The AVIATOR Study: Trastuzumab and Vinorelbine With Avelumab OR Avelumab & Utomilumab in Advanced HER2+ Breast Cancer

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ClinicalTrials.gov Identifier: NCT03414658

Recruitment Status : Active, not recruiting

First Posted : January 30, 2018

Results First Posted : April 18, 2024

Last Update Posted : April 18, 2024

View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborators:

Pfizer

Breast Cancer Research Foundation

Johns Hopkins University

Information provided by (Responsible Party):

Adrienne G. Waks, Dana-Farber Cancer Institute

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Breast Cancer
Interventions	Drug: Vinorelbine Drug: Trastuzumab Drug: Avelumab Drug: Utomilumab
Enrollment	100

Participant Flow

Recruitment Details	AVIATOR enrolled 100 patients in 16 centers in the US between June 21, 2018 and March 1, 2023.
Pre-assignment Details


Arm/Group Title	NH: Trastuzumab + Vinorelbine	NHA: Trastuzumab + Vinorelbine + Avelumab	NHAU: Trastuzumab + Vinorelbine + Avelumab + Utomilumab
Arm/Group Description	Trastuzumab is administered intrave...	Trastuzumab is administered intrave...	Trastuzumab is administered intrave...
Arm/Group Description	Trastuzumab is administered intravenously twice per cycle Vinorelbine is administered intravenously 3 times per cycle Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.	Trastuzumab is administered intravenously twice per cycle Vinorelbine is administered intravenously 3 times per cycle Avelumab is administered intravenously twice per cycle Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2. Avelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein	Trastuzumab is administered intravenously twice per cycle Vinorelbine is administered intravenously 3 times per cycle Avelumab is administered intravenously twice per cycle Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab Utomilumab is administered intravenously once per cycle Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2. Avelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein Utomilumab: Utomilumab is an antibody designed to stimulate the body's immune system to fight cancer cells
Period Title: Overall Study
Started	20	46	34
Completed	18	45	34
Not Completed	2	1	0

Baseline Characteristics

Arm/Group Title		NH: Trastuzumab + Vinorelbine	NHA: Trastuzumab + Vinorelbine + Avelumab	NHAU: Trastuzumab + Vinorelbine + Avelumab + Utomilumab	Total
Arm/Group Description		Trastuzumab is administered intrave...	Trastuzumab is administered intrave...	Trastuzumab is administered intrave...	Total of all reporting groups
Arm/Group Description		Trastuzumab is administered intravenously twice per cycle Vinorelbine is administered intravenously 3 times per cycle Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.	Trastuzumab is administered intravenously twice per cycle Vinorelbine is administered intravenously 3 times per cycle Avelumab is administered intravenously twice per cycle Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2. Avelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein	Trastuzumab is administered intravenously twice per cycle Vinorelbine is administered intravenously 3 times per cycle Avelumab is administered intravenously twice per cycle Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab Utomilumab is administered intravenously once per cycle Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2. Avelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein Utomilumab: Utomilumab is an antibody designed to stimulate the body's immune system to fight cancer cells	Total of all reporting groups
Overall Number of Baseline Participants		18	45	34	97
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Median (Inter-Quartile Range) Unit of measure: Years
	Number Analyzed	18 participants	45 participants	34 participants	97 participants
		54 (44 to 60)	53 (48 to 60)	57 (46 to 63)	54 (46 to 61)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	18 participants	45 participants	34 participants	97 participants
	Female	18 100.0%	45 100.0%	33 97.1%	96 99.0%
	Male	0 0.0%	0 0.0%	1 2.9%	1 1.0%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	18 participants	45 participants	34 participants	97 participants
	Hispanic or Latino	0 0.0%	6 13.3%	1 2.9%	7 7.2%
	Not Hispanic or Latino	18 100.0%	38 84.4%	31 91.2%	87 89.7%
	Unknown or Not Reported	0 0.0%	1 2.2%	2 5.9%	3 3.1%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	18 participants	45 participants	34 participants	97 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Asian	2 11.1%	4 8.9%	2 5.9%	8 8.2%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Black or African American	4 22.2%	6 13.3%	4 11.8%	14 14.4%
	White	11 61.1%	31 68.9%	26 76.5%	68 70.1%
	More than one race	0 0.0%	2 4.4%	0 0.0%	2 2.1%
	Unknown or Not Reported	1 5.6%	2 4.4%	2 5.9%	5 5.2%
Region of Enrollment Measure Type: Number Unit of measure: Participants
United States	Number Analyzed	18 participants	45 participants	34 participants	97 participants
United States		18	45	34	97
ECOG PS ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	18 participants	45 participants	34 participants	97 participants
	0	11 61.1%	24 53.3%	23 67.6%	58 59.8%
	1	7 38.9%	21 46.7%	11 32.4%	39 40.2%
		[1] Measure Description: The ECOG Performance Status Scale is a measurement used to assess how cancer impacts a patient's daily living abilities. Smaller grades are considered better outcomes, eg. grade 0 means "fully active, able to carry on all pre-disease performance without restriction."
BMI Median (Inter-Quartile Range) Unit of measure: Kg/m^2
	Number Analyzed	18 participants	45 participants	34 participants	97 participants
		23.8 (20.9 to 29.7)	24.9 (23.1 to 27.8)	26.4 (23.7 to 29.3)	25.2 (22.5 to 29.1)

