Trial Outcomes & Findings for Bempegaldesleukin (NKTR-214) With Radiation and Anti-PD-1 Immunotherapy for Head and Neck Squamous Cell Carcinoma (NCT NCT04936841)
NCT ID: NCT04936841
Last Updated: 2024-04-04
Results Overview
ORR is the percentage of participants whose cancer shrinks or disappears after treatment. ORR will include confirmed complete response (CR) + confirmed partial response (PR) and will be determined as per RECIST1.1, by investigator assessment.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
up to 7 months (at Standard-of-care imaging 3 to 6 months after Cycle 1)
Results posted on
2024-04-04
Participant Flow
Participants were consented from August 2021 to February 2022.
Participant milestones
| Measure |
NKTR-214, Anti-PD Therapy Plus Palliative Radiation
Cycle 1 consists of anti-PD-1 therapy (200mg) and NKTR-214 (0.006 mg/kg3 administered intravenously), followed by palliative radiation (8 Gy x 3 or 4 Gy x 5 fractions) combined with anti-PD-1 therapy and NKTR-214 in cycle 2.
In subsequent cycles participants will receive NKTR-214 and anti-PD-1.
NKTR-214: Bempegaldesleukin (NKTR-214) is an immunotherapeutic protein prodrug specifically designed to activate the patient's immune system for the treatment of cancer by providing a controlled, sustained signal to the interleukin-2 (IL-2) receptor pathway (pharmacological classification: immunostimulatory interleukin cytokine)
anti-PD-1 therapy: immunotherapy drug, monoclonal antibody
Palliative Radiation: radiation to relieve symptoms
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
On Treatment
|
5
|
|
Overall Study
C1D8
|
5
|
|
Overall Study
C2D8
|
4
|
|
Overall Study
C3D8
|
4
|
|
Overall Study
Off Treatment
|
4
|
|
Overall Study
30 Days Post Treatment
|
4
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
NKTR-214, Anti-PD Therapy Plus Palliative Radiation
Cycle 1 consists of anti-PD-1 therapy (200mg) and NKTR-214 (0.006 mg/kg3 administered intravenously), followed by palliative radiation (8 Gy x 3 or 4 Gy x 5 fractions) combined with anti-PD-1 therapy and NKTR-214 in cycle 2.
In subsequent cycles participants will receive NKTR-214 and anti-PD-1.
NKTR-214: Bempegaldesleukin (NKTR-214) is an immunotherapeutic protein prodrug specifically designed to activate the patient's immune system for the treatment of cancer by providing a controlled, sustained signal to the interleukin-2 (IL-2) receptor pathway (pharmacological classification: immunostimulatory interleukin cytokine)
anti-PD-1 therapy: immunotherapy drug, monoclonal antibody
Palliative Radiation: radiation to relieve symptoms
|
|---|---|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Bempegaldesleukin (NKTR-214) With Radiation and Anti-PD-1 Immunotherapy for Head and Neck Squamous Cell Carcinoma
Baseline characteristics by cohort
| Measure |
NKTR-214, Anti-PD Therapy Plus Palliative Radiation
n=5 Participants
Cycle 1 consists of anti-PD-1 therapy (200mg) and NKTR-214 (0.006 mg/kg3 administered intravenously), followed by palliative radiation (8 Gy x 3 or 4 Gy x 5 fractions) combined with anti-PD-1 therapy and NKTR-214 in cycle 2.
In subsequent cycles participants will receive NKTR-214 and anti-PD-1.
|
|---|---|
|
Age, Customized
50-59 years old
|
3 Participants
n=93 Participants
|
|
Age, Customized
60-69 years old
|
1 Participants
n=93 Participants
|
|
Age, Customized
70-79 years old
|
1 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: up to 7 months (at Standard-of-care imaging 3 to 6 months after Cycle 1)ORR is the percentage of participants whose cancer shrinks or disappears after treatment. ORR will include confirmed complete response (CR) + confirmed partial response (PR) and will be determined as per RECIST1.1, by investigator assessment.
Outcome measures
| Measure |
NKTR-214, Anti-PD Therapy Plus Palliative Radiation
n=5 Participants
Cycle 1 consists of anti-PD-1 therapy (200mg) and NKTR-214 (0.006 mg/kg3 administered intravenously), followed by palliative radiation (8 Gy x 3 or 4 Gy x 5 fractions) combined with anti-PD-1 therapy and NKTR-214 in cycle 2.
In subsequent cycles participants will receive NKTR-214 and anti-PD-1.
|
Grade 4
Total Grade 4 Adverse Events Among 5 Patients Evaluable for Toxicity
|
Grade 5
Total Grade 5 Adverse Events Among 5 Patients Evaluable for Toxicity
|
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)
Participants will receive NKTR-214 and anti-PD-1. Palliative Radiation: radiation to relieve symptoms.
|
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)
EORTC QLQ-C30: Global and Functional Sub-Scores Post Treatment
|
|---|---|---|---|---|---|
|
Objective Response Rate (ORR)
|
2 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 14 months (study terminated early)Toxicities ≥ Grade 3 is defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Toxicities not "unrelated" to treatment, will be considered treatment-related. Adverse events are evaluated by the physician graded from 1-5 where 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, and 5 = death.
