QUILT-3.009: Patients With Stage III (IIIB) or Stage (IV) Merkel Cell Carcinoma (MCC)
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|ClinicalTrials.gov Identifier: NCT02465957|
Recruitment Status : Active, not recruiting
First Posted : June 9, 2015
Last Update Posted : August 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Stage IIIB Merkel Cell Carcinoma Stage IV Merkel Cell Carcinoma||Biological: aNK (NK-92)||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||August 2015|
|Actual Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||April 2019|
Experimental: aNK (NK-92)
aNK (activated NK-92, formerly Neukoplast)
Biological: aNK (NK-92)
A natural killer cell line recovered from a patient with large granular lymphoma
Other Name: NK-92, Neukoplast
- 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).
- 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)
- Exploratory Genomic, Transcriptomic, and Proteomic Analysis [ Time Frame: 5 years ]To determine the genomic, transcriptomic, and proteomic profile of subjects' tumors to identify gene mutations, gene amplifications, RNA-expression levels, and protein-expression levels. Correlations between genomic, transcriptomic, and proteomic profiles and efficacy outcomes will be assessed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02465957
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center|
|Chicago, Illinois, United States, 60611|
|United States, Pennsylvania|
|UPMC Cancer Center|
|Pittsburgh, Pennsylvania, United States, 15232|
|United States, Washington|
|Seattle Cancer Care Alliance|
|Seattle, Washington, United States, 98109|