RWF_16-214-02

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.

In this four part study, NKTR-214 will be administered in combination with nivolumab in Parts 1 & 2, and with nivolumab and ipilimumab in Parts 3 & 4. In Part 1, the safety, efficacy and recommended Phase 2 dose (RP2D) of NKTR-214 in combination with nivolumab will be determined. In Part 2, the clinical benefit, safety, and tolerability of combining NKTR-214 with nivolumab at the RP2D in select patients with Melanoma, Renal Cell Carcinoma, Non-Small Cell Lung Cancer, Urothelial Carcinoma, or Triple Negative Breast Cancer. In Part 3, the safety, efficacy and RP2D of NKTR-214 in combination with nivolumab and ipilimumab will be determined. In Part 4, the clinical benefit, safety, and tolerability of the triplet combination will be evaluated in select patients with RCC or NSCLC. All three drugs target the immune system and may act synergistically to promote anti-cancer effects.
Inclusion Criteria:
Part 1-4
• Histologically confirmed diagnosis of a locally advanced (not amenable to curative therapy such as surgical resection) or metastatic melanoma, RCC, NSCLC, urothelial carcinoma, or TNBC
• Life expectancy >12 weeks
• Patients must not have received prior interleukin 2 (IL 2) therapy
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
• Measurable disease per RECIST 1.1
• Demonstrated adequate organ function within 14 days of treatment initiation
• Oxygen saturation > 92% on room air.
• Subjects must be recovered from the effects of any prior chemotherapy, immunotherapy, other prior system anticancer therapy, radiotherapy, or surgery
Refer to www.clinicaltrials.gov for more details on Parts 2-4 criteria.
Phase I/II
NCT02983045
Cancer
Multiple Tumor Types
Brendan Curti, M.D.
Nektar Therapeutics
Tara Foote
  • Providence Cancer Institute Franz Clinic