Trial Outcomes & Findings for Carboplatin, Nab-Paclitaxel, Durvalumab Before Surgery and Adjuvant Therapy in Head and Neck Squamous Cell Carcinoma (NCT NCT03174275)

Last Updated: 2025-02-07

Results Overview

The pCRR was assessed via surgical pathology report. Pathologic complete response will require no viable cancer cells on the surgical pathology report after neoadjuvant treatment with carboplatin, nab-paclitaxel, and durvalumab. This study protocol requires the same neoadjuvant therapy and surgery for all subjects. The primary outcome measure is the complete pathologic response defined by the surgical pathology report and is unrelated to adjuvant therapy.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

39 participants

Primary outcome timeframe

After surgery (approximately 8-12 weeks after start of study treatment)

Results posted on

2025-02-07

Participant Flow

Participants were recruited from 12/19/2017 through 11/09/2021 at 4 cancer centers in the United States.

A total of 44 participants consented, but 5 were deemed to be ineligible, and 39 subjects enrolled in the study; 37 out of 39 subjects completed neoadjuvant therapy, and 2 subjects were off the treatment due to toxicity; 35 out of 37 subjects underwent surgery at study centers, one subject had surgery elsewhere, and one subject declined the surgery. Subjects received adjuvant therapy based on surgical pathology results and treatment progress was submitted separately.

Participant milestones

Participant milestones
Measure	All Study Subjects Subjects received at least one dose of study treatment
Overall Study (Until End of Surgery) STARTED	39
Overall Study (Until End of Surgery) COMPLETED	25
Overall Study (Until End of Surgery) NOT COMPLETED	14
Adjuvant Chemotherapy STARTED	21
Adjuvant Chemotherapy COMPLETED	13
Adjuvant Chemotherapy NOT COMPLETED	8
Adjuvant Durvalumab STARTED	35
Adjuvant Durvalumab COMPLETED	25
Adjuvant Durvalumab NOT COMPLETED	10
Adjuvant Radiotherapy STARTED	21
Adjuvant Radiotherapy COMPLETED	14
Adjuvant Radiotherapy NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	All Study Subjects Subjects received at least one dose of study treatment
Overall Study (Until End of Surgery) Adverse Event	4
Overall Study (Until End of Surgery) Withdrawal by Subject	9
Overall Study (Until End of Surgery) Lack of Efficacy	1
Adjuvant Chemotherapy Withdrawal by Subject	6
Adjuvant Chemotherapy Progression	1
Adjuvant Chemotherapy Adverse Event	1
Adjuvant Durvalumab Withdrawal by Subject	6
Adjuvant Durvalumab Progression	1
Adjuvant Durvalumab Adverse Event	3
Adjuvant Radiotherapy Withdrawal by Subject	5
Adjuvant Radiotherapy Progression	1
Adjuvant Radiotherapy Adverse Event	1

Baseline Characteristics

Carboplatin, Nab-Paclitaxel, Durvalumab Before Surgery and Adjuvant Therapy in Head and Neck Squamous Cell Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects n=39 Participants All subjects received at least one dose of study treatment, from any of the arms (low risk, medium risk, and high risk). This study protocol requires the same neoadjuvant therapy and surgery for all subjects. Adjuvant treatment is assigned based on the risk group. Adjuvant treatment arms were not randomized. Therefore, baseline characteristics were reported based on the whole group.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	4 Participants n=5 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	39 participants n=5 Participants

PRIMARY outcome

Timeframe: After surgery (approximately 8-12 weeks after start of study treatment)

Population: Subjects received treatment in 4 cancer centers in the United States.

Outcome measures

Outcome measures
Measure	Pathologic Complete Response n=35 Participants All subjects received neoadjuvant chemotherapy and underwent surgery, and histopathological analyses were completed.
Pathologic Complete Response Rate (pCRR) After Induction Chemotherapy With Carboplatin, Nab-paclitaxel, and Durvalumab in Previously Untreated Stage III and IV SCCHN Amenable to Surgical Resection Pathologic complete response was achieved	10 Participants
Pathologic Complete Response Rate (pCRR) After Induction Chemotherapy With Carboplatin, Nab-paclitaxel, and Durvalumab in Previously Untreated Stage III and IV SCCHN Amenable to Surgical Resection Pathologic complete response was not achieved	25 Participants

SECONDARY outcome

Timeframe: 1-4 weeks post induction chemotherapy

Clinical complete response rate and clinical response rate (CR + PR) associated with induction chemotherapy will be estimated using RECIST 1.1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: After surgery (approximately 8-12 weeks after start of study treatment)

Risk level pre-induction will be based on physical examination and imaging and will be defined and documented in electronic Case Report Forms (eCRF) prior to the initiation of induction therapy. Post-induction risk level will be determined based on pathologic evaluation of surgical specimen.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

PFS will be defined as the time from day 1 of study treatment until progression per RECIST 1.1

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Overall survival will be defined as the time from day 1 of study treatment until death from any cause

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 90 days after the last dose of study treatment

Safety associated with both induction alone and with 3 part therapy consisting of induction chemotherapy, surgery and risk-adapted use of chemoradiation will be assessed via the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 8-12 weeks after the last dose of study treatment

Pre-treatment specimens will be studied for predictive markers of treatment response. Paired pre- and post-treatment specimens will be compared to assess for changes in the tumor micro-environment.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 8-12 weeks after the last dose of study treatment

Pre-treatment specimens will be studied for predictive markers of treatment response. Paired pre- and post-treatment specimens will be compared to assess for changes in the tumor micro-environment.

