Trial Outcomes & Findings for Testing A New Combination of Anti-cancer Immune Therapies, Atezolizumab and CDX-1127 (Varlilumab) With or Without the Addition of a Third Anti-cancer Drug, Cobimetinib, for Advanced-Stage Biliary Tract Cancer (NCT NCT04941287)
NCT ID: NCT04941287
Last Updated: 2025-05-23
Results Overview
Response is defined as a complete response (CR) (disappearance of all lesions) or partial response (PR) (\>= 30% decrease in the sum of target lesions) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria after receiving at least one dose of the assigned study regimen.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
57 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2025-05-23
Participant Flow
Participant milestones
| Measure |
Arm A (Cobimetinib, Atezolizumab, Varlilumab)
Patients receive cobimetinib PO QD on days 1-21 of each cycle, atezolizumab IV over 30-60 minutes on days 1 and 15 of each cycle, and varlilumab IV over 90 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Atezolizumab, Varlilumab)
Patients receive atezolizumab IV over 30-60 minutes on days 1 and 15 of each cycle and varlilumab IV over 90 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
28
|
|
Overall Study
COMPLETED
|
26
|
27
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Arm A (Cobimetinib, Atezolizumab, Varlilumab)
Patients receive cobimetinib PO QD on days 1-21 of each cycle, atezolizumab IV over 30-60 minutes on days 1 and 15 of each cycle, and varlilumab IV over 90 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Atezolizumab, Varlilumab)
Patients receive atezolizumab IV over 30-60 minutes on days 1 and 15 of each cycle and varlilumab IV over 90 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
Rapid decline before starting treatment
|
3
|
1
|
Baseline Characteristics
Testing A New Combination of Anti-cancer Immune Therapies, Atezolizumab and CDX-1127 (Varlilumab) With or Without the Addition of a Third Anti-cancer Drug, Cobimetinib, for Advanced-Stage Biliary Tract Cancer
Baseline characteristics by cohort
| Measure |
Arm A (Cobimetinib, Atezolizumab, Varlilumab)
n=29 Participants
Patients receive cobimetinib PO QD on days 1-21 of each cycle, atezolizumab IV over 30-60 minutes on days 1 and 15 of each cycle, and varlilumab IV over 90 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Atezolizumab, Varlilumab)
n=28 Participants
Patients receive atezolizumab IV over 30-60 minutes on days 1 and 15 of each cycle and varlilumab IV over 90 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 Years
n=5 Participants
|
67 Years
n=7 Participants
|
64 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
28 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
Subgroup
Gallbladder cancer
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Subgroup
Intrahepatic cholangiocarcinoma
|
21 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Subgroup
Extrahepatic cholangiocarcinoma
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsResponse is defined as a complete response (CR) (disappearance of all lesions) or partial response (PR) (\>= 30% decrease in the sum of target lesions) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria after receiving at least one dose of the assigned study regimen.
Outcome measures
| Measure |
Arm A (Cobimetinib, Atezolizumab, Varlilumab)
n=26 Participants
Patients receive cobimetinib PO QD on days 1-21 of each cycle, atezolizumab IV over 30-60 minutes on days 1 and 15 of each cycle, and varlilumab IV over 90 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Atezolizumab, Varlilumab)
n=27 Participants
Patients receive atezolizumab IV over 30-60 minutes on days 1 and 15 of each cycle and varlilumab IV over 90 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Number of Participants Experiencing a Response
Response
|
0 Participants
|
1 Participants
|
|
Number of Participants Experiencing a Response
No Response
|
23 Participants
|
23 Participants
|
|
Number of Participants Experiencing a Response
Not Assessed
|
3 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsTime from the date of enrollment to the date of documented tumor progression (\>= 20% increase in the sum of target lesions, measurable increase in a non-target lesion, or appearance of a new lesion) by RECIST v1.1 or death due to any cause, whichever occurs first for participants who received at least one dose of their assigned study regimen.
