NCT03342417

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

Phase 2 Study of Combination of Nivolumab and Ipilimumab in (1) Neoadjuvant Setting in Previously Untreated Breast Cancer Patients, (2) Platinum-Resistant/Refractory Advanced Ovarian Cancer Patients; and (3) Advanced Gastric Cancer Patients

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: ExcellaBio LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 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.

Conditions

• Breast Cancer Female
• Ovarian Cancer
• Gastric Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Nivolumab	Nivolumab 240 mg administered by IV infusion over 30 minutes
BIOLOGICAL	Ipilimumab	Ipilimumab 1 mg/kg administered by IV infusion over 30 minutes.

Timeline

• Start date: 2018-02-14
• Primary completion: 2019-05-29
• Completion: 2019-05-29
• First posted: 2017-11-17
• Last updated: 2021-11-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study