Combination of Nivolumab and Ipilimumab in Breast, Ovarian and Gastric Cancer Patients

Part of paid clinical trials in The Bronx, New York.

Sponsor
ExcellaBio LLC
Study ID
NCT03342417
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — BIOLOGICAL
    Nivolumab 240 mg administered by IV infusion over 30 minutes
  • Ipilimumab — BIOLOGICAL
    Ipilimumab 1 mg/kg administered by IV infusion over 30 minutes.

Study Details

Safety and tolerability of combination of Nivolumab and Ipilimumab will be studied in patients with 3 different types of cancers in 3 parts of the study, as shown below: Part 1 - Neoadjuvant Therapy of Breast Cancer; Part 2 - Therapy of Ovarian Cancer; and Part 3 - Therapy of Gastric Cancer.

Key Dates

Start date
Feb 14, 2018
Status verified
Nov 2021
Primary completion
May 29, 2019
Completion
May 29, 2019

Study Design

Enrollment
5 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant Breast Cancer
    Newly diagnosed patients who have Stage II-III breast cancer, with the primary cancer in place. These patients have not received prior therapy for their breast cancer and intend to undergo surgery after completion of investigational neoadjuvant therapy. Each patient will be treated with two 6-week treatment cycles of Nivolumab 240 mg administered by intravenous (IV) infusion over 30 minutes and Ipilimumab 1 mg/kg administered by IV infusion over 30 minutes. Nivolumab is given every two weeks (q2w) whereas Ipilimumab is given every 6 weeks (q6w), both starting on Day 1. Accordingly, Nivolumab and Ipilimumab are given on the same day on Days 1 and 43. On these days, Ipilimumab is to be given immediately after Nivolumab.
  • Experimental: Platinum-resistant ovarian cancer
    Platinum-resistant/refractory ovarian cancer (PRROC) patients. Each patient will be treated with four 6-week treatment cycles of Nivolumab 240 mg administered by IV infusion over 30 minutes and Ipilimumab 1 mg/kg administered by IV infusion over 30 minutes. Nivolumab is given q2w whereas Ipilimumab is given q6w, both starting on Day 1. Accordingly, Nivolumab and Ipilimumab are given on the same day on Days 1, 43, 85 and 127. On these days, Ipilimumab is to be given immediately after Nivolumab.
  • Experimental: Advanced gastric cancer patients
    Advanced gastric cancer patients who are recurrent/refractory to a prior therapy not involving herceptin. Each patient will be treated with four 6-week treatment cycles of Nivolumab and Ipilimumab . Nivolumab is given q2w whereas Ipilimumab is given q6w, both starting on Day 1. Accordingly, Nivolumab and Ipilimumab are given on the same day on Days 1, 43, 85 and 127. On these days, Ipilimumab is to be given immediately after Nivolumab.

Primary Outcome Measure

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Hoffman OncologyThe BronxNew York10469-

Find similar trials in The Bronx, NY

By condition
Gastric cancerOvarian cancer
By specialty
OncologyGI oncologyGynecologic oncologyWomen's health
By research site
Hoffman Oncology· The Bronx, NY

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