Outcome measures

Outcome data not reported

Adverse Events

All Subjects

Serious events: 9 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Subjects n=39 participants at risk This study protocol requires the same neoadjuvant therapy and surgery for all subjects. Adjuvant treatment is assigned based on the risk group. Adjuvant treatment arms were not randomized. Therefore, Adverse Events were reported based on the whole group.
Blood and lymphatic system disorders Febrile neutropenia	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Cardiac disorders Atrial fibrillation	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Endocrine disorders Endocrine disorders - Other, specify	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Gastrointestinal disorders Dysphagia	7.7% 3/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
General disorders General disorders and administration site conditions - Other, specify	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Infections and infestations Lung infection	5.1% 2/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Infections and infestations Sepsis	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Infections and infestations Skin infection	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Infections and infestations Tracheitis	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Infections and infestations Urinary tract infection	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Injury, poisoning and procedural complications Fracture	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Metabolism and nutrition disorders Dehydration	5.1% 2/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Metabolism and nutrition disorders Glucose intolerance	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Metabolism and nutrition disorders Hyperglycemia	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Respiratory, thoracic and mediastinal disorders Aspiration	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4

Other adverse events

Other adverse events
Measure	All Subjects n=39 participants at risk This study protocol requires the same neoadjuvant therapy and surgery for all subjects. Adjuvant treatment is assigned based on the risk group. Adjuvant treatment arms were not randomized. Therefore, Adverse Events were reported based on the whole group.
Blood and lymphatic system disorders Anemia	94.9% 37/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Blood and lymphatic system disorders Blood and lymphatic system disorders other	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Blood and lymphatic system disorders Leukocytosis	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Cardiac disorders Atrial fibrillation	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Cardiac disorders Cardiac disorders - Other, specify	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Cardiac disorders Heart failure	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Cardiac disorders Mitral valve disease	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Cardiac disorders Sinus bradycardia	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Cardiac disorders Sinus tachycardia	5.1% 2/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Ear and labyrinth disorders Ear pain	7.7% 3/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Ear and labyrinth disorders External ear pain	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Ear and labyrinth disorders Hearing impaired	7.7% 3/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Ear and labyrinth disorders Tinnitus	23.1% 9/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Endocrine disorders Hyperthyroidism	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Endocrine disorders Hypothyroidism	12.8% 5/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Eye disorders Blurred vision	7.7% 3/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Eye disorders Eye disorders - Other, specify	7.7% 3/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Eye disorders Flashing lights	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Eye disorders Floaters	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Eye disorders Photophobia	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Eye disorders Watering eyes	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Gastrointestinal disorders Abdominal pain	7.7% 3/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Gastrointestinal disorders Colitis	5.1% 2/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Gastrointestinal disorders Constipation	74.4% 29/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Gastrointestinal disorders Diarrhea	48.7% 19/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Gastrointestinal disorders Dry mouth	20.5% 8/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Gastrointestinal disorders Dysphagia	17.9% 7/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Gastrointestinal disorders Flatulence	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Gastrointestinal disorders Gastroesophageal reflux disease	20.5% 8/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	5.1% 2/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Gastrointestinal disorders Hemorrhoidal hemorrhage	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Gastrointestinal disorders Mucositis oral	35.9% 14/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Gastrointestinal disorders Nausea	71.8% 28/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Gastrointestinal disorders Oral hemorrhage	10.3% 4/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Gastrointestinal disorders oral pain	38.5% 15/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Gastrointestinal disorders Stomach pain	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Gastrointestinal disorders Vomiting	23.1% 9/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
General disorders Chills	7.7% 3/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
General disorders Edema face	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
General disorders Edema limbs	10.3% 4/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
General disorders Facial pain	5.1% 2/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
General disorders Fatigue	92.3% 36/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
General disorders Fever	12.8% 5/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
General disorders Flu like symptoms	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
General disorders General disorders and administration site conditions - Other, specify	12.8% 5/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
General disorders Localized edema	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
General disorders Malaise	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
General disorders Non-cardiac chest pain	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
General disorders Pain	25.6% 10/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Hepatobiliary disorders Autoimmune disorder	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Infections and infestations Infections and infestations - Other, specify	7.7% 3/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Infections and infestations Lung infection	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Infections and infestations Mucosal infection	12.8% 5/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Infections and infestations Paronychia	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Infections and infestations Sepsis	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Infections and infestations Sinusitis	5.1% 2/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Infections and infestations Skin infection	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Injury, poisoning and procedural complications Dermatitis radiation	28.2% 11/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Injury, poisoning and procedural complications Fracture	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specify	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Injury, poisoning and procedural complications Postoperative hemorrhage	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Injury, poisoning and procedural complications Wound complication	