Outcome measures
| Measure |
NKTR-214, Anti-PD Therapy Plus Palliative Radiation
n=5 Participants
Cycle 1 consists of anti-PD-1 therapy (200mg) and NKTR-214 (0.006 mg/kg3 administered intravenously), followed by palliative radiation (8 Gy x 3 or 4 Gy x 5 fractions) combined with anti-PD-1 therapy and NKTR-214 in cycle 2.
In subsequent cycles participants will receive NKTR-214 and anti-PD-1.
|
Grade 4
Total Grade 4 Adverse Events Among 5 Patients Evaluable for Toxicity
|
Grade 5
Total Grade 5 Adverse Events Among 5 Patients Evaluable for Toxicity
|
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)
Participants will receive NKTR-214 and anti-PD-1. Palliative Radiation: radiation to relieve symptoms.
|
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)
EORTC QLQ-C30: Global and Functional Sub-Scores Post Treatment
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events Greater Than or Equal to Grade 3
|
2 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 14 months (study terminated early)Toxicities ≥ Grade 3 is defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Toxicities not "unrelated" to treatment, will be considered treatment-related. Adverse events are evaluated by the physician and graded from 1-5 where 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, and 5 = death.
Outcome measures
| Measure |
NKTR-214, Anti-PD Therapy Plus Palliative Radiation
n=5 Participants
Cycle 1 consists of anti-PD-1 therapy (200mg) and NKTR-214 (0.006 mg/kg3 administered intravenously), followed by palliative radiation (8 Gy x 3 or 4 Gy x 5 fractions) combined with anti-PD-1 therapy and NKTR-214 in cycle 2.
In subsequent cycles participants will receive NKTR-214 and anti-PD-1.
|
Grade 4
n=5 Participants
Total Grade 4 Adverse Events Among 5 Patients Evaluable for Toxicity
|
Grade 5
n=5 Participants
Total Grade 5 Adverse Events Among 5 Patients Evaluable for Toxicity
|
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)
Participants will receive NKTR-214 and anti-PD-1. Palliative Radiation: radiation to relieve symptoms.
|
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)
EORTC QLQ-C30: Global and Functional Sub-Scores Post Treatment
|
|---|---|---|---|---|---|
|
Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them
Weight Loss
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them
Dry Mouth
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them
Sepsis
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them
Skin Ulceration
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them
Thrush
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them
Lymphocyte Count Decreased
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them
Hyperthyroidism
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them
Hypoalbuminemia
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them
Hyponatremia
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them
Hypercalcemia
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 14 months (study terminated early)PFS is the average length of time after the start of treatment in which a person is alive, and their cancer does not grow or spread. PFS is defined as the time from day 1 of treatment until the criteria for disease progression is met as defined by RECIST1.1 or death as a result of any cause.
Outcome measures
| Measure |
NKTR-214, Anti-PD Therapy Plus Palliative Radiation
n=5 Participants
Cycle 1 consists of anti-PD-1 therapy (200mg) and NKTR-214 (0.006 mg/kg3 administered intravenously), followed by palliative radiation (8 Gy x 3 or 4 Gy x 5 fractions) combined with anti-PD-1 therapy and NKTR-214 in cycle 2.
In subsequent cycles participants will receive NKTR-214 and anti-PD-1.
|
Grade 4
Total Grade 4 Adverse Events Among 5 Patients Evaluable for Toxicity
|
Grade 5
Total Grade 5 Adverse Events Among 5 Patients Evaluable for Toxicity
|
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)
Participants will receive NKTR-214 and anti-PD-1. Palliative Radiation: radiation to relieve symptoms.
|
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)
EORTC QLQ-C30: Global and Functional Sub-Scores Post Treatment
|
|---|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
4.2 months
Standard Deviation 4.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 14 months (study terminated early)OS is defined as time from day 1 of treatment until death as a result of any cause.
Outcome measures
| Measure |
NKTR-214, Anti-PD Therapy Plus Palliative Radiation
n=5 Participants
Cycle 1 consists of anti-PD-1 therapy (200mg) and NKTR-214 (0.006 mg/kg3 administered intravenously), followed by palliative radiation (8 Gy x 3 or 4 Gy x 5 fractions) combined with anti-PD-1 therapy and NKTR-214 in cycle 2.
In subsequent cycles participants will receive NKTR-214 and anti-PD-1.
|
Grade 4
Total Grade 4 Adverse Events Among 5 Patients Evaluable for Toxicity
|
Grade 5
Total Grade 5 Adverse Events Among 5 Patients Evaluable for Toxicity
|
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)
Participants will receive NKTR-214 and anti-PD-1. Palliative Radiation: radiation to relieve symptoms.
|
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)
EORTC QLQ-C30: Global and Functional Sub-Scores Post Treatment
|
|---|---|---|---|---|---|
|
Overall Survival (OS)
|
13.6 months
Standard Deviation 9.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 14 months (study terminated early)CB will include confirmed complete response (CR) + confirmed partial response (PR) + stable disease at ≥ 6 months (SD) and will be determined as per RECIST1.1.
