Trial Outcomes & Findings for A Study of CDX-3379 and Cetuximab and in Patients With Advanced Head and Neck Squamous Cell Carcinoma (NCT NCT03254927)

Last Updated: 2023-04-03

Results Overview

The percentage of patients who achieve a complete response or partial response per Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST version 1.1), Complete Response (CR) = disappearance of all target lesions and non-target lesions, Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions with no progression in non-target lesions and no new lesions.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

The proportion of evaluable patients who achieve a best overall response of complete or partial response according to RECIST 1.1 assessed up to 24 months.

Results posted on

2023-04-03

Participant Flow

Participant milestones

Participant milestones
Measure	CDX-3379 and Cetuximab During the treatment phase of the study, eligible patients will receive assigned treatments in 3 week cycles until progression. CDX-3379 and cetuximab: Dose: 12 mg/kg CDX-3379 once every 3 weeks in combination with 400 mg/m2 cetuximab on the first day followed by weekly doses of 250 mg/m2 cetuximab.
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of CDX-3379 and Cetuximab and in Patients With Advanced Head and Neck Squamous Cell Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CDX-3379 and Cetuximab n=30 Participants During the treatment phase of the study, eligible patients will receive assigned treatments in 3 week cycles until progression. CDX-3379 and cetuximab: Dose: 12 mg/kg CDX-3379 once every 3 weeks in combination with 400 mg/m2 cetuximab on the first day followed by weekly doses of 250 mg/m2 cetuximab.
Age, Continuous	62 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	25 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
Region of Enrollment United States	30 participants n=5 Participants
Site of Primary Tumor Pharynx/Oropharynx	12 Participants n=5 Participants
Site of Primary Tumor Oral Cavity	11 Participants n=5 Participants
Site of Primary Tumor Larynx	4 Participants n=5 Participants
Site of Primary Tumor Other	3 Participants n=5 Participants
Duration of Metastatic Disease	2.2 years n=5 Participants
ECOG Performance Status ECOG 0	4 Participants n=5 Participants
ECOG Performance Status ECOG 1	26 Participants n=5 Participants

PRIMARY outcome

Timeframe: The proportion of evaluable patients who achieve a best overall response of complete or partial response according to RECIST 1.1 assessed up to 24 months.

Outcome measures

Outcome measures
Measure	CDX-3379 and Cetuximab n=30 Participants During the treatment phase of the study, eligible patients will receive assigned treatments in 3 week cycles until progression. CDX-3379 and cetuximab: Dose: 12 mg/kg CDX-3379 once every 3 weeks in combination with 400 mg/m2 cetuximab on the first day followed by weekly doses of 250 mg/m2 cetuximab.
Objective Response Rate	7 percentage of participants Interval 0.8 to 22.1

SECONDARY outcome

Timeframe: Every 8 weeks, starting with first dose until disease progression, assessed up to approximately 2 years

The percentage of patients who achieve best response of confirmed CR or PR, or stable disease (SD) for at least 12 weeks

Outcome measures

Outcome measures
Measure	CDX-3379 and Cetuximab n=30 Participants During the treatment phase of the study, eligible patients will receive assigned treatments in 3 week cycles until progression. CDX-3379 and cetuximab: Dose: 12 mg/kg CDX-3379 once every 3 weeks in combination with 400 mg/m2 cetuximab on the first day followed by weekly doses of 250 mg/m2 cetuximab.
Clinical Benefit Response (CBR)	40 percentage of participants Interval 22.7 to 59.4

SECONDARY outcome

Timeframe: First occurrence of a documented objective response to disease progression or death (up to approximately 2 years)

The interval from which measurement criteria are first met for Complete Response (CR) or Partial Response (PR) until the first date that progressive disease is objectively documented

Outcome measures

Outcome measures
Measure	CDX-3379 and Cetuximab n=30 Participants During the treatment phase of the study, eligible patients will receive assigned treatments in 3 week cycles until progression. CDX-3379 and cetuximab: Dose: 12 mg/kg CDX-3379 once every 3 weeks in combination with 400 mg/m2 cetuximab on the first day followed by weekly doses of 250 mg/m2 cetuximab.
Duration of Response (DOR)	NA months 30 patients were treated, 2 patients achieved objective response. The duration of response was 5 months and 18.7 months for the 2 patients who achieved objective response.

