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

• ClinicalTrials.gov Identifier: NCT03657966
• Recruitment Status: Completed
• First Posted: September 5, 2018
• Last Update Posted: April 21, 2021
• Sponsor: SOTIO a.s.
• Information provided by (Responsible Party): SOTIO Biotech ( SOTIO a.s. )

Study Description

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)

Condition or disease	Intervention/treatment	Phase
Ovarian Cancer Recurrent	Biological: DCVAC/OvCa; Drug: Standard of Care Chemotherapy	Phase 2

Detailed Description:

All patients who fulfill all eligibility criteria will undergo a leukapheresis procedure. All eligible/enrolled patients will receive standard-of-care therapy with carboplatin/gemcitabine or carboplatin/paclitaxel starting 2 to 7 days after leukapheresis.

After 6 cycles of chemotherapy, patients will start maintenance treatment with DCVAC/OvCa.

Treatment will continue irrespective of tumor progression until completion, refusal, intolerance of treatment or death.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 33 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: open-label DCVAC/OvCa after treatment with carboplatin in combination with either gemcitabine or paclitaxel
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label, Single-group, Multi-center, Phase II Clinical Trial Evaluating the Effect of Maintenance DCVAC/OvCa After Standard-of-care Therapy in Women With First Relapse of Platinum-sensitive Epithelial Ovarian Cancer
• Actual Study Start Date: November 23, 2017
• Actual Primary Completion Date: November 11, 2020
• Actual Study Completion Date: February 25, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Standard of care chemotherapy + DCVAC/Ov; Standard-of-care carboplatin/gemcitabine or carboplatin/paclitaxel followed by DCVAC/OvCa	Biological: DCVAC/OvCa; activated dendritic cells (DCVAC/OvCa) for immune maintenance after chemotherapy; Drug: Standard of Care Chemotherapy; either carboplatin and gemcitabine or carboplatin and paclitaxel followed by DCVAC/OvCa; Other Names: carboplatin with gemcitabine; carboplatin with paclitaxel

Outcome Measures

Primary Outcome Measures :

1. Progression Free Survival by modifications to the RECIST 1.1 [ Time Frame: Assessed from enrollment up to 104 weeks ]
   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

Secondary Outcome Measures :

1. Overall survival [ Time Frame: Assessed from enrolment through study completion approximately 5 years ]
   Defined as the time from first dose of SoC therapy administered until death due to any cause assessed until study completion
2. Biological progression-free interval [ Time Frame: CA-125 assessed every 6 weeks up to 104 weeks ]
   Defined by increasing CA-125 levels per Gynecologic Cancer Intergroup (GCIG) criteria
3. Objective Response rate [ Time Frame: Response is assessed every 8 weeks up to 104 weeks ]
   CR and PR measured by the modifed RECIST 1.1 criteria
4. Immunologic Response [ Time Frame: Blood samples collected 5 times throughout the study from enrolment up to 104 weeks ]
   Detection of entire anti-tumor immune response int he serum
5. Incidence of Treatment-emergent adverse events [safety and tolerability] [ Time Frame: Screening through 30 days after completion of treatment ]
   Safety profile as determined by the nature, incidence, duration, severity and outcome of adverse events (AEs) including serious AEs (SAEs) as assessed by CTCAE v. 4.0
6. CA-125 response [ Time Frame: CA-125 assessed every 6 weeks up to 104 weeks ]
   Defined by GCIG criteria
7. Time to either tumor or biologic Response [ Time Frame: From first dose of chemotherapy until either objective or serologic progression for up to 104 weeks. ]
   Response according to RECIST or CA-125 measurements as increased to >2 times ULN

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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

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 (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

Contacts and Locations

Locations

Czechia

University Hospital Brno

Brno, Czechia, 625 00

Masaryk Memorial Cancer Institute

Brno, Czechia, 656 53

Hospital Novy Jicin

Nový Jičín, Czechia, 741 01

University Hospital in Ostrava

Ostrava, Czechia, 708 52

University Hospital Plzen

Plzen, Czechia, 304 60

University Hospital Kralovsko Vinohrady

Prague, Czechia, 100 34

General University Hospital in Prague

Prague, Czechia, 128 08

Hospital Bulovka

Prague, Czechia, 180 81

Sponsors and Collaborators

SOTIO a.s.

Investigators

• Study Director: Harald Fricke, MD, PhD; SOTIO a.s.

More Information

• Responsible Party: SOTIO a.s.
• ClinicalTrials.gov Identifier: NCT03657966
• Other Study ID Numbers: SOV06; 2017-002196-26 ( EudraCT Number )
• First Posted: September 5, 2018
• Last Update Posted: April 21, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by SOTIO Biotech ( SOTIO a.s. ):

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

Additional relevant MeSH terms:

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Hypersensitivity; 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; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Immune System Diseases; Paclitaxel; Carboplatin; Gemcitabine; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action