Last updated on June 2020

A Study of NKTR-262 in Combination With Bempegaldesleukin (NKTR-214) and With Bempegaldesleukin Plus Nivolumab in Patients With Locally Advanced or Metastatic Solid Tumor Malignancies

Brief description of study

Patients will receive intra-tumoral (IT) NKTR-262 in 3-week treatment cycles. During the Phase 1 dose escalation portion of the trial, NKTR-262 will be combined with systemic administration of bempegaldesleukin. After determination of the recommended Phase 2 dose (RP2D) of NKTR-262, between 6 and 18 patients may be enrolled at the RP2D to further characterize the safety and tolerability profile of the combination of NKTR 262 plus bempegaldesleukin (doublet) or NKTR 262 plus bempegaldesleukin in combination with nivolumab (triplet) in Cohorts A and B, respectively. In the Phase 2 dose expansion portion, patients will be treated with doublet or triplet in the relapsed/refractory setting and earlier lines of therapy.

Detailed Study Description

Cancer treatments that couple pharmacological activation of tumor antigen presentation with activation and expansion of CD8+ T and natural killer (NK) cells in the tumor environment have the potential to induce an effective anti-tumor immune response in patients. NKTR-262 is a small molecule agonist of toll-like receptors (TLRs) 7/8 designed to be retained in the tumor micro-environment in order to activate antigen-presenting cells (APC), such as dendritic cells, to create new antigen-specific cytotoxic T cells. As a CD122-biased agonist, bempegaldesleukin monotherapy increases newly proliferative CD8+ T cells in tumors. NKTR-262 plus bempegaldesleukin is expected to increase expansion of antigen-specific CD8+ T cells. In preclinical studies, a single IT injection of NKTR-262 plus IV bempegaldesleukin resulted in complete abscopal effects in tumor models. Preliminary clinical data show bempegaldesleukin plus nivolumab enhances immune-stimulatory responses. The REVEAL trial will assess safety and anti-tumor activity of NKTR-262 with bempegaldesleukin +/- nivolumab for the treatment of selected cancers.

  • Melanoma (1st-line and relapsed/refractory)
  • Merkel Cell Carcinoma (2nd-line and relapsed/refractory)
  • Triple Negative Breast Cancer (1st- and 2nd-line and relapsed/refractory)
  • Renal Cell Carcinoma (1st-line and relapsed/refractory)
  • Colorectal Cancer (2nd-line and relapsed/refractory; MSI non-high)
  • Colorectal Cancer (2nd 3rd-line+, I-O therapy naive; relapsed/refractory; MSI high)
  • Head and Neck Squamous Cell Carcinoma (2nd-line and relapsed/refractory)
  • Sarcoma (2nd-line and relapsed/refractory)

Clinical Study Identifier: NCT03435640

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Yale Cancer Center - New Haven

New Haven, CT United States
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Emory University - Atlanta

Atlanta, GA United States
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University of CA San Diego

La Jolla, CA United States
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University of Iowa

Iowa City, IA United States
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Henry Ford Health

Detroit, MI United States
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Mount Sinai Medical Center

New York, NY United States
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Cleveland Clinic

Cleveland, OH United States
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Vanderbilt Cancer Center

Nashville, TN United States
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Medical College of Wisconsin

Milwaukee, WI United States
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Recruitment Status: Open

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