PROPEL: This phase I/II trial is trying to understand how safe and well tolerated a new immunotherapy is when combined with a standard immunotherapy drug in patients with advanced cancerA 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

Summary

Eligible patients will be assigned to a dose optimisation or expansion phase. Dose Optimization: will evaluate a three weekly dose regimen (q3w) of NKTR-214 in combination with pembrolizumab in approximately 40 melanoma, non-small cell lung cancer (NSCLC), urothelial carcinoma, head and neck squamous cell carcinoma (HNSCC), and hepatocellular carcinoma (HCC) patients. NKTR-214 will be administered at a starting dose of 0.008 mg/kg q3w and Pembrolizumab will be administered at a dose of 200 mg q3w. Patients will undergo a fixed 3+3 dose escalation followed by intra-patient step-up dose escalation at a pre-determined dose. Dose Expansion: NKTR-214 will be administered in combination with pembrolizumab in approximately 58 first-line non-small cell lung cancer (NSCLC) patients. NKTR-214 will be administered at a dose of 0.006 mg/kg q3w and Pembrolizumab will be administered at a dose of 200mg q3w.