Trial Outcomes & Findings for IMRT Followed by Pembrolizumab in the Adjuvant Setting in Anaplastic Cancer of the Thyroid (IMPAACT): Phase II Trial Adjuvant Pembrolizumab After IMRT in ATC (NCT NCT05059470)
NCT ID: NCT05059470
Last Updated: 2026-03-23
Results Overview
To estimate the median progression-free survival (PFS) (from the start of adjuvant pembrolizumab until locoregional progression, development of distant metastatic disease, or death) in stage IVB ATC patients with gross disease, treated with external beam radiation (+/- concomitant chemotherapy) followed by adjuvant pembrolizumab. Patients will be patients enrolled from cohort 1 and 2 cohort 1: \>51 Gy; cohort 2: \<50 Gy).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
From the start of adjuvant pembrolizumab until disease progression or death
Results posted on
2026-03-23
Participant Flow
Participant milestones
| Measure |
Cohort 1
high dose group
|
Cohort 2
palliative dose group
|
Cohort 3
surgery plus IMRT plus concurrent chemotherapy
|
|---|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Cohort 1
high dose group
|
Cohort 2
palliative dose group
|
Cohort 3
surgery plus IMRT plus concurrent chemotherapy
|
|---|---|---|---|
|
Overall Study
Suspicious/equivocal metastatic disease in the lungs
|
0
|
0
|
1
|
|
Overall Study
Progressive Disease
|
0
|
0
|
1
|
Baseline Characteristics
IMRT Followed by Pembrolizumab in the Adjuvant Setting in Anaplastic Cancer of the Thyroid (IMPAACT): Phase II Trial Adjuvant Pembrolizumab After IMRT in ATC
Baseline characteristics by cohort
| Measure |
Cohort 1
high dose group
|
Cohort 2
palliative dose group
|
Cohort 3
n=6 Participants
surgery plus IMRT plus concurrent chemotherapy
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
—
|
—
|
0 Participants
n=18 Participants
|
0 Participants
n=158 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
—
|
—
|
3 Participants
n=18 Participants
|
3 Participants
n=158 Participants
|
|
Age, Categorical
>=65 years
|
—
|
—
|
3 Participants
n=18 Participants
|
3 Participants
n=158 Participants
|
|
Sex: Female, Male
Female
|
—
|
—
|
4 Participants
n=18 Participants
|
4 Participants
n=158 Participants
|
|
Sex: Female, Male
Male
|
—
|
—
|
2 Participants
n=18 Participants
|
2 Participants
n=158 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
—
|
0 Participants
n=18 Participants
|
0 Participants
n=158 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
—
|
6 Participants
n=18 Participants
|
6 Participants
n=158 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
—
|
0 Participants
n=18 Participants
|
0 Participants
n=158 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
—
|
0 Participants
n=18 Participants
|
0 Participants
n=158 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
—
|
0 Participants
n=18 Participants
|
0 Participants
n=158 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
—
|
0 Participants
n=18 Participants
|
0 Participants
n=158 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
—
|
0 Participants
n=18 Participants
|
0 Participants
n=158 Participants
|
|
Race (NIH/OMB)
White
|
—
|
—
|
6 Participants
n=18 Participants
|
6 Participants
n=158 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
—
|
0 Participants
n=18 Participants
|
0 Participants
n=158 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
—
|
0 Participants
n=18 Participants
|
0 Participants
n=158 Participants
|
|
Region of Enrollment
United States
|
—
|
—
|
6 participants
n=18 Participants
|
6 participants
n=158 Participants
|
PRIMARY outcome
Timeframe: From the start of adjuvant pembrolizumab until disease progression or deathPopulation: There were no participants enrolled in Cohorts 1 and 2.
To estimate the median progression-free survival (PFS) (from the start of adjuvant pembrolizumab until locoregional progression, development of distant metastatic disease, or death) in stage IVB ATC patients with gross disease, treated with external beam radiation (+/- concomitant chemotherapy) followed by adjuvant pembrolizumab. Patients will be patients enrolled from cohort 1 and 2 cohort 1: \>51 Gy; cohort 2: \<50 Gy).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From the start of adjuvant pembrolizumab until disease progression or deathPopulation: No participants enrolled in Cohort 1 or 2
To estimate median overall survival in stage IVB ATC patients treated with external beam radiation (+/- concurrent chemotherapy) followed by adjuvant pembrolizumab. Patients will be stratified by dose of external beam radiation.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From the start of adjuvant pembrolizumab until disease progression or deathTo estimate the median disease-free survival (DFS) in patients with stage IVB ATC treated with surgery/external beam radiation/concomitant chemotherapy followed by adjuvant pembrolizumab (cohort 3).
