Trial Outcomes & Findings for Pembrolizumab in Neoplasms or Lymphomas (NCT NCT03316573)

NCT ID: NCT03316573

Last Updated: 2026-02-10

Results Overview

The number of subjects with partial response (PR) or complete response (CR) by PET/CT scan Per Lugano criteria, CR is defined as positron emission tomography-computed tomography (PET-CT), score 1, 2, or 3 with or without a residual mass on 5 point scale (5PS) OR on CT, target nodes/nodal masses must regress to ≤1.5 cm in longest diameter (LDi). PR is defined as PET-CT score 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size. OR on CT ≥50% decrease in the sum of the products of the longest perpendicular diameters (SPD) of up to 6 target measurable nodes and extranodal sites.

• Recruitment status: SUSPENDED
• Study phase: PHASE2
• Target enrollment: 18 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2026-02-10

Participant Flow

Participant milestones

Measure	Pembrolizumab Pembrolizumab will be administered intravenously every 3 weeks for 35 cycles Pembrolizumab: The study drug is an antibody that targets a molecule called PD-1. Blocking PD-1 allow the immune system to attack the cancer more effectively.
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pembrolizumab in Neoplasms or Lymphomas

Baseline characteristics by cohort

Measure	Pembrolizumab n=18 Participants Pembrolizumab will be administered intravenously every 3 weeks for 35 cycles Pembrolizumab: The study drug is an antibody that targets a molecule called PD-1. Blocking PD-1 allow the immune system to attack the cancer more effectively.
Age, Categorical <=18 years	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=4 Participants
Age, Categorical >=65 years	10 Participants n=4 Participants
Age, Continuous	66 years n=4 Participants
Sex: Female, Male Female	6 Participants n=4 Participants
Sex: Female, Male Male	12 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=4 Participants
Race (NIH/OMB) White	15 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=4 Participants
Region of Enrollment United States	18 Participants n=4 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 00 - Fully active, able to carry on all pre-disease performance without restriction	6 Participants n=4 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 01 - Restricted in physically strenuous activity but ambulatory and able to carry out light work	12 Participants n=4 Participants

PRIMARY outcome

Timeframe: 2 years

The number of subjects with partial response (PR) or complete response (CR) by PET/CT scan

Per Lugano criteria, CR is defined as positron emission tomography-computed tomography (PET-CT), score 1, 2, or 3 with or without a residual mass on 5 point scale (5PS) OR on CT, target nodes/nodal masses must regress to ≤1.5 cm in longest diameter (LDi). PR is defined as PET-CT score 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size. OR on CT ≥50% decrease in the sum of the products of the longest perpendicular diameters (SPD) of up to 6 target measurable nodes and extranodal sites.

Outcome measures

Measure	Pembrolizumab n=18 Participants Pembrolizumab will be administered intravenously every 3 weeks for 35 cycles Pembrolizumab: The study drug is an antibody that targets a molecule called PD-1. Blocking PD-1 allow the immune system to attack the cancer more effectively.
Overall Response Rate	3 Participants

SECONDARY outcome

Timeframe: 2 years

The number of patients with complete response (CR)

Per Lugano criteria, CR is defined as PET-CT, score 1, 2, or 3 with or without a residual mass on 5PS OR on CT, target nodes/nodal masses must regress to ≤1.5 cm in LDi.

Outcome measures

Measure	Pembrolizumab n=18 Participants Pembrolizumab will be administered intravenously every 3 weeks for 35 cycles Pembrolizumab: The study drug is an antibody that targets a molecule called PD-1. Blocking PD-1 allow the immune system to attack the cancer more effectively.
Complete Response Rate	3 Participants

SECONDARY outcome

Timeframe: Up to 35 cycles of treatment (approximately 2 years) plus up to an additional 24 months of follow-up after treatment

The number of patients with an adverse event of any grade that has definite, probable, or possible attribution to study treatment.