Outcome measures
| Measure |
Arm A (Cobimetinib, Atezolizumab, Varlilumab)
n=29 Participants
Patients receive cobimetinib PO QD on days 1-21 of each cycle, atezolizumab IV over 30-60 minutes on days 1 and 15 of each cycle, and varlilumab IV over 90 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Atezolizumab, Varlilumab)
n=28 Participants
Patients receive atezolizumab IV over 30-60 minutes on days 1 and 15 of each cycle and varlilumab IV over 90 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Duration of Progression Free Survival (PFS)
|
2.40 months
Interval 1.97 to 5.0
|
1.84 months
Interval 1.64 to 2.43
|
SECONDARY outcome
Timeframe: Up to 2 yearsDefined by Common Terminology Criteria for Adverse Events, version 5.0. The highest grade experienced by the participant will be reported.
Outcome measures
| Measure |
Arm A (Cobimetinib, Atezolizumab, Varlilumab)
n=26 Participants
Patients receive cobimetinib PO QD on days 1-21 of each cycle, atezolizumab IV over 30-60 minutes on days 1 and 15 of each cycle, and varlilumab IV over 90 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Atezolizumab, Varlilumab)
n=27 Participants
Patients receive atezolizumab IV over 30-60 minutes on days 1 and 15 of each cycle and varlilumab IV over 90 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
The Number of Participants Experiencing Grade 3, 4 and 5 Adverse Events
Grade 5
|
1 Participants
|
2 Participants
|
|
The Number of Participants Experiencing Grade 3, 4 and 5 Adverse Events
Grade 4
|
1 Participants
|
3 Participants
|
|
The Number of Participants Experiencing Grade 3, 4 and 5 Adverse Events
Grade 3
|
20 Participants
|
14 Participants
|
|
The Number of Participants Experiencing Grade 3, 4 and 5 Adverse Events
Grade 1 or 2
|
4 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsTime from date of enrollment to time of death or censor date (Participants who withdrew consent were censored to the date of withdrawal and participants still in follow-up were censored to the date of last contact.).
Outcome measures
| Measure |
Arm A (Cobimetinib, Atezolizumab, Varlilumab)
n=29 Participants
Patients receive cobimetinib PO QD on days 1-21 of each cycle, atezolizumab IV over 30-60 minutes on days 1 and 15 of each cycle, and varlilumab IV over 90 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Atezolizumab, Varlilumab)
n=28 Participants
Patients receive atezolizumab IV over 30-60 minutes on days 1 and 15 of each cycle and varlilumab IV over 90 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Duration of Overall Survival (OS)
|
183 Days
Interval 19.0 to 381.0
|
157 Days
Interval 21.0 to 422.0
|
SECONDARY outcome
Timeframe: Baseline up to 2 yearsThe change in density of CD8+ T cells at baseline to after treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 6 weeksAnalysis of the activity of drugs in the body over a period of time, including the processes by which drugs are absorbed, distributed in the body, localized in the tissues, and excreted. The change will be assessed from before treatment to after 2 doses of treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsAnalysis of an agent's ability to provoke an immune response (humoral and/or cell-mediated) in the subject
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 yearsImmunological variables will be examined in plots and summary statistics, to characterize distributions, identify outliers and other potential problems in the data.
