Trial Outcomes & Findings for Assess the Efficacy of Pembrolizumab Plus Radiotherapy or Ablation in Metastatic Colorectal Cancer Patients (NCT NCT02437071)
NCT ID: NCT02437071
Last Updated: 2025-12-05
Results Overview
If at the end of the study ≥3 tumor responses per RECIST 1.1 are observed in a cohort, then further investigation of pembrolizumab plus RT and/or pembrolizumab plus ablation will be considered worthwhile. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD) no PR - no Progressive Disease (PD); Progressive Disease (PD) \>=20% increase sum of longest diameters of the target lesions (SLD) compared to smallest SLD in study or progression of non-target lesions or new lesions
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
approximately 9 weeks
Results posted on
2025-12-05
Participant Flow
Participant milestones
| Measure |
Pembrolizumab Plus Radiotherapy
pembrolizumab plus RT in subjects with metastatic CRC who are undergoing RT as standard therapy
Pembrolizumab: Pembrolizumab will be administered as a 30 minute IV infusion (every effort should be made to target infusion timing to be as close to 30 minutes as possible. However, given the variability of infusion pumps from site to site, a window of -5 minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min).
Radiotherapy
|
Pembrolizumab Plus Ablation
pembrolizumab plus ablation in subjects with metastatic CRC who are undergoing ablation as standard therapy
Pembrolizumab: Pembrolizumab will be administered as a 30 minute IV infusion (every effort should be made to target infusion timing to be as close to 30 minutes as possible. However, given the variability of infusion pumps from site to site, a window of -5 minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min).
Radiofrequency ablation
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
9
|
|
Overall Study
COMPLETED
|
24
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Pembrolizumab Plus Radiotherapy
pembrolizumab plus RT in subjects with metastatic CRC who are undergoing RT as standard therapy
Pembrolizumab: Pembrolizumab will be administered as a 30 minute IV infusion (every effort should be made to target infusion timing to be as close to 30 minutes as possible. However, given the variability of infusion pumps from site to site, a window of -5 minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min).
Radiotherapy
|
Pembrolizumab Plus Ablation
pembrolizumab plus ablation in subjects with metastatic CRC who are undergoing ablation as standard therapy
Pembrolizumab: Pembrolizumab will be administered as a 30 minute IV infusion (every effort should be made to target infusion timing to be as close to 30 minutes as possible. However, given the variability of infusion pumps from site to site, a window of -5 minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min).
Radiofrequency ablation
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Assess the Efficacy of Pembrolizumab Plus Radiotherapy or Ablation in Metastatic Colorectal Cancer Patients
Baseline characteristics by cohort
| Measure |
Pembrolizumab Plus Radiotherapy
n=25 Participants
pembrolizumab plus RT in subjects with metastatic CRC who are undergoing RT as standard therapy
Pembrolizumab: Pembrolizumab will be administered as a 30 minute IV infusion (every effort should be made to target infusion timing to be as close to 30 minutes as possible. However, given the variability of infusion pumps from site to site, a window of -5 minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min).
Radiotherapy
|
Pembrolizumab Plus Ablation
n=9 Participants
pembrolizumab plus ablation in subjects with metastatic CRC who are undergoing ablation as standard therapy
Pembrolizumab: Pembrolizumab will be administered as a 30 minute IV infusion (every effort should be made to target infusion timing to be as close to 30 minutes as possible. However, given the variability of infusion pumps from site to site, a window of -5 minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min).
