Trial Outcomes & Findings for QUILT-3.063: A Study of N-803, haNK and Avelumab in Patients With Merkel Cell Carcinoma That Has Progressed After Checkpoint Therapy (NCT NCT03853317)
NCT ID: NCT03853317
Last Updated: 2024-08-09
Results Overview
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
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
30 days after last dose, approximately 1 year 7 months
Results posted on
2024-08-09
Participant Flow
Participant milestones
| Measure |
Treatment With Avelumab, haNK™ and N-803
The primary objective is to determine the efficacy of the combination treatment of avelumab, haNK, and N-803 in subjects with MCC that has progressed on or after checkpoint inhibitor therapy by objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Avelumab: For the treatment of adults and pediatric patients 12 years and older with Metastatic Merkel Cell Carcinoma (MCC).
N-803: Recombinant human super agonist interleukin-15 (IL-15) complex
haNK™: 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).
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|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Treatment With Avelumab, haNK™ and N-803
The primary objective is to determine the efficacy of the combination treatment of avelumab, haNK, and N-803 in subjects with MCC that has progressed on or after checkpoint inhibitor therapy by objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Avelumab: For the treatment of adults and pediatric patients 12 years and older with Metastatic Merkel Cell Carcinoma (MCC).
N-803: Recombinant human super agonist interleukin-15 (IL-15) complex
haNK™: 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).
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|---|---|
|
Overall Study
Progressive Disease
|
5
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
other event
|
2
|
Baseline Characteristics
QUILT-3.063: A Study of N-803, haNK and Avelumab in Patients With Merkel Cell Carcinoma That Has Progressed After Checkpoint Therapy
Baseline characteristics by cohort
| Measure |
Treatment With Avelumab, haNK™ and N-803
n=9 Participants
The primary objective is to determine the efficacy of the combination treatment of avelumab, haNK, and N-803 in subjects with MCC that has progressed on or after checkpoint inhibitor therapy by objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Avelumab: For the treatment of adults and pediatric patients 12 years and older with Metastatic Merkel Cell Carcinoma (MCC).
N-803: Recombinant human super agonist interleukin-15 (IL-15) complex
haNK™: 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).
|
|---|---|
|
Age, Continuous
|
71.4 years
STANDARD_DEVIATION 8.06 • n=99 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Histologically-confirmed metastatic MCC that has progressed during treatment or within 6 months
|
9 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 30 days after last dose, approximately 1 year 7 monthsThe safety of the combination treatment of avelumab, haNK, and N-803 in subjects with MCC that has progressed on or after checkpoint inhibitor therapy
Outcome measures
| Measure |
Treatment With Avelumab, haNK™ and N-803
n=9 Participants
The primary objective is to determine the efficacy of the combination treatment of avelumab, haNK, and N-803 in subjects with MCC that has progressed on or after checkpoint inhibitor therapy by objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Avelumab: For the treatment of adults and pediatric patients 12 years and older with Metastatic Merkel Cell Carcinoma (MCC).
N-803: Recombinant human super agonist interleukin-15 (IL-15) complex
haNK™: 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).
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|---|---|
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Number of Participants With Adverse Events
|
9 Participants
|
PRIMARY outcome
Timeframe: approximately 1 year 7 monthsPercent 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
Outcome measures
| Measure |
Treatment With Avelumab, haNK™ and N-803
n=9 Participants
The primary objective is to determine the efficacy of the combination treatment of avelumab, haNK, and N-803 in subjects with MCC that has progressed on or after checkpoint inhibitor therapy by objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Avelumab: For the treatment of adults and pediatric patients 12 years and older with Metastatic Merkel Cell Carcinoma (MCC).
N-803: Recombinant human super agonist interleukin-15 (IL-15) complex
haNK™: 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).
|
|---|---|
|
Objective Response Rate
|
0 Percent of Subjects
Interval 0.0 to 33.6
|
SECONDARY outcome
Timeframe: Up to 2 yearsPercent 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
Outcome measures
| Measure |
Treatment With Avelumab, haNK™ and N-803
n=9 Participants
The primary objective is to determine the efficacy of the combination treatment of avelumab, haNK, and N-803 in subjects with MCC that has progressed on or after checkpoint inhibitor therapy by objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Avelumab: For the treatment of adults and pediatric patients 12 years and older with Metastatic Merkel Cell Carcinoma (MCC).
N-803: Recombinant human super agonist interleukin-15 (IL-15) complex
haNK™: 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).
