Trial Outcomes & Findings for HPV-16 Vaccination and Pembrolizumab Plus Cisplatin for "Intermediate Risk" HPV-16-associated Head and Neck Squamous Cell Carcinoma (NCT NCT04369937)
NCT ID: NCT04369937
Last Updated: 2026-05-13
Results Overview
The percentage of participants whose disease has to progressed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at 2 years. PFS will be calculated from treatment initiation to disease progression or death from any cause for 2 years. Per RECIST 1.1, Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
At 2 years
Results posted on
2026-05-13
Participant Flow
Participant milestones
| Measure |
IMRT + Pembrolizumab + Cisplatin + ISA101b
IMRT (Intensity Modulated Radiotherapy) of 70 Gy in 35 fractions over 7 weeks (5 fractions per week).
Pembrolizumab will be administered at 200 mg (fixed dose) IV every 3 weeks (+/- 3 days), beginning beginning one week (week -1) prior to concurrent cisplatin-IMRT.
Cisplatin will be administered at 100 mg/m2 IV on days 1(Week 0) and 22 (Week 3).
ISA101b will be administered as three rounds of vaccination 3-4 weeks apart via two SC injections per vaccination round at 100ug/peptide, before pembrolizumab treatment. Vaccination #1 will be administered 1 week before pembrolizumab.
IMRT (Intensity Modulated Radiotherapy): Radiation therapy
Pembrolizumab: A potent and highly selective humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between programmed cell death protein 1 (PD-1) and its ligands, PD-L1 and PD-L2.
Cisplatin: Chemotherapy
ISA101b: ISA101b is a therapeutic cancer vaccine that induces specific immune responses to the oncogenic E6 and E7 antigens from HPV16.
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
HPV-16 Vaccination and Pembrolizumab Plus Cisplatin for "Intermediate Risk" HPV-16-associated Head and Neck Squamous Cell Carcinoma
Baseline characteristics by cohort
| Measure |
IMRT + Pembrolizumab + Cisplatin + ISA101b
n=18 Participants
IMRT (Intensity Modulated Radiotherapy) of 70 Gy in 35 fractions over 7 weeks (5 fractions per week).
Pembrolizumab will be administered at 200 mg (fixed dose) IV every 3 weeks (+/- 3 days), beginning beginning one week (week -1) prior to concurrent cisplatin-IMRT.
Cisplatin will be administered at 100 mg/m2 IV on days 1(Week 0) and 22 (Week 3).
ISA101b will be administered as three rounds of vaccination 3-4 weeks apart via two SC injections per vaccination round at 100ug/peptide, before pembrolizumab treatment. Vaccination #1 will be administered 1 week before pembrolizumab.
IMRT (Intensity Modulated Radiotherapy): Radiation therapy
Pembrolizumab: A potent and highly selective humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between programmed cell death protein 1 (PD-1) and its ligands, PD-L1 and PD-L2.
Cisplatin: Chemotherapy
ISA101b: ISA101b is a therapeutic cancer vaccine that induces specific immune responses to the oncogenic E6 and E7 antigens from HPV16.
|
|---|---|
|
Age, Continuous
|
63 years
n=1512 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=1512 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=1512 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=1512 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=1512 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
|
ECOG
ECOG = 0
|
15 Participants
n=1512 Participants
|
|
ECOG
ECOG = 1
|
1 Participants
n=1512 Participants
|
|
ECOG
Unknown
|
2 Participants
n=1512 Participants
|
|
Overall Stage
STAGE IVA
|
7 Participants
n=1512 Participants
|
|
Overall Stage
STAGE III
|
5 Participants
n=1512 Participants
|
|
Overall Stage
STAGE IVB
|
4 Participants
n=1512 Participants
|
|
Overall Stage
STAGE II
|
1 Participants
n=1512 Participants
|
|
Overall Stage
STAGE IIIC
|
1 Participants
n=1512 Participants
|
|
Anatomic Location
OROPHARYNX - NOS
|
8 Participants
n=1512 Participants
|
|
Anatomic Location
TONGUE - BASE, NOS
|
7 Participants
n=1512 Participants
|
|
Anatomic Location
TONSIL - LINGUAL
|
1 Participants
n=1512 Participants
|
|
Anatomic Location
TONSIL - NOS
|
1 Participants
n=1512 Participants
|
|
Anatomic Location
TONSIL - TONSILLAR FOSSA
|
1 Participants
n=1512 Participants
|
|
Smoking Status
Greater than (>) 10 pack years
|
7 Participants
n=1512 Participants
|
|
Smoking Status
Less than (<) 10 pack years
|
2 Participants
n=1512 Participants
|
|
Smoking Status
Other (Chewing Tobacco, Pipe Tobacco, etc.)