Radiofrequency ablation
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
n=37 Participants
|
59 years
n=37 Participants
|
59.7 years
n=74 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=37 Participants
|
2 Participants
n=37 Participants
|
14 Participants
n=74 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=37 Participants
|
7 Participants
n=37 Participants
|
20 Participants
n=74 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=37 Participants
|
1 Participants
n=37 Participants
|
1 Participants
n=74 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=37 Participants
|
4 Participants
n=37 Participants
|
16 Participants
n=74 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=37 Participants
|
4 Participants
n=37 Participants
|
17 Participants
n=74 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=37 Participants
|
1 Participants
n=37 Participants
|
4 Participants
n=74 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=37 Participants
|
1 Participants
n=37 Participants
|
1 Participants
n=74 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=37 Participants
|
7 Participants
n=37 Participants
|
29 Participants
n=74 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=37 Participants
|
9 Participants
n=37 Participants
|
34 Participants
n=74 Participants
|
PRIMARY outcome
Timeframe: approximately 9 weeksIf at the end of the study ≥3 tumor responses per RECIST 1.1 are observed in a cohort, then further investigation of pembrolizumab plus RT and/or pembrolizumab plus ablation will be considered worthwhile. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD) no PR - no Progressive Disease (PD); Progressive Disease (PD) \>=20% increase sum of longest diameters of the target lesions (SLD) compared to smallest SLD in study or progression of non-target lesions or new lesions
Outcome measures
| Measure |
Pembrolizumab Plus Radiotherapy
n=24 Participants
pembrolizumab plus RT in subjects with metastatic CRC who are undergoing RT as standard therapy
Pembrolizumab: Pembrolizumab will be administered as a 30 minute IV infusion (every effort should be made to target infusion timing to be as close to 30 minutes as possible. However, given the variability of infusion pumps from site to site, a window of -5 minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min).
Radiotherapy
|
Pembrolizumab Plus Ablation
n=9 Participants
pembrolizumab plus ablation in subjects with metastatic CRC who are undergoing ablation as standard therapy
Pembrolizumab: Pembrolizumab will be administered as a 30 minute IV infusion (every effort should be made to target infusion timing to be as close to 30 minutes as possible. However, given the variability of infusion pumps from site to site, a window of -5 minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min).
Radiofrequency ablation
|
|---|---|---|
|
Number of Participants With Response
Complete Response
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response
Partial Response
|
1 Participants
|
1 Participants
|
|
Number of Participants With Response
Stable Disease
|
5 Participants
|
1 Participants
|
|
Number of Participants With Response
Progressive Disease
|
18 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 2 yearsAll recorded toxicity will be listed and tabulated by system organ class, preferred term and treatment. Any significant vital signs and clinical laboratory test results will be listed and summarized. Any significant physical examination findings, and clinical laboratory results will be listed. Will be recorded according to "Common Terminology Criteria for Adverse Events" V4.0 (CTCAE).
Outcome measures
| Measure |
Pembrolizumab Plus Radiotherapy
n=24 Participants
pembrolizumab plus RT in subjects with metastatic CRC who are undergoing RT as standard therapy
Pembrolizumab: Pembrolizumab will be administered as a 30 minute IV infusion (every effort should be made to target infusion timing to be as close to 30 minutes as possible. However, given the variability of infusion pumps from site to site, a window of -5 minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min).
Radiotherapy
|
Pembrolizumab Plus Ablation
n=9 Participants
pembrolizumab plus ablation in subjects with metastatic CRC who are undergoing ablation as standard therapy
Pembrolizumab: Pembrolizumab will be administered as a 30 minute IV infusion (every effort should be made to target infusion timing to be as close to 30 minutes as possible. However, given the variability of infusion pumps from site to site, a window of -5 minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min).
Radiofrequency ablation
|
|---|---|---|
|
Number of Participants With Toxicities
|
24 Participants
|
9 Participants
|
Adverse Events
Pembrolizumab Plus Radiotherapy
Serious events: 21 serious events
Other events: 25 other events
Deaths: 21 deaths
Pembrolizumab Plus Ablation
Serious events: 9 serious events
Other events: 9 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Pembrolizumab Plus Radiotherapy
n=25 participants at risk
pembrolizumab plus RT in subjects with metastatic CRC who are undergoing RT as standard therapy
Pembrolizumab: Pembrolizumab will be administered as a 30 minute IV infusion (every effort should be made to target infusion timing to be as close to 30 minutes as possible. However, given the variability of infusion pumps from site to site, a window of -5 minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min).