Outcome measures
| Measure |
NKTR-214, Anti-PD Therapy Plus Palliative Radiation
n=5 Participants
Cycle 1 consists of anti-PD-1 therapy (200mg) and NKTR-214 (0.006 mg/kg3 administered intravenously), followed by palliative radiation (8 Gy x 3 or 4 Gy x 5 fractions) combined with anti-PD-1 therapy and NKTR-214 in cycle 2.
In subsequent cycles participants will receive NKTR-214 and anti-PD-1.
|
Grade 4
Total Grade 4 Adverse Events Among 5 Patients Evaluable for Toxicity
|
Grade 5
Total Grade 5 Adverse Events Among 5 Patients Evaluable for Toxicity
|
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)
Participants will receive NKTR-214 and anti-PD-1. Palliative Radiation: radiation to relieve symptoms.
|
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)
EORTC QLQ-C30: Global and Functional Sub-Scores Post Treatment
|
|---|---|---|---|---|---|
|
Number of Participants With Clinical Benefit (CB)
|
2 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 14 months (study terminated early)Duration of response is the period measured from the time that measurement criteria are met for complete or partial response (whichever status is recorded first) until the date that recurrent or progressive disease is objectively documented.
Outcome measures
| Measure |
NKTR-214, Anti-PD Therapy Plus Palliative Radiation
n=5 Participants
Cycle 1 consists of anti-PD-1 therapy (200mg) and NKTR-214 (0.006 mg/kg3 administered intravenously), followed by palliative radiation (8 Gy x 3 or 4 Gy x 5 fractions) combined with anti-PD-1 therapy and NKTR-214 in cycle 2.
In subsequent cycles participants will receive NKTR-214 and anti-PD-1.
|
Grade 4
Total Grade 4 Adverse Events Among 5 Patients Evaluable for Toxicity
|
Grade 5
Total Grade 5 Adverse Events Among 5 Patients Evaluable for Toxicity
|
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)
Participants will receive NKTR-214 and anti-PD-1. Palliative Radiation: radiation to relieve symptoms.
|
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)
EORTC QLQ-C30: Global and Functional Sub-Scores Post Treatment
|
|---|---|---|---|---|---|
|
Duration of Response
|
6.59 months
Standard Deviation 3.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline at screening, cycle (C)1 day (D)8 (about 2 weeks on study), C2D8 (about 5 weeks on study), C3D8 (about 8 weeks on study), 30-day post (about 12 weeks on study)European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) is a measure of health-related quality of life for cancer patients participating in clinical trials. It scores the following domains from 0-100 where higher global or functional scores indicate increased quality of life and higher symptom scores indicate increased symptoms: Global health status (QL2), Physical functioning (PF2), Role functioning (RF2), Emotional functioning (EF), Cognitive functioning (CF), and Social functioning (SF).
Outcome measures
| Measure |
NKTR-214, Anti-PD Therapy Plus Palliative Radiation
n=5 Participants
Cycle 1 consists of anti-PD-1 therapy (200mg) and NKTR-214 (0.006 mg/kg3 administered intravenously), followed by palliative radiation (8 Gy x 3 or 4 Gy x 5 fractions) combined with anti-PD-1 therapy and NKTR-214 in cycle 2.
In subsequent cycles participants will receive NKTR-214 and anti-PD-1.
|
Grade 4
n=5 Participants
Total Grade 4 Adverse Events Among 5 Patients Evaluable for Toxicity
|
Grade 5
n=4 Participants
Total Grade 5 Adverse Events Among 5 Patients Evaluable for Toxicity
|
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)
n=4 Participants
Participants will receive NKTR-214 and anti-PD-1. Palliative Radiation: radiation to relieve symptoms.
|
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)
n=4 Participants
EORTC QLQ-C30: Global and Functional Sub-Scores Post Treatment
|
|---|---|---|---|---|---|
|
Health Related Quality of Life as Measured by EORTC QLQ-C30: Global and Functional Sub-Scores
QL2
|
66.7 score on a scale
Standard Deviation 34.56
|
50.0 score on a scale
Standard Deviation 22.82
|
70.8 score on a scale
Standard Deviation 20.83
|
75.0 score on a scale
Standard Deviation 40.82
|
62.5 score on a scale
Standard Deviation 29.27
|
|
Health Related Quality of Life as Measured by EORTC QLQ-C30: Global and Functional Sub-Scores
PF2
|
100 score on a scale
Standard Deviation 29.81
|
93.3 score on a scale
Standard Deviation 28.05
|
90.0 score on a scale
Standard Deviation 11.55
|
93.3 score on a scale
Standard Deviation 7.70
|
93.3 score on a scale
Standard Deviation 7.70
|
|
Health Related Quality of Life as Measured by EORTC QLQ-C30: Global and Functional Sub-Scores
RF2
|
100.0 score on a scale