|
2 Participants
n=1512 Participants
|
|
Smoking Status
Unknown
|
7 Participants
n=1512 Participants
|
|
T Stage
T4
|
7 Participants
n=1512 Participants
|
|
T Stage
T2
|
4 Participants
n=1512 Participants
|
|
T Stage
T1
|
2 Participants
n=1512 Participants
|
|
T Stage
T3
|
2 Participants
n=1512 Participants
|
|
T Stage
T2C
|
1 Participants
n=1512 Participants
|
|
T Stage
Unknown
|
2 Participants
n=1512 Participants
|
|
N Stage
N2
|
4 Participants
n=1512 Participants
|
|
N Stage
N3
|
4 Participants
n=1512 Participants
|
|
N Stage
N1
|
3 Participants
n=1512 Participants
|
|
N Stage
N2B
|
3 Participants
n=1512 Participants
|
|
N Stage
N0
|
1 Participants
n=1512 Participants
|
|
N Stage
N2A
|
1 Participants
n=1512 Participants
|
|
N Stage
Unknown
|
2 Participants
n=1512 Participants
|
PRIMARY outcome
Timeframe: At 2 yearsPopulation: Treated patients who were radiologically evaluable for response.
The percentage of participants whose disease has to progressed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at 2 years. PFS will be calculated from treatment initiation to disease progression or death from any cause for 2 years. Per RECIST 1.1, Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Outcome measures
| Measure |
IMRT + Pembrolizumab + Cisplatin + ISA101b
n=13 Participants
IMRT (Intensity Modulated Radiotherapy) of 70 Gy in 35 fractions over 7 weeks (5 fractions per week).
Pembrolizumab will be administered at 200 mg (fixed dose) IV every 3 weeks (+/- 3 days), beginning beginning one week (week -1) prior to concurrent cisplatin-IMRT.
Cisplatin will be administered at 100 mg/m2 IV on days 1(Week 0) and 22 (Week 3).
ISA101b will be administered as three rounds of vaccination 3-4 weeks apart via two SC injections per vaccination round at 100ug/peptide, before pembrolizumab treatment. Vaccination #1 will be administered 1 week before pembrolizumab.
IMRT (Intensity Modulated Radiotherapy): Radiation therapy
Pembrolizumab: A potent and highly selective humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between programmed cell death protein 1 (PD-1) and its ligands, PD-L1 and PD-L2.
Cisplatin: Chemotherapy
ISA101b: ISA101b is a therapeutic cancer vaccine that induces specific immune responses to the oncogenic E6 and E7 antigens from HPV16.
|
|---|---|
|
Progression-free Survival (PFS) at 2 Years
|
75.5 percentage of patients
Interval 54.9 to 100.0
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: All treated patients.
Number of patients who experienced Serious Adverse Events per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 that are possibly, probably or definitely related to study treatment.
Outcome measures
| Measure |
IMRT + Pembrolizumab + Cisplatin + ISA101b
n=18 Participants
IMRT (Intensity Modulated Radiotherapy) of 70 Gy in 35 fractions over 7 weeks (5 fractions per week).
Pembrolizumab will be administered at 200 mg (fixed dose) IV every 3 weeks (+/- 3 days), beginning beginning one week (week -1) prior to concurrent cisplatin-IMRT.
Cisplatin will be administered at 100 mg/m2 IV on days 1(Week 0) and 22 (Week 3).
ISA101b will be administered as three rounds of vaccination 3-4 weeks apart via two SC injections per vaccination round at 100ug/peptide, before pembrolizumab treatment. Vaccination #1 will be administered 1 week before pembrolizumab.
