Trial Outcomes & Findings for RADVAX: A Stratified Phase I Trial of Pembrolizumab With Hypofractionated Radiotherapy in Patients With Advanced and Metastatic Cancers (NCT NCT02303990)
NCT ID: NCT02303990
Last Updated: 2021-05-12
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
59 participants
Primary outcome timeframe
2 years
Results posted on
2021-05-12
Participant Flow
Participant milestones
| Measure |
Single Arm
Hypofractionated RT and Pembro
Pembrolizumab
Radiotherapy
|
|---|---|
|
Overall Study
STARTED
|
59
|
|
Overall Study
COMPLETED
|
59
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
RADVAX: A Stratified Phase I Trial of Pembrolizumab With Hypofractionated Radiotherapy in Patients With Advanced and Metastatic Cancers
Baseline characteristics by cohort
| Measure |
Single Arm
n=59 Participants
Hypofractionated RT and Pembro
Pembrolizumab
Radiotherapy
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
27 Participants
n=5 Participants
|
|
Age, Continuous
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
59 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 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
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
56 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: 2 yearsOutcome measures
| Measure |
Single Arm
n=59 Participants
Hypofractionated RT and Pembro
Pembrolizumab
Radiotherapy
|
|---|---|
|
Number of Adverse Events
|
428 Adverse Events
|
Adverse Events
Single Arm
Serious events: 21 serious events
Other events: 55 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Single Arm
n=59 participants at risk
Hypofractionated RT and Pembro
Pembrolizumab
Radiotherapy
|
|---|---|
|
General disorders
Death
|
13.6%
8/59 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
1.7%
1/59 • 2 years
|
|
General disorders
Not Otherwise Specified
|
10.2%
6/59 • 2 years
|
|
Gastrointestinal disorders
Dehydration
|
1.7%
1/59 • 2 years
|
|
General disorders
Dizziness
|
1.7%
1/59 • 2 years
|
|
General disorders
Fatigue
|
1.7%
1/59 • 2 years
|
|
General disorders
Fever
|
1.7%
1/59 • 2 years
|
|
Cardiac disorders
Hypotension
|
1.7%
1/59 • 2 years
|
|
General disorders
Nausea
|
1.7%
1/59 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.7%
1/59 • 2 years
|
|
General disorders
Sepsis
|
1.7%
1/59 • 2 years
|
|
Gastrointestinal disorders
Small Intestine Obstruction
|
1.7%
1/59 • 2 years
|
Other adverse events
| Measure |
Single Arm
n=59 participants at risk
Hypofractionated RT and Pembro
Pembrolizumab
Radiotherapy
|
|---|---|
|
General disorders
Not otherwise specified
|
40.7%
24/59 • 2 years
|
|
General disorders
Abdominal distension
|
1.7%
1/59 • 2 years
|
|
General disorders
Abdominal Pain
|
18.6%
11/59 • 2 years
|
|
General disorders
Alkaline phosphatase increased
|
1.7%
1/59 • 2 years
|
|
General disorders
Alopecia
|
1.7%
1/59 • 2 years
|
|
General disorders
Anemia
|
1.7%
1/59 • 2 years
|
|
General disorders
Anorexia
|
35.6%
21/59 • 2 years
|
|
General disorders
Anxiety
|
8.5%
5/59 • 2 years
|
|
General disorders
Arthralgia
|
3.4%
2/59 • 2 years
|
|
General disorders
Anrhritis
|
1.7%
1/59 • 2 years
|
|
General disorders
Ataxia
|
1.7%
1/59 • 2 years
|
|
General disorders
Back Pain
|
8.5%
5/59 • 2 years
|
|
General disorders
Bloating
|
11.9%
7/59 • 2 years
|
|
General disorders
Blurred vision
|
3.4%
2/59 • 2 years
|
|
General disorders
Bone Pain
|
5.1%
3/59 • 2 years
|
|
General disorders
Bronchospasm
|
1.7%
1/59 • 2 years
|
|
General disorders
Bruising
|
3.4%
2/59 • 2 years
|
|
General disorders
Chest wall pain
|
1.7%
1/59 • 2 years
|
|
General disorders
Chills
|
6.8%
4/59 • 2 years
|
|
General disorders
Colitis
|
1.7%
1/59 • 2 years
|
|
General disorders
Confusion
|
8.5%
5/59 • 2 years
|
|
General disorders
Conjunctivitis
|
1.7%
1/59 • 2 years
|
|
General disorders
Constipation
