Trial Outcomes & Findings for QUILT-3.009: Patients With Stage III (IIIB) or Stage (IV) Merkel Cell Carcinoma (MCC) (NCT NCT02465957)
NCT ID: NCT02465957
Last Updated: 2024-05-02
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
4 months
Results posted on
2024-05-02
Participant Flow
Participant milestones
| Measure |
aNK (NK-92)
aNK was to be given via IV infusion at a dose of 2 x 10\^9 cells/m2 on two consecutive days (= 1 cycle) every 4 weeks for a total of 8 infusions (2 each/cycle) for a total of 4 treatment cycles.
|
aNK (NK-92) + N-803
aNK was to be given via IV infusion at a dose of 2 x 10\^9 cells/m2 on two consecutive days (= 1 cycle) every 2 weeks.
N-803 was to be administered SC at 10 μg/kg on the first day of every aNK infusion (before the aNK infusion) every 2 weeks.
Treatment was permitted to continue until a complete response was achieved or it was deemed appropriate by the Investigator and/or Sponsor Medical Monitor.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
|
Overall Study
COMPLETED
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
QUILT-3.009: Patients With Stage III (IIIB) or Stage (IV) Merkel Cell Carcinoma (MCC)
Baseline characteristics by cohort
| Measure |
aNK (NK-92)
n=3 Participants
aNK (activated NK-92, formerly Neukoplast)
aNK (NK-92): A natural killer cell line recovered from a patient with large granular lymphoma
|
aNK (NK-92) + N-803
n=4 Participants
aNK (activated NK-92, formerly Neukoplast) N-803
aNK (NK-92) + N-803: aNK - A natural killer cell line recovered from a patient with large granular lymphoma N-803 - Recombinant human super agonist interleukin-15 (IL-15) complex
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
77.3 years
STANDARD_DEVIATION 3.21 • n=5 Participants
|
61.3 years
STANDARD_DEVIATION 1.26 • n=7 Participants
|
68.1 years
STANDARD_DEVIATION 8.84 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Histology of Primary Diagnosis
Carcinoma/Adenocarcinoma
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Histology of Primary Diagnosis
Neuroendocrine
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Histology of Primary Diagnosis
Merkel Cell Carcinoma
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Histology of Primary Diagnosis
Unknown
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 monthsOutcome measures
| Measure |
aNK (NK-92)
n=3 Participants
aNK (activated NK-92, formerly Neukoplast)
aNK (NK-92): A natural killer cell line recovered from a patient with large granular lymphoma
|
aNK (NK-92) + N-803
n=4 Participants
aNK (NK-92): A natural killer cell line recovered from a patient with large granular lymphoma
N-803: Recombinant human super agonist interleukin-15 (IL-15) complex
|
|---|---|---|
|
Number of Participants With Progression Free Survival Rate at 4 Months
|
3 Participants
|
3 Participants
|
Adverse Events
aNK (NK-92)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 1 deaths
aNK (NK-92) + N-803
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
aNK (NK-92)
n=3 participants at risk
aNK (activated NK-92, formerly Neukoplast)
aNK (NK-92): A natural killer cell line recovered from a patient with large granular lymphoma
|
aNK (NK-92) + N-803
n=4 participants at risk
aNK (NK-92): A natural killer cell line recovered from a patient with large granular lymphoma
N-803: Recombinant human super agonist interleukin-15 (IL-15) complex
|
|---|---|---|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
Renal and urinary disorders
Ureteric compression
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
Other adverse events
| Measure |
aNK (NK-92)
n=3 participants at risk
aNK (activated NK-92, formerly Neukoplast)
aNK (NK-92): A natural killer cell line recovered from a patient with large granular lymphoma
|
aNK (NK-92) + N-803
n=4 participants at risk
aNK (NK-92): A natural killer cell line recovered from a patient with large granular lymphoma
N-803: Recombinant human super agonist interleukin-15 (IL-15) complex
|
|---|---|---|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
Renal and urinary disorders
Urinary tract stoma complication
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • 30 days past treatment completion, up to 5 months
|
0.00%
0/4 • 30 days past treatment completion, up to 5 months
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
33.3%
1/3 • 30 days past treatment completion, up to 5 months
|
0.00%
0/4 • 30 days past treatment completion, up to 5 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
50.0%
2/4 • 30 days past treatment completion, up to 5 months
|
|
Renal and urinary disorders
Ureteric compression
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
Endocrine disorders
Hypothyroidism
|
33.3%
1/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
Eye disorders
Eye swelling
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
1/3 • 30 days past treatment completion, up to 5 months
|
0.00%
0/4 • 30 days past treatment completion, up to 5 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
50.0%
2/4 • 30 days past treatment completion, up to 5 months
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
General disorders
Chills
|
66.7%
2/3 • 30 days past treatment completion, up to 5 months
|
75.0%
3/4 • 30 days past treatment completion, up to 5 months
|
|
General disorders
Fatigue
|
33.3%
1/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
General disorders
Flushing
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
General disorders
Injection site erythema
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
75.0%
3/4 • 30 days past treatment completion, up to 5 months
|
|
General disorders
Injection site irritation
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
General disorders
Injection site rash
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
General disorders
Injection site reaction
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
50.0%
2/4 • 30 days past treatment completion, up to 5 months
|
|
General disorders
Night sweats
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
General disorders
Peripheral swelling
|
33.3%
1/3 • 30 days past treatment completion, up to 5 months
|
0.00%
0/4 • 30 days past treatment completion, up to 5 months
|
|
General disorders
Pyrexia
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
50.0%
2/4 • 30 days past treatment completion, up to 5 months
|
|
General disorders
Temperature intolerance
|
33.3%
1/3 • 30 days past treatment completion, up to 5 months
|
0.00%
0/4 • 30 days past treatment completion, up to 5 months
|
|
Infections and infestations
Localised infection
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
Investigations
Lymphocyte count
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
Investigations
Weight decreased
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
Investigations
Weight increased
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
50.0%
2/4 • 30 days past treatment completion, up to 5 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
Musculoskeletal and connective tissue disorders
Limb mass
|
33.3%
1/3 • 30 days past treatment completion, up to 5 months
|
0.00%
0/4 • 30 days past treatment completion, up to 5 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • 30 days past treatment completion, up to 5 months
|
0.00%
0/4 • 30 days past treatment completion, up to 5 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
Nervous system disorders
Paraesthesia
|
33.3%
1/3 • 30 days past treatment completion, up to 5 months
|
0.00%
0/4 • 30 days past treatment completion, up to 5 months
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3 • 30 days past treatment completion, up to 5 months
|
25.0%
1/4 • 30 days past treatment completion, up to 5 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place