Outcome Measures

1.Primary Outcome


Title	Progression Free Survival
Description	Progression Free Survival is defined from the time from randomization ...
Description	Progression Free Survival is defined from the time from randomization to the first occurrence of disease progression as determined by the investigator using RECIST 1.1 or death from any cause, whichever occurs first.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	NH: Trastuzumab + Vinorelbine	NHA: Trastuzumab + Vinorelbine + Avelumab	NHAU: Trastuzumab + Vinorelbine + Avelumab + Utomilumab
Arm/Group Description:	Trastuzumab is administered intrave...	Trastuzumab is administered intrave...	Trastuzumab is administered intrave...
Arm/Group Description:	Trastuzumab is administered intravenously twice per cycle Vinorelbine is administered intravenously 3 times per cycle Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.	Trastuzumab is administered intravenously twice per cycle Vinorelbine is administered intravenously 3 times per cycle Avelumab is administered intravenously twice per cycle Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2. Avelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein	Trastuzumab is administered intravenously twice per cycle Vinorelbine is administered intravenously 3 times per cycle Avelumab is administered intravenously twice per cycle Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab Utomilumab is administered intravenously once per cycle Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2. Avelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein Utomilumab: Utomilumab is an antibody designed to stimulate the body's immune system to fight cancer cells
Overall Number of Participants Analyzed	18	45	34
Median (90% Confidence Interval) Unit of Measure: months
	2 (1.7 to 3.9)	3.8 (3 to 5.5)	4.9 (3.7 to 5.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NH: Trastuzumab + Vinorelbine, NHA: Trastuzumab + Vinorelbine + Avelumab
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.025
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.53
	Confidence Interval	(2-Sided) 80% 0.35 to 0.81
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	NHA: Trastuzumab + Vinorelbine + Avelumab, NHAU: Trastuzumab + Vinorelbine + Avelumab + Utomilumab
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.32
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.14
	Confidence Interval	(2-Sided) 80% 0.8 to 1.64
	Estimation Comments	[Not Specified]

2.Secondary Outcome


Title	Objective Response Rate
Description	Objective Response Rate is determined by Complete Response or Partial ...
Description	Objective Response Rate is determined by Complete Response or Partial Response by RECIST 1.1. Per RECIST 1.1 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; Overall Response (OR) = CR + PR.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	NH: Trastuzumab + Vinorelbine	NHA: Trastuzumab + Vinorelbine + Avelumab	NHAU: Trastuzumab + Vinorelbine + Avelumab + Utomilumab
Arm/Group Description:	Trastuzumab is administered intrave...	Trastuzumab is administered intrave...	Trastuzumab is administered intrave...
Arm/Group Description:	Trastuzumab is administered intravenously twice per cycle Vinorelbine is administered intravenously 3 times per cycle Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.	Trastuzumab is administered intravenously twice per cycle Vinorelbine is administered intravenously 3 times per cycle Avelumab is administered intravenously twice per cycle Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2. Avelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein	Trastuzumab is administered intravenously twice per cycle Vinorelbine is administered intravenously 3 times per cycle Avelumab is administered intravenously twice per cycle Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab Utomilumab is administered intravenously once per cycle Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2. Avelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein Utomilumab: Utomilumab is an antibody designed to stimulate the body's immune system to fight cancer cells
Overall Number of Participants Analyzed	18	45	34
Measure Type: Number Number (90% Confidence Interval) Unit of Measure: percent of participants
	11.1 (2 to 31)	20 (10.9 to 32.3)	11.8 (4.1 to 24.9)

3.Secondary Outcome


Title	Duration of Response
Description	Duration of Response is measured from the time criteria are met for CR...
Description	Duration of Response is measured from the time criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Per RECIST 1.1 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.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Participants who had response.


