Education and Training
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
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.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Dose Escalation Doublet: Combination of NKTR-214 + nivolumab
- drug: Dose Expansion Doublet: Combination of NKTR-214 + nivolumab
- drug: Schedule Finding Triplet: Combination of NKTR-214+ nivolumab+ ipilimumab
- drug: Dose Expansion Triplet: Combination of NKTR-214+ nivolumab+ ipilimumab
Eligibility
INCLUSION 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
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Brianna Velazquez
650-723-0270
Not Recruiting