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 cancer.
This trial is treating patients with first-line and second-line melanoma, non-small cell lung cancer (NSCLC), urothelial carcinoma, head and neck squamous cell carcinoma (HNSCC), and hepatocellular carcinoma (HCC, liver cancer).
This is a systemic therapy trial.
You may be able to join this trial if:
- Your cancer has spread to other parts of the body.
You may be excluded from this trial if:
- You have a certain disease or psychological condition.
- You have had certain treatments, surgical procedures or drugs.
- You have previously been treated (or are currently being treated) on a clinical trial.
Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.
Clinical Summary Read More
Trial Identifiers
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Scientific Title
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
Commercial Sponsor
Nektar Therapeutics
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.
Recruiting Hospitals Read More