Atezolizumab With Neoadjuvant Chemotherapy for Patients With Newly-Diagnosed Advanced-Stage Ovarian Cancer

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Duke University
Study ID
NCT03394885
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    1200mg IV q3weeks
  • Carboplatin — DRUG
    5-6mg/ML IV q3 weeks
  • Paclitaxel — DRUG
    70-80 mg/m2 IV q1 week
  • Bevacizumab — DRUG
    15 mg/kg IV q3 weeks

Study Details

The main purpose of this study is to validate a safe dose of atezolizumab with dose-dense paclitaxel and carboplatin when utilized with neoadjuvant chemotherapy and interval cytoreductive surgery followed by maintenance atezolizumab in women with advanced ovarian cancer.

Key Dates

Start date
Jun 19, 2018
Status verified
Aug 2021
Primary completion
Jul 20, 2020
Completion
Jul 20, 2020

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Atezolizumab, Carboplatin, Paclitaxel (+Optional Bevacizumab)
    1. Atezolizumab administered over 90 (± 15) minutes (for the first infusion, shortening to 60 (± 15) minutes and 30 ± 15) minutes for subsequent infusions as described below) followed by 2. Paclitaxel 70-80mg/m2 IV administered over approximately one hour followed by 3. Carboplatin IV administered over 15-30 minutes to achieve an initial target AUC of 5-6 mg/mL/Min (Calvert formula dosing). 4. (Optional, Physician choice) Bevacizumab IV maintenance administered starting at cycle 5 of chemotherapy over 30-90 minutes. For those who receive bevacizumab, it will be given for a total duration of 16 cycles

Primary Outcome Measure

Safety: Incidence of Post Chemotherapy Surgical Debulking [ Time Frame: 9 weeks ]

Locations (3)

FacilityCityStateZIPSite coordinators
Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21287-
Duke Cancer InstituteDurhamNorth Carolina27710-
University of VirginiaCharlottesvilleVirginia22908-

Find similar trials in Baltimore, MD

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center· Baltimore, MDDuke Cancer Institute· Durham, NCUniversity of Virginia· Charlottesville, VA

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