Status:
TERMINATED
REVEAL Study of NKTR-262 in Combination With NKTR-214 and Nivolumab in Patients With Locally Advanced / Metastatic Solid Tumor Malignancies
Lead Sponsor:
Nektar Therapeutics
Conditions:
Melanoma
Merkel Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Patients received intratumoral (IT) injections of NKTR-262 in 3-week cycles for up to 3 cycles; bempegaldesleukin with or without nivolumab was administered every 3 weeks (q3w), and treatment continue...
Detailed 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...
Eligibility Criteria
Inclusion
- Key
- Histologically confirmed diagnosis of a locally advanced (not amenable to curative therapy such as surgical resection) metastatic cancer of the following histologies: melanoma (MEL), Merkel cell carcinoma (MCC), triple-negative breast cancer (TNBC), renal cell carcinoma (RCC), colorectal cancer, head and neck squamous cell carcinoma (HNSCC), or sarcoma.
- 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 enrolled in Cohorts 1-10, Cohort A, Cohort B and Phase 2 Doublet must be refractory to all therapies known to confer clinical benefit to their disease.
- Fresh tumor tissue available for cellular characterization and programmed cell death protein 1 (PD-L1) status.
- Injected lesions (up to two) must be between 20 mm and 90 mm in diameter for IT injection; lesions must be accessible for baseline and on-treatment biopsies. Any liver lesion targeted for injection must not exceed 50 mm at the time of injection.
- Demonstrated adequate organ function within 14 days of Cycle 1 Day 1 (C1D1).
- Key
Exclusion
- Use of an investigational agent or an investigational device within 21 days before administration of first dose of study drug(s).
- Patients treated with prior interleukin-2 (IL-2).
- Patients who have been previously treated with a toll-like receptor (TLR) agonist (excluding topical agents) and patients who have received experimental cancer vaccines.
- Patients who have received systemic interferon (IFN)α within the previous 6 months prior to enrollment to the study.
- Other active malignancy, except non-melanomic skin cancer
- 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.
- Prolonged Fridericia's corrected QT interval (QTcF) \> 450 ms for men and \> 470 ms for women at Screening.
- History of unstable or deteriorating cardiac disease within the previous 6 months prior to screening including but not limited to the following:
- Unstable angina or myocardial infarction.
- Congestive heart failure (NYHA Class III or IV).
- Uncontrolled clinically significant arrhythmias.
- Patients with a history of any retinal disorders (e.g., retinal detachment, diabetic retinopathy, retinal hemorrhage, macular degeneration).
- Uveal melanoma will be excluded
- Patients with tumor that invade the superior vena cava or other major blood vessels.
- Additional general and tumor specific inclusion and exclusion criteria will apply.
Key Trial Info
Start Date :
March 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 9 2022
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT03435640
Start Date
March 15 2018
End Date
May 9 2022
Last Update
March 8 2023
Active Locations (14)
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1
HonorHealth
Scottsdale, Arizona, United States, 85258
2
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
3
Moffitt Cancer Center
Tampa, Florida, United States, 33612
4
Winship Cancer Center, Emory University Hospital
Atlanta, Georgia, United States, 30322