A Phase 1/2, Open-Label, Multicenter Study to Investigate the Safety and Preliminary Efficacy of NKTR-214 in Combination with Pembrolizumab in Patients with Locally Advanced or Metastatic Solid Tumors
Categories (click each to see list of all clinical trials associated with that category): Genitourinary (GU), Lung/Thoracic, Melanoma
Current Status: Open to accrual
Phase: I
Principal Investigator: Ganti, Apar
Contact Information:
Brandie Booker, RN
402-559-8197
brandie.booker@unmc.edu
Eligibility: https://clinicaltrials.gov/ct2/show/NCT03138889#eligibility
Summary
The study will evaluate the clinical benefit, safety and tolerability of combining NKTR-214 with pembrolizumab or atezolizumab and will enroll approximately 75 patients into two separate arms concurrently. The first arm will evaluate an every three-week dose regimen (q3w) of NKTR-214 in combination with pembrolizumab in up to 46 patients in approved treatment settings of pembrolizumab, including patients with melanoma or non-small cell lung cancer. The second arm will evaluate a q3w dose regimen of NKTR-214 in combination with atezolizumab in up to 29 patients in approved treatment settings of atezolizumab, including patients with urothelial carcinoma. The NKTR-214 dose to be studied is 0.006 mg/kg q3w based on the safety observed in the monotherapy trial with NKTR-214 (Study 15-214-01, NCT02869295) and an ongoing combination trial (16-214-02, NCT02983045). The dose of pembrolizumab or atezolizumab to be studied will be that in their approved labelling.