Standard Deviation 44.72
|
100.0 score on a scale
Standard Deviation 22.36
|
66.7 score on a scale
Standard Deviation 16.67
|
91.7 score on a scale
Standard Deviation 15.96
|
83.3 score on a scale
Standard Deviation 19.25
|
|
Health Related Quality of Life as Measured by EORTC QLQ-C30: Global and Functional Sub-Scores
EF
|
66.7 score on a scale
Standard Deviation 25.00
|
66.7 score on a scale
Standard Deviation 20.07
|
87.5 score on a scale
Standard Deviation 17.18
|
83.3 score on a scale
Standard Deviation 21.92
|
83.3 score on a scale
Standard Deviation 21.92
|
|
Health Related Quality of Life as Measured by EORTC QLQ-C30: Global and Functional Sub-Scores
CF
|
83.3 score on a scale
Standard Deviation 13.94
|
83.3 score on a scale
Standard Deviation 21.73
|
100.0 score on a scale
Standard Deviation 0
|
91.7 score on a scale
Standard Deviation 15.96
|
83.3 score on a scale
Standard Deviation 25.00
|
|
Health Related Quality of Life as Measured by EORTC QLQ-C30: Global and Functional Sub-Scores
SF
|
83.3 score on a scale
Standard Deviation 13.9
|
83.3 score on a scale
Standard Deviation 20.41
|
100.0 score on a scale
Standard Deviation 25.00
|
91.7 score on a scale
Standard Deviation 31.55
|
91.7 score on a scale
Standard Deviation 23.57
|
SECONDARY outcome
Timeframe: Baseline at screening, cycle (C)1 day (D)8 (about 2 weeks on study), C2D8 (about 5 weeks on study), C3D8 (about 8 weeks on study), 30-day post (about 12 weeks on study)European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) is a measure of health-related quality of life for cancer patients participating in clinical trials. It scores the following domains from 0-100 where higher symptom scores indicate increased symptoms: Fatigue (FA), Nausea and vomiting (NV), Pain (PA), Dyspnea (DY), Insomnia (SL), Appetite loss (AP), Constipation (CO), Diarrhea (DI), Financial difficulties (FI)
Outcome measures
| Measure |
NKTR-214, Anti-PD Therapy Plus Palliative Radiation
n=5 Participants
Cycle 1 consists of anti-PD-1 therapy (200mg) and NKTR-214 (0.006 mg/kg3 administered intravenously), followed by palliative radiation (8 Gy x 3 or 4 Gy x 5 fractions) combined with anti-PD-1 therapy and NKTR-214 in cycle 2.
In subsequent cycles participants will receive NKTR-214 and anti-PD-1.
|
Grade 4
n=5 Participants
Total Grade 4 Adverse Events Among 5 Patients Evaluable for Toxicity
|
Grade 5
n=4 Participants
Total Grade 5 Adverse Events Among 5 Patients Evaluable for Toxicity
|
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)
n=4 Participants
Participants will receive NKTR-214 and anti-PD-1. Palliative Radiation: radiation to relieve symptoms.
|
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)
n=4 Participants
EORTC QLQ-C30: Global and Functional Sub-Scores Post Treatment
|
|---|---|---|---|---|---|
|
Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores
FA
|
13.3 score on a scale
Standard Deviation 20.76
|
20.0 score on a scale
Standard Deviation 10.11
|
16.7 score on a scale
Standard Deviation 9.43
|
13.3 score on a scale
Standard Deviation 17.53
|
23.3 score on a scale
Standard Deviation 18.36
|
|
Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores
NV
|
0.0 score on a scale
Standard Deviation 21.73
|
16.7 score on a scale
Standard Deviation 19.00
|
16.7 score on a scale
Standard Deviation 20.97
|
16.7 score on a scale
Standard Deviation 25.00
|
0.0 score on a scale
Standard Deviation 16.67
|
|
Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores
PA
|
33.3 score on a scale
Standard Deviation 40.14
|
33.3 score on a scale
Standard Deviation 21.73
|
25.0 score on a scale
Standard Deviation 21.52
|
25.0 score on a scale
Standard Deviation 28.87
|
16.7 score on a scale
Standard Deviation 39.38
|
|
Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores
DY
|
0.0 score on a scale
Standard Deviation 14.91
|
0.0 score on a scale
Standard Deviation 18.26
|
0.0 score on a scale
Standard Deviation 16.67
|
0.0 score on a scale
Standard Deviation 16.67
|
0.0 score on a scale
Standard Deviation 16.67
|
|
Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores
SL
|
33.3 score on a scale
Standard Deviation 27.89
|
33.3 score on a scale
Standard Deviation 27.89
|
16.7 score on a scale
Standard Deviation 31.91
|
16.7 score on a scale
Standard Deviation 47.14
|
0.0 score on a scale
Standard Deviation 33.33
|
|
Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores
AP
|
33.3 score on a scale
Standard Deviation 40.82
|
33.3 score on a scale
Standard Deviation 33.33
|
16.7 score on a scale
Standard Deviation 31.91
|
16.7 score on a scale
Standard Deviation 31.91
|
0.0 score on a scale
