Trial Outcomes & Findings for Nivolumab With Standard of Care Chemotherapy for Peripheral T Cell Lymphomas (NCT NCT03586999)
NCT ID: NCT03586999
Last Updated: 2024-10-29
Results Overview
Efficacy will be measured according to 2017 RECIL criteria. Responses will be assessed by the investigator and will be based on PET/CT scan to be obtained after 6 cycles of induction chemotherapy.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
18 participants
Primary outcome timeframe
up to 100 days post transplant
Results posted on
2024-10-29
Participant Flow
Participant milestones
| Measure |
Nivolumab and EPOCH
Patients will all receive nivolumab in combination with standard dose adjusted EPOCH for a planned 6 cycles, unless treatment is stopped early for disease progression or toxicity. Patients that have already received up to 1 cycle of standard of care chemotherapy will receive 5 cycles of experimental nivolumab + DA-EPOCH (dose adjusted, continuous infusion etoposide, prednisone, vincristine, doxorubicin, and bolus dosing of cyclophosphamide) for a total of 6 cycles of chemotherapy.
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Nivolumab and EPOCH
Patients will all receive nivolumab in combination with standard dose adjusted EPOCH for a planned 6 cycles, unless treatment is stopped early for disease progression or toxicity. Patients that have already received up to 1 cycle of standard of care chemotherapy will receive 5 cycles of experimental nivolumab + DA-EPOCH (dose adjusted, continuous infusion etoposide, prednisone, vincristine, doxorubicin, and bolus dosing of cyclophosphamide) for a total of 6 cycles of chemotherapy.
|
|---|---|
|
Overall Study
Lack of Efficacy
|
2
|
Baseline Characteristics
Nivolumab With Standard of Care Chemotherapy for Peripheral T Cell Lymphomas
Baseline characteristics by cohort
| Measure |
Nivolumab and EPOCH
n=18 Participants
Patients will all receive nivolumab in combination with standard dose adjusted EPOCH for a planned 6 cycles, unless treatment is stopped early for disease progression or toxicity. Patients that have already received up to 1 cycle of standard of care chemotherapy will receive 5 cycles of experimental nivolumab + DA-EPOCH (dose adjusted, continuous infusion etoposide, prednisone, vincristine, doxorubicin, and bolus dosing of cyclophosphamide) for a total of 6 cycles of chemotherapy.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
63.16 years
STANDARD_DEVIATION 10.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 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
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 100 days post transplantEfficacy will be measured according to 2017 RECIL criteria. Responses will be assessed by the investigator and will be based on PET/CT scan to be obtained after 6 cycles of induction chemotherapy.
Outcome measures
| Measure |
Nivolumab and EPOCH
n=18 Participants
Patients will all receive nivolumab in combination with standard dose adjusted EPOCH for a planned 6 cycles, unless treatment is stopped early for disease progression or toxicity. Patients that have already received up to 1 cycle of standard of care chemotherapy will receive 5 cycles of experimental nivolumab + DA-EPOCH (dose adjusted, continuous infusion etoposide, prednisone, vincristine, doxorubicin, and bolus dosing of cyclophosphamide) for a total of 6 cycles of chemotherapy.
|
|---|---|
|
Efficacy: Complete Response Rate
|
11 Participants
|
SECONDARY outcome
Timeframe: up to 100 days after last dose of nivolumabToxicity analysis of nivolumab will be summarized by dose and severity as assessed by the Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0 and relationship to study drug or the amount of grade 4-5 non-hematologic toxicities.
Outcome measures
| Measure |
Nivolumab and EPOCH
n=18 Participants
Patients will all receive nivolumab in combination with standard dose adjusted EPOCH for a planned 6 cycles, unless treatment is stopped early for disease progression or toxicity. Patients that have already received up to 1 cycle of standard of care chemotherapy will receive 5 cycles of experimental nivolumab + DA-EPOCH (dose adjusted, continuous infusion etoposide, prednisone, vincristine, doxorubicin, and bolus dosing of cyclophosphamide) for a total of 6 cycles of chemotherapy.
|
|---|---|
|
Number of Participants With Adverse Events
|
18 Participants
|
SECONDARY outcome
Timeframe: up to 100 days post transplantPopulation: All patients on trial.
Efficacy will be measured according to 2017 RECIL criteria. Responses will be assessed by the investigator and will be based on PET/CT scan to be obtained after 6 cycles of induction chemotherapy. Complete response (CR), complete disappearance of all target lesions and Deauville score 1-3. Partial response (PR), ≥30% decrease in the sum of longest diameters of target lesions but not a CR and Deauville score 4-5. Stable disease (SD), \<30% decrease or ≤ 20% increase in the sum of longest diameters of target lesions. Progressive disease (PD), \>20% increase in the sum of longest diameters of target lesions, For small lymph nodes measuring \< 15 mm post-therapy, a minimum of 5 mm increase in longest diameter to \> 15 mm, or new lesions.
