Niraparib + Ipilimumab or Nivolumab in Progression Free Pancreatic Adenocarcinoma After Platinum-Based Chemotherapy

Summary

The main purpose of this study is to look at the effectiveness, safety, and anti-tumor activity (preventing growth of the tumor) of the drugs Niraparib with either Ipilimumab or Nivolumab on patients and their pancreatic cancer.

Timeline

Start

2018-01-31

Primary completion

2022-04-05

Completion

2024-10-09

Outcome

Mixed primary results

paper The primary endpoint of 6-month progression-free survival was met in the niraparib plus ipilimumab maintenance group, whereas niraparib plus nivolumab yielded inferior progression-free survival. PMID 35810751 ↗

paper 6-month progression-free survival was 20·6% (95% CI 8·3-32·9; p=0·0002 vs the null hypothesis of 44%) in the niraparib plus nivolumab group PMID 35810751 ↗

paper and 59·6% (44·3-74·9; p=0·045) in the niraparib plus ipilimumab group. PMID 35810751 ↗

Publications

• Reiss KA, Mick R, Teitelbaum U, O'Hara M, Schneider C, Massa R, Karasic T, Tondon R, Onyiah C, Gosselin MK, Donze A, Domchek SM, Vonderheide RH. Niraparib plus nivolumab or niraparib plus ipilimumab in patients with platinum-sensitive advanced pancreatic cancer: a randomised, phase 1b/2 trial. Lancet Oncol. 2022 Aug;23(8):1009-1020. doi: 10.1016/S1470-2045(22)00369-2. Epub 2022 Jul 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ipilimumab	Monoclonal antibody	3 mg/kg	Intravenous
Subject	Niraparib	Small molecule	200 mg	Oral
Subject	Nivolumab	Monoclonal antibody	240 mg	Intravenous
Subject	Nivolumab	Monoclonal antibody	480 mg	Intravenous

Indications