Outcome measures

Measure	Pembrolizumab n=18 Participants Pembrolizumab will be administered intravenously every 3 weeks for 35 cycles Pembrolizumab: The study drug is an antibody that targets a molecule called PD-1. Blocking PD-1 allow the immune system to attack the cancer more effectively.
Number of Patients With Adverse Events of Any Grade	18 Participants

SECONDARY outcome

Timeframe: Up to 35 cycles of treatment (approximately 2 years) plus up to an additional 24 months of follow-up after treatment

Length of first complete (CR) or partial response (PR) until progression (PD)

Per Lugano criteria, CR is defined as PET-CT, score 1, 2, or 3 with/without a residual mass on 5PS OR on CT, target nodes/nodal masses must regress to ≤1.5 cm in LDi. PR is defined as PET-CT score 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size. OR on CT ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites. PD is defined as PET-CT score 4 or 5 with an increase in intensity of uptake from baseline and/or new fluoro-2-deoxy-D-glucose (FDG)-avid foci consistent with lymphoma at interim or end-of-treatment assessment. OR on CT, an individual node/lesion must be abnormal. OR new/clear progression of pre-existing nonmeasured lesions. OR regrowth of previously resolved lesions. OR new node >1.5 cm in any axis or new extranodal site >1.0 cm in any axis or be unequivocal and attributable to lymphoma. AND/OR new/recurrent involvement of the bone marrow

Outcome measures

Measure	Pembrolizumab n=3 Participants Pembrolizumab will be administered intravenously every 3 weeks for 35 cycles Pembrolizumab: The study drug is an antibody that targets a molecule called PD-1. Blocking PD-1 allow the immune system to attack the cancer more effectively.
Duration of Response	15 months Interval 4.0 to 26.0

SECONDARY outcome

Timeframe: Up to 35 cycles of treatment (approximately 2 years) plus up to an additional 24 months of follow-up after treatment

Time from study registration until the earlier of first progression or death from any cause, censored for patients alive without progression or lost to follow-up without documented progression.

Per Lugano criteria, progression is defined as PET-CT score 4 or 5 with an increase in intensity of uptake from baseline and/or new FDG-avid foci consistent with lymphoma at interim or end-of-treatment assessment. OR on CT, an individual node/lesion must be abnormal. OR new or clear progression of pre-existing nonmeasured lesions. OR regrowth of previously resolved lesions. OR a new node >1.5 cm in any axis or a new extranodal site >1.0 cm in any axis or be unequivocal and must be attributable to lymphoma. AND/OR new or recurrent involvement of the bone marrow

Outcome measures

Measure	Pembrolizumab n=18 Participants Pembrolizumab will be administered intravenously every 3 weeks for 35 cycles Pembrolizumab: The study drug is an antibody that targets a molecule called PD-1. Blocking PD-1 allow the immune system to attack the cancer more effectively.
Progression-free Survival	1.5 months Interval 0.5 to 28.0

SECONDARY outcome

Timeframe: Up to 35 cycles of treatment (approximately 2 years) plus up to an additional 24 months of follow-up after treatment

The length of first complete response (CR) until progression (PD)

Per Lugano criteria, CR is defined as PET-CT, score 1, 2, or 3 with or without a residual mass on 5PS OR on CT, target nodes/nodal masses must regress to ≤1.5 cm in LDi. PD is defined as PET-CT score 4 or 5 with an increase in intensity of uptake from baseline and/or new FDG-avid foci consistent with lymphoma at interim or end-of-treatment assessment. OR on CT, an individual node/lesion must be abnormal. OR new or clear progression of pre-existing nonmeasured lesions. OR regrowth of previously resolved lesions. OR a new node >1.5 cm in any axis or a new extranodal site >1.0 cm in any axis or be unequivocal and must be attributable to lymphoma. AND/OR new or recurrent involvement of the bone marrow

Outcome measures

Measure	Pembrolizumab n=3 Participants Pembrolizumab will be administered intravenously every 3 weeks for 35 cycles Pembrolizumab: The study drug is an antibody that targets a molecule called PD-1. Blocking PD-1 allow the immune system to attack the cancer more effectively.
Duration of Complete Response	12 months Interval 0.0 to 24.0

SECONDARY outcome

Timeframe: Up to 35 cycles of treatment (approximately 2 years) plus up to an additional 24 months of follow-up after treatment

