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CompletedLast updated: 5 February 2024

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

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 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).

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I/II

Trial Acronym

PROPEL

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

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

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.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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