Clinical Trial: QUILT-3.009: Study of aNK Infusions in Combination With ALT-803 in Patients With Stage III (IIIB) or Stage (IV) Merkel Cell Carcinoma (MCC)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase 2 Study of aNK (Activated NK-92 Natural Killer Cells) Infusions in Combination With ALT-803 (IL-15) in Patients With Stage III (IIIB) or Stage IV Merkel Cell Carcinoma (MCC)

Brief Summary: Phase II study to determine the effects of aNK infusions in combination with ALT-803 in patients with stage III (IIIB) or stage (IV) merkel cell carcinoma (MCC).

Detailed Summary:

This is a multi-center, non-randomized, open-label, phase 2 trial to determine the effects of aNK in combination with ALT-803 in patients with stage III (IIIB) or stage IV MCC. The study will use an adaptive Simon optimal two-stage design, which detects efficacy signals, allows for early assessment, and avoids enrolling larger numbers of patients in case of inefficacy.

In the original protocol, an initial cohort of up to 12 patients with stage III (IIIB) or stage IV MCC were to be enrolled and treated with aNK monotherapy (first stage). If the treatment in the first stage improved the 4-month progression free survival (PFS) rate from 4% to 20% (e.g. at least 1 patient out of 12 patients has PFS ≥ 16 weeks [4 months]), then the study would proceed to the second stage, in which 12 more patients were planned to be enrolled and treated. As of July 2016, the trial has met the required efficacy signal defined for the first stage and will continue to enroll a planned total of 24 patients who will receive the combination of aNK and ALT-803. Any patients who are already receiving aNK cells as monotherapy will receive aNK cells in combination with ALT-803 in subsequent cycles.

aNK will be given via IV infusion at a dose of 2 x 10^9 cells/m^2 on two consecutive days (= 1 cycle) every 2 weeks. In addition, ALT-803 will be administered SC at 10 μg/kg on the first day of every aNK infusion (before the aNK infusion) every 2 weeks.


Sponsor: NantKwest, Inc.

Current Primary Outcome: Progression Free Survival [ Time Frame: 4 months ]

Determine the effect of aNK infusions in combination with ALT-803 on the 4-month (~16 weeks) progression-free survival (PFS) rate in patients with stage III (IIIB) or stage IV MCC based on Response Evaluation Criteria in Solid Tumors (RECIST v1.1).


Original Primary Outcome: Progression Free Survival [ Time Frame: 4 months ]

Determine the effect of Neukoplast infusions on the 4-month (~16 weeks) progression-free survival (PFS) rate in patients with unresectable stage III (IIIB) or distant metastatic (stage IV) MCC based on Response Evaluation Criteria in Solid Tumors (RECIST) (v1.1).


Current Secondary Outcome:

  • Overall Response Rate [ Time Frame: 16 weeks ]
    Determine the overall response rate, as assessed by RECIST at week 16
  • Time to disease progression [ Time Frame: 4 months ]
    Time to disease progression
  • Overall survival [ Time Frame: 4 months ]
    Overall survival
  • Safety and tolerability of aNK in combination with ALT-803 [ Time Frame: 4 months ]
    Assess the safety and tolerability of aNK in combination with ALT-803
  • Quality of life assessment [ Time Frame: 4 months ]
    Quality of life assessment (FACT-G)


Original Secondary Outcome:

  • Overall Response Rate [ Time Frame: 16 weeks ]
    Determine the overall response rate, as assessed by RECIST at week 16
  • Time to disease progression [ Time Frame: 4 months ]
    Time to disease progression
  • Median overall survival [ Time Frame: 4 months ]
    Median overall survival
  • Number of Subjects with Adverse Events as a Measure of Safety and Toxicity [ Time Frame: 4 months ]
    Assess the safety and toxicity of Neukoplast
  • Quality of life assessment [ Time Frame: 4 months ]
    Quality of life assessment (FACT-G)


Information By: NantKwest, Inc.

Dates:
Date Received: June 3, 2015
Date Started: August 2015
Date Completion: December 2017
Last Updated: March 8, 2017
Last Verified: March 2017