Outcome measures
Outcome data not reported
Adverse Events
Arm A (Cobimetinib, Atezolizumab, Varlilumab)
Serious events: 24 serious events
Other events: 25 other events
Deaths: 21 deaths
Arm B (Atezolizumab, Varlilumab)
Serious events: 25 serious events
Other events: 27 other events
Deaths: 23 deaths
Serious adverse events
| Measure |
Arm A (Cobimetinib, Atezolizumab, Varlilumab)
n=29 participants at risk
Patients receive cobimetinib PO QD on days 1-21 of each cycle, atezolizumab IV over 30-60 minutes on days 1 and 15 of each cycle, and varlilumab IV over 90 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Atezolizumab, Varlilumab)
n=28 participants at risk
Patients receive atezolizumab IV over 30-60 minutes on days 1 and 15 of each cycle and varlilumab IV over 90 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/29 • 2 Years
|
7.1%
2/28 • 2 Years
|
|
Gastrointestinal disorders
Abdominal pain
|
6.9%
2/29 • 2 Years
|
0.00%
0/28 • 2 Years
|
|
Gastrointestinal disorders
Ascites
|
3.4%
1/29 • 2 Years
|
0.00%
0/28 • 2 Years
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/29 • 2 Years
|
3.6%
1/28 • 2 Years
|
|
Gastrointestinal disorders
Nausea
|
6.9%
2/29 • 2 Years
|
0.00%
0/28 • 2 Years
|
|
Gastrointestinal disorders
Obstruction gastric
|
3.4%
1/29 • 2 Years
|
0.00%
0/28 • 2 Years
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
3.4%
1/29 • 2 Years
|
3.6%
1/28 • 2 Years
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
1/29 • 2 Years
|
0.00%
0/28 • 2 Years
|
|
General disorders
Disease progression
|
51.7%
15/29 • 2 Years
|
57.1%
16/28 • 2 Years
|
|
General disorders
Fever
|
13.8%
4/29 • 2 Years
|
0.00%
0/28 • 2 Years
|
|
General disorders
Pain
|
3.4%
1/29 • 2 Years
|
3.6%
1/28 • 2 Years
|
|
Hepatobiliary disorders
Cholangitis due to biliary stent obstruction
|
3.4%
1/29 • 2 Years
|
0.00%
0/28 • 2 Years
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/29 • 2 Years
|
3.6%
1/28 • 2 Years
|
|
Hepatobiliary disorders
Gallbladder perforation
|
0.00%
0/29 • 2 Years
|
3.6%
1/28 • 2 Years
|
|
Immune system disorders
Cytokine release syndrome
|
3.4%
1/29 • 2 Years
|
0.00%
0/28 • 2 Years
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/29 • 2 Years
|
3.6%
1/28 • 2 Years
|
|
Infections and infestations
Covid Positive
|
3.4%
1/29 • 2 Years
|
0.00%
0/28 • 2 Years
|
|
Infections and infestations
E.coli infection
|
0.00%
0/29 • 2 Years
|
3.6%
1/28 • 2 Years
|
|
Infections and infestations
Gallbladder infection
|
0.00%
0/29 • 2 Years
|
3.6%
1/28 • 2 Years
|
|
Infections and infestations
Papulopustular rash
|
3.4%
1/29 • 2 Years
|
0.00%
0/28 • 2 Years
|
|
Infections and infestations
Sepsis
|
6.9%
2/29 • 2 Years
|
14.3%
4/28 • 2 Years
|
|
Injury, poisoning and procedural complications
Biopsy related hemorrhage
|
0.00%
0/29 • 2 Years
|
3.6%
1/28 • 2 Years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
3.4%
1/29 • 2 Years
|
0.00%
0/28 • 2 Years
|
|
Investigations
Alanine aminotransferase increased
|
6.9%
2/29 • 2 Years
|
0.00%
0/28 • 2 Years
|
|
Investigations
Alkaline phosphatase increased
|
3.4%
1/29 • 2 Years
|
0.00%
0/28 • 2 Years
|
|
Investigations
Aspartate aminotransferase increased
|
