Status: Active Trial | Marker: no marker

Title

A Phase II, multi-center, open label study of NIR178 in combination with PDR001 in patients with selected advanced solid tumors and non-Hodgkin lymphoma

Study Number

NCT03207867

Indication

Histologically confirmed diagnosis of advanced/metastatic NSCLC, histologically confirmed renal cell carcinoma (RCC), pancreatic cancer, urothelial cancer, head and neck squamous cell carcinoma (HNSCC), diffuse large Bcell lymphoma (DLBCL), microsatellite stable colorectal cancer (MSS CRC), triple negative breast cancer (TNBC) or cutaneous melanoma

Primary objective

The primary objective of this study is to evaluate the efficacy of NIR178 in combination to PDR001 in patients with selected advanced solid tumors and DLBCL.

In- and exclusion Criteria

• Histologically documented advanced or metastatic solid tumors or lymphomas
• Patient must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution’s guidelines. Patient must be willing to undergo a new tumor biopsy at screening, and again during therapy on this study
• Ongoing or prior treatment with A2aR inhibitors. Patients previously treated with A2aR inhibitors for non-oncologic indications (e.g. Parkinson’s disease) may be considered for enrollment on a case by case basis

Study design

Phase II, multicentric

Responsibilities

Novartis Pharma GmbH
Phone: +49 911 2730
Fax: +49 911 27312683

Trial Centre

University Hospital of Cologne
Dep. I of Internal Medicine
Phone: +49 221 478 87008
Fax: +49 221 478 87010
lungenkrebs@uk-koeln.de

Principal investigator

Prof. Dr. J. Wolf

Last Update: 13. February 2019