Radiotherapy
|
Pembrolizumab Plus Ablation
n=9 participants at risk
pembrolizumab plus ablation in subjects with metastatic CRC who are undergoing ablation as standard therapy
Pembrolizumab: Pembrolizumab will be administered as a 30 minute IV infusion (every effort should be made to target infusion timing to be as close to 30 minutes as possible. However, given the variability of infusion pumps from site to site, a window of -5 minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min).
Radiofrequency ablation
|
|---|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
8.0%
2/25 • 2 years
|
11.1%
1/9 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Gastrointestinal disorders
Gastric Obstruction
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
16.0%
4/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/25 • 2 years
|
11.1%
1/9 • 2 years
|
|
Hepatobiliary disorders
Hepatic Failure
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Nervous system disorders
Memory Impairment
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
General disorders
Death NOS
|
84.0%
21/25 • 2 years
|
100.0%
9/9 • 2 years
|
|
Infections and infestations
Abdominal Infection
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Metabolism and nutrition disorders
Metabolic Acidosis
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Vascular disorders
Thromboembolic Event
|
0.00%
0/25 • 2 years
|
11.1%
1/9 • 2 years
|
Other adverse events
| Measure |
Pembrolizumab Plus Radiotherapy
n=25 participants at risk
pembrolizumab plus RT in subjects with metastatic CRC who are undergoing RT as standard therapy
Pembrolizumab: Pembrolizumab will be administered as a 30 minute IV infusion (every effort should be made to target infusion timing to be as close to 30 minutes as possible. However, given the variability of infusion pumps from site to site, a window of -5 minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min).
Radiotherapy
|
Pembrolizumab Plus Ablation
n=9 participants at risk
pembrolizumab plus ablation in subjects with metastatic CRC who are undergoing ablation as standard therapy
Pembrolizumab: Pembrolizumab will be administered as a 30 minute IV infusion (every effort should be made to target infusion timing to be as close to 30 minutes as possible. However, given the variability of infusion pumps from site to site, a window of -5 minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min).
Radiofrequency ablation
|
|---|---|---|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Psychiatric disorders
Insomnia
|
24.0%
6/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
8.0%
2/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Nervous system disorders
Memory impairment
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
12.0%
3/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Metabolism and nutrition disorders
Myalgia
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
48.0%
12/25 • 2 years
|
11.1%
1/9 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms ben/mal/unk (inc cyst/polyp) Other, spec
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Investigations
Neutrophil count decreased
|
8.0%
2/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
General disorders
Non-cardiac chest pain
|
12.0%
3/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
General disorders
Pain
|
24.0%
6/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Nervous system disorders
Paresthesia
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
40.0%
10/25 • 2 years
|
11.1%
1/9 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.0%
2/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
8.0%
2/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Reproductive system and breast disorders
Prostratic obstruction
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
32.0%
8/25 • 2 years
|
22.2%
2/9 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
8.0%
2/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.0%
4/25 • 2 years
|
55.6%
5/9 • 2 years
|
|
Nervous system disorders
Restlessness
|
0.00%
0/25 • 2 years
|
11.1%
1/9 • 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
8.0%
2/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Infections and infestations
Skin infection
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue disorders Other, spec
|
0.00%
0/25 • 2 years
|
11.1%
1/9 • 2 years
|
|
Nervous system disorders
Somnolence
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Cardiac disorders
Supraventricular tachycardia
|
4.0%
1/25 • 2 years
|
11.1%
1/9 • 2 years
|
|
Ear and labyrinth disorders
Tinnitus
|
8.0%
2/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Renal and urinary disorders
Urinary frequency
|
8.0%
2/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/25 • 2 years
|
11.1%
1/9 • 2 years
|
|
Infections and infestations
Urinary tract infection
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Renal and urinary disorders
Urinary tract pain