Outcome measures
| Measure |
Cohort 1
n=6 Participants
high dose group
|
Cohort 2
palliative dose group
|
|---|---|---|
|
Median Disease-free Survival (DFS) in Patients With Stage IVB ATC Treated With Surgery/External Beam Radiation/Concomitant Chemotherapy Followed by Adjuvant Pembrolizumab
|
0.67 months
Interval 0.38 to 1.0
|
—
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 3
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
high dose group
|
Cohort 2
palliative dose group
|
Cohort 3
n=6 participants at risk
surgery plus IMRT plus concurrent chemotherapy
|
|---|---|---|---|
|
Nervous system disorders
Aphonia
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
16.7%
1/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Vascular disorders
Hypertension
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
16.7%
1/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Investigations
Lymphocyte Count Decreased
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
33.3%
2/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
16.7%
1/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Infections and infestations
Tracheitis
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
16.7%
1/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
Other adverse events
| Measure |
Cohort 1
high dose group
|
Cohort 2
palliative dose group
|
Cohort 3
n=6 participants at risk
surgery plus IMRT plus concurrent chemotherapy
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
66.7%
4/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Investigations
Hemoglobin Increased
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
16.7%
1/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Gastrointestinal disorders
Hemorrhoids
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
16.7%
1/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Investigations
Neutrophil Count Decreased
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
33.3%
2/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
33.3%
2/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
66.7%
4/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
33.3%
2/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
16.7%
1/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
16.7%
1/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Blood and lymphatic system disorders
Blood and Lymphatic System Disorders - Other Specify
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
100.0%
6/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Investigations
Blood Bilirubin Increased
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
16.7%
1/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
66.7%
4/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Investigations
Creatinine Increased
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
16.7%
1/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Psychiatric disorders
Depression
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
16.7%
1/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Injury, poisoning and procedural complications
Dermatitis Radiation
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
16.7%
1/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Gastrointestinal disorders
Diarrhea
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
50.0%
3/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Nervous system disorders
Dysgeusia
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
16.7%
1/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Gastrointestinal disorders
Dysphagia
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
33.3%
2/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
16.7%
1/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Ear and labyrinth disorders
Ear Pain
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
16.7%
1/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
General disorders
Edema Limbs
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
16.7%
1/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Endocrine disorders
Endocrine Disorders - Other Specify
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
66.7%
4/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Eye disorders
Eye Disorders - Other Specify
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
16.7%
1/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
General disorders
Fatigue
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
33.3%
2/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
General disorders
Fever
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
16.7%
1/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
General disorders
Flu Like Symptoms
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
16.7%
1/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Gastrointestinal disorders
Gastrointestinal Disorders - Other Specify
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
16.7%
1/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Investigations
Alkaline Phosphatase Increased
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
16.7%
1/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
16.7%
1/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
16.7%
1/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Blood and lymphatic system disorders
Anemia
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
33.3%
2/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Metabolism and nutrition disorders
Anorexia
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
50.0%
3/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Psychiatric disorders
Anxiety
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
50.0%
3/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Nervous system disorders
Aphonia
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
16.7%
1/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
16.7%
1/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Gastrointestinal disorders
Belching
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
16.7%
1/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Vascular disorders
Hypertension
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
50.0%
3/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
16.7%
1/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
50.0%
3/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Endocrine disorders
Hypothyroidism
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
50.0%
3/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Injury, poisoning and procedural complications
Injury Poisoning and Procedural Complications - Other Specify
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
16.7%
1/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Psychiatric disorders
Insomnia
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
16.7%
1/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Investigations
Investigations - Other Specify
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
16.7%
1/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Vascular disorders
Lymphedema
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
16.7%
1/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Investigations
Lymphocyte Count Decreased
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
100.0%
6/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Gastrointestinal disorders
Nausea
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
33.3%
2/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
50.0%
3/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
16.7%
1/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Nervous system disorders
Paresthesia
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
16.7%
1/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Investigations
Platelet Count Decreased
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
33.3%
2/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Renal and urinary disorders
Proteinuria
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
50.0%
3/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
33.3%
2/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
33.3%
2/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Renal and urinary disorders
Renal and Urinary Disorders - Other Specify
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
16.7%
1/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Reproductive system and breast disorders
Reproductive System and Breast Disorders - Other Specify
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
16.7%
1/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous Tissue Disorders - Other Specify
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
33.3%
2/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnea
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
16.7%
1/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
50.0%
3/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
16.7%
1/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Vascular disorders
Thromboembolic Event
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
16.7%
1/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Infections and infestations
Tracheitis
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
33.3%
2/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Infections and infestations
Upper Respiratory Infection
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
16.7%
1/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Investigations
Weight Gain
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
16.7%
1/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
|
Investigations
White Blood Cell Decreased
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
—
0/0 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
66.7%
4/6 • 2 years, 10 months, 10 days
There were no participants enrolled in Cohort 1 and 2.
|
Additional Information
Dr. Maria E Cabanillas
The University of Texas MD Anderson Cancer Center
Phone: (713) 563-0764
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place