A Dose Escalation and Cohort Expansion Study of NKTR-214 in Combination With Nivolumab and Other Anti-Cancer Therapies in Patients With Select Advanced Solid Tumors
Trial ID or NCT#
Status
NOT RECRUITING
Purpose
In this four-part study, NKTR-214 was administered in combination with nivolumab and with/without other anticancer therapies. Part 1 considered escalating doublet (NKTR 214 + nivolumab) doses to determine the RP2D. Part 2 considered dose expansion cohorts for the doublet (NKTR 214 + nivolumab ± chemotherapy). Part 3 was schedule-finding for a triplet therapy (NKTR 214 + nivolumab + ipilimumab). Part 4 dose expansion for the triplet (NKTR 214 + nivolumab + ipilimumab) was planned to further assess the efficacy of the RP2D triplet combination at dosing schedules from Part 3.
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
Eligibility Criteria
- - 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.
- EXCLUSION CRITERIA - 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
- - 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
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Brianna Velazquez
650-723-0270
View on ClinicalTrials.gov
