A Phase 2 Study of NIR178 in Combination With PDR001 in Patients With Solid Tumors and Non-Hodgkin Lymphoma

    Not Recruiting
  • End date
    Dec 16, 2022
  • participants needed
  • sponsor
    Novartis Pharmaceuticals
Updated on 18 April 2022
monoclonal antibodies
measurable disease
breast cancer
melanoma skin
kinase inhibitor
cancer chemotherapy
solid tumour
triple negative breast cancer
mek inhibitor
squamous cell carcinoma of head and neck
bladder cancer
vascular endothelial growth factor
cytotoxic t-lymphocyte antigen 4
malignant melanoma of skin
braf v600e mutation


The purpose of this phase 2 study is to evaluate the efficacy and safety of NIR178 in combination with PDR001 in multiple solid tumors and diffuse large B-cell lymphoma (DLBCL) and further explore schedule variations of NIR178 to optimize immune activation through inhibition of A2aR.


The study has three parts: part 1: Multi-arm Bayesian adaptive signal finding design in solid tumors and diffuse large B cell lymphoma (DLBCL); part 2: NIR178 schedule exploration in NSCLC; part 3: Further evaluation of intermittent or continuous dosing schedules of NIR178 in combination with PDR001 in additional tumor types, if part 2 identifies an intermittent or continuous dosing schedule of NIR178 as warranting further exploration. In addition, a separate safety run-in part will be conducted in Japan in order to adequately characterize the safety and pharmacokinetic profiles of NIR178 as a single-agent and in combination with PDR001.

Parts 1 and 2 and the safety run-in in Japan will enroll in parallel. Part 3 will be opened based on the results from part 1 and part 2 and may enroll in parallel with Part 1.

Patients enrolled in this study will receive NIR178 either BID continuously or based on the assigned intermittent schedule within 60 minutes prior to PDR001 infusion. PDR001 will be administered via IV infusion over 30 minutes once every 4 weeks. Each treatment cycle is 28 days. Patients enrolled in the Japanese safety run-in part will receive NIR178 as single agent for the first cycle (28 days). If the patients complete cycle 1 without experiencing DLTs, they will initiate combination therapy with PDR001 starting cycle 2 onwards, and continue at the same dose of NIR178. An additional cohort in the Japanese safety run-in part of the study will receive NIR178 in combination with PDR001 starting with Cycle 1. If the patients complete cycle 1 without experiencing DLTs, they will continue to receive combination treatment.

Patients will receive treatment with the combination until disease progression (assessed by investigator per immune-related response criteria (iRECIST) or Cheson 2014, unacceptable toxicity, death or discontinuation from study treatment for any other reason (e.g., withdrawal of consent, start of a new anti-neoplastic therapy or at the discretion of the investigator), otherwise known as End of Treatment.

Condition NSCLC, Non Small Cell Lung Cancer, RCC, Renal Cell Cancer, Pancreatic Cancer, Urothelial Cancer, Head and Neck Cancer, DLBCL, Diffused Large B Cell Lymphoma, MSS, Microsatellite Stable Colon Cancer, TNBC, Triple Negative Breast Cancer, Melanoma, mCRPC, Metastatic Castration Resistant Prostate Cancer
Treatment PDR001, NIR178
Clinical Study IdentifierNCT03207867
SponsorNovartis Pharmaceuticals
Last Modified on18 April 2022

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