Arm/Group Title	NH: Trastuzumab + Vinorelbine	NHA: Trastuzumab + Vinorelbine + Avelumab	NHAU: Trastuzumab + Vinorelbine + Avelumab + Utomilumab
Arm/Group Description:	Trastuzumab is administered intrave...	Trastuzumab is administered intrave...	Trastuzumab is administered intrave...
Arm/Group Description:	Trastuzumab is administered intravenously twice per cycle Vinorelbine is administered intravenously 3 times per cycle Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.	Trastuzumab is administered intravenously twice per cycle Vinorelbine is administered intravenously 3 times per cycle Avelumab is administered intravenously twice per cycle Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2. Avelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein	Trastuzumab is administered intravenously twice per cycle Vinorelbine is administered intravenously 3 times per cycle Avelumab is administered intravenously twice per cycle Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab Utomilumab is administered intravenously once per cycle Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2. Avelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein Utomilumab: Utomilumab is an antibody designed to stimulate the body's immune system to fight cancer cells
Overall Number of Participants Analyzed	2	9	4
Median (90% Confidence Interval) Unit of Measure: months
	NA ^[1] (NA to NA)	15.8 (3.6 to 25.2)	4.2 ^[2] (3 to NA)

[1]

Values are NA due to insufficient number of participants with events: only 2 patients had response in NH arm. The DOR of them are 4 and 10.3 months.

[2]

90% UCL could not be estimated due to insufficient number of participants with event.

4.Secondary Outcome


Title	Overall Survival
Description	Overall survival is defined as the time from randomization to death fr...
Description	Overall survival is defined as the time from randomization to death from any cause, or is censored at date last known alive.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	NH: Trastuzumab + Vinorelbine	NHA: Trastuzumab + Vinorelbine + Avelumab	NHAU: Trastuzumab + Vinorelbine + Avelumab + Utomilumab
Arm/Group Description:	Trastuzumab is administered intrave...	Trastuzumab is administered intrave...	Trastuzumab is administered intrave...
Arm/Group Description:	Trastuzumab is administered intravenously twice per cycle Vinorelbine is administered intravenously 3 times per cycle Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.	Trastuzumab is administered intravenously twice per cycle Vinorelbine is administered intravenously 3 times per cycle Avelumab is administered intravenously twice per cycle Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2. Avelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein	Trastuzumab is administered intravenously twice per cycle Vinorelbine is administered intravenously 3 times per cycle Avelumab is administered intravenously twice per cycle Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab Utomilumab is administered intravenously once per cycle Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2. Avelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein Utomilumab: Utomilumab is an antibody designed to stimulate the body's immune system to fight cancer cells
Overall Number of Participants Analyzed	18	45	34
Median (90% Confidence Interval) Unit of Measure: months
	22.8 ^[1] (17.4 to NA)	26.3 (15.9 to 36.1)	27 (17.3 to 33.7)

[1]

90% UCL could not be estimated due to insufficient number of participants with events.

Adverse Events

Time Frame	All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks.
Adverse Event Reporting Description	A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).