IMRT (Intensity Modulated Radiotherapy): Radiation therapy
Pembrolizumab: A potent and highly selective humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between programmed cell death protein 1 (PD-1) and its ligands, PD-L1 and PD-L2.
Cisplatin: Chemotherapy
ISA101b: ISA101b is a therapeutic cancer vaccine that induces specific immune responses to the oncogenic E6 and E7 antigens from HPV16.
|
|---|---|
|
Serious Adverse Events Related to Study Treatment
Hypoalbuminemia
|
4 Participants
|
|
Serious Adverse Events Related to Study Treatment
Hypocalcemia
|
3 Participants
|
|
Serious Adverse Events Related to Study Treatment
Hypokalemia
|
4 Participants
|
|
Serious Adverse Events Related to Study Treatment
Hypomagnesemia
|
5 Participants
|
|
Serious Adverse Events Related to Study Treatment
Hyponatremia
|
11 Participants
|
|
Serious Adverse Events Related to Study Treatment
Hypophosphatemia
|
1 Participants
|
|
Serious Adverse Events Related to Study Treatment
Hypotension
|
5 Participants
|
|
Serious Adverse Events Related to Study Treatment
Hypothyroidism
|
6 Participants
|
|
Serious Adverse Events Related to Study Treatment
Infections and infestations - Other
|
3 Participants
|
|
Serious Adverse Events Related to Study Treatment
Infusion related reaction
|
2 Participants
|
|
Serious Adverse Events Related to Study Treatment
Injection site reaction
|
9 Participants
|
|
Serious Adverse Events Related to Study Treatment
Insomnia
|
3 Participants
|
|
Serious Adverse Events Related to Study Treatment
Investigations - Other
|
3 Participants
|
|
Serious Adverse Events Related to Study Treatment
Lung infection
|
1 Participants
|
|
Serious Adverse Events Related to Study Treatment
Lymph gland infection
|
1 Participants
|
|
Serious Adverse Events Related to Study Treatment
Lymphedema
|
6 Participants
|
|
Serious Adverse Events Related to Study Treatment
Lymphocyte count decreased
|
18 Participants
|
|
Serious Adverse Events Related to Study Treatment
Malaise
|
1 Participants
|
|
Serious Adverse Events Related to Study Treatment
Mucositis oral
|
14 Participants
|
|
Serious Adverse Events Related to Study Treatment
Musculoskeletal and connective tissue disorder - Other
|
3 Participants
|
|
Serious Adverse Events Related to Study Treatment
Myalgia
|
4 Participants
|
|
Serious Adverse Events Related to Study Treatment
Nausea
|
12 Participants
|
|
Serious Adverse Events Related to Study Treatment
Neck edema
|
1 Participants
|
|
Serious Adverse Events Related to Study Treatment
Neck pain
|
3 Participants
|
|
Serious Adverse Events Related to Study Treatment
Neutrophil count decreased
|
12 Participants
|
|
Serious Adverse Events Related to Study Treatment
Oral pain
|
7 Participants
|
|
Serious Adverse Events Related to Study Treatment
Pain
|
1 Participants
|
|
Serious Adverse Events Related to Study Treatment
Pain in extremity
|
3 Participants
|
|
Serious Adverse Events Related to Study Treatment
Paresthesia
|
2 Participants
|
|
Serious Adverse Events Related to Study Treatment
Peripheral sensory neuropathy
|
1 Participants
|
|
Serious Adverse Events Related to Study Treatment
Platelet count decreased
|
11 Participants
|
|
Serious Adverse Events Related to Study Treatment
Postnasal drip
|
1 Participants
|
|
Serious Adverse Events Related to Study Treatment
Pruritus
|
5 Participants
|
|
Serious Adverse Events Related to Study Treatment
Rash maculo-papular
|
3 Participants
|
|
Serious Adverse Events Related to Study Treatment
Renal and urinary disorders - Other,
|
1 Participants
|
|
Serious Adverse Events Related to Study Treatment
Respiratory, thoracic and mediastinal disorders - Other
|
3 Participants
|
|
Serious Adverse Events Related to Study Treatment
Salivary duct inflammation
|
8 Participants
|
|
Serious Adverse Events Related to Study Treatment
Sepsis
|
1 Participants
