Trial Outcomes & Findings for A Study of Nivolumab in Selected Uterine Cancer Patients (NCT NCT03241745)
NCT ID: NCT03241745
Last Updated: 2024-12-27
Results Overview
will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
at 24 weeks
Results posted on
2024-12-27
Participant Flow
Participant milestones
| Measure |
Nivolumab
Nivolumab treatment: Nivolumab 480 mg IV once every 4 weeks. Treatment will continue until time of disease progression or until development of unacceptable toxicity, whichever comes first.
Nivolumab: Nivolumab 480 mg IV once every 4 weeks
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
29
|
Reasons for withdrawal
| Measure |
Nivolumab
Nivolumab treatment: Nivolumab 480 mg IV once every 4 weeks. Treatment will continue until time of disease progression or until development of unacceptable toxicity, whichever comes first.
Nivolumab: Nivolumab 480 mg IV once every 4 weeks
|
|---|---|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Death
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Treatment delay >28 days
|
2
|
|
Overall Study
Lack of Efficacy
|
14
|
Baseline Characteristics
A Study of Nivolumab in Selected Uterine Cancer Patients
Baseline characteristics by cohort
| Measure |
Nivolumab
n=35 Participants
Nivolumab treatment: Nivolumab 480 mg IV once every 4 weeks. Treatment will continue until time of disease progression or until development of unacceptable toxicity, whichever comes first.
Nivolumab: Nivolumab 480 mg IV once every 4 weeks
|
|---|---|
|
Age, Continuous
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 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
|
2 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
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at 24 weekswill be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)
Outcome measures
| Measure |
Nivolumab
n=35 Participants
Nivolumab treatment: Nivolumab 480 mg IV once every 4 weeks. Treatment will continue until time of disease progression or until development of unacceptable toxicity, whichever comes first.
Nivolumab: Nivolumab 480 mg IV once every 4 weeks
|
|---|---|
|
Progression-Free Survival
|
64.7 percentage of patients
Interval 46.5 to 100.0
|
Adverse Events
Nivolumab
Serious events: 12 serious events
Other events: 35 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
Nivolumab
n=35 participants at risk
Nivolumab treatment: Nivolumab 480 mg IV once every 4 weeks. Treatment will continue until time of disease progression or until development of unacceptable toxicity, whichever comes first.
Nivolumab: Nivolumab 480 mg IV once every 4 weeks
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
2.9%
1/35 • 24 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
5.7%
2/35 • 24 weeks
|
|
Eye disorders
Acute optic neuritis
|
2.9%
1/35 • 24 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
2.9%
1/35 • 24 weeks
|
|
Cardiac disorders
Atrioventricular Block Complete
|
2.9%
1/35 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.7%
2/35 • 24 weeks
|
|
Investigations
Blood bilirubin increased
|
2.9%
1/35 • 24 weeks
|
|
Nervous system disorders
Cognitive disturbance
|
2.9%
1/35 • 24 weeks
|
|
Investigations
Creatinine increased
|
2.9%
1/35 • 24 weeks
|
|
Infections and infestations
Device related infection
|
2.9%
1/35 • 24 weeks
|
|
Nervous system disorders
Dizziness
|
2.9%
1/35 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.7%
2/35 • 24 weeks
|
|
General disorders
Fever
|
2.9%
1/35 • 24 weeks
|
|
Blood and lymphatic system disorders
Hemolysis
|
2.9%
1/35 • 24 weeks
|
|
Cardiac disorders
Myocarditis
|
2.9%
1/35 • 24 weeks
|
|
Gastrointestinal disorders
Nausea
|
5.7%
2/35 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.9%
1/35 • 24 weeks
|
|
General disorders
Pain
|
2.9%
1/35 • 24 weeks
|
|
Gastrointestinal disorders
Pancreatitis
|
2.9%
1/35 • 24 weeks
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
2.9%
1/35 • 24 weeks
|
|
Renal and urinary disorders
Renal calculi
|
2.9%
1/35 • 24 weeks
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
2.9%
1/35 • 24 weeks
|
|
Vascular disorders
Thromboembolic Event
|
8.6%
3/35 • 24 weeks
|
|
Infections and infestations
Urinary tract infection
|
2.9%
1/35 • 24 weeks
|
|
Gastrointestinal disorders
Vomiting
|
5.7%
2/35 • 24 weeks
|
Other adverse events
| Measure |
Nivolumab
n=35 participants at risk
Nivolumab treatment: Nivolumab 480 mg IV once every 4 weeks. Treatment will continue until time of disease progression or until development of unacceptable toxicity, whichever comes first.
