for people ages 18 years and up (full criteria)
study started
estimated completion



In this four-part study, NKTR-214 will be administered in combination with nivolumab in Part 1, in combination with nivolumab with or without various chemotherapies in Part 2, and with nivolumab in Parts 3 & 4. In Part 1, the Recommended Phase 2 Dose (RP2D) of NKTR-214 in combination with nivolumab will be determined. In Part 2, NKTR-214 with nivolumab at the RP2D will be evaluated as first-line therapy and/or as second or third line therapy in select patients with Melanoma, Renal Cell Carcinoma (RCC), Non-Small Cell Lung Cancer (NSCLC), Urothelial Carcinoma (UC), triple negative Breast Cancer (TNBC), HR+/HER2- breast cancer, gastric cancer, and Colorectal Cancer (CRC). In addition, in Part 2, the RP2D of NKTR-214 with nivolumab and various chemotherapies and regimens in select cohorts of NSCLC patients will be determined. In Part 3, several different regimens of the doublet combination of NKTR-214 plus nivolumab will be evaluated in select patients with RCC, NSCLC, Melanoma, and UC. In Part 4, the safety and efficacy of the doublet combination will be evaluated further in select patients with RCC, NSCLC, Melanoma and UC.

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


The study is designed in four parts. Part 1: Dose escalation of NKTR-214 in combination with nivolumab. Part 1 has been completed and the recommended phase 2 dose (RP2D) has been identified, which is being studied further in Parts 2, 3 and 4 of the study. Part 2: Dose expansion of NKTR-214 in combination with nivolumab. Patients with the following tumor types (Melanoma, RCC, NSCLC, UC, triple negative breast cancer (TNBC), HR+/HER2- breast cancer, gastric cancer, and CRC) will be enrolled to receive the RP2D of NKTR-214 in combination with nivolumab. In addition, NKTR-214 with nivolumab and other anti-cancer therapies including cytotoxic chemotherapy will be evaluated in select patients with NSCLC. Each cohort in Part 2 has a target enrollment of 12-36 patients and could add up to a total of 936 patients who are either checkpoint-therapy naïve or anti-PD-1 or anti-PD-L1 relapsed/refractory. One dedicated and separate cohort in Part 2 will evaluate NKTR-214 with nivolumab in an additional 100 second-line NSCLC patients previously treated with an anti-PD-1 or anti-PD-L1 in combination with doublet platinum-containing cytotoxic chemotherapy in first-line. Part 3: Schedule and safety finding of NKTR-214 in combination with nivolumab. During this part of the study, the RP2D doublet combination schedules will be determined in the following tumor types: RCC, NSCLC, Melanoma, or UC. Part 4: Dose expansion of doublet combinations of NKTR-214 in combination with nivolumab in select tumor types. Each cohort will enroll between 6-36 patients and could include up to 106 patients. Enrollment into Part 4 will commence once the RP2D for the doublet combination has been established in Part 3 for each respective tumor type. All patients enrolled in the study will be closely monitored for safety, tolerability and response per RECIST criteria. The primary efficacy endpoint of the combination will be assessed using objective response rate (ORR). Exploratory immunological biomarkers in plasma and tumor samples will evaluate immune activation.


Melanoma Renal Cell Carcinoma Non Small Cell Lung Cancer Urothelial Carcinoma Triple Negative Breast Cancer HR+/HER2- Breast Cancer Gastric Cancer NKTR-214 Bempegaldesleukin Nivolumab Paclitaxel Carboplatin Cisplatin Pemetrexed Colorectal Cancer Metastatic Advanced Immunotherapy Anti-PD-1 anti-CTLA-4 Carcinoma Breast Neoplasms Carcinoma, Non-Small-Cell Lung Stomach Neoplasms Carcinoma, Renal Cell Triple Negative Breast Neoplasms Carcinoma, Transitional Cell Combination of NKTR-214 + nivolumab


You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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


  • UCSD, Moores Cancer Center
    La Jolla California 92093 United States
  • UCLA
    Los Angeles California 90095 United States
  • Stanford Cancer Institute
    Stanford California 94305 United States


in progress, not accepting new patients
Start Date
Completion Date
Nektar Therapeutics
Phase 1/2 research study
Study Type
At least 557 people participating
Last Updated