Trial Outcomes & Findings for Plerixafor and Cemiplimab in Metastatic Pancreatic Cancer (NCT NCT04177810)

Last Updated: 2024-02-23

Results Overview

ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on immune Response Evaluation Criteria in Solid Tumors (iRECIST) at any time during the study. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions, progressive disease (PD) is \>20% increase in sum of diameters of target lesions, stable disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

25 participants

Primary outcome timeframe

10 months

Results posted on

2024-02-23

Participant Flow

4 participants were excluded from analysis because they did not receive at least one dose of study drug.

Participant milestones

Participant milestones
Measure	Cemiplimab and Plerixafor All participants will receive Cemiplimab and Plerixafor. Cemiplimab (350 mg) will be administered IV on day 1 of each cycle (21 day cycle) for up to 2 years. Plerixafor (80mcg/kg/hr) will be administered as a continuous IV infusion of the first 7 days of each cycle (21 day cycle) for up to 2 years.
Overall Study STARTED	21
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Plerixafor and Cemiplimab in Metastatic Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cemiplimab and Plerixafor n=21 Participants All participants will receive Cemiplimab and Plerixafor. Cemiplimab (350 mg) will be administered IV on day 1 of each cycle (21 day cycle) for up to 2 years. Plerixafor (80mcg/kg/hr) will be administered as a continuous IV infusion of the first 7 days of each cycle (21 day cycle) for up to 2 years.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 10 months

Outcome measures

Outcome measures
Measure	Cemiplimab and Plerixafor n=21 Participants All participants will receive Cemiplimab and Plerixafor. Cemiplimab (350 mg) will be administered IV on day 1 of each cycle (21 day cycle) for up to 2 years. Plerixafor (80mcg/kg/hr) will be administered as a continuous IV infusion of the first 7 days of each cycle (21 day cycle) for up to 2 years.
Objective Response Rate (ORR) Using Immune RECIST (iRECIST) Criteria	0 Participants

SECONDARY outcome

Timeframe: 10 months

Objective Response Rate (ORR) is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions. Subjects who discontinue due to toxicity or clinical progression prior to post-baseline tumor assessments will be considered as non-responders.

Outcome measures

Outcome measures
Measure	Cemiplimab and Plerixafor n=21 Participants All participants will receive Cemiplimab and Plerixafor. Cemiplimab (350 mg) will be administered IV on day 1 of each cycle (21 day cycle) for up to 2 years. Plerixafor (80mcg/kg/hr) will be administered as a continuous IV infusion of the first 7 days of each cycle (21 day cycle) for up to 2 years.
Overall Response Rate (ORR) Using RECIST 1.1 Criteria	0 Participants

SECONDARY outcome

Timeframe: 13 months

Defined using NCI CTCAE v5.0

Outcome measures

Outcome measures
Measure	Cemiplimab and Plerixafor n=21 Participants All participants will receive Cemiplimab and Plerixafor. Cemiplimab (350 mg) will be administered IV on day 1 of each cycle (21 day cycle) for up to 2 years. Plerixafor (80mcg/kg/hr) will be administered as a continuous IV infusion of the first 7 days of each cycle (21 day cycle) for up to 2 years.
Number of Participants Experiencing Grade 3 or Above Drug-related Toxicities	4 Participants

Adverse Events

Cemiplimab and Plerixafor

Serious events: 13 serious events

Other events: 21 other events

Deaths: 21 deaths

Serious adverse events

Serious adverse events
Measure	Cemiplimab and Plerixafor n=21 participants at risk All participants will receive Cemiplimab and Plerixafor. Cemiplimab (350 mg) will be administered IV on day 1 of each cycle (21 day cycle) for up to 2 years. Plerixafor (80mcg/kg/hr) will be administered as a continuous IV infusion of the first 7 days of each cycle (21 day cycle) for up to 2 years.
Gastrointestinal disorders Abdominal pain	14.3% 3/21 • Number of events 3 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Hepatobiliary disorders Bile Duct Stenosis	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Psychiatric disorders Confusion	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Psychiatric disorders Delerium	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
General disorders Disease Progression	38.1% 8/21 • Number of events 8 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
General disorders Fever	14.3% 3/21 • Number of events 3 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Hepatobiliary disorders Immune-Mediated Hepatitis	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
General disorders Lactic Acidosis	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Gastrointestinal disorders Lower Gastrointestinal Hemorrhage	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Cardiac disorders Pericarditis	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Respiratory, thoracic and mediastinal disorders Pneumothorax	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Infections and infestations Sepsis	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Nervous system disorders Stroke	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.

