Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Clinical summary
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.
Conditions
This trial is treating people 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)
Eligibility
Inclusion
Dose Optimization and Dose Expansion Inclusion Criteria:
- Willing and able to provide written informed consent.
- Male or female patients, age 18 years or older at the time of signing the informed consent form (ICF).
- Life expectancy > 12 weeks from the time of enrollment as determined by the Investigator.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Oxygen saturation ≥ 92% on room air for all indications.
- Measurable disease per RECIST 1.1.
- Patients with brain metastases are eligible if certain criteria are met.
- Availability of fresh or archival tumor tissue
- Patients must have a minimum of 6 months of response to any nonpalliative cancer-directed treatment
Dose Expansion Inclusion Criteria (Non-Small Cell Lung Cancer):
- Histologically confirmed diagnosis of stage IV NSCLC.
- Patients must have a minimum of 6 months of response to any nonpalliative cancer-directed treatment.
- Patients with actionable mutations with approved targeted therapy in NSCLC are excluded. Testing for mutations should be performed per standard of care.
- Must not have received anti-cancer therapy for treatment of metastatic lung cancer
- Must not have received prior immunotherapy
Exclusion
- Use of an investigational agent or an investigational device within 28 days before administration of first dose of study drug(s).
- Females who are pregnant or breastfeeding.
- Patients who have an active autoimmune disease
- History of allergy or hypersensitivity to study drug components
- Evidence of clinically significant interstitial lung disease or active, noninfectious pneumonitis.
- Prior surgery or radiotherapy within 14 days of therapy.
- For Dose Optimization Cohort 1 only: Chemotherapy or biological therapy within 28 days of enrollment. Targeted therapy (e.g., tyrosine kinase inhibitors) within 14 days of enrollment. Patients with ongoing AEs related to prior cancer therapies will be excluded.
- Participant's inability to adhere to or tolerate protocol or study procedures
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
- You are currently being treated on a clinical trial.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Nektar Therapeutics
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
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