3.4%
1/29 • 2 Years
|
0.00%
0/28 • 2 Years
|
|
Investigations
Blood bilirubin increased
|
10.3%
3/29 • 2 Years
|
7.1%
2/28 • 2 Years
|
|
Investigations
CPK increased
|
3.4%
1/29 • 2 Years
|
0.00%
0/28 • 2 Years
|
|
Investigations
Lymphocyte count decreased
|
3.4%
1/29 • 2 Years
|
0.00%
0/28 • 2 Years
|
|
Metabolism and nutrition disorders
Anorexia
|
3.4%
1/29 • 2 Years
|
0.00%
0/28 • 2 Years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.4%
1/29 • 2 Years
|
3.6%
1/28 • 2 Years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/29 • 2 Years
|
3.6%
1/28 • 2 Years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.4%
1/29 • 2 Years
|
0.00%
0/28 • 2 Years
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.00%
0/29 • 2 Years
|
3.6%
1/28 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/29 • 2 Years
|
3.6%
1/28 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
3.4%
1/29 • 2 Years
|
0.00%
0/28 • 2 Years
|
|
Nervous system disorders
Altered mental status
|
3.4%
1/29 • 2 Years
|
0.00%
0/28 • 2 Years
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/29 • 2 Years
|
3.6%
1/28 • 2 Years
|
|
Nervous system disorders
Myasthenia gravis
|
3.4%
1/29 • 2 Years
|
0.00%
0/28 • 2 Years
|
|
Nervous system disorders
Stroke
|
6.9%
2/29 • 2 Years
|
0.00%
0/28 • 2 Years
|
|
Renal and urinary disorders
Acute kidney injury
|
3.4%
1/29 • 2 Years
|
7.1%
2/28 • 2 Years
|
|
Renal and urinary disorders
Urosepsis
|
0.00%
0/29 • 2 Years
|
3.6%
1/28 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.4%
1/29 • 2 Years
|
3.6%
1/28 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/29 • 2 Years
|
3.6%
1/28 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
3.4%
1/29 • 2 Years
|
0.00%
0/28 • 2 Years
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/29 • 2 Years
|
3.6%
1/28 • 2 Years
|
|
General disorders
Death NOS
|
13.8%
4/29 • 2 Years
|
21.4%
6/28 • 2 Years
|
Other adverse events
| Measure |
Arm A (Cobimetinib, Atezolizumab, Varlilumab)
n=29 participants at risk
Patients receive cobimetinib PO QD on days 1-21 of each cycle, atezolizumab IV over 30-60 minutes on days 1 and 15 of each cycle, and varlilumab IV over 90 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Atezolizumab, Varlilumab)
n=28 participants at risk
Patients receive atezolizumab IV over 30-60 minutes on days 1 and 15 of each cycle and varlilumab IV over 90 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
37.9%
11/29 • 2 Years
|
28.6%
8/28 • 2 Years
|
|
Cardiac disorders
Sinus tachycardia
|
3.4%
1/29 • 2 Years
|
7.1%
2/28 • 2 Years
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/29 • 2 Years
|
7.1%
2/28 • 2 Years
|
|
Endocrine disorders
Hypothyroidism
|
6.9%
2/29 • 2 Years
|
3.6%
1/28 • 2 Years
|
|
Eye disorders
Blurred vision
|
10.3%
3/29 • 2 Years
|
7.1%
2/28 • 2 Years
|
|
Eye disorders
Difficulty focusing
|
6.9%
2/29 • 2 Years
|
0.00%
0/28 • 2 Years
|
|
Eye disorders
Flashing lights
|
6.9%
2/29 • 2 Years
|
0.00%
0/28 • 2 Years
|
|
Eye disorders
Periorbital edema
|
6.9%
2/29 • 2 Years
|
0.00%
0/28 • 2 Years
|
|
Gastrointestinal disorders
Abdominal distension
|
6.9%
2/29 • 2 Years
|
7.1%
2/28 • 2 Years
|
|
Gastrointestinal disorders
