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CompletedPhase 1 / Phase 2NCT02983045
Official study title

A Dose Escalation and Cohort Expansion Study of NKTR-214 in Combination With Nivolumab and Other Anti-Cancer Therapies in Patients With Select Advanced Solid Tumors

Study summary

In this four-part study, NKTR-214 was administered in combination with nivolumab and with/without other anticancer therapies. Part 1 considered escalating doublet (NKTR 214 + nivolumab) doses to determine the RP2D. Part 2 considered dose expansion cohorts for the doublet (NKTR 214 + nivolumab ± chemotherapy). Part 3 was schedule-finding for a triplet therapy (NKTR 214 + nivolumab + ipilimumab). Part 4 dose expansion for the triplet (NKTR 214 + nivolumab + ipilimumab) was planned to further assess the efficacy of the RP2D triplet combination at dosing schedules from Part 3.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedDose Escalation Doublet: Combination of NKTR-214 + nivolumab and Dose Expansion Doublet: Combination of NKTR-214 + nivolumab

Plus 2 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · HER2

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 13, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?58 U.S. locations

Locations may change over time.

Who runs it?Nektar Therapeutics

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Nektar Therapeutics
Interventions being studied
Drug: Dose Escalation Doublet: Combination of NKTR-214 + nivolumab; Drug: Dose Expansion Doublet: Combination of NKTR-214 + nivolumab; Drug: Schedule Finding Triplet: Combination of NKTR-214+ nivolumab+ ipilimumab; Drug: Dose Expansion Triplet: Combination of NKTR-214+ nivolumab+ ipilimumab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Biomarkers
HER2→
Treatment approach
Immunotherapy→Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • 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.
Reasons someone may not be able to joinExclusion criteria
  • 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • UCSD, Moores Cancer CenterLa Jolla, California
  • UCLALos Angeles, California
  • Stanford Cancer InstituteStanford, California
  • University of Colorado, DenverDenver, Colorado
  • Yale School of MedicineNew Haven, Connecticut
  • University of FloridaGainesville, Florida
  • Orlando Health Inc.Orlando, Florida
  • Emory University HospitalAtlanta, Georgia
  • Loyola University Medical Center, ChicagoMaywood, Illinois
  • Indiana University Health Melvin & Bren Simon Cancer CenterIndianapolis, Indiana
  • University of Kansas Cancer CenterKansas City, Kansas
  • Dana-Farber Cancer InstituteBoston, Massachusetts

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 13, 2023. Always confirm current availability with the study team.

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