|
|
Serious Adverse Events Related to Study Treatment
Sinus tachycardia
|
5 Participants
|
|
Serious Adverse Events Related to Study Treatment
Skin and subcutaneous tissue disorders - Other
|
3 Participants
|
|
Serious Adverse Events Related to Study Treatment
Sore Throat
|
8 Participants
|
|
Serious Adverse Events Related to Study Treatment
Stomach Pain
|
1 Participants
|
|
Serious Adverse Events Related to Study Treatment
Surgical and medical procedures - Other,
|
1 Participants
|
|
Serious Adverse Events Related to Study Treatment
Thrush
|
7 Participants
|
|
Serious Adverse Events Related to Study Treatment
Thyroid stimulating hormone increased
|
3 Participants
|
|
Serious Adverse Events Related to Study Treatment
Tinnitus
|
7 Participants
|
|
Serious Adverse Events Related to Study Treatment
Trismus
|
4 Participants
|
|
Serious Adverse Events Related to Study Treatment
Vaccination complication
|
1 Participants
|
|
Serious Adverse Events Related to Study Treatment
Vascular disorders - Other
|
1 Participants
|
|
Serious Adverse Events Related to Study Treatment
Vomiting
|
6 Participants
|
|
Serious Adverse Events Related to Study Treatment
Weight Loss
|
16 Participants
|
|
Serious Adverse Events Related to Study Treatment
White blood cell decreased
|
17 Participants
|
|
Serious Adverse Events Related to Study Treatment
Wound infection
|
1 Participants
|
|
Serious Adverse Events Related to Study Treatment
Arthralgia
|
1 Participants
|
|
Serious Adverse Events Related to Study Treatment
Blood and lymphatic system disorders - Other
|
1 Participants
|
|
Serious Adverse Events Related to Study Treatment
Blood lactate dehydrogenase increased
|
6 Participants
|
|
Serious Adverse Events Related to Study Treatment
Chills
|
4 Participants
|
|
Serious Adverse Events Related to Study Treatment
Constipation
|
4 Participants
|
|
Serious Adverse Events Related to Study Treatment
Creatinine increased
|
6 Participants
|
|
Serious Adverse Events Related to Study Treatment
Dehydration
|
7 Participants
|
|
Serious Adverse Events Related to Study Treatment
Dermatitis radiation
|
12 Participants
|
|
Serious Adverse Events Related to Study Treatment
Diarrhea
|
3 Participants
|
|
Serious Adverse Events Related to Study Treatment
Dizziness
|
6 Participants
|
|
Serious Adverse Events Related to Study Treatment
Dry mouth
|
17 Participants
|
|
Serious Adverse Events Related to Study Treatment
Dysgeusia
|
18 Participants
|
|
Serious Adverse Events Related to Study Treatment
Dyspepsia
|
1 Participants
|
|
Serious Adverse Events Related to Study Treatment
Dysphagia
|
9 Participants
|
|
Serious Adverse Events Related to Study Treatment
Edema limbs
|
1 Participants
|
|
Serious Adverse Events Related to Study Treatment
Endocrine disorders - Other
|
1 Participants
|
|
Serious Adverse Events Related to Study Treatment
Eosinophilia
|
1 Participants
|
|
Serious Adverse Events Related to Study Treatment
Epistaxis
|
1 Participants
|
|
Serious Adverse Events Related to Study Treatment
Fatigue
|
16 Participants
|
|
Serious Adverse Events Related to Study Treatment
Fever
|
4 Participants
|
|
Serious Adverse Events Related to Study Treatment
Fibrosis deep connective tissue
|
1 Participants
|
|
Serious Adverse Events Related to Study Treatment
Gastroesophageal reflux disease
|
3 Participants
|
|
Serious Adverse Events Related to Study Treatment
Gastrointestinal disorders - Other
|
4 Participants
|
|
Serious Adverse Events Related to Study Treatment
General disorders and administration site conditions - Other
|
2 Participants
|
|
Serious Adverse Events Related to Study Treatment
Generalized muscle weakness
|
2 Participants
|
|
Serious Adverse Events Related to Study Treatment
Headache
|
1 Participants
|
|
Serious Adverse Events Related to Study Treatment
Hearing impaired
|
2 Participants
|
|
