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CompletedLast updated: 1 February 2024

PIVOT-02: This phase I/II trial is evaluating different immunotherapy and anti-cancer therapy combinations in patients with select advanced or metastatic cancersA Phase 1/2, Open-label, Multicenter Study of the Combination of NKTR-214 and Nivolumab or the Combination of NKTR-214, Nivolumab, and Ipilimumab in Patients With Select Locally Advanced or Metastatic Solid Tumor Malignancies

Clinical summary

Summary

At St Vincent's Hospital Melbourne, this trial is currently only recruiting patients who have a confirmed diagnosis of stage IV non-small cell lung cancer (NSCLC). Eligible patients will receive a recommended phase II dose of NKTR-214 in combination with nivolumab and other anti-cancer therapies.

Conditions

This trial is treating patients with non-small cell lung cancer (NSCLC).

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

I/II

Trial Acronym

PIVOT-02

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 of the Combination of NKTR-214 and Nivolumab or the Combination of NKTR-214, Nivolumab, and Ipilimumab in Patients With Select Locally Advanced or Metastatic Solid Tumor Malignancies

Eligibility

Inclusion

For Parts 1-4:

  • Histologically confirmed diagnosis of a locally advanced (not amenable to curative therapy such as surgical resection) or metastatic solid tumors
  • Life expectancy > 12 weeks
  • Patients must not have received prior interleukin-2 (IL-2) therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Measurable disease per RECIST 1.1
  • Patients with stable brain metastases under certain criteria
  • Fresh and archival tumor tissue available Tumor specific inclusion criteria may apply.

Exclusion

For Parts 1-4:

  • Use of an investigational agent or an investigational device within 28 days before administration of first dose of NKTR--214
  • Females who are pregnant or breastfeeding
  • Participants who have an active autoimmune disease requiring systemic treatment within the past 3 months or have a documented history of clinically severe autoimmune disease that requires systemic steroids or immunosuppressive agents
  • History of organ transplant that requires use of immune suppressive agents
  • Active malignancy not related to the current diagnosed malignancy
  • Evidence of clinically significant interstitial lung disease or active, noninfectious pneumonitis
  • Participants who have had < 28 days since the last chemotherapy, biological therapy, or < 14 days from approved tyrosine kinase inhibitor (TKI) therapy, or systemic or inhaled steroid therapy at doses greater than 10mg of prednisone Tumor specific exclusion criteria may apply.

Other protocol defined inclusion/exclusion criteria may apply

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • 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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