SECONDARY outcome

Timeframe: From first dose to the first occurrence of disease progression or death due to any cause (up to approximately 2 years)

The time from start of study drug to time of progression or death, whichever occurs first

Outcome measures

Outcome measures
Measure	CDX-3379 and Cetuximab n=30 Participants During the treatment phase of the study, eligible patients will receive assigned treatments in 3 week cycles until progression. CDX-3379 and cetuximab: Dose: 12 mg/kg CDX-3379 once every 3 weeks in combination with 400 mg/m2 cetuximab on the first day followed by weekly doses of 250 mg/m2 cetuximab.
Progression-free Survival (PFS)	2.2 months Interval 1.3 to 3.6

SECONDARY outcome

Timeframe: The time from start of study drug to death from any cause (up to approximately 2 years)

The time from start of study drug to death

Outcome measures

Outcome measures
Measure	CDX-3379 and Cetuximab n=30 Participants During the treatment phase of the study, eligible patients will receive assigned treatments in 3 week cycles until progression. CDX-3379 and cetuximab: Dose: 12 mg/kg CDX-3379 once every 3 weeks in combination with 400 mg/m2 cetuximab on the first day followed by weekly doses of 250 mg/m2 cetuximab.
Overall Survival (OS)	6.6 months Interval 2.7 to 7.5

SECONDARY outcome

Timeframe: Following at least one dose of study treatment through 30 days after last dose of CDX-3379.

Safety and tolerability of CDX-3379 in combination with cetuximab as determined by incidence and severity of adverse events. Percentage of patients reporting one or more adverse events.

Outcome measures

Outcome measures
Measure	CDX-3379 and Cetuximab n=30 Participants During the treatment phase of the study, eligible patients will receive assigned treatments in 3 week cycles until progression. CDX-3379 and cetuximab: Dose: 12 mg/kg CDX-3379 once every 3 weeks in combination with 400 mg/m2 cetuximab on the first day followed by weekly doses of 250 mg/m2 cetuximab.
Incidence of Adverse Events [Safety and Tolerability]	30 Participants

SECONDARY outcome

Timeframe: Tumor tissue is obtained during screening window via single biopsy procedure.

Population: patients with FAT1 positive tumors

Tumor DNA biomarkers will be evaluated and assessed for correlation with clinical efficacy. Objective response rate for subset of patients with FAT1 positive tumor is reported.

Outcome measures

Outcome measures
Measure	CDX-3379 and Cetuximab n=10 Participants During the treatment phase of the study, eligible patients will receive assigned treatments in 3 week cycles until progression. CDX-3379 and cetuximab: Dose: 12 mg/kg CDX-3379 once every 3 weeks in combination with 400 mg/m2 cetuximab on the first day followed by weekly doses of 250 mg/m2 cetuximab.
Tumor DNA Biomarkers.	1 Participants

Adverse Events

CDX-3379 and Cetuximab

Serious events: 13 serious events

Other events: 30 other events

Deaths: 26 deaths

Serious adverse events

Serious adverse events
Measure	CDX-3379 and Cetuximab n=30 participants at risk During the treatment phase of the study, eligible patients will receive assigned treatments in 3 week cycles until progression. CDX-3379 and cetuximab: Dose: 12 mg/kg CDX-3379 once every 3 weeks in combination with 400 mg/m2 cetuximab on the first day followed by weekly doses of 250 mg/m2 cetuximab.
Infections and infestations Pneumonia	10.0% 3/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Infections and infestations Lung abscess	3.3% 1/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Infections and infestations Infection	3.3% 1/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Infections and infestations Urinary tract infection	3.3% 1/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Gastrointestinal disorders Diarrhoea	6.7% 2/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Gastrointestinal disorders Small intestinal haemorrhage	3.3% 1/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
General disorders Pyrexia	6.7% 2/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
General disorders Mucosal inflammation	3.3% 1/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
General disorders Non-cardiac chest pain	3.3% 1/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Injury, poisoning and procedural complications Femoral neck fracture	3.3% 1/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Injury, poisoning and procedural complications Gastrostomy tube site complication	3.3% 1/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Injury, poisoning and procedural complications Tracheal obstruction	3.3% 1/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.3% 1/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	3.3% 1/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Blood and lymphatic system disorders Leukocytosis	3.3% 1/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Investigations Electrocardiogram QT prolonged	3.3% 1/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Metabolism and nutrition disorders Failure to thrive	3.3% 1/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	3.3% 1/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Nervous system disorders Encephalopathy	3.3% 1/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.