Serious Adverse Events Related to Study Treatment
Hematoma
|
2 Participants
|
|
Serious Adverse Events Related to Study Treatment
Herpes simplex reactivation
|
1 Participants
|
|
Serious Adverse Events Related to Study Treatment
Hiccups
|
2 Participants
|
|
Serious Adverse Events Related to Study Treatment
Hoarseness
|
3 Participants
|
|
Serious Adverse Events Related to Study Treatment
Hypercalcemia
|
2 Participants
|
|
Serious Adverse Events Related to Study Treatment
Hyperglycemia
|
2 Participants
|
|
Serious Adverse Events Related to Study Treatment
Hypermagnesemia
|
1 Participants
|
|
Serious Adverse Events Related to Study Treatment
Hypertension
|
3 Participants
|
|
Serious Adverse Events Related to Study Treatment
Hyperthyroidism
|
2 Participants
|
|
Serious Adverse Events Related to Study Treatment
Hyperuricemia
|
2 Participants
|
|
Serious Adverse Events Related to Study Treatment
Autoimmune disorder
|
1 Participants
|
|
Serious Adverse Events Related to Study Treatment
Alkaline phosphatase increased
|
1 Participants
|
|
Serious Adverse Events Related to Study Treatment
Anaphylaxis
|
1 Participants
|
|
Serious Adverse Events Related to Study Treatment
Anemia
|
16 Participants
|
|
Serious Adverse Events Related to Study Treatment
Anorexia
|
11 Participants
|
|
Serious Adverse Events Related to Study Treatment
Anosmia
|
1 Participants
|
|
Serious Adverse Events Related to Study Treatment
Bloating
|
1 Participants
|
|
Serious Adverse Events Related to Study Treatment
Aspartate aminotransferase increased
|
4 Participants
|
|
Serious Adverse Events Related to Study Treatment
Aspiration
|
1 Participants
|
|
Serious Adverse Events Related to Study Treatment
Adult respiratory distress syndrome
|
1 Participants
|
|
Serious Adverse Events Related to Study Treatment
Alanine aminotransferase increased
|
3 Participants
|
POST_HOC outcome
Timeframe: Up to 3 yearsPopulation: Treated patients who were radiologically evaluable for response.
The length of time during and after the treatment that patients remain alive with disease that does not progress. PFS will be calculated from treatment initiation to disease progression or death from any cause or last follow up. Per RECIST 1.1, Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Outcome measures
| Measure |
IMRT + Pembrolizumab + Cisplatin + ISA101b
n=13 Participants
IMRT (Intensity Modulated Radiotherapy) of 70 Gy in 35 fractions over 7 weeks (5 fractions per week).
Pembrolizumab will be administered at 200 mg (fixed dose) IV every 3 weeks (+/- 3 days), beginning beginning one week (week -1) prior to concurrent cisplatin-IMRT.
Cisplatin will be administered at 100 mg/m2 IV on days 1(Week 0) and 22 (Week 3).
ISA101b will be administered as three rounds of vaccination 3-4 weeks apart via two SC injections per vaccination round at 100ug/peptide, before pembrolizumab treatment. Vaccination #1 will be administered 1 week before pembrolizumab.
IMRT (Intensity Modulated Radiotherapy): Radiation therapy
Pembrolizumab: A potent and highly selective humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between programmed cell death protein 1 (PD-1) and its ligands, PD-L1 and PD-L2.
Cisplatin: Chemotherapy
ISA101b: ISA101b is a therapeutic cancer vaccine that induces specific immune responses to the oncogenic E6 and E7 antigens from HPV16.
|
|---|---|
|
Progression-free Survival (PFS)
|
44.9 months
Interval 44.9 to
insufficient number of participants with events (\<50% of the patients experienced progression)
|
Adverse Events
IMRT + Pembrolizumab + Cisplatin + ISA101b
Serious events: 8 serious events
Other events: 18 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
IMRT + Pembrolizumab + Cisplatin + ISA101b
n=18 participants at risk
IMRT (Intensity Modulated Radiotherapy) of 70 Gy in 35 fractions over 7 weeks (5 fractions per week).