Nivolumab: Nivolumab 480 mg IV once every 4 weeks
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
5.7%
2/35 • 24 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
25.7%
9/35 • 24 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
2.9%
1/35 • 24 weeks
|
|
Eye disorders
Acute optic neuritis
|
2.9%
1/35 • 24 weeks
|
|
Investigations
Alanine aminotransferase increased
|
5.7%
2/35 • 24 weeks
|
|
Investigations
Alkaline phosphatase increased
|
8.6%
3/35 • 24 weeks
|
|
Immune system disorders
Allergic reaction
|
2.9%
1/35 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
2.9%
1/35 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.6%
3/35 • 24 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
11.4%
4/35 • 24 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
25.7%
9/35 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
28.6%
10/35 • 24 weeks
|
|
Gastrointestinal disorders
Ascites
|
2.9%
1/35 • 24 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
8.6%
3/35 • 24 weeks
|
|
Cardiac disorders
Atrioventricular block complete
|
2.9%
1/35 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.9%
1/35 • 24 weeks
|
|
Infections and infestations
Bleeding from gums
|
2.9%
1/35 • 24 weeks
|
|
Gastrointestinal disorders
Bloating
|
2.9%
1/35 • 24 weeks
|
|
Investigations
Blood bilirubin increased
|
2.9%
1/35 • 24 weeks
|
|
Eye disorders
Blurred vision
|
8.6%
3/35 • 24 weeks
|
|
Reproductive system and breast disorders
Breast pain
|
2.9%
1/35 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
2.9%
1/35 • 24 weeks
|
|
Infections and infestations
C. Difficile
|
2.9%
1/35 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
2.9%
1/35 • 24 weeks
|
|
General disorders
Chills
|
5.7%
2/35 • 24 weeks
|
|
Nervous system disorders
Cognitive disturbance
|
2.9%
1/35 • 24 weeks
|
|
Psychiatric disorders
Confusion
|
2.9%
1/35 • 24 weeks
|
|
Gastrointestinal disorders
Constipation
|
25.7%
9/35 • 24 weeks
|
|
Eye disorders
Corneal ulcer
|
2.9%
1/35 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.4%
4/35 • 24 weeks
|
|
Infections and infestations
COVID 19
|
5.7%
2/35 • 24 weeks
|
|
Investigations
Creatinine increased
|
5.7%
2/35 • 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cyst in Left Shoulder
|
2.9%
1/35 • 24 weeks
|
|
Psychiatric disorders
Depression
|
11.4%
4/35 • 24 weeks
|
|
Infections and infestations
Dermatitis radiation
|
2.9%
1/35 • 24 weeks
|
|
Infections and infestations
Device related infection
|
2.9%
1/35 • 24 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
37.1%
13/35 • 24 weeks
|
|
Nervous system disorders
Dizziness
|
22.9%
8/35 • 24 weeks
|
|
Eye disorders
Dry eye
|
2.9%
1/35 • 24 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
17.1%
6/35 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.4%
4/35 • 24 weeks
|
|
Nervous system disorders
Dysgeusia
|
8.6%
3/35 • 24 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
2.9%
1/35 • 24 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
2.9%
1/35 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
28.6%
10/35 • 24 weeks
|
|
General disorders
Edema limbs
|
11.4%
4/35 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.9%
1/35 • 24 weeks
|
|
Eye disorders
Extraocular muscle paresis
|
2.9%
1/35 • 24 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
14.3%
5/35 • 24 weeks
|
|
General disorders
Fatigue
|
42.9%
15/35 • 24 weeks
|
|
General disorders
Fever
|
25.7%
9/35 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.9%
1/35 • 24 weeks
|
|
Gastrointestinal disorders
Flatulence
|
2.9%
1/35 • 24 weeks
|
|
General disorders
Flu like symptoms
|
2.9%
1/35 • 24 weeks
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify (frequency)
|
2.9%
1/35 • 24 weeks
|
|
General disorders
Gait disturbance
|
2.9%
1/35 • 24 weeks
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
5.7%
2/35 • 24 weeks
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
2.9%
1/35 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
8.6%
3/35 • 24 weeks
|
|
Nervous system disorders
Headache
|
20.0%
7/35 • 24 weeks
|
|
Ear and labyrinth disorders
Hearing impaired
|
2.9%
1/35 • 24 weeks
|
|
Renal and urinary disorders
Hematuria
|
2.9%
1/35 • 24 weeks
|
|
Blood and lymphatic system disorders
Hemolysis
|
2.9%
1/35 • 24 weeks
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.9%
1/35 • 24 weeks
|
|
Infections and infestations
Herpes Zoster (no open vesicles)
|
2.9%
1/35 • 24 weeks
|
|
Vascular disorders
Hot flashes
|
5.7%
2/35 • 24 weeks
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
14.3%
5/35 • 24 weeks
|
|
Vascular disorders
Hypertension
|
20.0%
7/35 • 24 weeks
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.7%
2/35 • 24 weeks
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.9%
1/35 • 24 weeks
