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

Not Recruiting

Trial ID: NCT02983045


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.

Official 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 Other Anti-Cancer Therapies in Patients With Select Locally Advanced or Metastatic Solid Tumor Malignancies

Stanford Investigator(s)

Joel Neal, MD, PhD
Joel Neal, MD, PhD

Associate Professor of Medicine (Oncology)

Heather Wakelee
Heather Wakelee

Winston Chen and Phyllis Huang Professor



   - 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.


   - 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

   - 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


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

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Brianna Velazquez

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