NCT02465957

QUILT-3.009: Patients With Stage III (IIIB) or Stage (IV) Merkel Cell Carcinoma (MCC)

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)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: ImmunityBio, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Stage IIIB Merkel Cell Carcinoma
• Stage IV Merkel Cell Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	aNK (NK-92)	A natural killer cell line recovered from a patient with large granular lymphoma
BIOLOGICAL	aNK (NK-92) + N-803	aNK - A natural killer cell line recovered from a patient with large granular lymphoma and N-803 - Recombinant human super agonist interleukin-15 (IL-15) complex

Timeline

• Start date: 2015-09-24
• Primary completion: 2018-03-19
• Completion: 2018-03-19
• First posted: 2015-06-09
• Last updated: 2024-05-02
• Results posted: 2024-05-02

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study