Standard Deviation 50.00
|
|
Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores
CO
|
0.0 score on a scale
Standard Deviation 18.26
|
0.0 score on a scale
Standard Deviation 43.46
|
0.0 score on a scale
Standard Deviation 33.33
|
0.0 score on a scale
Standard Deviation 16.67
|
0.0 score on a scale
Standard Deviation 16.67
|
|
Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores
DI
|
0.0 score on a scale
Standard Deviation 0
|
0.0 score on a scale
Standard Deviation 0
|
0.0 score on a scale
Standard Deviation 16.67
|
0.0 score on a scale
Standard Deviation 16.67
|
16.7 score on a scale
Standard Deviation 19.25
|
|
Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores
FI
|
0.0 score on a scale
Standard Deviation 43.46
|
0.0 score on a scale
Standard Deviation 29.81
|
0.0 score on a scale
Standard Deviation 16.67
|
0.0 score on a scale
Standard Deviation 16.67
|
0.0 score on a scale
Standard Deviation 16.67
|
SECONDARY outcome
Timeframe: Baseline at screening, cycle (C)1 day (D)8 (about 2 weeks on study), C2D8 (about 5 weeks on study), C3D8 (about 8 weeks on study), 30-day post (about 12 weeks on study)European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire - Head and Neck (EORTC QLQ-H\&N35) is comprised of the following subscales, scored from 0-100 where higher scores indicate increased symptoms: Pain (HNPA), Swallowing (HNSW), Senses problem (HNSE), Speech problems (HNSP), Trouble with social eating (HNSO), Trouble with social contact (HNSC), Less sexuality (HNSX), Teeth (HNTE), Opening mouth (HNOM), Dry mouth (HNDR), Sticky saliva (HNSS), Coughing (HNCO), Felt ill (HNFI), pain killers (HNPK), Nutritional supplements (HNNU), Feeding tube (HNFE), Weight loss (HNFL), Weight gain (HNWG)
Outcome measures
| Measure |
NKTR-214, Anti-PD Therapy Plus Palliative Radiation
n=5 Participants
Cycle 1 consists of anti-PD-1 therapy (200mg) and NKTR-214 (0.006 mg/kg3 administered intravenously), followed by palliative radiation (8 Gy x 3 or 4 Gy x 5 fractions) combined with anti-PD-1 therapy and NKTR-214 in cycle 2.
In subsequent cycles participants will receive NKTR-214 and anti-PD-1.
|
Grade 4
n=5 Participants
Total Grade 4 Adverse Events Among 5 Patients Evaluable for Toxicity
|
Grade 5
n=4 Participants
Total Grade 5 Adverse Events Among 5 Patients Evaluable for Toxicity
|
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)
n=4 Participants
Participants will receive NKTR-214 and anti-PD-1. Palliative Radiation: radiation to relieve symptoms.
|
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)
n=4 Participants
EORTC QLQ-C30: Global and Functional Sub-Scores Post Treatment
|
|---|---|---|---|---|---|
|
Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores
HNSC
|
0 score on a scale
Standard Deviation 12.99
|
0 score on a scale
Standard Deviation 21.29
|
6.67 score on a scale
Standard Deviation 22.03
|
6.67 score on a scale
Standard Deviation 28.48
|
10 score on a scale
Standard Deviation 28.24
|
|
Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores
HNSX
|
0 score on a scale
Standard Deviation 54.77
|
16.67 score on a scale
Standard Deviation 41.83
|
0 score on a scale
Standard Deviation 50.00
|
16.67 score on a scale
Standard Deviation 47.14
|
16.67 score on a scale
Standard Deviation 47.17
|
|
Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores
HNTE
|
0 score on a scale
Standard Deviation 14.91
|
0 score on a scale
Standard Deviation 29.81
|
0 score on a scale
Standard Deviation 16.67
|
0 score on a scale
Standard Deviation 16.67
|
16.67 score on a scale
Standard Deviation 19.25
|
|
Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores
HNOM
|
0 score on a scale
Standard Deviation 18.26
|
0 score on a scale
Standard Deviation 18.26
|
16.67 score on a scale
Standard Deviation 19.25
|
16.67 score on a scale
Standard Deviation 19.25
|
0 score on a scale
Standard Deviation 50.00
|
|
Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores
HNDR
|
66.67 score on a scale
Standard Deviation 43.46
|
66.67 score on a scale
Standard Deviation 27.89
|
50 score on a scale
Standard Deviation 19.25
|
50 score on a scale
Standard Deviation 43.03
|
33.33 score on a scale
Standard Deviation 50.00
|
|
Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores
HNSS
|
66.67 score on a scale
Standard Deviation 18.26
|
33.33 score on a scale
Standard Deviation 33.33
|
33.33 score on a scale
Standard Deviation 16.67
|
16.67 score on a scale
Standard Deviation 31.91
|
33.34 score on a scale
Standard Deviation 50.00
|
|
Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores
HNCO
|
33.33 score on a scale
Standard Deviation 23.57
|
