Phase 2, single-arm study to evaluate combination therapy of avelumab, haNK and N-803 in patients with Merkel Cell Carcinoma who have progressed on or after checkpoint inhibitor therapy as assessed by ORR. Patients will receive treatment for a maximum of two years.
This is a phase II, single-arm study of combination therapy of avelumab, haNK, and N-803 in patients with Merkel Cell Carcinoma who have progressed on or after checkpoint inhibitor therapy as assessed by ORR. Patients must have progressed on or within six months of completing treatment with either avelumab or pembrolizumab. Patients will received treatment for a maximum of two years, with avelumab and haNK administered every two weeks, and N-803 administered every three weeks. Radiologic evaluation will occur every eight weeks during the first year of treatment, and every twelve weeks during the second year of treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
For the treatment of adults and pediatric patients 12 years and older with Metastatic Merkel Cell Carcinoma (MCC).
Recombinant human super agonist interleukin-15 (IL-15) complex
haNK™ for Infusion is a human, allogeneic, NK cell line that has been engineered to produce endogenous, intracellularly retained IL-2 and to express CD16, the high-affinity (158V) Fc gamma receptor (FcγRIIIa/CD16a).
University of California San Francisco
San Francisco, California, United States
University of Miami, Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Miami Cancer Institute - Baptist Health
Miami, Florida, United States
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States
Number of Participants With Adverse Events
The safety of the combination treatment of avelumab, haNK, and N-803 in subjects with MCC that has progressed on or after checkpoint inhibitor therapy
Time frame: 30 days after last dose, approximately 1 year 7 months
Objective Response Rate
Percent of subjects with confirmed complete Response (CR; disappearance of all target lesions) or partial response (PR; \>=30% decrease in the sum of the longest diameter of target lesions) by RECIST v1.1
Time frame: approximately 1 year 7 months
Overall Response Rate by iRECIST (Percent of Subjects With Confirmed Complete or Partial Overall Response)
Percent of subjects with confirmed complete Response (CR; disappearance of all target lesions) or partial response (PR; \>=30% decrease in the sum of the longest diameter of target lesions) by iRECIST
Time frame: Up to 2 years
Progression Free Survival
Defined as the time from the date of first treatment to disease progression or death by any cause, whichever occurs first by RECIST v1.1
Time frame: Up to 2 years
Progression Free Survival
Defined as the time from the date of first treatment to disease progression or death by any cause, whichever occurs first by iRECIST
Time frame: Up to 2 years
Overall Survival
Overall Survival defined as the time from the date of first treatment to death by any cause
Time frame: Up to 2 years
Disease-Specific Survival
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Cleveland Clinic Foundation
Cleveland, Ohio, United States
Disease-Specific Survival defined as the time from the date of first treatment to death resulting from MCC
Time frame: Up to 2 years
Disease Control Rate
Percent of subjects with stable disease for \>= 8 weeks, or confirmed complete Response (CR; disappearance of all target lesions) or partial response (PR; \>=30% decrease in the sum of the longest diameter of target lesions) by RECIST v1.1
Time frame: Up to 2 years
Disease Control Rate
Percent of subjects with stable disease for \>= 8 weeks, or confirmed complete Response (CR; disappearance of all target lesions) or partial response (PR; \>=30% decrease in the sum of the longest diameter of target lesions) by iRECIST
Time frame: Up to 2 years
FACT-M Total Score
Quality of Life Measures as measured by the Functional Assessment of Cancer Therapy-Melanoma (FACT-M) instrument's FACT-M Total Score. The FACT-M total score is a sum of the questions from its six subscales (a sum of 51 questions in total): Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, Additional Concerns, and At the Site of Melanoma. All subscale questions use a 5-point Likert-type response score ranging from 0 = 'not at all' to 4 = 'very much'. The FACT-M Total score, therefore, ranges from 0 to 204. Negatively worded items are reverse scored prior to summing so that higher subscale and total scores indicate a better quality of life
Time frame: Baseline, Week 13, and End of Treatment visit, up to 2 years
Duration of Response by RECIST Version 1.1 and iRECIST
Duration of Response is defined as the time from the date of first response (Investigator-assessed PR or CR) to the date of disease progression or death (any cause) whichever occurs first. Per RECIST and iRECIST: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: From time of CR or PR up to 2 years