Trial Outcomes & Findings for A Phase 2 Study of Mirvetuximab Soravtansine (IMGN853) and Pembrolizumab in Endometrial Cancer (EC) (NCT NCT03835819)

Last Updated: 2025-05-15

Results Overview

The objective response rate was determined by the frequency of patients who had objective tumor response, determined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI, where objective response represents either a confirmed complete response (CR; disappearance of all target lesions) or a confirmed partial response (PR; at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum diameters); objective response = CR + PR. The ORR is therefore reported as the percentage of participants who achieved a CR or PR per RECIST v1.1.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

18 participants

Primary outcome timeframe

6 months

Results posted on

2025-05-15

Participant Flow

Of the 18 participants enrolled, all 18 participants are considered evaluable for assessment. Enrollment was closed before the total accrual goal of 35 was met.

Participant milestones

Participant milestones
Measure	IMGN853 + Pembrolizumab * Pembrolizumab is administered intravenously once every 3 weeks * IMGN853 is administered intravenously once every 3 weeks Pembrolizumab: Pembrolizumab is an immunotherapy that activates a patient's own immune system to recognize and kill tumor cells IMGN853: Mirvetuximab soravtansine is an antibody-drug conjugate.
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase 2 Study of Mirvetuximab Soravtansine (IMGN853) and Pembrolizumab in Endometrial Cancer (EC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IMGN853 + Pembrolizumab n=18 Participants * Pembrolizumab is administered intravenously once every 3 weeks * IMGN853 is administered intravenously once every 3 weeks Pembrolizumab: Pembrolizumab is an immunotherapy that activates a patient's own immune system to recognize and kill tumor cells IMGN853: Mirvetuximab soravtansine is an antibody-drug conjugate.
Age, Continuous	67.2 years n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 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	1 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Stage at Initial Diagnosis Stage I	5 Participants n=5 Participants
Stage at Initial Diagnosis Stage II	0 Participants n=5 Participants
Stage at Initial Diagnosis Stage III	7 Participants n=5 Participants
Stage at Initial Diagnosis Stage IV	6 Participants n=5 Participants
ECOG Performance Status 00 - Fully active	12 Participants n=5 Participants
ECOG Performance Status 01 - Restricted	6 Participants n=5 Participants
Prior Lines 1	2 Participants n=5 Participants
Prior Lines 2	7 Participants n=5 Participants
Prior Lines 3	5 Participants n=5 Participants
Prior Lines 4	4 Participants n=5 Participants
Prior Anti-PD-1/PD-L1 Exposure IO-exposed (avelumab)	1 Participants n=5 Participants
Prior Anti-PD-1/PD-L1 Exposure IO-exposed (dostarlimab)	1 Participants n=5 Participants
Prior Anti-PD-1/PD-L1 Exposure IO-exposed (pembrolizumab)	6 Participants n=5 Participants
Prior Anti-PD-1/PD-L1 Exposure IO-naïve	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Among 18 patients, 5 had a confirmed response. Confirmed ORR is 28%, with 95% confidence interval of \[ 10%, 53%\].

Outcome measures

Outcome measures
Measure	IMGN853 + Pembrolizumab n=18 Participants * Pembrolizumab is administered intravenously once every 3 weeks * IMGN853 is administered intravenously once every 3 weeks Pembrolizumab: Pembrolizumab is an immunotherapy that activates a patient's own immune system to recognize and kill tumor cells IMGN853: Mirvetuximab soravtansine is an antibody-drug conjugate.
Objective Response Rate	28 percentage of participants Interval 10.0 to 53.0

PRIMARY outcome

Timeframe: 6 months

Population: 4 patients were alive and progression-free at 6 months.

Progression-free survival at 6 months was determined by the frequency of patients who survived progression-free for at least 6 months after initiating study treatment by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), where disease progression represents at least a 20% increase in the sum of diameters of target lesions, appearance of one or more new lesions, or unequivocal progression of existing non-target lesions.

Outcome measures

Outcome measures
Measure	IMGN853 + Pembrolizumab n=18 Participants * Pembrolizumab is administered intravenously once every 3 weeks * IMGN853 is administered intravenously once every 3 weeks Pembrolizumab: Pembrolizumab is an immunotherapy that activates a patient's own immune system to recognize and kill tumor cells IMGN853: Mirvetuximab soravtansine is an antibody-drug conjugate.
Progression-Free Survival at 6 Months (PFS6)	4 Participants

SECONDARY outcome

Timeframe: Interval from start of treatment to documented disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death from any cause, whichever occurs first.

Progression-free survival was determined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), where disease progression represents at least a 20% increase in the sum of diameters of target lesions, appearance of one or more new lesions, or unequivocal progression of existing non-target lesions. The distribution of progression-free times will be estimated using Kaplan-Meier analysis.

