCa; Drug: Standard of Care Chemotherapy

Interventions

DCVAC/OvCa BIOLOGICAL

activated dendritic cells (DCVAC/OvCa) for immune maintenance after chemotherapy

Standard of care chemotherapy + DCVAC/Ov

Standard of Care Chemotherapy DRUG

either carboplatin and gemcitabine or carboplatin and paclitaxel followed by DCVAC/OvCa

Also known as: carboplatin with gemcitabine, carboplatin with paclitaxel

Standard of care chemotherapy + DCVAC/Ov

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically confirmed 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-based chemotherapy
• Radiologically confirmed relapse after \>6 months of remission ( platinum-sensitive cancer)
• Laboratory parameters per protocol

You may not qualify if:

• 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 (chemotherapy, monoclonal antibody therapy, tyrosine kinase inhibitory therapy, vascular endothelial growth factor or hormonal therapy) except first-line Pt based chemotherapy ( with or without bevacizumab)
• fertile women of child-bearing potential not willing to use a highly effective method of contraception or a combination of methods
• Pregnant of lactating women
• Pre-defined co-morbidities
• Known hypersensitivity to any constituent of DCVAC/OVCa or the selected chemotherapy compounds

Sponsors & Collaborators

• SOTIO a.s.: lead

Study Sites (8)

University Hospital Brno

Brno, 625 00, Czechia

Location

Masaryk Memorial Cancer Institute

Brno, 656 53, Czechia

Location

Hospital Novy Jicin

Nový Jičín, 741 01, Czechia

Location

University Hospital in Ostrava

Ostrava, 708 52, Czechia

Location

University Hospital Plzen

Pilsen, 304 60, Czechia

Location

University Hospital Kralovsko Vinohrady

Prague, 100 34, Czechia

Location

General University Hospital in Prague

Prague, 128 08, Czechia

Location

Hospital Bulovka

Prague, 180 81, Czechia

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

Carboplatin; Gemcitabine; Paclitaxel

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Harald Fricke, MD, PhD

  SOTIO a.s.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: open-label DCVAC/OvCa after treatment with carboplatin in combination with either gemcitabine or paclitaxel

Study Record Dates

• First Submitted: August 24, 2018
• First Posted: September 5, 2018
• Study Start: November 23, 2017
• Primary Completion: November 11, 2020
• Study Completion: February 25, 2021
• Last Updated: April 21, 2021

Record last verified: 2021-04

Locations

CZ (8)