|
22.0%
13/59 • 2 years
|
|
General disorders
Cough
|
25.4%
15/59 • 2 years
|
|
General disorders
Dehydration
|
8.5%
5/59 • 2 years
|
|
General disorders
Depressed Level of Consciousness
|
1.7%
1/59 • 2 years
|
|
General disorders
Depression
|
13.6%
8/59 • 2 years
|
|
General disorders
Dermatitis Radiation
|
1.7%
1/59 • 2 years
|
|
General disorders
Diarrhea
|
10.2%
6/59 • 2 years
|
|
General disorders
Dizziness
|
8.5%
5/59 • 2 years
|
|
General disorders
Dry Mouth
|
3.4%
2/59 • 2 years
|
|
General disorders
Dysgeusia
|
3.4%
2/59 • 2 years
|
|
General disorders
Dyspepsia
|
13.6%
8/59 • 2 years
|
|
General disorders
Dysphagia
|
5.1%
3/59 • 2 years
|
|
General disorders
Dyspnea
|
15.3%
9/59 • 2 years
|
|
General disorders
Edema limbs
|
10.2%
6/59 • 2 years
|
|
General disorders
Erythema Multiforme
|
1.7%
1/59 • 2 years
|
|
General disorders
Esphagitis
|
1.7%
1/59 • 2 years
|
|
General disorders
Extraocular muscle disorder
|
1.7%
1/59 • 2 years
|
|
General disorders
Facial muscle weakness
|
1.7%
1/59 • 2 years
|
|
General disorders
Fall
|
5.1%
3/59 • 2 years
|
|
General disorders
Fatigue
|
47.5%
28/59 • 2 years
|
|
General disorders
Fecal Incontinence
|
1.7%
1/59 • 2 years
|
|
General disorders
Fever
|
10.2%
6/59 • 2 years
|
|
General disorders
Flank pain
|
3.4%
2/59 • 2 years
|
|
General disorders
Flatulence
|
3.4%
2/59 • 2 years
|
|
General disorders
Flu like symptoms
|
1.7%
1/59 • 2 years
|
|
General disorders
Flushing
|
1.7%
1/59 • 2 years
|
|
General disorders
Gastritis
|
1.7%
1/59 • 2 years
|
|
General disorders
Gastroesophageal reflux disease
|
5.1%
3/59 • 2 years
|
|
General disorders
Generalized muscle weakness
|
3.4%
2/59 • 2 years
|
|
General disorders
Hand-and-foot syndrome
|
1.7%
1/59 • 2 years
|
|
General disorders
headache
|
10.2%
6/59 • 2 years
|
|
General disorders
Hematuria
|
1.7%
1/59 • 2 years
|
|
General disorders
Hoarseness
|
1.7%
1/59 • 2 years
|
|
General disorders
Hot flashes
|
1.7%
1/59 • 2 years
|
|
General disorders
Hypercalcemia
|
1.7%
1/59 • 2 years
|
|
General disorders
Hypoxia
|
1.7%
1/59 • 2 years
|
|
General disorders
Ileus
|
1.7%
1/59 • 2 years
|
|
General disorders
Insomnia
|
10.2%
6/59 • 2 years
|
|
General disorders
Localized Edema
|
5.1%
3/59 • 2 years
|
|
General disorders
Lymphocyte count decreased
|
3.4%
2/59 • 2 years
|
|
General disorders
Muscle weakness upper limb
|
1.7%
1/59 • 2 years
|
|
General disorders
Myalgia
|
1.7%
1/59 • 2 years
|
|
General disorders
Nausea
|
37.3%
22/59 • 2 years
|
|
General disorders
Neck Edema
|
1.7%
1/59 • 2 years
|
|
General disorders
Neck pain
|
5.1%
3/59 • 2 years
|
|
General disorders
Non-cardiac chest pain
|
3.4%
2/59 • 2 years
|
|
General disorders
pain
|
5.1%
3/59 • 2 years
|
|
General disorders
Pain in extremity
|
5.1%
3/59 • 2 years
|
|
General disorders
palpitations
|
5.1%
3/59 • 2 years
|
|
General disorders
paresthesia
|
3.4%
2/59 • 2 years
|
|
General disorders
Pelvic pain
|
1.7%
1/59 • 2 years
|
|
General disorders
Peripheral sensory neuropathy
|
1.7%
1/59 • 2 years
|
|
General disorders
Pleural effusion
|
6.8%
4/59 • 2 years
|
|
General disorders
portal vein thrombosis
|
1.7%
1/59 • 2 years
|
|
General disorders
pruritus
|
8.5%
5/59 • 2 years
|
|
General disorders
scalp pain
|
3.4%
2/59 • 2 years
|
|
General disorders
sepsis
|
1.7%
1/59 • 2 years
|
|
General disorders
Sinusititis
|
1.7%
1/59 • 2 years
|
|
General disorders
Sore throat
|
1.7%
1/59 • 2 years
|
|
General disorders
Upper respiratory infection
|
8.5%
5/59 • 2 years
|
|
General disorders
Urinary tract infection
|
3.4%
2/59 • 2 years
|
|
General disorders
Voice alteration
|
1.7%
1/59 • 2 years
|
|
General disorders
Vomiting
|
13.6%
8/59 • 2 years
|
|
General disorders
Weight loss
|
5.1%
3/59 • 2 years
|
|
General disorders
Wheezing
|
1.7%
1/59 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place