Last updated on March 2019

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

Brief description of study

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.

Detailed Study Description

Open-Label, Non-Randomization and Safety Run-In: Part 1 of the study is a Phase 2 clinical trial in 20 newly diagnosed patients who have Stage II-III breast cancer, with the primary cancer in place. Parts 2 and 3 of the Study are Phase 2 clinical trials in 20 platinum resistant refractory ovarian cancer (PRROC) and gastric cancer patients, respectively.

Also in all Parts 1, 2 and 3 of the study, there will be a safety run-in involving 3-6 patients. Specifically, the enrollment of patients in each of the 3 parts of the study will begin with 3 patients. If no dose-limiting toxicities (DLTs, defined as toxicity Grade 3) are observed in the first 3 patients during the first cycle, enrollment can continue for the remaining 17 patients. If 1 of the first 3 patients experiences a DLT, the enrollment will be expanded to a total of 6 subjects. If no more than 1 of 6 subjects experiences a DLT, enrollment can continue for the remaining 14 patients. If 2 or more of the first 2-6 subjects experience a DLT, enrollment may be paused. The study data will be reviewed to determine whether alternate dose levels or treatment schedules should be evaluated.

Clinical Study Identifier: NCT03342417

Contact Investigators or Research Sites near you

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Hoffman Oncology

Bronx, NY United States
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Recruitment Status: Open

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