Title: 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 Patients1
Principal Investigator: Anthony Hoffman, MD, ExcellaBio LLC
Description: For this open-label phase 2 study (ClinicalTrials.gov Identifier: NCT03342417), researchers are evaluating the safety and efficacy of nivolumab and ipilimumab among patients enrolled to 1 of 3 trial parts. Part 1 will include patients with newly diagnosed stage II or III breast cancer, part 2 will include patients with platinum-resistant/refractory ovarian cancer, and part 3 will include patients with gastric cancer.
Twenty patients will be enrolled into each study part. Patients will receive intravenous (IV) nivolumab 240 mg and IV ipilimumab 1 mg/kg over 30 minutes. Patients in part 1 and parts 2/3 will receive 2 and 4 6-week treatment cycles, respectively.
The primary outcomes include the number of patients with treatment-related adverse events as assessed by CTCAE v4.0 and the number of clinical responses. Clinical response will be assessed by pathological Complete Response (pCR) in part 1, and best objective response (BOR) and overall response rates (ORR) in parts 2 and 3.
For more study information, including exclusion and inclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT03342417.
Status: Open and recruiting patients as of December 15, 2017.
This study is sponsored by ExcellaBio LLC.
- ClinicalTrials.gov. Combination of nivolumab and ipilimumab in breast, ovarian, and gastric cancer patients. NCT03342417. https://clinicaltrials.gov/ct2/show/NCT03342417. Accessed December 15, 2017.