66.67 score on a scale
Standard Deviation 43.46
|
3.33 score on a scale
Standard Deviation 41.93
|
16.67 score on a scale
Standard Deviation 31.91
|
50 score on a scale
Standard Deviation 31.91
|
|
Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores
HNFI
|
0 score on a scale
Standard Deviation 14.91
|
3.33 score on a scale
Standard Deviation 23.57
|
16.67 score on a scale
Standard Deviation 31.91
|
16.67 score on a scale
Standard Deviation 47.14
|
0 score on a scale
Standard Deviation 33.33
|
|
Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores
HNPK
|
60 score on a scale
Standard Deviation 54.77
|
80 score on a scale
Standard Deviation 44.72
|
75 score on a scale
Standard Deviation 50.00
|
50 score on a scale
Standard Deviation 57.74
|
50 score on a scale
Standard Deviation 57.74
|
|
Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores
HNNU
|
60 score on a scale
Standard Deviation 54.77
|
40 score on a scale
Standard Deviation 54.77
|
75 score on a scale
Standard Deviation 50.00
|
50 score on a scale
Standard Deviation 57.74
|
50 score on a scale
Standard Deviation 0
|
|
Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores
HNFE
|
20 score on a scale
Standard Deviation 44.72
|
20 score on a scale
Standard Deviation 44.72
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores
HNWL
|
40 score on a scale
Standard Deviation 54.77
|
20 score on a scale
Standard Deviation 44.72
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
75 score on a scale
Standard Deviation 50.00
|
|
Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores
HNWG
|
40 score on a scale
Standard Deviation 54.77
|
20 score on a scale
Standard Deviation 44.72
|
25 score on a scale
Standard Deviation 50
|
25 score on a scale
Standard Deviation 25
|
0 score on a scale
Standard Deviation 0
|
|
Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores
HNPA
|
25 score on a scale
Standard Deviation 19.00
|
33.33 score on a scale
Standard Deviation 18.26
|
20.83 score on a scale
Standard Deviation 22.95
|
0 score on a scale
Standard Deviation 29.17
|
29.17 score on a scale
Standard Deviation 42.22
|
|
Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores
HNSW
|
8.33 score on a scale
Standard Deviation 12.63
|
8.33 score on a scale
Standard Deviation 18.07
|
20.83 score on a scale
Standard Deviation 27.64
|
8.33 score on a scale
Standard Deviation 27.53
|
20.83 score on a scale
Standard Deviation 39.89
|
|
Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores
HNSE
|
16.67 score on a scale
Standard Deviation 21.73
|
0 score on a scale
Standard Deviation 36.13
|
0 score on a scale
Standard Deviation 25.00
|
8.33 score on a scale
Standard Deviation 31.55
|
16.67 score on a scale
Standard Deviation 25.00
|
|
Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores
HNSP
|
11.11 score on a scale
Standard Deviation 14.49
|
0 score on a scale
Standard Deviation 21.29
|
16.67 score on a scale
Standard Deviation 19.25
|
5.56 score on a scale
Standard Deviation 15.71
|
22.22 score on a scale
Standard Deviation 25.66
|
|
Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores
HNSO
|
25 score on a scale
Standard Deviation 24.58
|
16.67 score on a scale
Standard Deviation 36.13
|
16.67 score on a scale
Standard Deviation 35.60
|
12.5 score on a scale
Standard Deviation 39.31
|
45.83 score on a scale
Standard Deviation 55.43
|
SECONDARY outcome
Timeframe: Baseline at screening, cycle (C)1 day (D)8 (about 2 weeks on study), C2D8 (about 5 weeks on study), C3D8 (about 8 weeks on study), 30-day post (about 12 weeks on study)The EQ-5D is a 5 question measure of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression plus an overall measure of health reported on a visual analog scale. Participant counts are reported for each of 5 dimensions: mobility, self-care, usual activities, pain / discomfort, anxiety / depression.
Outcome measures
| Measure |
NKTR-214, Anti-PD Therapy Plus Palliative Radiation
n=5 Participants
Cycle 1 consists of anti-PD-1 therapy (200mg) and NKTR-214 (0.006 mg/kg3 administered intravenously), followed by palliative radiation (8 Gy x 3 or 4 Gy x 5 fractions) combined with anti-PD-1 therapy and NKTR-214 in cycle 2.
In subsequent cycles participants will receive NKTR-214 and anti-PD-1.
|
Grade 4
n=5 Participants
Total Grade 4 Adverse Events Among 5 Patients Evaluable for Toxicity
|
Grade 5
n=4 Participants
Total Grade 5 Adverse Events Among 5 Patients Evaluable for Toxicity
|
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)
n=4 Participants
Participants will receive NKTR-214 and anti-PD-1. Palliative Radiation: radiation to relieve symptoms.