Other adverse events

Other adverse events
Measure	CDX-3379 and Cetuximab n=30 participants at risk During the treatment phase of the study, eligible patients will receive assigned treatments in 3 week cycles until progression. CDX-3379 and cetuximab: Dose: 12 mg/kg CDX-3379 once every 3 weeks in combination with 400 mg/m2 cetuximab on the first day followed by weekly doses of 250 mg/m2 cetuximab.
Gastrointestinal disorders Diarrhoea	80.0% 24/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Gastrointestinal disorders Nausea	33.3% 10/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Gastrointestinal disorders Vomiting	16.7% 5/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Gastrointestinal disorders Dysphagia	26.7% 8/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Gastrointestinal disorders Stomatitis	16.7% 5/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Gastrointestinal disorders Abdominal pain	10.0% 3/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Gastrointestinal disorders Constipation	10.0% 3/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Gastrointestinal disorders Flatulence	6.7% 2/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Metabolism and nutrition disorders Hypomagnesaemia	53.3% 16/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Metabolism and nutrition disorders Hypokalaemia	46.7% 14/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Metabolism and nutrition disorders Hypocalcaemia	26.7% 8/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Metabolism and nutrition disorders Hypercalcaemia	16.7% 5/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Metabolism and nutrition disorders Hypoalbuminaemia	33.3% 10/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Metabolism and nutrition disorders Hypophosphataemia	30.0% 9/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Metabolism and nutrition disorders Dehydration	26.7% 8/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Metabolism and nutrition disorders Decreased appetite	20.0% 6/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Metabolism and nutrition disorders Malnutrition	13.3% 4/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Metabolism and nutrition disorders Hypoglycaemia	13.3% 4/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Metabolism and nutrition disorders Hypernatraemia	10.0% 3/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Skin and subcutaneous tissue disorders Dermatitis acneiform	56.7% 17/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Skin and subcutaneous tissue disorders Dry skin	26.7% 8/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Skin and subcutaneous tissue disorders Skin induration	10.0% 3/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Skin and subcutaneous tissue disorders Rash	13.3% 4/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Skin and subcutaneous tissue disorders Rash maculo-papular	10.0% 3/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	10.0% 3/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Skin and subcutaneous tissue disorders Pruritis	10.0% 3/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Skin and subcutaneous tissue disorders Erythema	6.7% 2/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Skin and subcutaneous tissue disorders Urticaria	6.7% 2/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
General disorders Fatigue	36.7% 11/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
General disorders Asthenia	6.7% 2/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
General disorders Chills	16.7% 5/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
General disorders Thirst	6.7% 2/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
General disorders Face oedema	10.0% 3/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
General disorders Catheter site pain	6.7% 2/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Investigations Weight decreased	33.3% 10/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Investigations Blood creatinine increased	20.0% 6/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Investigations Blood lactate dehydrogenase increased	13.3% 4/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Investigations Blood alkaline phosphatase increased	6.7% 2/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Investigations Lymphocyte count decreased	13.3% 4/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Investigations White blood cell count decreased	6.7% 2/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Investigations Amylase increased	10.0% 3/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Investigations Lipase increased	6.7% 2/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Investigations Alanine aminotransferase increased	10.0% 3/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Investigations Aspartate aminotransferase increased	6.7% 2/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Investigations Electrocardiogram QT prolonged	6.7% 2/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Investigations International normalised ratio increased	6.7% 2/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Investigations Platelet count decreased	6.7% 2/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Respiratory, thoracic and mediastinal disorders Cough	13.3% 4/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Respiratory, thoracic and mediastinal disorders Productive cough	6.7% 2/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Respiratory, thoracic and mediastinal disorders Dyspnoea	16.7% 5/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Respiratory, thoracic and mediastinal disorders Epistaxis	13.3% 4/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	10.0% 3/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Nervous system disorders Dizziness	20.0% 6/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Nervous system disorders Presyncope	10.0% 3/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Nervous system disorders Headache	16.7% 5/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Nervous system disorders Dysgeusia	10.0% 3/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Infections and infestations Paronychia	13.3% 4/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Infections and infestations Skin infection	10.0% 3/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Infections and infestations Fungal skin infection	6.7% 2/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Injury, poisoning and procedural complications Radiation skin injury	6.7% 2/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Injury, poisoning and procedural complications Skin laceration	6.7% 2/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Blood and lymphatic system disorders Anaemia	23.3% 7/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Eye disorders Blepharitis	6.7% 2/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Eye disorders Vision blurred	6.7% 2/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Renal and urinary disorders Proteinuria	16.7% 5/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Vascular disorders Hypotension	13.3% 4/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Musculoskeletal and connective tissue disorders Back pain	6.7% 2/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Psychiatric disorders Confusional state	10.0% 3/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Psychiatric disorders Insomnia	10.0% 3/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Psychiatric disorders Agitation	6.7% 2/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	6.7% 2/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.
Injury, poisoning and procedural complications Fall	10.0% 3/30 • Adverse events were collected from initiation of treatment until 30 days after discontinuing treatment or initiation of new anti-cancer medication.

Additional Information

Chief Medical Officer

Celldex Therapeutics

Phone: 844-723-9363

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place