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Investigations Alanine aminotransferase increased	28.2% 11/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Investigations Alkaline phosphatase increased	5.1% 2/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Investigations Aspartate aminotransferase increased	25.6% 10/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Investigations Blood bilirubin increased	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Investigations Cholesterol high	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Investigations Creatinine increased	12.8% 5/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Investigations Lipase increased	10.3% 4/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Investigations Lymphocyte count decreased	69.2% 27/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Investigations Neutrophil count decreased	69.2% 27/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Investigations Platelet count decreased	59.0% 23/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Investigations Weight loss	33.3% 13/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Investigations White blood cell decreased	76.9% 30/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Metabolism and nutrition disorders Anorexia	20.5% 8/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Metabolism and nutrition disorders Dehydration	20.5% 8/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Metabolism and nutrition disorders Hypercalcemia	12.8% 5/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Metabolism and nutrition disorders Hyperglycemia	15.4% 6/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Metabolism and nutrition disorders Hyperkalemia	23.1% 9/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Metabolism and nutrition disorders Hypermagnesemia	10.3% 4/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Metabolism and nutrition disorders Hypernatremia	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Metabolism and nutrition disorders Hypoalbuminemia	28.2% 11/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Metabolism and nutrition disorders Hypocalcemia	12.8% 5/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Metabolism and nutrition disorders Hypokalemia	33.3% 13/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Metabolism and nutrition disorders Hypomagnesemia	41.0% 16/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Metabolism and nutrition disorders Hyponatremia	51.3% 20/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Metabolism and nutrition disorders Hypophosphatemia	5.1% 2/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Musculoskeletal and connective tissue disorders Arthralgia	10.3% 4/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Musculoskeletal and connective tissue disorders Arthritis	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Musculoskeletal and connective tissue disorders Back pain	5.1% 2/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Musculoskeletal and connective tissue disorders Bone pain	5.1% 2/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	7.7% 3/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Musculoskeletal and connective tissue disorders Myalgia	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Musculoskeletal and connective tissue disorders Neck pain	7.7% 3/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Musculoskeletal and connective tissue disorders Pain in extremity	5.1% 2/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	5.1% 2/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Nervous system disorders Dizziness	5.1% 2/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Nervous system disorders Dysarthria	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Nervous system disorders Dysgeusia	38.5% 15/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Nervous system disorders Headache	15.4% 6/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Nervous system disorders Memory impairment	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Nervous system disorders Paresthesia	17.9% 7/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Nervous system disorders Peripheral sensory neuropathy	25.6% 10/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Nervous system disorders Seizure	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Nervous system disorders Stroke	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Nervous system disorders Tremor	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Psychiatric disorders Anxiety	28.2% 11/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Psychiatric disorders Depression	5.1% 2/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Psychiatric disorders Insomnia	35.9% 14/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Renal and urinary disorders Acute kidney injury	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Renal and urinary disorders Renal and urinary disorders - Other, specify	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Renal and urinary disorders Urinary frequency	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Renal and urinary disorders Urinary retention	5.1% 2/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	7.7% 3/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Respiratory, thoracic and mediastinal disorders Cough	15.4% 6/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Respiratory, thoracic and mediastinal disorders Dyspnea	5.1% 2/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Respiratory, thoracic and mediastinal disorders Epistaxis	23.1% 9/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Respiratory, thoracic and mediastinal disorders Hoarseness	7.7% 3/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Respiratory, thoracic and mediastinal disorders Hypoxia	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Respiratory, thoracic and mediastinal disorders Laryngeal edema	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Respiratory, thoracic and mediastinal disorders Nasal congestion	7.7% 3/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Respiratory, thoracic and mediastinal disorders Postnasal drip	7.7% 3/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Respiratory, thoracic and mediastinal disorders Productive cough	10.3% 4/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	10.3% 4/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Respiratory, thoracic and mediastinal disorders Sore throat	15.4% 6/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Skin and subcutaneous tissue disorders Alopecia	69.2% 27/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Skin and subcutaneous tissue disorders Dry skin	10.3% 4/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Skin and subcutaneous tissue disorders Nail discoloration	5.1% 2/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Skin and subcutaneous tissue disorders Pain of skin	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Skin and subcutaneous tissue disorders Pruritus	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Skin and subcutaneous tissue disorders Rash acneiform	10.3% 4/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Skin and subcutaneous tissue disorders Rash maculo-papular	41.0% 16/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	12.8% 5/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Skin and subcutaneous tissue disorders Skin ulceration	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Vascular disorders Hypertension	12.8% 5/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Vascular disorders Hypotension	5.1% 2/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Vascular disorders Superficial thrombophlebitis	2.6% 1/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4
Vascular disorders Thromboembolic event	5.1% 2/39 • Adverse events were collected from day one of the study drug administration to 30 days after completion of adjuvant treatment, up to 9 months. CTCAEv4

Additional Information

Dr. Jared Weiss

University of North Carolina Lineberger Comprehensive Cancer Center

Phone: +1 919-843-7718

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Results should be deferred until published.
Publication restrictions are in place

Restriction type: OTHER