Arm/Group Title	NH: Trastuzumab + Vinorelbine	NHA: Trastuzumab + Vinorelbine + Avelumab	NHAU: Trastuzumab + Vinorelbine + Avelumab + Utomilumab
Arm/Group Description	Trastuzumab is administered intrave...	Trastuzumab is administered intrave...	Trastuzumab is administered intrave...
Arm/Group Description	Trastuzumab is administered intravenously twice per cycle Vinorelbine is administered intravenously 3 times per cycle Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.	Trastuzumab is administered intravenously twice per cycle Vinorelbine is administered intravenously 3 times per cycle Avelumab is administered intravenously twice per cycle Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2. Avelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein	Trastuzumab is administered intravenously twice per cycle Vinorelbine is administered intravenously 3 times per cycle Avelumab is administered intravenously twice per cycle Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab Utomilumab is administered intravenously once per cycle Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2. Avelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein Utomilumab: Utomilumab is an antibody designed to stimulate the body's immune system to fight cancer cells
All-Cause Mortality
	NH: Trastuzumab + Vinorelbine	NHA: Trastuzumab + Vinorelbine + Avelumab	NHAU: Trastuzumab + Vinorelbine + Avelumab + Utomilumab
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	10/18 (55.56%)	23/45 (51.11%)	20/34 (58.82%)
Serious Adverse Events Serious Adverse Events
	NH: Trastuzumab + Vinorelbine	NHA: Trastuzumab + Vinorelbine + Avelumab	NHAU: Trastuzumab + Vinorelbine + Avelumab + Utomilumab
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	5/18 (27.78%)	9/45 (20.00%)	9/34 (26.47%)
Blood and lymphatic system disorders
Febrile neutropenia ^† 1	0/18 (0.00%)	0/45 (0.00%)	1/34 (2.94%)
Endocrine disorders
Adrenal insufficiency ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Gastrointestinal disorders
Abdominal pain ^† 1	0/18 (0.00%)	1/45 (2.22%)	1/34 (2.94%)
Constipation ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Nausea ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Obstruction gastric ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
General disorders
Death NOS ^† 1	1/18 (5.56%)	0/45 (0.00%)	0/34 (0.00%)
Fever ^† 1	2/18 (11.11%)	0/45 (0.00%)	1/34 (2.94%)
Pain ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Hepatobiliary disorders
Gallbladder perforation ^† 1	0/18 (0.00%)	0/45 (0.00%)	1/34 (2.94%)
Infections and infestations
Skin infection ^† 1	1/18 (5.56%)	0/45 (0.00%)	0/34 (0.00%)
Lung infection ^† 1	1/18 (5.56%)	0/45 (0.00%)	0/34 (0.00%)
Urinary tract infection ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Abdominal infection ^† 1	0/18 (0.00%)	0/45 (0.00%)	1/34 (2.94%)
Sinusitis ^† 1	0/18 (0.00%)	0/45 (0.00%)	1/34 (2.94%)
Investigations
Neutrophil count decreased ^† 1	1/18 (5.56%)	2/45 (4.44%)	2/34 (5.88%)
Lipase increased ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Serum amylase increased ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
White blood cell decreased ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Blood bilirubin increased ^† 1	0/18 (0.00%)	0/45 (0.00%)	1/34 (2.94%)
Metabolism and nutrition disorders
Hypocalcemia ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Hyperglycemia ^† 1	0/18 (0.00%)	0/45 (0.00%)	1/34 (2.94%)
Psychiatric disorders
Confusion ^† 1	0/18 (0.00%)	0/45 (0.00%)	1/34 (2.94%)
Renal and urinary disorders
Acute kidney injury ^† 1	0/18 (0.00%)	0/45 (0.00%)	1/34 (2.94%)
Reproductive system and breast disorders
Breast pain ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Respiratory, thoracic and mediastinal disorders
