Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 51 of 526 for:    "Primary Peritoneal Carcinoma"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03905902
Recruitment Status : Not yet recruiting
First Posted : April 8, 2019
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Sotio a.s.

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Fallopian Tube Cancer Peritoneal Carcinoma Biological: DCVAC/OvCa Biological: DCVAC/OvCa placebo Phase 3

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 678 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: parallel-group, placebo-controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: double-blind
Primary Purpose: Treatment
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
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : October 2026
Estimated Study Completion Date : December 2026


Arm Intervention/treatment
Experimental: DCVAC/OvCa with standard of care

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

Biological: DCVAC/OvCa
activated autologous dendritic cells
Other Name: dendritic cell vaccine/ ovarian cancer

Biological: DCVAC/OvCa placebo
placebo for activated autologous cells

Placebo Comparator: Placebo with standard of care

Induction period: DCVAC Placebo with carboplatin and gemcitabine, or carboplatin and paclitaxel, or carboplatin and doxorubicin, with or without bevacizumab

Maintenance Period:DCVAC placebo with bevacizumab, best supportive care or a PARPi carboplatin and gemcitabine or carboplatin and paclitaxel with or without bevacizumab, best supportive care or a PARPi

Biological: DCVAC/OvCa
activated autologous dendritic cells
Other Name: dendritic cell vaccine/ ovarian cancer

Biological: DCVAC/OvCa placebo
placebo for activated autologous cells




Primary Outcome Measures :
  1. Overall Survival(OS) [ Time Frame: Assessed from enrolment up to study completion, approximately 6.6 years ]
    Defined as the time from randomization until the date of death due to any cause.


Secondary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: Assessed from enrollment to up to 4 years ]
    Defined as the time from randomization to the earlier date of objective progression or death due to any cause in the absence of progression.

  2. Objective Response Rate [ Time Frame: Assessed from start of treatment to up to 4 years ]
    Assessment of Objective Response Rate per RECIST1.1 until objective progression as defined by the Investigator.

  3. Time to Relapse [ Time Frame: Assessed from start of treatment up to 4 years ]
    Assessment of Time to Relapse, per objective progression according to RECIST 1.1.

  4. Duration of Response [ Time Frame: Assessed from start of study treatment up to 4 years ]
    Assessment of Duration of Response until objective progression per RECIST 1.1.

  5. Biological Progression-Free Survival [ Time Frame: Assessed from randomization up to study completion up to 6.6 years. ]
    Defined as the time from randomization to the earlier date of assessment of biological progression evaluated by increasing CA 125 levels or death due to any cause in the absence of progression.

  6. Safety Assessments: NCI CTCAE version 5.0 [ Time Frame: Assessed from Screening through 30 days after the completion of Investigational Medicinal Product approximately 18 months. ]
    Defined as the incidence, severity and outcome of treatment emergent adverse events (TEAEs), and serious adverse events (SAEs) assessed by NCI CTCAE version 5.0.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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:

  • Histologically confirmed high-grade serous or endometrioid carcinoma of the ovary, peritoneum or fallopian tube.
  • Without disease progression during any 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 or second relapse identified by the criteria above up to 28 days prior to study randomization
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Known germline 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
  • Use of immunotherapy within the last 3 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03905902


Contacts
Layout table for location contacts
Contact: Richard Kapsa (+420) 2241 74448 kapsa@sotio.com

Sponsors and Collaborators
Sotio a.s.
Investigators
Layout table for investigator information
Study Director: Harald Fricke, MD PhD Sotio a.s.

Layout table for additonal information
Responsible Party: Sotio a.s.
ClinicalTrials.gov Identifier: NCT03905902     History of Changes
Other Study ID Numbers: SOV09
First Posted: April 8, 2019    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Clinical Study Report (CSR)

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sotio a.s.:
active cellular immunotherapy
dendritic cells
platinum-sensitive
relapsed ovarian cancer
biologic

Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases