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A Phase 1/2, Open-label, Multicenter, Dose Escalation and Dose Expansion Study of NKTR-214 and Nivolumab in Patients With Select Locally Advanced or Metastatic Solid Tumor Malignancies.

Status
Active
Cancer Type
Kidney Cancer
Lung Cancer
Melanoma
Trial Phase
Phase I
Phase II
Eligibility
18 and over, Male and Female
Study Type
Treatment
NCD ID
NCT02983045
Protocol IDs
16-214-02 (primary)
NCI-2017-00053
Study Sponsor
Nektar

Summary

This study is to determine first, the recommended Phase 2 dose of NKTR-214 when administered

in combination with nivolumab, and then, the clinical benefit, safety, and tolerability of

combining NKTR-214 with nivolumab in select patients with melanoma, renal cell carcinoma or

non-small cell lung cancer. Both drugs target the immune system and may act synergistically

to promote anti-cancer effects.

Objectives

NKTR-214 is a cytokine (investigational agent) that is designed to target CD122, a protein

which is found on certain immune cells (known as CD8+ T Cells and Natural Killer Cells) to

expand these cells to promote their anti-tumor effects. Nivolumab is a full human monoclonal

antibody that binds to a molecule called PD-1 on immune cells and promotes anti-tumor

effects.

Approximately 40 eligible patients that enroll in the dose escalation portion of the study

(Phase 1) will be assigned to one of five dose regimens of NKTR-214 in combination with

nivolumab (0.006 mg/kg NKTR-214 every 21 days with 240 mg nivolumab every 14 days, 0.003

mg/kg NKTR-214 every 14 days with 240 mg nivolumab every 14 days, 0.006 mg/kg NKTR-214 every

14 days with 240 mg nivolumab every 14 days, 0.006 mg/kg NKTR-214 every 21 days with 360 mg

nivolumab every 21 days, 0.003 mg/kg NKTR-214 every 21 days with 360 mg nivolumab every 21

days). Based on safety, tolerability and efficacy observed in the trial, enrollment to

additional dose escalation cohorts are planned. The first phase of the study will test the

safety and efficacy profile of the combination and determine which dose will be studied in

Phase 2 of the overall study. During Phase 2, cohorts of patients with specific cancers will

be expanded and these patients will receive the recommended Phase 2 dose and schedule of

NKTR-214 in combination with nivolumab.

All patients enrolled in the study will be closely monitored to determine if there is

response to the treatment as well as for any side effects that may occur. The efficacy of

the combination will be assessed using objective response rate (ORR). Exploratory

immunological biomarkers in plasma and tumor samples will evaluate immune activation.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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