A Phase 2, multi-center, open label study of NIR178 in combination with PDR001 in patients with selected ad-vanced solid tumors and non-Hodgkin lymphoma
|
abstract
|
This is a multi-center, open label, phase 2 study to evaluate
efficacy of the NIR178 and PDR001 combination in NSCLC, other solid
tumors, and diffuse large B-cell lymphoma (DLBCL). 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 dosing schedules of NIR178 in combination
with PDR001 in additional tumor types, if part 2 identifies an
intermittent dosing schedule of NIR178 as warranting further
exploration. Parts 1 and 2 will enroll in parallel. Part 3 will be
opened based on the results from part 2. Patients enrolled in this
study will receive NIR178 160mg 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 will receive treatment with the combination until disease
progression (assessed by investigator per immunerelated response
criteria (irRC) (Appendix 3 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. Adult patients with histologically documented advanced or
metastatic solid tumors (e.g. non-small cell lung cancer (NSCLC),
renal cell carcinoma (RCC), pancreatic cancer, urothelial cancer,
head and neck cancer, diffuse large B-cell lymphoma (DLBCL),
microsatellite stable (MSS) colon cancer, triple negative breast
cancer (TNBC) or melanoma will be en-rolled. All patients must have
disease amenable to biopsy and must be willing to undergo biopsy at
screening/baseline, and during the course of study treatment as per
protocol requirement. For parts 1 and 2, patients must not have
received prior Immunotherapy. For part 3, patients in the NSCLC
group must have received prior immunotherapy.
|
| |
|
|
type of project
|
clinical studies
|
|
status
|
ongoing - recruiting phase
|
|
start of project
|
2017
|
|
end of project
|
2019
|
|
responsible person
|
PD Dr. med. Markus Jörger
|
additional links & downloads