Dyspnea ^† 1	1/18 (5.56%)	1/45 (2.22%)	2/34 (5.88%)
Cough ^† 1	1/18 (5.56%)	0/45 (0.00%)	1/34 (2.94%)
Hypoxia ^† 1	1/18 (5.56%)	1/45 (2.22%)	1/34 (2.94%)
Pneumonitis ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Skin and subcutaneous tissue disorders
Pruritus ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Vascular disorders
Thromboembolic event ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
1 Term from vocabulary, CTCAE (5.0) † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	NH: Trastuzumab + Vinorelbine	NHA: Trastuzumab + Vinorelbine + Avelumab	NHAU: Trastuzumab + Vinorelbine + Avelumab + Utomilumab
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	18/18 (100.00%)	45/45 (100.00%)	34/34 (100.00%)
Blood and lymphatic system disorders
Anemia ^† 1	11/18 (61.11%)	17/45 (37.78%)	15/34 (44.12%)
Blood and lymphatic system disorders - Other, specify ^† 1	0/18 (0.00%)	0/45 (0.00%)	1/34 (2.94%)
Febrile neutropenia ^† 1	0/18 (0.00%)	1/45 (2.22%)	1/34 (2.94%)
Leukocytosis ^† 1	1/18 (5.56%)	1/45 (2.22%)	0/34 (0.00%)
Cardiac disorders
Atrial fibrillation ^† 1	0/18 (0.00%)	0/45 (0.00%)	1/34 (2.94%)
Cardiac disorders - Other, specify ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Palpitations ^† 1	0/18 (0.00%)	0/45 (0.00%)	1/34 (2.94%)
Sinus tachycardia ^† 1	0/18 (0.00%)	0/45 (0.00%)	1/34 (2.94%)
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Tinnitus ^† 1	2/18 (11.11%)	0/45 (0.00%)	1/34 (2.94%)
Endocrine disorders
Adrenal insufficiency ^† 1	0/18 (0.00%)	0/45 (0.00%)	1/34 (2.94%)
Endocrine disorders - Other, specify ^† 1	0/18 (0.00%)	1/45 (2.22%)	2/34 (5.88%)
Hyperthyroidism ^† 1	0/18 (0.00%)	1/45 (2.22%)	1/34 (2.94%)
Hypothyroidism ^† 1	3/18 (16.67%)	11/45 (24.44%)	4/34 (11.76%)
Eye disorders
Blurred vision ^† 1	1/18 (5.56%)	3/45 (6.67%)	2/34 (5.88%)
Cataract ^† 1	0/18 (0.00%)	1/45 (2.22%)	1/34 (2.94%)
Conjunctivitis ^† 1	0/18 (0.00%)	1/45 (2.22%)	1/34 (2.94%)
Dry eye ^† 1	1/18 (5.56%)	4/45 (8.89%)	0/34 (0.00%)
Eye disorders - Other, specify ^† 1	1/18 (5.56%)	3/45 (6.67%)	1/34 (2.94%)
Eye pain ^† 1	1/18 (5.56%)	0/45 (0.00%)	0/34 (0.00%)
Eyelid function disorder ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Floaters ^† 1	0/18 (0.00%)	0/45 (0.00%)	1/34 (2.94%)
Glaucoma ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Uveitis ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Watering eyes ^† 1	0/18 (0.00%)	3/45 (6.67%)	2/34 (5.88%)
Gastrointestinal disorders
Abdominal distension ^† 1	0/18 (0.00%)	1/45 (2.22%)	1/34 (2.94%)
Abdominal pain ^† 1	3/18 (16.67%)	7/45 (15.56%)	10/34 (29.41%)
Anal hemorrhage ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Ascites ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Bloating ^† 1	3/18 (16.67%)	3/45 (6.67%)	2/34 (5.88%)
Cheilitis ^† 1	0/18 (0.00%)	0/45 (0.00%)	1/34 (2.94%)
Colonic ulcer ^† 1	1/18 (5.56%)	0/45 (0.00%)	1/34 (2.94%)
Constipation ^† 1	8/18 (44.44%)	17/45 (37.78%)	16/34 (47.06%)
Diarrhea ^† 1	4/18 (22.22%)	10/45 (22.22%)	10/34 (29.41%)
Dry mouth ^† 1	0/18 (0.00%)	3/45 (6.67%)	2/34 (5.88%)
Dyspepsia ^† 1	0/18 (0.00%)	3/45 (6.67%)	1/34 (2.94%)
Enterocolitis ^† 1	1/18 (5.56%)	0/45 (0.00%)	0/34 (0.00%)
Fecal incontinence ^† 1	1/18 (5.56%)	0/45 (0.00%)	0/34 (0.00%)
Flatulence ^† 1	1/18 (5.56%)	2/45 (4.44%)	1/34 (2.94%)
Gastroesophageal reflux disease ^† 1	3/18 (16.67%)	5/45 (11.11%)	5/34 (14.71%)
Gastrointestinal disorders - Other, specify ^† 1	0/18 (0.00%)	1/45 (2.22%)	1/34 (2.94%)
Mucositis oral ^† 1	1/18 (5.56%)	6/45 (13.33%)	5/34 (14.71%)
Nausea ^† 1	9/18 (50.00%)	17/45 (37.78%)	15/34 (44.12%)
Oral dysesthesia ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Oral pain ^† 1	0/18 (0.00%)	2/45 (4.44%)	0/34 (0.00%)
Stomach pain ^† 1	0/18 (0.00%)	0/45 (0.00%)	2/34 (5.88%)
Vomiting ^† 1	5/18 (27.78%)	2/45 (4.44%)	8/34 (23.53%)
