DCVAC/OvCa and Standard of Care (SoC) in Relapsed Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma

Brief Title

DCVAC/OvCa and Standard of Care (SoC) in Relapsed Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma

Official Title

A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of DCVAC/OvCa Added to Standard of Care in Patients With Relapsed Platinum-sensitive Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma

Brief Summary

      Multi-center, phase III trial of DCVAC/OvCa added to standard of care treatments for relapsed
      ovarian cancer. Patients will receive study treatment until all doses are administered, or
      other criteria are met.

Detailed Description

      All patients who meet entry criteria will be randomized, and will undergo a leukapheresis
      procedure. During the Induction period, all patients will receive DCVAC/OvCa or placebo
      (study treatment) with concurrent standard-of-care platinum-based chemotherapy, with or
      without use of bevacizumab. In the Maintenance period, patients will continue treatment with
      study treatment in combination with bevacizumab, a poly (ADP-ribose) polymerase inhibitor
      (PARPi) or best supportive care only. Study treatment will continue irrespective of disease
      progression

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Overall Survival(OS)

Secondary Outcome

 Progression-Free Survival (PFS)

Condition

Ovarian Cancer

Intervention

DCVAC/OvCa

Study Arms / Comparison Groups

 DCVAC/OvCa with standard of care

Description:  Induction period: DCVAC/OvCa with carboplatin and gemcitabine, or carboplatin and paclitaxel, or carboplatin and pegylated liposomal doxorubicin, with or without bevacizumab
Maintenance period: DCVAC/OvCa with bevacizumab, best supportive care or a PARPi

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Biological

Estimated Enrollment

Start Date

August 2021

Completion Date

August 16, 2021

Primary Completion Date

August 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically confirmed high-grade serous or endometrioid carcinoma of the ovary,
             peritoneum or fallopian tube.

          -  Without disease progression during preceding platinum-based chemotherapy

          -  Platinum-sensitive patients defined as Platinum-Free Interval of more than 6 months
             between the end of the last cycle of platinum-based chemotherapy and radiologic
             evidence of progression.

          -  First relapse identified by the criteria above up to 28 days prior to study
             randomization

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1

          -  Known BRCA (breast cancer susceptibility gene) mutation status before randomization

          -  Patient is intended to be treated with bevacizumab, best supportive care (BSC) only or
             PARPi

        Exclusion Criteria:

          -  Tumor-specific: any other histology sub-type that is not high grade serous or
             endometrioid, however a combination of these is allowed

          -  Disease Treatment history: started or ongoing systemic treatment for current relapse
             of Epithelial Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer
             before signing informed consent form (ICF), concomitant use of anti-neoplastic anti-
             hormonal therapy

          -  Intention to treat with intra-peritoneal chemotherapy

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Harald Fricke, MD PhD, ,

Administrative Informations

NCT ID

NCT03905902

Organization ID

SOV09

Secondary IDs

VITALIA/ ENGOT-ov53

Responsible Party

Sponsor

Study Sponsor

SOTIO a.s.

Collaborators

 European Network of Gynaecological Oncological Trial Groups (ENGOT)

Study Sponsor

Harald Fricke, MD PhD, Study Director, SOTIO a.s.

Verification Date

December 2021