A phase 1/2, open-label, multicenter study of the combination of NKTR-214 and Nivolumab or the combination of NKTR-214, Nivolumab and Ipilimumab in patients with select locally advanced or metastatic solid tumor malignancies (NEKTAR)

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General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT02983045

Background Information

Patients will receive intratumoral (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 NKTR-214. After determination of the recommended Phase 2 dose (RP2D) of NKTR-262, NKTR-262 will be combined with NKTR-214 (Cohort A) and with NKTR-214 plus nivolumab (Cohort B). In the Phase 2 dose expansion portion, patients will be treated with NKTR-262 and NKTR-214 (doublet) or NKTR-262 and NKTR-214 plus nivolumab (triplet) in the relapsed/refractory setting and earlier lines of therapy.

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031
A department of Inova Fairfax Hospital

Inova Fair Oaks Medical Campus
3580 Joseph Siewick Drive
Fairfax, VA 22033

Eligibility Information

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), ovarian carcinoma, renal cell carcinoma (RCC), colorectal cancer, urothelial carcinoma, or sarcoma.
Additional eligibility in protocol

Ineligibility Information

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.
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.
Additional ineligibility in protocol

Additional Information can be found at https://clinicaltrials.gov/ct2/show/NCT02983045