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Trial record 3 of 3 for:    NKTR-214

A Study of a CD122-Biased Cytokine (NKTR-214) in Combination With Anti-PD-L1 (Atezolizumab) in Patients With Metastatic Urothelial Bladder Cancer or Metastatic Non-Small Cell Lung Cancer (PROPEL)

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Nektar Therapeutics
Sponsor:
Information provided by (Responsible Party):
Nektar Therapeutics
ClinicalTrials.gov Identifier:
NCT03138889
First received: May 1, 2017
Last updated: June 19, 2017
Last verified: June 2017
  Purpose
This study is to assess the safety and tolerability, determine the recommended Phase 2 dose, and assess the preliminary clinical benefit of NKTR-214 when combined with atezolizumab (Tecentriq) in select patients with urothelial bladder cancer or metastatic non-small cell lung cancer. Both drugs target the immune system and may act synergistically to promote anticancer effects.

Condition Intervention Phase
Non-Small Cell Lung Cancer Urinary Bladder Neoplasms Neoplasm Metastasis Drug: Combination of NKTR-214 + atezolizumab Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase 1b, Open-label, Multicenter Study to Investigate the Safety and Preliminary Efficacy of NKTR 214 and Anti-PD-L1 (Atezolizumab) in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer or Metastatic Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Nektar Therapeutics:

Primary Outcome Measures:
  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of NKTR-214 in combination with atezolizumab (Tecentriq) [ Time Frame: 100 days after last dose ]
    Safety and Tolerability of NKTR-214 in combination with atezolizumab (Tecentriq) as evaluated by incidence of drug-related Adverse Events (AEs), Serious Adverse Events (SAEs), and adverse events leading to discontinuation, deaths, and clinical laboratory test abnormalities

  • Recommended Phase 2 Dose (RP2D) of NKTR-214 in combination with atezolizumab (Tecentriq) [ Time Frame: 100 days after last dose ]
    To define the Recommended Phase 2 Dose (RP2D), or Maximum Tolerated Dose (MTD), of NKTR-214 in combination with atezolizumab (Tecentriq), by evaluating the incidence of Dose Limiting Toxicities (DLTs), drug-related AEs, SAEs, adverse events leading to discontinuation, deaths and clinical laboratory test abnormalities.


Secondary Outcome Measures:
  • Efficacy of NKTR-214 in combination with atezolizumab (Tecentriq) [ Time Frame: Through study completion, an expected average of 2 years ]
    Efficacy, or the preliminary anti-tumor activity, of NKTR-214 in combination with atezolizumab (Tecentriq), as assessed by the Objective Response Rate (ORR) based on RECIST 1.1

  • Progression-Free Survival (PFS) [ Time Frame: Through study completion, an expected average of 2 years ]
    PFS is defined as the time from date of first dose to the date of the first objectively documented tumor progression or death due to any cause

  • Overall Survival (OS) [ Time Frame: Through study completion, an expected average of 2 years ]
    Overall survival is defined as the time from date of first dose to the date of death.


Estimated Enrollment: 36
Actual Study Start Date: June 9, 2017
Estimated Study Completion Date: May 30, 2020
Estimated Primary Completion Date: May 30, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Combination of NKTR-214 + Atezolizumab
NKTR-214 in escalating doses, will be combined with atezolizumab in several cohorts.
Drug: Combination of NKTR-214 + atezolizumab

NKTR-214: The starting dose will be a 0.006 mg/kg intravenous (IV) infusion administered over 15 (± 5) minutes q3w.

Atezolizumab (anti-PD-L1) will be dosed as per label.

Other Name: Tecentriq (atezolizumab)

Detailed Description:

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. Atezolizumab is a fully humanized, engineered monoclonal antibody of IgG1 isotype against the protein programmed cell death-ligand 1 (PD-L1) that promotes anti-tumor effects.

NKTR-214 will be combined with atezolizumab. The first NKTR-214 dose to be studied will be 0.006 mg/kg based on the safety observed in the ongoing monotherapy trial with NKTR-214 (Study 15-214-01, NCT02869295). It is estimated that approximately 36 patients will be enrolled to the study to different dose cohorts with doses of NKTR-214 up to 0.009 mg/kg administered IV every 3 weeks (q3w).

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willing and able to provide written informed consent.
  • Histologically confirmed locally advanced or metastatic urothelial carcinoma or histologically confirmed or cytologically confirmed diagnosis of stage IV NSCLC lacking epidermal growth factor receptor (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK) translocation.
  • Male or female patients, age 18 years or older at the time of signing the informed consent form (ICF).
  • Life expectancy > 12 weeks as determined by the Investigator.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Measurable disease per RECIST 1.1.
  • Patients must not have received prior immunotherapy with immunomodulators, including but not limited to checkpoint inhibitors such as anti PD-1, anti-PD-L1, anti-PD-L2, anti CD137, or anti CTLA-4 (cytotoxic T lymphocyte-associated protein 4) antibody, or any other antibody or drug specifically targeting T cell co stimulation or checkpoint pathways, indoleamine 2,3 dioxydenase pathway inhibitors, cancer vaccines, adoptive cell therapies, or other cytokine therapies.
  • Patients must have received no more than 1 line of platinum-containing chemotherapy and have disease progression during or following this therapy, or patient refuses standard of care.
  • Additional criteria may apply

Exclusion Criteria:

  • Use of an investigational agent or an investigational device within 28 days before administration of first dose of study drug(s).
  • Females who are pregnant or breastfeeding.
  • Patients who have an active, known or suspected autoimmune disease. Patients requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease that requires systemic steroids or immunosuppressive agents. (Exceptions include any patient on 10 mg or less of prednisone or equivalent, patients with vitiligo, hypothyroidism stable on hormone replacement, Type I diabetes, Graves' disease, Hashimoto's disease, alopecia areata, eczema, or with Medical Monitor approval).
  • History of allergy or hypersensitivity to study drug components.
  • Active malignancy not related to the current diagnosed malignancy.
  • History of organ transplant that requires use of immune suppressive agents.
  • Use of warfarin within 14 days of initiating study drug(s). (Note: Low molecular weight heparin is allowed on the study.)
  • Evidence of clinically significant interstitial lung disease or active, noninfectious pneumonitis.
  • Prior surgery or radiotherapy within 14 days of initiating study drug(s). Patients must have recovered from all radiation-related toxicities, not required corticosteroids and have not had radiation pneumonitis.
  • Additional criteria may apply
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03138889

Contacts
Contact: Nektar Recruitment 855-482-8676 StudyInquiry@nektar.com

Locations
United States, Tennessee
Investigator Site - Germantown Recruiting
Memphis, Tennessee, United States, 38138
United States, Washington
Investigator Site - Tacoma Not yet recruiting
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Nektar Therapeutics
Investigators
Study Director: Michael Imperial, MD Nektar Therapeutics
  More Information

Responsible Party: Nektar Therapeutics
ClinicalTrials.gov Identifier: NCT03138889     History of Changes
Other Study ID Numbers: 16-214-05
Study First Received: May 1, 2017
Last Updated: June 19, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nektar Therapeutics:
NKTR-214
Atezolizumab
Tecentriq
Metastatic Urothelial Bladder Cancer
Metastatic Non-Small Cell Lung Cancer

Additional relevant MeSH terms:
Lung Neoplasms
Neoplasms
Carcinoma, Non-Small-Cell Lung
Urinary Bladder Neoplasms
Neoplasm Metastasis
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Neoplastic Processes
Pathologic Processes
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 23, 2017