Outcome measures

Outcome measures
Measure	IMGN853 + Pembrolizumab n=18 Participants * Pembrolizumab is administered intravenously once every 3 weeks * IMGN853 is administered intravenously once every 3 weeks Pembrolizumab: Pembrolizumab is an immunotherapy that activates a patient's own immune system to recognize and kill tumor cells IMGN853: Mirvetuximab soravtansine is an antibody-drug conjugate.
Progression-free Survival	2.73 months Interval 1.2 to 4.5

SECONDARY outcome

Timeframe: Participants are followed for survival status from registration through up to 3 years after removal from study intervention

Overall survival (OS) is defined as the time from registration to death due to any cause, or censored at date last known alive. The distribution of overall survival times will be estimated using Kaplan-Meier analysis.

Outcome measures

Outcome measures
Measure	IMGN853 + Pembrolizumab n=18 Participants * Pembrolizumab is administered intravenously once every 3 weeks * IMGN853 is administered intravenously once every 3 weeks Pembrolizumab: Pembrolizumab is an immunotherapy that activates a patient's own immune system to recognize and kill tumor cells IMGN853: Mirvetuximab soravtansine is an antibody-drug conjugate.
Overall Survival	11.3 months Interval 3.32 to Upper bound not reached using the KM method.

SECONDARY outcome

Timeframe: Interval from best overall response to documented disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death from any cause, whichever occurs first.

Population: Due to the small number of responses, reporting the confidence interval or interquartile range is not meaningful. Out of the 5 confirmed responders, 2 experienced events (progression or death), while 3 were censored.

Duration of response (DoR) is defined as time from best overall response to the time of disease progression.

Outcome measures

Outcome measures
Measure	IMGN853 + Pembrolizumab n=18 Participants * Pembrolizumab is administered intravenously once every 3 weeks * IMGN853 is administered intravenously once every 3 weeks Pembrolizumab: Pembrolizumab is an immunotherapy that activates a patient's own immune system to recognize and kill tumor cells IMGN853: Mirvetuximab soravtansine is an antibody-drug conjugate.
Duration of Response	7.1 months Interval 2.76 to 18.14

Adverse Events

IMGN853 + Pembrolizumab

Serious events: 4 serious events

Other events: 18 other events

Deaths: 12 deaths

Serious adverse events

Serious adverse events
Measure	IMGN853 + Pembrolizumab n=18 participants at risk * Pembrolizumab is administered intravenously once every 3 weeks * IMGN853 is administered intravenously once every 3 weeks Pembrolizumab: Pembrolizumab is an immunotherapy that activates a patient's own immune system to recognize and kill tumor cells IMGN853: Mirvetuximab soravtansine is an antibody-drug conjugate.
Eye disorders Corneal ulcer	5.6% 1/18 • Number of events 1 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Renal and urinary disorders Acute kidney injury	5.6% 1/18 • Number of events 1 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Endocrine disorders Adrenal insufficiency	5.6% 1/18 • Number of events 1 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	5.6% 1/18 • Number of events 1 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Investigations Platelet count decreased	5.6% 1/18 • Number of events 3 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Gastrointestinal disorders Abdominal pain	5.6% 1/18 • Number of events 1 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Nervous system disorders Dizziness	5.6% 1/18 • Number of events 1 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Injury, poisoning and procedural complications Fall	5.6% 1/18 • Number of events 1 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Gastrointestinal disorders Nausea	5.6% 1/18 • Number of events 1 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Investigations Neutrophil count decreased	5.6% 1/18 • Number of events 1 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Gastrointestinal disorders Small intestinal obstruction	5.6% 1/18 • Number of events 1 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Gastrointestinal disorders Vomiting	5.6% 1/18 • Number of events 1 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).