Pembrolizumab will be administered at 200 mg (fixed dose) IV every 3 weeks (+/- 3 days), beginning beginning one week (week -1) prior to concurrent cisplatin-IMRT.
Cisplatin will be administered at 100 mg/m2 IV on days 1(Week 0) and 22 (Week 3).
ISA101b will be administered as three rounds of vaccination 3-4 weeks apart via two SC injections per vaccination round at 100ug/peptide, before pembrolizumab treatment. Vaccination #1 will be administered 1 week before pembrolizumab.
IMRT (Intensity Modulated Radiotherapy): Radiation therapy
Pembrolizumab: A potent and highly selective humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between programmed cell death protein 1 (PD-1) and its ligands, PD-L1 and PD-L2.
Cisplatin: Chemotherapy
ISA101b: ISA101b is a therapeutic cancer vaccine that induces specific immune responses to the oncogenic E6 and E7 antigens from HPV16.
|
|---|---|
|
Cardiac disorders
Myocardial infarction
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Gastrointestinal disorders
Dysphagia
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Gastrointestinal disorders
Nausea
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Gastrointestinal disorders
Oral pain
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
General disorders
Chills
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
General disorders
Fever
|
11.1%
2/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
General disorders
Neck edema
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Immune system disorders
Anaphylaxis
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Infections and infestations
Lymph gland infection
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Infections and infestations
Sepsis
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
11.1%
2/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Nervous system disorders
Syncope
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Vascular disorders
Thromboembolic event
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Vascular disorders
Vascular disorders - Other, specify
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
Other adverse events
| Measure |
IMRT + Pembrolizumab + Cisplatin + ISA101b
n=18 participants at risk
IMRT (Intensity Modulated Radiotherapy) of 70 Gy in 35 fractions over 7 weeks (5 fractions per week).
Pembrolizumab will be administered at 200 mg (fixed dose) IV every 3 weeks (+/- 3 days), beginning beginning one week (week -1) prior to concurrent cisplatin-IMRT.
Cisplatin will be administered at 100 mg/m2 IV on days 1(Week 0) and 22 (Week 3).
ISA101b will be administered as three rounds of vaccination 3-4 weeks apart via two SC injections per vaccination round at 100ug/peptide, before pembrolizumab treatment. Vaccination #1 will be administered 1 week before pembrolizumab.
IMRT (Intensity Modulated Radiotherapy): Radiation therapy
Pembrolizumab: A potent and highly selective humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between programmed cell death protein 1 (PD-1) and its ligands, PD-L1 and PD-L2.
Cisplatin: Chemotherapy
ISA101b: ISA101b is a therapeutic cancer vaccine that induces specific immune responses to the oncogenic E6 and E7 antigens from HPV16.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
11.1%
2/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
16.7%
3/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
3/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Vascular disorders
Lymphedema
|
33.3%
6/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
11.1%
2/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Vascular disorders
Thromboembolic event
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Cardiac disorders
Palpitations
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Cardiac disorders
Right ventricular dysfunction
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Cardiac disorders
Sinus bradycardia
|
38.9%
7/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Cardiac disorders
Sinus tachycardia
|
44.4%
8/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Cardiac disorders
Supraventricular tachycardia
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Ear and labyrinth disorders
Ear pain
|
11.1%
2/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Ear and labyrinth disorders
Hearing impaired
|
11.1%
2/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Ear and labyrinth disorders
Tinnitus
|
38.9%
7/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Endocrine disorders
Hyperthyroidism
|
11.1%
2/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Endocrine disorders
Hypothyroidism
|
38.9%
7/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Eye disorders
Eye disorders - Other, specify
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Gastrointestinal disorders
Bloating
|
11.1%
2/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Gastrointestinal disorders
Constipation
|
55.6%
10/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
6/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Gastrointestinal disorders
Dry mouth
|
94.4%
17/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
2/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Gastrointestinal disorders
Dysphagia
|
55.6%
10/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
22.2%
4/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
22.2%
4/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Gastrointestinal disorders
Mucositis oral
|
77.8%
14/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Gastrointestinal disorders
Nausea
|
77.8%
14/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Gastrointestinal disorders
Oral pain
|
33.3%
6/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Gastrointestinal disorders
Salivary duct inflammation
|
44.4%
8/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Gastrointestinal disorders
Stomach pain
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
6/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
General disorders
Chills
|
16.7%
3/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
General disorders
Edema limbs
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
General disorders
Fatigue
|
88.9%
16/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
General disorders
Fever
|
16.7%
3/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
11.1%
2/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
General disorders
Generalized edema