|
NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)
n=4 Participants
EORTC QLQ-C30: Global and Functional Sub-Scores Post Treatment
|
|---|---|---|---|---|---|
|
Health Related Quality of Life as Measured by EQ-5D Participant Counts
MOBILITY · No problems / No Pain / No Anxiety
|
4 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
|
Health Related Quality of Life as Measured by EQ-5D Participant Counts
MOBILITY · Slight problems / Slight pain / Slight anxiety
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Health Related Quality of Life as Measured by EQ-5D Participant Counts
MOBILITY · Moderate problems / Moderate pain / Moderate anxiety
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Health Related Quality of Life as Measured by EQ-5D Participant Counts
MOBILITY · Severe problems / Severe pain / Severe anxiety
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Health Related Quality of Life as Measured by EQ-5D Participant Counts
MOBILITY · Unable / Extreme pain / Extreme anxiety
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Health Related Quality of Life as Measured by EQ-5D Participant Counts
SELF-CARE · No problems / No Pain / No Anxiety
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
|
Health Related Quality of Life as Measured by EQ-5D Participant Counts
SELF-CARE · Slight problems / Slight pain / Slight anxiety
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Health Related Quality of Life as Measured by EQ-5D Participant Counts
SELF-CARE · Moderate problems / Moderate pain / Moderate anxiety
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Health Related Quality of Life as Measured by EQ-5D Participant Counts
SELF-CARE · Severe problems / Severe pain / Severe anxiety
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Health Related Quality of Life as Measured by EQ-5D Participant Counts
SELF-CARE · Unable / Extreme pain / Extreme anxiety
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Health Related Quality of Life as Measured by EQ-5D Participant Counts
USUAL ACTIVITIES · No problems / No Pain / No Anxiety
|
4 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
|
Health Related Quality of Life as Measured by EQ-5D Participant Counts
USUAL ACTIVITIES · Slight problems / Slight pain / Slight anxiety
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Health Related Quality of Life as Measured by EQ-5D Participant Counts
USUAL ACTIVITIES · Moderate problems / Moderate pain / Moderate anxiety
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Health Related Quality of Life as Measured by EQ-5D Participant Counts
USUAL ACTIVITIES · Severe problems / Severe pain / Severe anxiety
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Health Related Quality of Life as Measured by EQ-5D Participant Counts
USUAL ACTIVITIES · Unable / Extreme pain / Extreme anxiety
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Health Related Quality of Life as Measured by EQ-5D Participant Counts
PAIN / DISCOMFORT · No problems / No Pain / No Anxiety
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Health Related Quality of Life as Measured by EQ-5D Participant Counts
PAIN / DISCOMFORT · Slight problems / Slight pain / Slight anxiety
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Health Related Quality of Life as Measured by EQ-5D Participant Counts
PAIN / DISCOMFORT · Moderate problems / Moderate pain / Moderate anxiety
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Health Related Quality of Life as Measured by EQ-5D Participant Counts
PAIN / DISCOMFORT · Severe problems / Severe pain / Severe anxiety
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Health Related Quality of Life as Measured by EQ-5D Participant Counts
PAIN / DISCOMFORT · Unable / Extreme pain / Extreme anxiety
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Health Related Quality of Life as Measured by EQ-5D Participant Counts
ANXIETY / DEPRESSION · No problems / No Pain / No Anxiety
|
2 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Health Related Quality of Life as Measured by EQ-5D Participant Counts
ANXIETY / DEPRESSION · Slight problems / Slight pain / Slight anxiety
|
3 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Health Related Quality of Life as Measured by EQ-5D Participant Counts
ANXIETY / DEPRESSION · Moderate problems / Moderate pain / Moderate anxiety
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Health Related Quality of Life as Measured by EQ-5D Participant Counts
ANXIETY / DEPRESSION · Severe problems / Severe pain / Severe anxiety
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Health Related Quality of Life as Measured by EQ-5D Participant Counts
ANXIETY / DEPRESSION · Unable / Extreme pain / Extreme anxiety
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 3 monthsPD-L1 expression has been shown to predict response to immunotherapy regimens. If PD-L1 expression correlates with outcome, it could be used in the future to select patients who have greatest benefit from this regimen.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 5 yearsEvaluation of the in vivo immune response will help better define the mechanism of action of this combination therapy.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 5 yearsEvaluation of the in vivo immune response will help better define the mechanism of action of this combination therapy.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 3 monthsEvaluation of the in vivo immune response will help better define the mechanism of action of this combination therapy.
Outcome measures
Outcome data not reported
Adverse Events
NKTR-214, Anti-PD Therapy Plus Palliative Radiation
Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
NKTR-214, Anti-PD Therapy Plus Palliative Radiation
n=5 participants at risk
Cycle 1 consists of anti-PD-1 therapy (200mg) and NKTR-214 (0.006 mg/kg3 administered intravenously), followed by palliative radiation (8 Gy x 3 or 4 Gy x 5 fractions) combined with anti-PD-1 therapy and NKTR-214 in cycle 2.
In subsequent cycles participants will receive NKTR-214 and anti-PD-1.
NKTR-214: Bempegaldesleukin (NKTR-214) is an immunotherapeutic protein prodrug specifically designed to activate the patient's immune system for the treatment of cancer by providing a controlled, sustained signal to the interleukin-2 (IL-2) receptor pathway (pharmacological classification: immunostimulatory interleukin cytokine)
anti-PD-1 therapy: immunotherapy drug, monoclonal antibody
Palliative Radiation: radiation to relieve symptoms
|
|---|---|
|
Infections and infestations
Sepsis
|
20.0%
1/5 • up to 14 months (study terminated early per Sponsor)
|
|
Investigations
Lymphocyte count decreased
|
20.0%
1/5 • up to 14 months (study terminated early per Sponsor)
|
|
Renal and urinary disorders
Hyponatremia
|
20.0%
1/5 • up to 14 months (study terminated early per Sponsor)
|
|
Renal and urinary disorders
Hypercalcemia
|
20.0%
1/5 • up to 14 months (study terminated early per Sponsor)
|
Other adverse events
| Measure |
NKTR-214, Anti-PD Therapy Plus Palliative Radiation
n=5 participants at risk
Cycle 1 consists of anti-PD-1 therapy (200mg) and NKTR-214 (0.006 mg/kg3 administered intravenously), followed by palliative radiation (8 Gy x 3 or 4 Gy x 5 fractions) combined with anti-PD-1 therapy and NKTR-214 in cycle 2.