Time from study registration until death from any cause, censored for patients still alive or lost to follow-up

Outcome measures

Measure	Pembrolizumab n=18 Participants Pembrolizumab will be administered intravenously every 3 weeks for 35 cycles Pembrolizumab: The study drug is an antibody that targets a molecule called PD-1. Blocking PD-1 allow the immune system to attack the cancer more effectively.
Overall Survival	24 months Interval 1.0 to 35.0

Adverse Events

Pembrolizumab

Serious events: 8 serious events

Other events: 18 other events

Deaths: 10 deaths

Serious adverse events

Measure	Pembrolizumab n=18 participants at risk Pembrolizumab will be administered intravenously every 3 weeks for 35 cycles Pembrolizumab: The study drug is an antibody that targets a molecule called PD-1. Blocking PD-1 allow the immune system to attack the cancer more effectively.
Investigations Aspartate aminotransferase increased	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
General disorders Death NOS	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Nervous system disorders Dysarthria	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Gastrointestinal disorders Dysphagia	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Respiratory, thoracic and mediastinal disorders Dyspnea	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Eye disorders Eye disorders - Other, specify	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Vascular disorders Hypertension	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Respiratory, thoracic and mediastinal disorders Hypoxia	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Investigations Lymphocyte count decreased	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Gastrointestinal disorders Mucositis oral	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Investigations Neutrophil count decreased	5.6% 1/18 • Number of events 2 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Cardiac disorders Pericardial effusion	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Investigations Platelet count decreased	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Skin and subcutaneous tissue disorders Rash maculo-papular	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Infections and infestations Sepsis	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Vascular disorders Thromboembolic event	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Infections and infestations Upper respiratory infection	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Investigations White blood cell decreased	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment

