Trial Outcomes & Findings for A Study of Chemoradiation Plus Pembrolizumab for Locally Advanced Laryngeal Squamous Cell Carcinoma (NCT NCT02759575)
NCT ID: NCT02759575
Last Updated: 2021-03-12
Results Overview
Greater than 2 grade 3 or 4 adverse events that are definitely, probably or possibly related to the pembrolizumab in the first cohort of 6 participants
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
9 participants
Primary outcome timeframe
30 days following completion of treatment for the first 6 participants
Results posted on
2021-03-12
Participant Flow
Participant milestones
| Measure |
Pembrolizumab
Pembrolizumab every 3 weeks in combination with 7 weeks of radiation therapy and every 3 week cisplatin
Pembrolizumab: 200mg every 3 weeks starting 3 weeks prior to chemoradiotherapy. Maximum of 4 doses
Radiation Therapy: 70 Gy in 35 fractions over 7 weeks
Cisplatin: 100 mg/m2 every 3 weeks starting on day 1 of chemoradiotherapy. Maximum of 3 doses.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Chemoradiation Plus Pembrolizumab for Locally Advanced Laryngeal Squamous Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Pembrolizumab
n=9 Participants
Pembrolizumab every 3 weeks in combination with 7 weeks of radiation therapy and every 3 week cisplatin
Pembrolizumab: 200mg every 3 weeks starting 3 weeks prior to chemoradiotherapy. Maximum of 4 doses
Radiation Therapy: 70 Gy in 35 fractions over 7 weeks
Cisplatin: 100 mg/m2 every 3 weeks starting on day 1 of chemoradiotherapy. Maximum of 3 doses.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
54 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 days following completion of treatment for the first 6 participantsPopulation: These are the first six participants that completed the study.
Greater than 2 grade 3 or 4 adverse events that are definitely, probably or possibly related to the pembrolizumab in the first cohort of 6 participants
Outcome measures
| Measure |
Pembrolizumab
n=6 Participants
Pembrolizumab every 3 weeks in combination with 7 weeks of radiation therapy and every 3 week cisplatin
Pembrolizumab: 200mg every 3 weeks starting 3 weeks prior to chemoradiotherapy. Maximum of 4 doses
Radiation Therapy: 70 Gy in 35 fractions over 7 weeks
Cisplatin: 100 mg/m2 every 3 weeks starting on day 1 of chemoradiotherapy. Maximum of 3 doses.
|
|---|---|
|
Number of Participants With Treatment-Related Grade 3 or 4 Adverse Events as Assessed by CTCAE V4.0
|
2 Participants
|
PRIMARY outcome
Timeframe: 18 monthsThis is the number of subjects that are laryngectomy-free at 18 months.
Outcome measures
| Measure |
Pembrolizumab
n=9 Participants
Pembrolizumab every 3 weeks in combination with 7 weeks of radiation therapy and every 3 week cisplatin
Pembrolizumab: 200mg every 3 weeks starting 3 weeks prior to chemoradiotherapy. Maximum of 4 doses
Radiation Therapy: 70 Gy in 35 fractions over 7 weeks
Cisplatin: 100 mg/m2 every 3 weeks starting on day 1 of chemoradiotherapy. Maximum of 3 doses.
|
|---|---|
|
Laryngectomy-free Survival in Locally Advanced Laryngeal Squamous Cell Carcinoma
|
9 Participants
|
SECONDARY outcome
Timeframe: 12 monthsThis is the number of subjects that are laryngectomy-free at 12 months.
Outcome measures
| Measure |
Pembrolizumab
n=9 Participants
Pembrolizumab every 3 weeks in combination with 7 weeks of radiation therapy and every 3 week cisplatin
Pembrolizumab: 200mg every 3 weeks starting 3 weeks prior to chemoradiotherapy. Maximum of 4 doses
Radiation Therapy: 70 Gy in 35 fractions over 7 weeks
Cisplatin: 100 mg/m2 every 3 weeks starting on day 1 of chemoradiotherapy. Maximum of 3 doses.
|
|---|---|
|
Laryngectomy-free Survival in Locally Advanced Laryngeal Squamous Cell Carcinoma
|
9 Participants
|
Adverse Events
Pembrolizumab
Serious events: 3 serious events
Other events: 9 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Pembrolizumab
n=9 participants at risk
Pembrolizumab every 3 weeks in combination with 7 weeks of radiation therapy and every 3 week cisplatin
Pembrolizumab: 200mg every 3 weeks starting 3 weeks prior to chemoradiotherapy. Maximum of 4 doses
Radiation Therapy: 70 Gy in 35 fractions over 7 weeks
Cisplatin: 100 mg/m2 every 3 weeks starting on day 1 of chemoradiotherapy. Maximum of 3 doses.