In subsequent cycles participants will receive NKTR-214 and anti-PD-1.
NKTR-214: Bempegaldesleukin (NKTR-214) is an immunotherapeutic protein prodrug specifically designed to activate the patient's immune system for the treatment of cancer by providing a controlled, sustained signal to the interleukin-2 (IL-2) receptor pathway (pharmacological classification: immunostimulatory interleukin cytokine)
anti-PD-1 therapy: immunotherapy drug, monoclonal antibody
Palliative Radiation: radiation to relieve symptoms
|
|---|---|
|
General disorders
Fever
|
20.0%
1/5 • up to 14 months (study terminated early per Sponsor)
|
|
General disorders
Fatigue
|
40.0%
2/5 • up to 14 months (study terminated early per Sponsor)
|
|
General disorders
Myalgias
|
20.0%
1/5 • up to 14 months (study terminated early per Sponsor)
|
|
General disorders
Anorexia
|
20.0%
1/5 • up to 14 months (study terminated early per Sponsor)
|
|
General disorders
Weight Loss
|
20.0%
1/5 • up to 14 months (study terminated early per Sponsor)
|
|
General disorders
Dry Mouth
|
20.0%
1/5 • up to 14 months (study terminated early per Sponsor)
|
|
General disorders
Pain
|
20.0%
1/5 • up to 14 months (study terminated early per Sponsor)
|
|
General disorders
Insomnia
|
20.0%
1/5 • up to 14 months (study terminated early per Sponsor)
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
20.0%
1/5 • up to 14 months (study terminated early per Sponsor)
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
20.0%
1/5 • up to 14 months (study terminated early per Sponsor)
|
|
Skin and subcutaneous tissue disorders
Maculopapular Rash
|
20.0%
1/5 • up to 14 months (study terminated early per Sponsor)
|
|
Skin and subcutaneous tissue disorders
Skin Ulceration
|
20.0%
1/5 • up to 14 months (study terminated early per Sponsor)
|
|
Skin and subcutaneous tissue disorders
Thrush
|
20.0%
1/5 • up to 14 months (study terminated early per Sponsor)
|
|
Nervous system disorders
Concentration Impairment
|
20.0%
1/5 • up to 14 months (study terminated early per Sponsor)
|
|
Nervous system disorders
Confusion
|
20.0%
1/5 • up to 14 months (study terminated early per Sponsor)
|
|
Nervous system disorders
Gait Disturbance
|
20.0%
1/5 • up to 14 months (study terminated early per Sponsor)
|
|
Nervous system disorders
Muscle Weakness
|
20.0%
1/5 • up to 14 months (study terminated early per Sponsor)
|
|
Cardiac disorders
Hypotension
|
20.0%
1/5 • up to 14 months (study terminated early per Sponsor)
|
|
Cardiac disorders
Sinus Tachycardia
|
20.0%
1/5 • up to 14 months (study terminated early per Sponsor)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.0%
2/5 • up to 14 months (study terminated early per Sponsor)
|
|
Gastrointestinal disorders
Dysphagia
|
40.0%
2/5 • up to 14 months (study terminated early per Sponsor)
|
|
Gastrointestinal disorders
Constipation
|
40.0%
2/5 • up to 14 months (study terminated early per Sponsor)
|
|
Gastrointestinal disorders
Hyperbilirubinemia
|
20.0%
1/5 • up to 14 months (study terminated early per Sponsor)
|
|
Blood and lymphatic system disorders
Anemia
|
60.0%
3/5 • up to 14 months (study terminated early per Sponsor)
|
|
Blood and lymphatic system disorders
Eosinophilia
|
60.0%
3/5 • up to 14 months (study terminated early per Sponsor)
|
|
Blood and lymphatic system disorders
Lymphocyte Count Decrease
|
20.0%
1/5 • up to 14 months (study terminated early per Sponsor)
|
|
Blood and lymphatic system disorders
Neutrophil Count Decrease
|
20.0%
1/5 • up to 14 months (study terminated early per Sponsor)
|
|
Endocrine disorders
Hyperglycemia
|
40.0%
2/5 • up to 14 months (study terminated early per Sponsor)
|
|
Endocrine disorders
Hypothyroidism
|
40.0%
2/5 • up to 14 months (study terminated early per Sponsor)
|
|
Endocrine disorders
Hyperthyroidism
|
40.0%
2/5 • up to 14 months (study terminated early per Sponsor)
|
|
Endocrine disorders
Hypoalbuminemia
|
40.0%
2/5 • up to 14 months (study terminated early per Sponsor)
|
|
Renal and urinary disorders
Creatinine Increase
|
20.0%
1/5 • up to 14 months (study terminated early per Sponsor)
|
|
Renal and urinary disorders
Hyponatremia
|
20.0%
1/5 • up to 14 months (study terminated early per Sponsor)
|
|
Renal and urinary disorders
Hypokalemia
|
20.0%
1/5 • up to 14 months (study terminated early per Sponsor)
|
Additional Information
Zachary Morris, MD, PhD
University of Wisconsin School of Medicine and Public Health
Phone: (608) 263-2603
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place