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Renal and urinary disorders
Urinary urgency
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
36.0%
9/25 • 2 years
|
22.2%
2/9 • 2 years
|
|
Eye disorders
Watering eyes
|
0.00%
0/25 • 2 years
|
11.1%
1/9 • 2 years
|
|
Investigations
Weight loss
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Investigations
White blood cell decreased
|
8.0%
2/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
25/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/25 • 2 years
|
11.1%
1/9 • 2 years
|
|
Psychiatric disorders
Anxiety
|
8.0%
2/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Gastrointestinal disorders
Ascites
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
12.0%
3/25 • 2 years
|
22.2%
2/9 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
40.0%
10/25 • 2 years
|
44.4%
4/9 • 2 years
|
|
Hepatobiliary disorders
Bile duct stenosis
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Gastrointestinal disorders
Bloating
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Investigations
Blood bilirubin increased
|
20.0%
5/25 • 2 years
|
11.1%
1/9 • 2 years
|
|
Eye disorders
Blurred vision
|
0.00%
0/25 • 2 years
|
11.1%
1/9 • 2 years
|
|
Skin and subcutaneous tissue disorders
Burn
|
0.00%
0/25 • 2 years
|
11.1%
1/9 • 2 years
|
|
Eye disorders
Cataract
|
0.00%
0/25 • 2 years
|
11.1%
1/9 • 2 years
|
|
General disorders
Chills
|
12.0%
3/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
General disorders
Colitis
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Nervous system disorders
Concentration impairment
|
8.0%
2/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Infections and infestations
Conjunctivitis
|
12.0%
3/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
44.0%
11/25 • 2 years
|
33.3%
3/9 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
36.0%
9/25 • 2 years
|
11.1%
1/9 • 2 years
|
|
Psychiatric disorders
Depression
|
8.0%
2/25 • 2 years
|
11.1%
1/9 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
48.0%
12/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Nervous system disorders
Dizziness
|
12.0%
3/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Gastrointestinal disorders
Dry mouth
|
24.0%
6/25 • 2 years
|
11.1%
1/9 • 2 years
|
|
Eye disorders
Dry eye
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.0%
5/25 • 2 years
|
11.1%
1/9 • 2 years
|
|
Nervous system disorders
Dysgeusia
|
12.0%
3/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
32.0%
8/25 • 2 years
|
33.3%
3/9 • 2 years
|
|
General disorders
Edema face
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
General disorders
Edema limbs
|
8.0%
2/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Reproductive system and breast disorders
Ejaculation disorder
|
0.00%
0/25 • 2 years
|
11.1%
1/9 • 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/25 • 2 years
|
11.1%
1/9 • 2 years
|
|
General disorders
Fatigue
|
68.0%
17/25 • 2 years
|
88.9%
8/9 • 2 years
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/25 • 2 years
|
11.1%
1/9 • 2 years
|
|
General disorders
Fever
|
12.0%
3/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Eye disorders
Floaters
|
8.0%
2/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
General disorders
Gait disturbance
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/25 • 2 years
|
11.1%
1/9 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/25 • 2 years
|
11.1%
1/9 • 2 years
|
|
Nervous system disorders
Headache
|
4.0%
1/25 • 2 years
|
11.1%
1/9 • 2 years
|
|
Ear and labyrinth disorders
Hearing impaired
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Renal and urinary disorders
Hematuria
|
16.0%
4/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.0%
1/25 • 2 years
|
11.1%
1/9 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.0%
3/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Vascular disorders
Hypertension
|
16.0%
4/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
4.0%
1/25 • 2 years
|
11.1%
1/9 • 2 years
|
|
Endocrine disorders
Hyperthyroidism
|
4.0%
1/25 • 2 years
|
11.1%
1/9 • 2 years
|
|
Infections and infestations
Infections and infestations - Other, specify
|
12.0%
3/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Gastrointestinal disorders
Abdominal distension
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
52.0%
13/25 • 2 years
|
33.3%
3/9 • 2 years
|
|
Investigations
Activated partial thromboplastin time prolonged
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Psychiatric disorders
Agitation
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Investigations
Alanine aminotransferase increased
|
4.0%
1/25 • 2 years
|
0.00%
0/9 • 2 years
|
|
Investigations
Alkaline phosphatase increased
|
12.0%
3/25 • 2 years
|
11.1%
1/9 • 2 years
|
Additional Information
Dr. Neil Segal, MD, PhD
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4187
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place