|
|---|---|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other- Diabetic Ketoacidosis
|
11.1%
1/9 • Number of events 3 • 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Acute Kidney Disease
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
General disorders
Failure to Thrive
|
11.1%
1/9 • Number of events 1 • 2 years
|
Other adverse events
| Measure |
Pembrolizumab
n=9 participants at risk
Pembrolizumab every 3 weeks in combination with 7 weeks of radiation therapy and every 3 week cisplatin
Pembrolizumab: 200mg every 3 weeks starting 3 weeks prior to chemoradiotherapy. Maximum of 4 doses
Radiation Therapy: 70 Gy in 35 fractions over 7 weeks
Cisplatin: 100 mg/m2 every 3 weeks starting on day 1 of chemoradiotherapy. Maximum of 3 doses.
|
|---|---|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
33.3%
3/9 • Number of events 5 • 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.1%
1/9 • Number of events 4 • 2 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
22.2%
2/9 • Number of events 2 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Infections and infestations
Orchitis
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Injury, poisoning and procedural complications
Tenderness (around feeding tube)
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
33.3%
3/9 • Number of events 4 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mucositis
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Psychiatric disorders
Libido decreased
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
General disorders
Localized edema
|
22.2%
2/9 • Number of events 3 • 2 years
|
|
Investigations
Lymphocyte count decreased
|
22.2%
2/9 • Number of events 3 • 2 years
|
|
Infections and infestations
Mucosal infection
|
22.2%
2/9 • Number of events 2 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Sensitive fingertips
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Neck soft tissue necrosis
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Two white spots on ventricular fold
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Nervous system disorders
Intermittent lightheadedness
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Oral dysesthesia
|
22.2%
2/9 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Oral pain
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Nervous system disorders
Paresthesia
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
44.4%
4/9 • Number of events 4 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Proteinuria
|
22.2%
2/9 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Salivary duct inflammation
|
55.6%
5/9 • Number of events 5 • 2 years
|
|
Infections and infestations
Sepsis
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin of lower lip
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Infections and infestations
Stoma site infection
|
22.2%
2/9 • Number of events 3 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
11.1%
1/9 • Number of events 2 • 2 years
|
|
Renal and urinary disorders
Acute Kidney Injury
|
44.4%
4/9 • Number of events 6 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
3/9 • Number of events 5 • 2 years
|
|
Psychiatric disorders
Anxiety
|
33.3%
3/9 • Number of events 3 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Colitis
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
33.3%
3/9 • Number of events 4 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
44.4%
4/9 • Number of events 4 • 2 years
|
|
Investigations
Creatinine increased
|
11.1%
1/9 • Number of events 2 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
3/9 • Number of events 4 • 2 years
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
100.0%
9/9 • Number of events 12 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
3/9 • Number of events 3 • 2 years
|
|
Gastrointestinal disorders
Dry mouth
|
88.9%
8/9 • Number of events 9 • 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Nervous system disorders
Dysgeusia
|
88.9%
8/9 • Number of events 15 • 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
77.8%
7/9 • Number of events 13 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
22.2%
2/9 • Number of events 2 • 2 years
|
|
General disorders
Fatigue
|
88.9%
8/9 • Number of events 15 • 2 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
General disorders
Increased Mucus Production
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
22.2%
2/9 • Number of events 2 • 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
44.4%
4/9 • Number of events 5 • 2 years
|
|
Psychiatric disorders
Insomnia
|
22.2%
2/9 • Number of events 2 • 2 years
|
|
Vascular disorders
Lymphedema
|
33.3%
3/9 • Number of events 4 • 2 years
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
11.1%
1/9 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
55.6%
5/9 • Number of events 7 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
44.4%
4/9 • Number of events 8 • 2 years
|
|
Investigations
Neutrophil count decreased
|
22.2%
2/9 • Number of events 2 • 2 years
|
|
General disorders
Pain
|
22.2%
2/9 • Number of events 3 • 2 years
|
|
Investigations
Platelet count decreased
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
22.2%
2/9 • Number of events 2 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
22.2%
2/9 • Number of events 2 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Throat swelling
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
77.8%
7/9 • Number of events 12 • 2 years
|
|
Ear and labyrinth disorders
Tinnitus
|
55.6%
5/9 • Number of events 5 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
22.2%
2/9 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
3/9 • Number of events 3 • 2 years
|
|
Investigations
Weight loss
|
66.7%
6/9 • Number of events 14 • 2 years
|
|
Investigations
White blood cell decreased
|
22.2%
2/9 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
66.7%
6/9 • Number of events 10 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
22.2%
2/9 • Number of events 2 • 2 years
|
|
Eye disorders
Blurred vision
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Cardiac disorders
Electrocardiogram QT corrected interval prolonged
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Psychiatric disorders
Depression
|
33.3%
3/9 • Number of events 3 • 2 years
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Ear and labyrinth disorders
Hearing loss
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Ear and labyrinth disorders
Ear pain
|
11.1%
1/9 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
11.1%
1/9 • Number of events 1 • 2 years
|
Additional Information
Vinita Takiar, MD, PhD, Associate Professor
University of Cincinnati
Phone: (513)584-8956
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place