Chills ^† 1	0/18 (0.00%)	4/45 (8.89%)	0/34 (0.00%)
General disorders and administration site conditions - Other, specify ^† 1	1/18 (5.56%)	4/45 (8.89%)	3/34 (8.82%)
General disorders
Edema face ^† 1	0/18 (0.00%)	1/45 (2.22%)	1/34 (2.94%)
Edema limbs ^† 1	4/18 (22.22%)	0/45 (0.00%)	2/34 (5.88%)
Fatigue ^† 1	15/18 (83.33%)	28/45 (62.22%)	27/34 (79.41%)
Fever ^† 1	3/18 (16.67%)	3/45 (6.67%)	3/34 (8.82%)
Flu like symptoms ^† 1	1/18 (5.56%)	3/45 (6.67%)	2/34 (5.88%)
Gait disturbance ^† 1	1/18 (5.56%)	2/45 (4.44%)	0/34 (0.00%)
Infusion related reaction ^† 1	1/18 (5.56%)	0/45 (0.00%)	1/34 (2.94%)
Infusion site extravasation ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Injection site reaction ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Localized edema ^† 1	0/18 (0.00%)	1/45 (2.22%)	1/34 (2.94%)
Malaise ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Neck edema ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Non-cardiac chest pain ^† 1	1/18 (5.56%)	1/45 (2.22%)	2/34 (5.88%)
Pain ^† 1	1/18 (5.56%)	7/45 (15.56%)	7/34 (20.59%)
Hepatobiliary disorders
Hepatic pain ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Immune system disorders
Allergic reaction ^† 1	0/18 (0.00%)	1/45 (2.22%)	1/34 (2.94%)
Autoimmune disorder ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Immune system disorders - Other, specify ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Infections and infestations
Catheter related infection ^† 1	1/18 (5.56%)	0/45 (0.00%)	0/34 (0.00%)
Eye infection ^† 1	1/18 (5.56%)	0/45 (0.00%)	0/34 (0.00%)
Infections and infestations - Other, specify ^† 1	2/18 (11.11%)	2/45 (4.44%)	0/34 (0.00%)
Lung infection ^† 1	1/18 (5.56%)	0/45 (0.00%)	0/34 (0.00%)
Papulopustular rash ^† 1	1/18 (5.56%)	0/45 (0.00%)	0/34 (0.00%)
Rash pustular ^† 1	0/18 (0.00%)	0/45 (0.00%)	1/34 (2.94%)
Rhinitis infective ^† 1	0/18 (0.00%)	0/45 (0.00%)	1/34 (2.94%)
Sinusitis ^† 1	0/18 (0.00%)	2/45 (4.44%)	2/34 (5.88%)
Skin infection ^† 1	3/18 (16.67%)	0/45 (0.00%)	0/34 (0.00%)
Upper respiratory infection ^† 1	0/18 (0.00%)	4/45 (8.89%)	1/34 (2.94%)
Urinary tract infection ^† 1	1/18 (5.56%)	6/45 (13.33%)	2/34 (5.88%)
Vaginal infection ^† 1	1/18 (5.56%)	0/45 (0.00%)	0/34 (0.00%)
Wound infection ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Injury, poisoning and procedural complications
Bruising ^† 1	1/18 (5.56%)	2/45 (4.44%)	0/34 (0.00%)
Burn ^† 1	0/18 (0.00%)	0/45 (0.00%)	1/34 (2.94%)
Fall ^† 1	1/18 (5.56%)	1/45 (2.22%)	0/34 (0.00%)
Radiation recall reaction (dermatologic) ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Investigations
Alanine aminotransferase increased ^† 1	1/18 (5.56%)	10/45 (22.22%)	4/34 (11.76%)
Alkaline phosphatase increased ^† 1	2/18 (11.11%)	11/45 (24.44%)	5/34 (14.71%)
Aspartate aminotransferase increased ^† 1	4/18 (22.22%)	14/45 (31.11%)	8/34 (23.53%)
Blood bilirubin increased ^† 1	0/18 (0.00%)	1/45 (2.22%)	2/34 (5.88%)
CD4 lymphocytes decreased ^† 1	0/18 (0.00%)	0/45 (0.00%)	1/34 (2.94%)
Cholesterol high ^† 1	0/18 (0.00%)	0/45 (0.00%)	1/34 (2.94%)
Creatinine increased ^† 1	0/18 (0.00%)	2/45 (4.44%)	3/34 (8.82%)
Ejection fraction decreased ^† 1	0/18 (0.00%)	0/45 (0.00%)	1/34 (2.94%)
Investigations - Other, specify ^† 1	0/18 (0.00%)	2/45 (4.44%)	3/34 (8.82%)
Lipase increased ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Lymphocyte count decreased ^† 1	2/18 (11.11%)	4/45 (8.89%)	6/34 (17.65%)
Neutrophil count decreased ^† 1	12/18 (66.67%)	29/45 (64.44%)	22/34 (64.71%)
Platelet count decreased ^† 1	2/18 (11.11%)	7/45 (15.56%)	6/34 (17.65%)
Serum amylase increased ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Weight gain ^† 1	1/18 (5.56%)	2/45 (4.44%)	0/34 (0.00%)
Weight loss ^† 1	0/18 (0.00%)	3/45 (6.67%)	3/34 (8.82%)