Other adverse events

Other adverse events
Measure	IMGN853 + Pembrolizumab n=18 participants at risk * Pembrolizumab is administered intravenously once every 3 weeks * IMGN853 is administered intravenously once every 3 weeks Pembrolizumab: Pembrolizumab is an immunotherapy that activates a patient's own immune system to recognize and kill tumor cells IMGN853: Mirvetuximab soravtansine is an antibody-drug conjugate.
Blood and lymphatic system disorders Anemia	55.6% 10/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Cardiac disorders Sinus tachycardia	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Ear and labyrinth disorders Hearing impaired	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Endocrine disorders Adrenal insufficiency	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Endocrine disorders Hyperthyroidism	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Endocrine disorders Hypothyroidism	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Eye disorders Blurred vision	44.4% 8/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Eye disorders Cataract	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Eye disorders Dry eye	11.1% 2/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Eye disorders Eye disorders - Other, specify	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Eye disorders Photophobia	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Gastrointestinal disorders Abdominal distention	11.1% 2/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Gastrointestinal disorders Abdominal pain	38.9% 7/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Gastrointestinal disorders Ascites	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Gastrointestinal disorders Belching	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Gastrointestinal disorders Bloating	11.1% 2/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Gastrointestinal disorders Constipation	22.2% 4/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Gastrointestinal disorders Diarrhea	50.0% 9/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Gastrointestinal disorders Dry mouth	11.1% 2/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Gastrointestinal disorders Dyspepsia	11.1% 2/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Gastrointestinal disorders Flatulence	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Gastrointestinal disorders Gastritis	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Gastrointestinal disorders Hemorrhoids	11.1% 2/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Gastrointestinal disorders Nausea	50.0% 9/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Gastrointestinal disorders Rectal hemorrhage	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Gastrointestinal disorders Vomiting	33.3% 6/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
General disorders Chills	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
General disorders Edema limbs	16.7% 3/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
General disorders Fatigue	72.2% 13/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
General disorders Fever	22.2% 4/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
General disorders Flu like symptoms	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
General disorders General disorders and administration site conditions - Other, specify	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
General disorders Generalized edema	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
General disorders Non-cardiac chest pain	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
General disorders Pain	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Infections and infestations Bacteremia	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Infections and infestations Otitis media	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Infections and infestations Thrush	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Infections and infestations Upper respiratory infection	11.1% 2/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Infections and infestations Urinary tract infection	11.1% 2/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Infections and infestations Vaginal infection	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Injury, poisoning and procedural complications Fall	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Investigations Activated partial thromboplastin time prolonged	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Investigations Alanine aminotransferase increased	44.4% 8/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Investigations Alkaline phosphatase increased	27.8% 5/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Investigations Aspartate aminotransferase increased	61.1% 11/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Investigations Blood bilirubin increased	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Investigations Blood lactate dehydrogenase increased	11.1% 2/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Investigations Creatinine increased	33.3% 6/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Investigations Fibrinogen decreased	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Investigations Lymphocyte count decreased	22.2% 4/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Investigations Neutrophil count decreased	16.7% 3/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Investigations Platelet count decreased	44.4% 8/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Investigations Weight loss	11.1% 2/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Investigations White blood cell decreased	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Metabolism and nutrition disorders Anorexia	50.0% 9/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Metabolism and nutrition disorders Glucose intolerance	11.1% 2/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Metabolism and nutrition disorders Hypercalcemia	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Metabolism and nutrition disorders Hyperglycemia	16.7% 3/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Metabolism and nutrition disorders Hyperkalemia	11.1% 2/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Metabolism and nutrition disorders Hypernatremia	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Metabolism and nutrition disorders Hyperphosphatemia	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Metabolism and nutrition disorders Hyperuricemia	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Metabolism and nutrition disorders Hypoalbuminemia	16.7% 3/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Metabolism and nutrition disorders Hypocalcemia	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Metabolism and nutrition disorders Hypokalemia	33.3% 6/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Metabolism and nutrition disorders Hypomagnesemia	33.3% 6/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Metabolism and nutrition disorders Hyponatremia	33.3% 6/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Musculoskeletal and connective tissue disorders Arthralgia	11.1% 2/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Musculoskeletal and connective tissue disorders Back pain	22.2% 4/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Musculoskeletal and connective tissue disorders Bone pain	11.1% 2/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Musculoskeletal and connective tissue disorders Generalized muscle weakness	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Musculoskeletal and connective tissue disorders Myalgia	11.1% 2/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Musculoskeletal and connective tissue disorders Neck pain	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Musculoskeletal and connective tissue disorders Pain in extremity	11.1% 2/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Nervous system disorders Dizziness	16.7% 3/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Nervous system disorders Dysarthia	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Nervous system disorders Dysgeusia	16.7% 3/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Nervous system disorders Encephalopathy	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Nervous system disorders Headache	33.3% 6/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Nervous system disorders Memory impairment	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Nervous system disorders Peripheral sensory neuropathy	33.3% 6/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Nervous system disorders Presyncope	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Nervous system disorders Tremor	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Psychiatric disorders Delirium	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Psychiatric disorders Restlessness	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Renal and urinary disorders Chronic kidney disease	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Renal and urinary disorders Dysuria	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Renal and urinary disorders Hematuria	16.7% 3/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Reproductive system and breast disorders Reproductive system and breast disorders - Other, specify	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Reproductive system and breast disorders Vaginal hemorrhage	11.1% 2/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Respiratory, thoracic and mediastinal disorders Atelectasis	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Respiratory, thoracic and mediastinal disorders Cough	11.1% 2/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Respiratory, thoracic and mediastinal disorders Dyspnea	11.1% 2/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Respiratory, thoracic and mediastinal disorders Epistaxis	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Respiratory, thoracic and mediastinal disorders Hoarseness	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Respiratory, thoracic and mediastinal disorders Pneumonitis	22.2% 4/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Respiratory, thoracic and mediastinal disorders Sore throat	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Skin and subcutaneous tissue disorders Dry skin	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Skin and subcutaneous tissue disorders Hyperkeratosis	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Skin and subcutaneous tissue disorders Pruritis	22.2% 4/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Skin and subcutaneous tissue disorders Rash maculo-papular	16.7% 3/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Vascular disorders Flushing	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Vascular disorders Hot flashes	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Vascular disorders Hypertension	22.2% 4/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Eye disorders Keratitis	11.1% 2/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specify	5.6% 1/18 • Adverse event data was collected for all participants through 30 days after last intervention (up to 21 months).

Additional Information

Dr. Panagiotis Konstantinopoulos

Dana-Farber Cancer Institute

Phone: 617-632-5269

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place