A Study of NKTR-214 in Combination With Nivolumab in Patients With Metastatic and/or Locally Advanced Sarcoma

Part of paid clinical trials in New York, New York.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT03282344
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • SARCOMA

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NKTR-214 — DRUG
    0.006mg/kg IV on day 1 and every 3 weeks thereafter will be an intravenous (IV) infusion administered over 30 (±5) minutes every 3 weeks.
  • Nivolumab — DRUG
    360mg (flat dose) IV infusion administered over 30 (±5) minutes every 3 weeks.

Study Details

The purpose of this study is to test any good and bad effects of the combination of study drugs called NKTR-214 and nivolumab.

Key Dates

Start date
Sep 12, 2017
Status verified
Sep 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
88 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: participants ≥18 years old NKTR-214 and Nivolumab
    NKTR-214 0.006mg/kg and nivolumab 360mg will be administered intravenously on day 1 of week 1 of cycle one and every 3 weeks (±3 days) thereafter.
  • Experimental: participants 12 - 17 years old NKTR-214 0.006mg/kg and Nivo
    NKTR-214 0.006mg/kg and nivolumab 360mg will be administered intravenously on day 1 of week 1 of cycle one and every 3 weeks (±3 days) thereafter.

Primary Outcome Measure

number of patients with a response [ Time Frame: 2 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer Center (only recruiting to the Vascular/Angiosarcoma cohort)New YorkNew York10065-
MD Anderson Cancer Center (only recruiting to the Vascular/Angiosarcoma cohort)HoustonTexas77030-

Find similar trials in New York, NY

By research site
Memorial Sloan Kettering Cancer Center (only recruiting to the Vascular/Angiosarcoma cohort)· New York, NYMD Anderson Cancer Center (only recruiting to the Vascular/Angiosarcoma cohort)· Houston, TX

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