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.6%
3/35 • 24 weeks
|
|
Investigations
Hypomagnesemia
|
14.3%
5/35 • 24 weeks
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.6%
3/35 • 24 weeks
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.7%
2/35 • 24 weeks
|
|
Vascular disorders
Hypotension
|
5.7%
2/35 • 24 weeks
|
|
Endocrine disorders
Hypothyroidism
|
8.6%
3/35 • 24 weeks
|
|
Psychiatric disorders
Insomnia
|
8.6%
3/35 • 24 weeks
|
|
Eye disorders
Keratitis
|
2.9%
1/35 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Leg cramps
|
2.9%
1/35 • 24 weeks
|
|
Infections and infestations
Lip infection
|
2.9%
1/35 • 24 weeks
|
|
Investigations
Lipase increased
|
8.6%
3/35 • 24 weeks
|
|
General disorders
Localized edema
|
2.9%
1/35 • 24 weeks
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
2.9%
1/35 • 24 weeks
|
|
Vascular disorders
Lymphedema
|
2.9%
1/35 • 24 weeks
|
|
Investigations
Lymphocyte count decreased
|
2.9%
1/35 • 24 weeks
|
|
General disorders
Malaise
|
5.7%
2/35 • 24 weeks
|
|
Nervous system disorders
Memory impairment
|
8.6%
3/35 • 24 weeks
|
|
Infections and infestations
Mucosal infection
|
2.9%
1/35 • 24 weeks
|
|
Gastrointestinal disorders
Mucositis oral
|
5.7%
2/35 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.9%
1/35 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.4%
4/35 • 24 weeks
|
|
Cardiac disorders
Myocarditis
|
2.9%
1/35 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
17.1%
6/35 • 24 weeks
|
|
Gastrointestinal disorders
Nausea
|
48.6%
17/35 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.9%
1/35 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
2.9%
1/35 • 24 weeks
|
|
General disorders
Non-cardiac chest pain
|
5.7%
2/35 • 24 weeks
|
|
Infections and infestations
Overactive Bladder
|
2.9%
1/35 • 24 weeks
|
|
General disorders
Pain
|
14.3%
5/35 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.7%
2/35 • 24 weeks
|
|
Gastrointestinal disorders
Pancreatitis
|
2.9%
1/35 • 24 weeks
|
|
Reproductive system and breast disorders
Pelvic pain
|
8.6%
3/35 • 24 weeks
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.4%
4/35 • 24 weeks
|
|
Infections and infestations
Pharyngitis
|
2.9%
1/35 • 24 weeks
|
|
Eye disorders
Photophobia
|
2.9%
1/35 • 24 weeks
|
|
Reproductive system and breast disorders
Pneumonitis
|
2.9%
1/35 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.7%
2/35 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
31.4%
11/35 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
2.9%
1/35 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
20.0%
7/35 • 24 weeks
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
5.7%
2/35 • 24 weeks
|
|
Renal and urinary disorders
Renal calculi
|
2.9%
1/35 • 24 weeks
|
|
Eye disorders
Retinal vascular disorder
|
2.9%
1/35 • 24 weeks
|
|
Investigations
Serum amylase increased
|
2.9%
1/35 • 24 weeks
|
|
Infections and infestations
Shingles
|
2.9%
1/35 • 24 weeks
|
|
Infections and infestations
Sinusitis
|
2.9%
1/35 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
5.7%
2/35 • 24 weeks
|
|
Infections and infestations
Skin infection
|
8.6%
3/35 • 24 weeks
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.9%
1/35 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.7%
2/35 • 24 weeks
|
|
Vascular disorders
Thromboembolic event
|
8.6%
3/35 • 24 weeks
|
|
Ear and labyrinth disorders
Tinnitus
|
5.7%
2/35 • 24 weeks
|
|
Nervous system disorders
Tremor
|
2.9%
1/35 • 24 weeks
|
|
Endocrine disorders
Type 1 Diabetes
|
2.9%
1/35 • 24 weeks
|
|
Infections and infestations
Upper respiratory infection
|
17.1%
6/35 • 24 weeks
|
|
Renal and urinary disorders
Urinary frequency
|
8.6%
3/35 • 24 weeks
|
|
Renal and urinary disorders
Urinary incontinence
|
2.9%
1/35 • 24 weeks
|
|
Infections and infestations
Urinary tract infection
|
17.1%
6/35 • 24 weeks
|
|
Renal and urinary disorders
Urinary tract obstruction
|
2.9%
1/35 • 24 weeks
|
|
Renal and urinary disorders
Urinary tract pain
|
8.6%
3/35 • 24 weeks
|
|
Reproductive system and breast disorders
Vaginal discharge
|
5.7%
2/35 • 24 weeks
|
|
Reproductive system and breast disorders
Vaginal dryness
|
11.4%
4/35 • 24 weeks
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
2.9%
1/35 • 24 weeks
|
|
Infections and infestations
Vaginal infection
|
5.7%
2/35 • 24 weeks
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
2.9%
1/35 • 24 weeks
|
|
Reproductive system and breast disorders
Vaginal pain
|
2.9%
1/35 • 24 weeks
|
|
Gastrointestinal disorders
Vomiting
|
31.4%
11/35 • 24 weeks
|
|
Investigations
Weight gain
|
5.7%
2/35 • 24 weeks
|
|
Investigations
Weight loss
|
5.7%
2/35 • 24 weeks
|
Additional Information
Dr. Claire Friedman, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4247
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place