ALT-803 Plus Nivolumab in Patients With Pretreated, Advanced or Metastatic Non-Small Cell Lung Cancer

Part of paid clinical trials in Weston, Florida.

Sponsor
Medical University of South Carolina
Study ID
NCT02523469
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • ALT-803 — BIOLOGICAL
    ALT-803 administered IV at doses per arm (6, 10, 15, 20 µg/kg)
  • Nivolumab — BIOLOGICAL
    Nivolumab administered IV at 3 mg/kg per protocol

Study Details

The purpose of the study is to define the safety and tolerability of this drug combination. The study will also define the response rate of patients with advanced and unresectable NSCLC.

Key Dates

Start date
Jan 8, 2016
Status verified
Jan 2026
Primary completion
Feb 24, 2023
Completion
Feb 24, 2023

Study Design

Enrollment
67 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: ALT-803 6 µg/kg + Nivolumab 3 mg/kg
    Participants receive ALT-803 6 µg/kg + Nivolumab 3 mg/kg IV per protocol
  • Experimental: Cohort 2: ALT-803 10 µg/kg + Nivolumab 3 mg/kg
    Participants receive ALT-803 10 µg/kg + Nivolumab 3 mg/kg IV per protocol
  • Experimental: Cohort 3: ALT-803 15 µg/kg + Nivolumab 3 mg/kg
    Participants receive ALT-803 15 µg/kg + Nivolumab 3 mg/kg IV per protocol
  • Experimental: Cohort 4: ALT-803 20 µg/kg + Nivolumab 3 mg/kg (RP2D)
    Participants receive ALT-803 20 µg/kg + Nivolumab 3 mg/kg IV per protocol
  • Experimental: Arm A: RP2D ALT-803 + Nivolumab (Nivo-naïve)
    Participants receive ALT-803 20 µg/kg + Nivolumab 3 mg/kg IV; Nivolumab-naïve population
  • Experimental: Arm B: RP2D ALT-803 + Nivolumab (Nivo-progressor)
    Participants receive ALT-803 20 µg/kg + Nivolumab 3 mg/kg IV; prior Nivolumab exposure
  • No Intervention: Exploratory Arm 1
    ALT-803 ± Nivolumab for biomarker analysis only
  • No Intervention: Exploratory Arm 2
    ALT-803 ± Nivolumab for biomarker analysis only

Primary Outcome Measure

Presence or Absence of a Dose Limiting Toxicity (DLT) of ALT-803 in Combination With Nivolumab [ Time Frame: Cycles 1-4: Weeks 1-6 of each cycle ]

Locations (4)

FacilityCityStateZIPSite coordinators
Cleveland Clinic FloridaWestonFlorida33331-
University of MinnesotaMinneapolisMinnesota55455-
Cleveland ClinicClevelandOhio44195-
Medical University of South CarolinaCharlestonSouth Carolina29425-

Related coverage on Hipa.ai

Find similar trials in Weston, FL

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Cleveland Clinic Florida· Weston, FLUniversity of Minnesota· Minneapolis, MNCleveland Clinic· Cleveland, OHMedical University of South Carolina· Charleston, SC

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