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|---|---|
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Overall Response Rate by iRECIST (Percent of Subjects With Confirmed Complete or Partial Overall Response)
|
0 Percent of Subjects
Interval 0.0 to 33.6
|
SECONDARY outcome
Timeframe: Up to 2 yearsDefined as the time from the date of first treatment to disease progression or death by any cause, whichever occurs first by RECIST v1.1
Outcome measures
| Measure |
Treatment With Avelumab, haNK™ and N-803
n=9 Participants
The primary objective is to determine the efficacy of the combination treatment of avelumab, haNK, and N-803 in subjects with MCC that has progressed on or after checkpoint inhibitor therapy by objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Avelumab: For the treatment of adults and pediatric patients 12 years and older with Metastatic Merkel Cell Carcinoma (MCC).
N-803: Recombinant human super agonist interleukin-15 (IL-15) complex
haNK™: 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).
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|---|---|
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Progression Free Survival
|
1.9 months
Interval 1.1 to 1.9
|
SECONDARY outcome
Timeframe: Up to 2 yearsDefined as the time from the date of first treatment to disease progression or death by any cause, whichever occurs first by iRECIST
Outcome measures
| Measure |
Treatment With Avelumab, haNK™ and N-803
n=9 Participants
The primary objective is to determine the efficacy of the combination treatment of avelumab, haNK, and N-803 in subjects with MCC that has progressed on or after checkpoint inhibitor therapy by objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Avelumab: For the treatment of adults and pediatric patients 12 years and older with Metastatic Merkel Cell Carcinoma (MCC).
N-803: Recombinant human super agonist interleukin-15 (IL-15) complex
haNK™: 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).
|
|---|---|
|
Progression Free Survival
|
1.9 Months
Interval 1.1 to
Due to the small number of subjects an upper bound on the confidence interval was not able to be calculated
|
SECONDARY outcome
Timeframe: Up to 2 yearsOverall Survival defined as the time from the date of first treatment to death by any cause
Outcome measures
| Measure |
Treatment With Avelumab, haNK™ and N-803
n=9 Participants
The primary objective is to determine the efficacy of the combination treatment of avelumab, haNK, and N-803 in subjects with MCC that has progressed on or after checkpoint inhibitor therapy by objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Avelumab: For the treatment of adults and pediatric patients 12 years and older with Metastatic Merkel Cell Carcinoma (MCC).
N-803: Recombinant human super agonist interleukin-15 (IL-15) complex
haNK™: 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).
|
|---|---|
|
Overall Survival
|
5.6 months
Interval 1.1 to
Due to the small number of subjects an upper bound on the confidence interval was not able to be calculated
|
SECONDARY outcome
Timeframe: Up to 2 yearsDisease-Specific Survival defined as the time from the date of first treatment to death resulting from MCC
Outcome measures
| Measure |
Treatment With Avelumab, haNK™ and N-803
n=9 Participants
The primary objective is to determine the efficacy of the combination treatment of avelumab, haNK, and N-803 in subjects with MCC that has progressed on or after checkpoint inhibitor therapy by objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Avelumab: For the treatment of adults and pediatric patients 12 years and older with Metastatic Merkel Cell Carcinoma (MCC).
N-803: Recombinant human super agonist interleukin-15 (IL-15) complex
haNK™: 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).
|
|---|---|
|
Disease-Specific Survival
|
NA months
Interval 1.9 to
Due to the small number of subjects the median disease-specific survival and the upper bound on the confidence interval were not able to be calculated
|
SECONDARY outcome
Timeframe: Up to 2 yearsPercent 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
Outcome measures
| Measure |
Treatment With Avelumab, haNK™ and N-803
n=9 Participants
The primary objective is to determine the efficacy of the combination treatment of avelumab, haNK, and N-803 in subjects with MCC that has progressed on or after checkpoint inhibitor therapy by objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Avelumab: For the treatment of adults and pediatric patients 12 years and older with Metastatic Merkel Cell Carcinoma (MCC).
N-803: Recombinant human super agonist interleukin-15 (IL-15) complex
haNK™: 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).
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|---|---|
|
Disease Control Rate
|
0.00 Percent of Subjects
Interval 0.0 to 33.6
|
SECONDARY outcome
Timeframe: Up to 2 yearsPercent 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
Outcome measures
| Measure |
Treatment With Avelumab, haNK™ and N-803
n=9 Participants
The primary objective is to determine the efficacy of the combination treatment of avelumab, haNK, and N-803 in subjects with MCC that has progressed on or after checkpoint inhibitor therapy by objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Avelumab: For the treatment of adults and pediatric patients 12 years and older with Metastatic Merkel Cell Carcinoma (MCC).