Other adverse events

Measure	Pembrolizumab n=18 participants at risk Pembrolizumab will be administered intravenously every 3 weeks for 35 cycles Pembrolizumab: The study drug is an antibody that targets a molecule called PD-1. Blocking PD-1 allow the immune system to attack the cancer more effectively.
Blood and lymphatic system disorders Anemia	55.6% 10/18 • Number of events 29 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
General disorders Fatigue	55.6% 10/18 • Number of events 12 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Investigations Alkaline phosphatase increased	50.0% 9/18 • Number of events 15 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Metabolism and nutrition disorders Hyperglycemia	38.9% 7/18 • Number of events 17 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Investigations Platelet count decreased	38.9% 7/18 • Number of events 13 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Gastrointestinal disorders Nausea	38.9% 7/18 • Number of events 8 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Investigations White blood cell decreased	33.3% 6/18 • Number of events 18 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Investigations Aspartate aminotransferase increased	33.3% 6/18 • Number of events 16 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Investigations Alanine aminotransferase increased	33.3% 6/18 • Number of events 10 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Gastrointestinal disorders Diarrhea	33.3% 6/18 • Number of events 8 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Investigations Neutrophil count decreased	27.8% 5/18 • Number of events 21 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Gastrointestinal disorders Abdominal pain	27.8% 5/18 • Number of events 5 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Respiratory, thoracic and mediastinal disorders Cough	27.8% 5/18 • Number of events 5 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Metabolism and nutrition disorders Hyponatremia	22.2% 4/18 • Number of events 15 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Metabolism and nutrition disorders Hypoalbuminemia	22.2% 4/18 • Number of events 9 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Respiratory, thoracic and mediastinal disorders Dyspnea	22.2% 4/18 • Number of events 6 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
General disorders Fever	22.2% 4/18 • Number of events 5 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Skin and subcutaneous tissue disorders Rash maculo-papular	22.2% 4/18 • Number of events 5 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
General disorders Chills	22.2% 4/18 • Number of events 4 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Gastrointestinal disorders Constipation	22.2% 4/18 • Number of events 4 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Respiratory, thoracic and mediastinal disorders Nasal congestion	22.2% 4/18 • Number of events 4 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Investigations Lymphocyte count decreased	16.7% 3/18 • Number of events 9 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Metabolism and nutrition disorders Hypocalcemia	16.7% 3/18 • Number of events 8 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Cardiac disorders Sinus tachycardia	16.7% 3/18 • Number of events 5 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Nervous system disorders Headache	16.7% 3/18 • Number of events 4 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Metabolism and nutrition disorders Hypophosphatemia	16.7% 3/18 • Number of events 4 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Skin and subcutaneous tissue disorders Hyperhidrosis	16.7% 3/18 • Number of events 3 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
General disorders Pain	16.7% 3/18 • Number of events 3 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Investigations Blood bilirubin increased	11.1% 2/18 • Number of events 6 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Metabolism and nutrition disorders Anorexia	11.1% 2/18 • Number of events 3 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	11.1% 2/18 • Number of events 3 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Endocrine disorders Hyperthyroidism	11.1% 2/18 • Number of events 3 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Musculoskeletal and connective tissue disorders Arthralgia	11.1% 2/18 • Number of events 2 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Musculoskeletal and connective tissue disorders Back pain	11.1% 2/18 • Number of events 2 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	11.1% 2/18 • Number of events 2 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Vascular disorders Hypertension	11.1% 2/18 • Number of events 2 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Metabolism and nutrition disorders Hypomagnesemia	11.1% 2/18 • Number of events 2 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Endocrine disorders Hypothyroidism	11.1% 2/18 • Number of events 2 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Gastrointestinal disorders Mucositis oral	11.1% 2/18 • Number of events 2 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Cardiac disorders Palpitations	11.1% 2/18 • Number of events 2 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Cardiac disorders Sinus bradycardia	11.1% 2/18 • Number of events 2 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Blood and lymphatic system disorders Febrile neutropenia	5.6% 1/18 • Number of events 4 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	5.6% 1/18 • Number of events 4 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Metabolism and nutrition disorders Hypokalemia	5.6% 1/18 • Number of events 3 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Investigations Weight loss	5.6% 1/18 • Number of events 2 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Infections and infestations Wound infection	5.6% 1/18 • Number of events 2 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Psychiatric disorders Anxiety	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Eye disorders Blurred vision	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Musculoskeletal and connective tissue disorders Bone pain	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Injury, poisoning and procedural complications Bruising	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Nervous system disorders Dizziness	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Skin and subcutaneous tissue disorders Dry skin	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Gastrointestinal disorders Dysphagia	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Gastrointestinal disorders Enterocolitis	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Eye disorders Eye disorders - Other, specify	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Gastrointestinal disorders Gastroesophageal reflux disease	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
General disorders General disorders and administration site conditions - Other, specify	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Musculoskeletal and connective tissue disorders Generalized muscle weakness	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Metabolism and nutrition disorders Hyperkalemia	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Vascular disorders Hypotension	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Infections and infestations Infections and infestations - Other, specify	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
General disorders Infusion related reaction	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Psychiatric disorders Insomnia	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
General disorders Localized edema	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Blood and lymphatic system disorders Lymph node pain	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Investigations Lymphocyte count increased	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Musculoskeletal and connective tissue disorders Myalgia	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
General disorders Non-cardiac chest pain	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Gastrointestinal disorders Oral pain	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Cardiac disorders Pericardial effusion	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Nervous system disorders Peripheral sensory neuropathy	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Respiratory, thoracic and mediastinal disorders Pneumonitis	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Respiratory, thoracic and mediastinal disorders Postnasal drip	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Skin and subcutaneous tissue disorders Rash acneiform	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Infections and infestations Rhinitis infective	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Skin and subcutaneous tissue disorders Skin/subcutaneous tissue disorders; Other, specify	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Respiratory, thoracic and mediastinal disorders Sore throat	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Skin and subcutaneous tissue disorders Stevens-Johnson syndrome	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Gastrointestinal disorders Stomach pain	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Infections and infestations Upper respiratory infection	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Skin and subcutaneous tissue disorders Urticaria	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Infections and infestations Vaginal infection	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Gastrointestinal disorders Vomiting	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Respiratory, thoracic and mediastinal disorders Wheezing	5.6% 1/18 • Number of events 1 • Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment

Additional Information

Eric Jacobsen, MD

Dana-Farber Cancer Institute

Phone: 617-632-6633

Email: edjacobsen@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place