Abdominal pain
|
20.7%
6/29 • 2 Years
|
25.0%
7/28 • 2 Years
|
|
Gastrointestinal disorders
Ascites
|
6.9%
2/29 • 2 Years
|
14.3%
4/28 • 2 Years
|
|
Gastrointestinal disorders
Bloating
|
13.8%
4/29 • 2 Years
|
10.7%
3/28 • 2 Years
|
|
Gastrointestinal disorders
Constipation
|
27.6%
8/29 • 2 Years
|
17.9%
5/28 • 2 Years
|
|
Gastrointestinal disorders
Diarrhea
|
58.6%
17/29 • 2 Years
|
10.7%
3/28 • 2 Years
|
|
Gastrointestinal disorders
Dry mouth
|
13.8%
4/29 • 2 Years
|
3.6%
1/28 • 2 Years
|
|
Gastrointestinal disorders
Dysphagia
|
3.4%
1/29 • 2 Years
|
7.1%
2/28 • 2 Years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.9%
2/29 • 2 Years
|
0.00%
0/28 • 2 Years
|
|
Gastrointestinal disorders
Mucositis oral
|
6.9%
2/29 • 2 Years
|
3.6%
1/28 • 2 Years
|
|
Gastrointestinal disorders
Nausea
|
34.5%
10/29 • 2 Years
|
21.4%
6/28 • 2 Years
|
|
Gastrointestinal disorders
Vomiting
|
44.8%
13/29 • 2 Years
|
28.6%
8/28 • 2 Years
|
|
General disorders
Chills
|
20.7%
6/29 • 2 Years
|
10.7%
3/28 • 2 Years
|
|
General disorders
Edema limbs
|
17.2%
5/29 • 2 Years
|
7.1%
2/28 • 2 Years
|
|
General disorders
Fatigue
|
41.4%
12/29 • 2 Years
|
35.7%
10/28 • 2 Years
|
|
General disorders
Fever
|
10.3%
3/29 • 2 Years
|
10.7%
3/28 • 2 Years
|
|
General disorders
Flu like symptoms
|
6.9%
2/29 • 2 Years
|
0.00%
0/28 • 2 Years
|
|
General disorders
Generalized edema
|
3.4%
1/29 • 2 Years
|
7.1%
2/28 • 2 Years
|
|
General disorders
Localized edema
|
6.9%
2/29 • 2 Years
|
0.00%
0/28 • 2 Years
|
|
General disorders
Non-cardiac chest pain
|
3.4%
1/29 • 2 Years
|
10.7%
3/28 • 2 Years
|
|
General disorders
Pain
|
6.9%
2/29 • 2 Years
|
10.7%
3/28 • 2 Years
|
|
Infections and infestations
Thrush
|
10.3%
3/29 • 2 Years
|
7.1%
2/28 • 2 Years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/29 • 2 Years
|
7.1%
2/28 • 2 Years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/29 • 2 Years
|
17.9%
5/28 • 2 Years
|
|
Investigations
Alanine aminotransferase increased
|
17.2%
5/29 • 2 Years
|
7.1%
2/28 • 2 Years
|
|
Investigations
Alkaline phosphatase increased
|
13.8%
4/29 • 2 Years
|
14.3%
4/28 • 2 Years
|
|
Investigations
Aspartate aminotransferase increased
|
13.8%
4/29 • 2 Years
|
14.3%
4/28 • 2 Years
|
|
Investigations
Blood bilirubin increased
|
3.4%
1/29 • 2 Years
|
14.3%
4/28 • 2 Years
|
|
Investigations
Blood lactate dehydrogenase increased
|
10.3%
3/29 • 2 Years
|
3.6%
1/28 • 2 Years
|
|
Investigations
Cardiac troponin I increased
|
6.9%
2/29 • 2 Years
|
0.00%
0/28 • 2 Years
|
|
Investigations
Creatinine increased
|
6.9%
2/29 • 2 Years
|
14.3%
4/28 • 2 Years
|
|
Investigations
GGT increased
|
17.2%
5/29 • 2 Years
|
21.4%
6/28 • 2 Years
|
|
Investigations
Lipase increased
|
10.3%
3/29 • 2 Years
|
3.6%
1/28 • 2 Years
|
|
Investigations
Lymphocyte count decreased
|
51.7%
15/29 • 2 Years
|
50.0%
14/28 • 2 Years
|
|
Investigations
Neutrophil count decreased
|
6.9%
2/29 • 2 Years
|
3.6%
1/28 • 2 Years
|
|
Investigations
Platelet count decreased
|
34.5%
10/29 • 2 Years
|
32.1%
9/28 • 2 Years
|
|
Investigations
Thyroid stimulating hormone increased
|
6.9%
2/29 • 2 Years
|
0.00%
0/28 • 2 Years
|
|
Investigations
Weight loss
|