N-803: Recombinant human super agonist interleukin-15 (IL-15) complex
haNK™: 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).
|
|---|---|
|
Disease Control Rate
|
0 Percent of Subjects
Interval 0.0 to 33.6
|
SECONDARY outcome
Timeframe: Baseline, Week 13, and End of Treatment visit, up to 2 yearsPopulation: At week 13 only 2 subjects had quality of life measurements. At end of treatment only 5 subjects had quality of life measurements.
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
Outcome measures
| Measure |
Treatment With Avelumab, haNK™ and N-803
n=9 Participants
The primary objective is to determine the efficacy of the combination treatment of avelumab, haNK, and N-803 in subjects with MCC that has progressed on or after checkpoint inhibitor therapy by objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Avelumab: For the treatment of adults and pediatric patients 12 years and older with Metastatic Merkel Cell Carcinoma (MCC).
N-803: Recombinant human super agonist interleukin-15 (IL-15) complex
haNK™: 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).
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|---|---|
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FACT-M Total Score
Week 13
|
144.5 Scores on a scale
Standard Deviation 13.44
|
|
FACT-M Total Score
Baseline
|
143.8 Scores on a scale
Standard Deviation 26.55
|
|
FACT-M Total Score
End of Treatment
|
126.6 Scores on a scale
Standard Deviation 31.55
|
SECONDARY outcome
Timeframe: From time of CR or PR up to 2 yearsPopulation: No subject had a complete or partial response
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.
Outcome measures
Outcome data not reported
Adverse Events
Treatment With Avelumab, haNK™ and N-803
Serious events: 5 serious events
Other events: 9 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Treatment With Avelumab, haNK™ and N-803
n=9 participants at risk
The primary objective is to determine the efficacy of the combination treatment of avelumab, haNK, and N-803 in subjects with MCC that has progressed on or after checkpoint inhibitor therapy by objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Avelumab: For the treatment of adults and pediatric patients 12 years and older with Metastatic Merkel Cell Carcinoma (MCC).
N-803: Recombinant human super agonist interleukin-15 (IL-15) complex
haNK™: 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).
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|---|---|
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Blood and lymphatic system disorders
Anaemia
|
22.2%
2/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
General disorders
Oedema peripheral
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Renal and urinary disorders
Haematuria
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
Other adverse events
| Measure |
Treatment With Avelumab, haNK™ and N-803
n=9 participants at risk
The primary objective is to determine the efficacy of the combination treatment of avelumab, haNK, and N-803 in subjects with MCC that has progressed on or after checkpoint inhibitor therapy by objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Avelumab: For the treatment of adults and pediatric patients 12 years and older with Metastatic Merkel Cell Carcinoma (MCC).
N-803: Recombinant human super agonist interleukin-15 (IL-15) complex
haNK™: 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).
|
|---|---|
|
General disorders
Chills
|
55.6%
5/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
General disorders
pyrexia
|
44.4%
4/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
General disorders
fatigue
|
22.2%
2/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
General disorders
Injection site erythrma
|
22.2%
2/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
General disorders
Injection site pruritus
|
22.2%
2/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
General disorders
Injection site reaction
|
22.2%
2/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
General disorders
asthenia
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
General disorders
Chest discomfort
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
General disorders
Oedema peripheral
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
General disorders
Pain
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Blood and lymphatic system disorders
Anaemia
|
44.4%
4/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Investigations
Alanine aminotransferase increased
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Investigations
Aspartate aminotransferase increased
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Investigations
Blood alkaline phosphatase increased
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Investigations
Blood bilirubin increased
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Investigations
Blood creatinine increased
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Investigations
Blood lactate dehydrogenase
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Investigations
Lymphocyte count decreased
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Investigations
Platelet count decreased
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Investigations
Weight decreased
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
44.4%
4/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
22.2%
2/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Renal and urinary disorders
Proteinuria
|
22.2%
2/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Renal and urinary disorders
Chromaturia
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Renal and urinary disorders
Glycosuria
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Renal and urinary disorders
Haematuria
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Renal and urinary disorders
Pollakiuria
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Gastrointestinal disorders
Dysphagia
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Gastrointestinal disorders
Toothache
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
33.3%
3/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Injury, poisoning and procedural complications
Wound complication
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Infections and infestations
Candida infection
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Infections and infestations
Fungal infection
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Vascular disorders
Rash maculo-papular
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Vascular disorders
Hypertension
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Vascular disorders
Lymphoedema
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Psychiatric disorders
Insomnia
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.1%
1/9 • 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place