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
General disorders
Injection site reaction
|
50.0%
9/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
General disorders
Malaise
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
General disorders
Pain
|
11.1%
2/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Hepatobiliary disorders
Cholecystitis
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Immune system disorders
Autoimmune disorder
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Infections and infestations
Device related infection
|
11.1%
2/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Infections and infestations
Herpes simplex reactivation
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
27.8%
5/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Infections and infestations
Lung infection
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Infections and infestations
Thrush
|
44.4%
8/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Infections and infestations
Wound infection
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
66.7%
12/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
11.1%
2/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Investigations
Alanine aminotransferase increased
|
22.2%
4/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Investigations
Alkaline phosphatase increased
|
11.1%
2/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Investigations
Aspartate aminotransferase increased
|
27.8%
5/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Investigations
Blood lactate dehydrogenase increased
|
72.2%
13/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Investigations
Cardiac troponin I increased
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Investigations
Cholesterol high
|
11.1%
2/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Investigations
Creatinine increased
|
33.3%
6/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Investigations
Investigations - Other, specify
|
33.3%
6/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Investigations
Lymphocyte count decreased
|
100.0%
18/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Investigations
Neutrophil count decreased
|
66.7%
12/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Investigations
Platelet count decreased
|
61.1%
11/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Investigations
Thyroid stimulating hormone increased
|
16.7%
3/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Investigations
Weight loss
|
88.9%
16/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Investigations
White blood cell decreased
|
94.4%
17/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
61.1%
11/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
38.9%
7/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
27.8%
5/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
55.6%
10/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
22.2%
4/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
11.1%
2/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
22.2%
4/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
33.3%
6/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
33.3%
6/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
16.7%
3/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
22.2%
4/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
27.8%
5/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
72.2%
13/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Musculoskeletal and connective tissue disorders
Fibrosis deep connective tissue
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
16.7%
3/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
22.2%
4/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
22.2%
4/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
27.8%
5/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
22.2%
4/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
22.2%
4/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
55.6%
10/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
27.8%
5/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
22.2%
4/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
16.7%
3/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Vascular disorders
Hematoma
|
11.1%
2/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Nervous system disorders
Anosmia
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Nervous system disorders
Dizziness
|
33.3%
6/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Nervous system disorders
Dysgeusia
|
100.0%
18/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Nervous system disorders
Headache
|
11.1%
2/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Vascular disorders
Hypertension
|
72.2%
13/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Vascular disorders
Hypotension
|
33.3%
6/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Nervous system disorders
Paresthesia
|
11.1%
2/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Nervous system disorders
Stroke
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Nervous system disorders
Syncope
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Nervous system disorders
Tremor
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Psychiatric disorders
Agitation
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Psychiatric disorders
Anxiety
|
22.2%
4/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Psychiatric disorders
Depression
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Psychiatric disorders
Insomnia
|
27.8%
5/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Renal and urinary disorders
Renal calculi
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Renal and urinary disorders
Urinary urgency
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.8%
5/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.1%
2/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Blood and lymphatic system disorders
Anemia
|
94.4%
17/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
11.1%
2/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
|
Cardiac disorders
Atrial fibrillation
|
5.6%
1/18 • Adverse events data were collected for a total of 39 months. All-Cause Mortality data were collected for a total of 5 years, 8 months.
|
Additional Information
Barbara M Stadterman, MPH, MSCR
UPMC Hillman Cancer Center
Phone: 412-647-5554
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place