White blood cell decreased ^† 1	4/18 (22.22%)	12/45 (26.67%)	10/34 (29.41%)
Metabolism and nutrition disorders
Anorexia ^† 1	5/18 (27.78%)	5/45 (11.11%)	11/34 (32.35%)
Dehydration ^† 1	0/18 (0.00%)	1/45 (2.22%)	1/34 (2.94%)
Hypercalcemia ^† 1	2/18 (11.11%)	0/45 (0.00%)	2/34 (5.88%)
Hyperglycemia ^† 1	4/18 (22.22%)	5/45 (11.11%)	6/34 (17.65%)
Hyperkalemia ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Hypernatremia ^† 1	0/18 (0.00%)	0/45 (0.00%)	2/34 (5.88%)
Hyperuricemia ^† 1	0/18 (0.00%)	0/45 (0.00%)	1/34 (2.94%)
Hypoalbuminemia ^† 1	2/18 (11.11%)	2/45 (4.44%)	0/34 (0.00%)
Hypocalcemia ^† 1	1/18 (5.56%)	2/45 (4.44%)	4/34 (11.76%)
Hypokalemia ^† 1	0/18 (0.00%)	3/45 (6.67%)	6/34 (17.65%)
Hyponatremia ^† 1	2/18 (11.11%)	2/45 (4.44%)	1/34 (2.94%)
Hypophosphatemia ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Metabolism and nutrition disorders - Other, specify ^† 1	1/18 (5.56%)	1/45 (2.22%)	0/34 (0.00%)
Obesity ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	1/18 (5.56%)	6/45 (13.33%)	5/34 (14.71%)
Arthritis ^† 1	0/18 (0.00%)	1/45 (2.22%)	3/34 (8.82%)
Back pain ^† 1	3/18 (16.67%)	11/45 (24.44%)	11/34 (32.35%)
Bone pain ^† 1	1/18 (5.56%)	5/45 (11.11%)	5/34 (14.71%)
Chest wall pain ^† 1	0/18 (0.00%)	1/45 (2.22%)	2/34 (5.88%)
Flank pain ^† 1	0/18 (0.00%)	0/45 (0.00%)	4/34 (11.76%)
Generalized muscle weakness ^† 1	0/18 (0.00%)	5/45 (11.11%)	4/34 (11.76%)
Joint range of motion decreased ^† 1	1/18 (5.56%)	1/45 (2.22%)	1/34 (2.94%)
Muscle weakness lower limb ^† 1	2/18 (11.11%)	0/45 (0.00%)	1/34 (2.94%)
Musculoskeletal and connective tissue disorder - Other, specify ^† 1	1/18 (5.56%)	2/45 (4.44%)	5/34 (14.71%)
Myalgia ^† 1	3/18 (16.67%)	9/45 (20.00%)	5/34 (14.71%)
Neck pain ^† 1	0/18 (0.00%)	4/45 (8.89%)	0/34 (0.00%)
Osteonecrosis of jaw ^† 1	0/18 (0.00%)	0/45 (0.00%)	1/34 (2.94%)
Pain in extremity ^† 1	4/18 (22.22%)	4/45 (8.89%)	3/34 (8.82%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify ^† 1	0/18 (0.00%)	2/45 (4.44%)	0/34 (0.00%)
Tumor pain ^† 1	1/18 (5.56%)	1/45 (2.22%)	0/34 (0.00%)
Nervous system disorders
Cognitive disturbance ^† 1	1/18 (5.56%)	0/45 (0.00%)	0/34 (0.00%)
Depressed level of consciousness ^† 1	0/18 (0.00%)	0/45 (0.00%)	1/34 (2.94%)
Dizziness ^† 1	3/18 (16.67%)	4/45 (8.89%)	4/34 (11.76%)
Dysarthria ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Dysgeusia ^† 1	0/18 (0.00%)	1/45 (2.22%)	5/34 (14.71%)
Headache ^† 1	2/18 (11.11%)	13/45 (28.89%)	7/34 (20.59%)
Hydrocephalus ^† 1	1/18 (5.56%)	0/45 (0.00%)	0/34 (0.00%)
Memory impairment ^† 1	2/18 (11.11%)	1/45 (2.22%)	0/34 (0.00%)
Nervous system disorders - Other, specify ^† 1	1/18 (5.56%)	1/45 (2.22%)	0/34 (0.00%)
Paresthesia ^† 1	0/18 (0.00%)	4/45 (8.89%)	1/34 (2.94%)
Peripheral motor neuropathy ^† 1	0/18 (0.00%)	3/45 (6.67%)	2/34 (5.88%)
Peripheral sensory neuropathy ^† 1	9/18 (50.00%)	20/45 (44.44%)	15/34 (44.12%)
Presyncope ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Sinus pain ^† 1	0/18 (0.00%)	0/45 (0.00%)	1/34 (2.94%)
Syncope ^† 1	0/18 (0.00%)	1/45 (2.22%)	1/34 (2.94%)
Tremor ^† 1	1/18 (5.56%)	2/45 (4.44%)	0/34 (0.00%)
Psychiatric disorders
Anxiety ^† 1	3/18 (16.67%)	4/45 (8.89%)	11/34 (32.35%)
Confusion ^† 1	1/18 (5.56%)	0/45 (0.00%)	0/34 (0.00%)
Depression ^† 1	2/18 (11.11%)	4/45 (8.89%)	6/34 (17.65%)
Insomnia ^† 1	0/18 (0.00%)	5/45 (11.11%)	9/34 (26.47%)
Psychiatric disorders - Other, specify ^† 1	0/18 (0.00%)	2/45 (4.44%)	0/34 (0.00%)
Restlessness ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Renal and urinary disorders
Acute kidney injury ^† 1	0/18 (0.00%)	0/45 (0.00%)	1/34 (2.94%)
Renal and urinary disorders - Other, specify ^† 1	0/18 (0.00%)	0/45 (0.00%)	1/34 (2.94%)
Urinary frequency ^† 1	0/18 (0.00%)	2/45 (4.44%)	0/34 (0.00%)
Urinary incontinence ^† 1	1/18 (5.56%)	1/45 (2.22%)	1/34 (2.94%)