Other adverse events

Other adverse events
Measure	Cemiplimab and Plerixafor n=21 participants at risk All participants will receive Cemiplimab and Plerixafor. Cemiplimab (350 mg) will be administered IV on day 1 of each cycle (21 day cycle) for up to 2 years. Plerixafor (80mcg/kg/hr) will be administered as a continuous IV infusion of the first 7 days of each cycle (21 day cycle) for up to 2 years.
Gastrointestinal disorders Abdominal Distension	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Gastrointestinal disorders Abdominal Pain	23.8% 5/21 • Number of events 6 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Investigations Alanine Aminotransferase Increased	19.0% 4/21 • Number of events 5 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Investigations Alkaline Phosphatase Increased	28.6% 6/21 • Number of events 7 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Respiratory, thoracic and mediastinal disorders Allergic Rhinitis	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Blood and lymphatic system disorders Anemia	42.9% 9/21 • Number of events 33 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Metabolism and nutrition disorders Anorexia	14.3% 3/21 • Number of events 3 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Musculoskeletal and connective tissue disorders Arthralgia	9.5% 2/21 • Number of events 2 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Musculoskeletal and connective tissue disorders Arthritis	9.5% 2/21 • Number of events 2 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Gastrointestinal disorders Ascites	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Investigations Aspartate Aminotransferase Increased	19.0% 4/21 • Number of events 5 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Musculoskeletal and connective tissue disorders Back Pain	9.5% 2/21 • Number of events 2 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Infections and infestations Bacteremia	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Investigations Blood Bicarbonate Decreased	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Investigations Blood Bilirubin Increased	14.3% 3/21 • Number of events 5 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Musculoskeletal and connective tissue disorders Bone Pain	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Injury, poisoning and procedural complications Bruising	14.3% 3/21 • Number of events 3 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Investigations Cardiac Troponin I Increased	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Gastrointestinal disorders Constipation	14.3% 3/21 • Number of events 3 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Respiratory, thoracic and mediastinal disorders Cough	14.3% 3/21 • Number of events 4 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Metabolism and nutrition disorders Dehydration	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Psychiatric disorders Depression	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Gastrointestinal disorders Diarrhea	38.1% 8/21 • Number of events 11 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Nervous system disorders Dizziness	28.6% 6/21 • Number of events 6 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Gastrointestinal disorders Dry Mouth	9.5% 2/21 • Number of events 2 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Nervous system disorders Dysesthesia	9.5% 2/21 • Number of events 2 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Gastrointestinal disorders Dyspepsia	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Renal and urinary disorders Dysuria	9.5% 2/21 • Number of events 2 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Ear and labyrinth disorders Ear and Labyrinth Disorders (Altered Balance)	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
General disorders Edema Limbs	14.3% 3/21 • Number of events 3 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Injury, poisoning and procedural complications Fall	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
General disorders Fatigue	14.3% 3/21 • Number of events 4 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
General disorders Fever	33.3% 7/21 • Number of events 13 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Gastrointestinal disorders Flatulence	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Gastrointestinal disorders Gastrointestinal Disorders- Melena	9.5% 2/21 • Number of events 2 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Psychiatric disorders Hallucinations	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Nervous system disorders Headache	33.3% 7/21 • Number of events 7 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Ear and labyrinth disorders Hearing Impaired	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Hepatobiliary disorders Hepatobiliary Disorders- Biliary Obstruction	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Metabolism and nutrition disorders Hyperglycemia	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Skin and subcutaneous tissue disorders Hyperhidrosis	47.6% 10/21 • Number of events 12 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Vascular disorders Hypertension	19.0% 4/21 • Number of events 16 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Metabolism and nutrition disorders Hypermagnesemia	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Metabolism and nutrition disorders Hyponatremia	4.8% 1/21 • Number of events 4 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Injury, poisoning and procedural complications Infusion Related Reaction	9.5% 2/21 • Number of events 4 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Psychiatric disorders Insomnia	14.3% 3/21 • Number of events 3 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Investigations Investigations (Left Axis Deviation)	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Investigations Lymphocyte Count Decreased	4.8% 1/21 • Number of events 4 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
General disorders Malaise	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Gastrointestinal disorders Mucositis Oral	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Musculoskeletal and connective tissue disorders Muscle Cramp	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Musculoskeletal and connective tissue disorders Myalgia	9.5% 2/21 • Number of events 2 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	14.3% 3/21 • Number of events 3 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Gastrointestinal disorders Nausea	23.8% 5/21 • Number of events 6 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
General disorders Non-Cardiac Chest Pain	4.8% 1/21 • Number of events 2 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
General disorders Pain	14.3% 3/21 • Number of events 3 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Nervous system disorders Paresthesia	47.6% 10/21 • Number of events 16 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Nervous system disorders Peripheral Sensory Neuropathy	9.5% 2/21 • Number of events 3 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	14.3% 3/21 • Number of events 3 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Nervous system disorders Presyncope	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Skin and subcutaneous tissue disorders Pruritus	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Psychiatric disorders Psychiatric disorders - Vivid dreams	14.3% 3/21 • Number of events 3 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	9.5% 2/21 • Number of events 3 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Infections and infestations Rhinitis Infective	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Infections and infestations Sepsis	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Infections and infestations Shingles	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Cardiac disorders Sinus Bradycardia	19.0% 4/21 • Number of events 8 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Cardiac disorders Sinus Tachycardia	28.6% 6/21 • Number of events 14 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Skin and subcutaneous tissue disorders Skin and Subcutaneous Disorders (Blisters on Ear Lobes)	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Gastrointestinal disorders Stomach Pain	14.3% 3/21 • Number of events 3 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Nervous system disorders Syncope	9.5% 2/21 • Number of events 3 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Vascular disorders Thromboembolic Event	14.3% 3/21 • Number of events 3 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Infections and infestations Thrush	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Ear and labyrinth disorders Tinnitus	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Renal and urinary disorders Urinary Incontinence	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Renal and urinary disorders Urinary Tract Infection	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Gastrointestinal disorders Vomiting	4.8% 1/21 • Number of events 1 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Investigations Weight Gain	9.5% 2/21 • Number of events 2 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.
Investigations Weight Loss	23.8% 5/21 • Number of events 6 • Up to 17 months Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 13 months. All-cause mortality was evaluated for up to 17 months.

Additional Information

Dung Le, MD

SKCCC Johns Hopkins Medical Institution

Phone: 443-287-0002

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place