10.3%
3/29 • 2 Years
|
0.00%
0/28 • 2 Years
|
|
Investigations
White blood cell decreased
|
10.3%
3/29 • 2 Years
|
3.6%
1/28 • 2 Years
|
|
Metabolism and nutrition disorders
Anorexia
|
27.6%
8/29 • 2 Years
|
46.4%
13/28 • 2 Years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.4%
1/29 • 2 Years
|
14.3%
4/28 • 2 Years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
37.9%
11/29 • 2 Years
|
21.4%
6/28 • 2 Years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
17.2%
5/29 • 2 Years
|
3.6%
1/28 • 2 Years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
24.1%
7/29 • 2 Years
|
17.9%
5/28 • 2 Years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.9%
2/29 • 2 Years
|
10.7%
3/28 • 2 Years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
24.1%
7/29 • 2 Years
|
25.0%
7/28 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.4%
1/29 • 2 Years
|
10.7%
3/28 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.3%
3/29 • 2 Years
|
10.7%
3/28 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
6.9%
2/29 • 2 Years
|
3.6%
1/28 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.9%
2/29 • 2 Years
|
7.1%
2/28 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/29 • 2 Years
|
7.1%
2/28 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.9%
2/29 • 2 Years
|
3.6%
1/28 • 2 Years
|
|
Nervous system disorders
Dizziness
|
13.8%
4/29 • 2 Years
|
17.9%
5/28 • 2 Years
|
|
Nervous system disorders
Dysgeusia
|
10.3%
3/29 • 2 Years
|
0.00%
0/28 • 2 Years
|
|
Nervous system disorders
Headache
|
10.3%
3/29 • 2 Years
|
14.3%
4/28 • 2 Years
|
|
Nervous system disorders
Lethargy
|
0.00%
0/29 • 2 Years
|
7.1%
2/28 • 2 Years
|
|
Nervous system disorders
Paresthesia
|
6.9%
2/29 • 2 Years
|
0.00%
0/28 • 2 Years
|
|
Nervous system disorders
Somnolence
|
6.9%
2/29 • 2 Years
|
0.00%
0/28 • 2 Years
|
|
Psychiatric disorders
Insomnia
|
10.3%
3/29 • 2 Years
|
7.1%
2/28 • 2 Years
|
|
Renal and urinary disorders
Hematuria
|
6.9%
2/29 • 2 Years
|
0.00%
0/28 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.8%
4/29 • 2 Years
|
10.7%
3/28 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
17.2%
5/29 • 2 Years
|
7.1%
2/28 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
13.8%
4/29 • 2 Years
|
0.00%
0/28 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.4%
1/29 • 2 Years
|
7.1%
2/28 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.9%
2/29 • 2 Years
|
7.1%
2/28 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
13.8%
4/29 • 2 Years
|
7.1%
2/28 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
27.6%
8/29 • 2 Years
|
21.4%
6/28 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
44.8%
13/29 • 2 Years
|
0.00%
0/28 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
37.9%
11/29 • 2 Years
|
21.4%
6/28 • 2 Years
|
|
Vascular disorders
Flushing
|
6.9%
2/29 • 2 Years
|
0.00%
0/28 • 2 Years
|
|
Vascular disorders
Hypertension
|
6.9%
2/29 • 2 Years
|
7.1%
2/28 • 2 Years
|
|
Vascular disorders
Hypotension
|
0.00%
0/29 • 2 Years
|
7.1%
2/28 • 2 Years
|
Additional Information
Grants Administrative Manager
Johns Hopkins University/SKCCC
Phone: 4439273568
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60