Urinary retention ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Urinary urgency ^† 1	0/18 (0.00%)	1/45 (2.22%)	1/34 (2.94%)
Reproductive system and breast disorders
Breast pain ^† 1	4/18 (22.22%)	4/45 (8.89%)	4/34 (11.76%)
Menorrhagia ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Nipple deformity ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Pelvic pain ^† 1	0/18 (0.00%)	2/45 (4.44%)	2/34 (5.88%)
Reproductive system and breast disorders - Other, specify ^† 1	1/18 (5.56%)	2/45 (4.44%)	1/34 (2.94%)
Uterine obstruction ^† 1	0/18 (0.00%)	0/45 (0.00%)	1/34 (2.94%)
Vaginal dryness ^† 1	0/18 (0.00%)	0/45 (0.00%)	1/34 (2.94%)
Vaginal hemorrhage ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Vaginal inflammation ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis ^† 1	2/18 (11.11%)	3/45 (6.67%)	5/34 (14.71%)
Atelectasis ^† 1	0/18 (0.00%)	0/45 (0.00%)	1/34 (2.94%)
Cough ^† 1	5/18 (27.78%)	10/45 (22.22%)	8/34 (23.53%)
Dyspnea ^† 1	5/18 (27.78%)	6/45 (13.33%)	7/34 (20.59%)
Epistaxis ^† 1	1/18 (5.56%)	1/45 (2.22%)	1/34 (2.94%)
Nasal congestion ^† 1	1/18 (5.56%)	5/45 (11.11%)	1/34 (2.94%)
Pleural effusion ^† 1	2/18 (11.11%)	2/45 (4.44%)	3/34 (8.82%)
Pleuritic pain ^† 1	0/18 (0.00%)	2/45 (4.44%)	1/34 (2.94%)
Pneumonitis ^† 1	1/18 (5.56%)	1/45 (2.22%)	0/34 (0.00%)
Postnasal drip ^† 1	1/18 (5.56%)	2/45 (4.44%)	1/34 (2.94%)
Pulmonary fibrosis ^† 1	0/18 (0.00%)	0/45 (0.00%)	1/34 (2.94%)
Pulmonary hypertension ^† 1	0/18 (0.00%)	0/45 (0.00%)	1/34 (2.94%)
Respiratory, thoracic and mediastinal disorders ^† 1	1/18 (5.56%)	2/45 (4.44%)	2/34 (5.88%)
Sleep apnea ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Sore throat ^† 1	0/18 (0.00%)	1/45 (2.22%)	1/34 (2.94%)
Voice alteration ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Wheezing ^† 1	0/18 (0.00%)	0/45 (0.00%)	1/34 (2.94%)
Skin and subcutaneous tissue disorders
Alopecia ^† 1	3/18 (16.67%)	9/45 (20.00%)	7/34 (20.59%)
Body odor ^† 1	1/18 (5.56%)	0/45 (0.00%)	0/34 (0.00%)
Bullous dermatitis ^† 1	0/18 (0.00%)	1/45 (2.22%)	0/34 (0.00%)
Dry skin ^† 1	0/18 (0.00%)	4/45 (8.89%)	2/34 (5.88%)
Erythema multiforme ^† 1	0/18 (0.00%)	0/45 (0.00%)	2/34 (5.88%)
Hyperhidrosis ^† 1	1/18 (5.56%)	1/45 (2.22%)	0/34 (0.00%)
Nail loss ^† 1	0/18 (0.00%)	0/45 (0.00%)	1/34 (2.94%)
Palmar-plantar erythrodysesthesia syndrome ^† 1	0/18 (0.00%)	2/45 (4.44%)	1/34 (2.94%)
Pruritus ^† 1	4/18 (22.22%)	5/45 (11.11%)	4/34 (11.76%)
Rash acneiform ^† 1	1/18 (5.56%)	1/45 (2.22%)	3/34 (8.82%)
Rash maculo-papular ^† 1	0/18 (0.00%)	6/45 (13.33%)	3/34 (8.82%)
Skin hyperpigmentation ^† 1	0/18 (0.00%)	1/45 (2.22%)	1/34 (2.94%)
Skin ulceration ^† 1	1/18 (5.56%)	0/45 (0.00%)	1/34 (2.94%)
Skin/subcutaneous tissue disorders; Other, specify ^† 1	2/18 (11.11%)	4/45 (8.89%)	4/34 (11.76%)
Vascular disorders
Hot flashes ^† 1	0/18 (0.00%)	3/45 (6.67%)	5/34 (14.71%)
Hypertension ^† 1	3/18 (16.67%)	4/45 (8.89%)	6/34 (17.65%)
Hypotension ^† 1	0/18 (0.00%)	3/45 (6.67%)	1/34 (2.94%)
Lymphedema ^† 1	1/18 (5.56%)	5/45 (11.11%)	3/34 (8.82%)
Thromboembolic event ^† 1	0/18 (0.00%)	0/45 (0.00%)	1/34 (2.94%)
1 Term from vocabulary, CTCAE (5.0) † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

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Name/Title:	Adrienne G. Waks, MD
Organization:	Dana-Farber Cancer Institute
Phone:	617-632-3800
EMail:	Adrienne_Waks@dfci.harvard.edu

Layout table for additonal information

Responsible Party:	Adrienne G. Waks, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT03414658
Other Study ID Numbers:	17-455 TBCRC045 ( Other Identifier: TBCRC )
First Submitted:	November 10, 2017
First Posted:	January 30, 2018
Results First Submitted:	February 20, 2024
Results First Posted:	April 18, 2024
Last Update Posted:	April 18, 2024

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