Outcome measures
| Measure |
Nivolumab and EPOCH
n=18 Participants
Patients will all receive nivolumab in combination with standard dose adjusted EPOCH for a planned 6 cycles, unless treatment is stopped early for disease progression or toxicity. Patients that have already received up to 1 cycle of standard of care chemotherapy will receive 5 cycles of experimental nivolumab + DA-EPOCH (dose adjusted, continuous infusion etoposide, prednisone, vincristine, doxorubicin, and bolus dosing of cyclophosphamide) for a total of 6 cycles of chemotherapy.
|
|---|---|
|
Efficacy: Overall Response Rate
|
16 Participants
|
SECONDARY outcome
Timeframe: up to 2 years after completion of treatmentPopulation: All patients treated on trial.
Efficacy will be measured according to 2017 RECIL criteria. Responses will be assessed by the investigator and will be based on PET/CT scan to be obtained after 6 cycles of induction chemotherapy.
Outcome measures
| Measure |
Nivolumab and EPOCH
n=18 Participants
Patients will all receive nivolumab in combination with standard dose adjusted EPOCH for a planned 6 cycles, unless treatment is stopped early for disease progression or toxicity. Patients that have already received up to 1 cycle of standard of care chemotherapy will receive 5 cycles of experimental nivolumab + DA-EPOCH (dose adjusted, continuous infusion etoposide, prednisone, vincristine, doxorubicin, and bolus dosing of cyclophosphamide) for a total of 6 cycles of chemotherapy.
|
|---|---|
|
Efficacy: Progression Free Survival Rate
|
14.5 months
Interval 7.5 to 22.2
|
SECONDARY outcome
Timeframe: up to 2 years after completion of treatmentPopulation: All patients treated on trial
Efficacy will be measured according to 2017 RECIL criteria. Responses will be assessed by the investigator and will be based on PET/CT scan to be obtained after 6 cycles of induction chemotherapy. Events defined as start of new treatment, progression, or death.
Outcome measures
| Measure |
Nivolumab and EPOCH
n=18 Participants
Patients will all receive nivolumab in combination with standard dose adjusted EPOCH for a planned 6 cycles, unless treatment is stopped early for disease progression or toxicity. Patients that have already received up to 1 cycle of standard of care chemotherapy will receive 5 cycles of experimental nivolumab + DA-EPOCH (dose adjusted, continuous infusion etoposide, prednisone, vincristine, doxorubicin, and bolus dosing of cyclophosphamide) for a total of 6 cycles of chemotherapy.
|
|---|---|
|
Efficacy: Event Free Survival
|
10.5 months
Interval 6.9 to 20.5
|
SECONDARY outcome
Timeframe: Within 6 months of treatmentPopulation: Only 17 participants had tumor tissue available.
We assessed PD-L1 expression using immunohistochemistry on pre-treatment tumor tissue. The outcome of measurement was complete response yes vs. no. Using logistic regression, we assessed if the percentage of PDL1+ cells was predictive of achieving a complete response.
Outcome measures
| Measure |
Nivolumab and EPOCH
n=17 Participants
Patients will all receive nivolumab in combination with standard dose adjusted EPOCH for a planned 6 cycles, unless treatment is stopped early for disease progression or toxicity. Patients that have already received up to 1 cycle of standard of care chemotherapy will receive 5 cycles of experimental nivolumab + DA-EPOCH (dose adjusted, continuous infusion etoposide, prednisone, vincristine, doxorubicin, and bolus dosing of cyclophosphamide) for a total of 6 cycles of chemotherapy.
|
|---|---|
|
Immune-related Predictors of Response
|
0.985 odds ratio
Interval 0.938 to 1.034
|
Adverse Events
Nivolumab and EPOCH
Serious events: 13 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nivolumab and EPOCH
n=18 participants at risk
Patients will all receive nivolumab in combination with standard dose adjusted EPOCH for a planned 6 cycles, unless treatment is stopped early for disease progression or toxicity. Patients that have already received up to 1 cycle of standard of care chemotherapy will receive 5 cycles of experimental nivolumab + DA-EPOCH (dose adjusted, continuous infusion etoposide, prednisone, vincristine, doxorubicin, and bolus dosing of cyclophosphamide) for a total of 6 cycles of chemotherapy.
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Cardiac disorders
Atrial fibrillation
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
General disorders
Dehydration
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Nervous system disorders
Encephalopathy
|
11.1%
2/18 • Number of events 2 • up to 100 days after last dose of nivolumab
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
16.7%
3/18 • Number of events 4 • up to 100 days after last dose of nivolumab
|
|
General disorders
Fever
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Gastrointestinal disorders
Gastritis
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Cardiac disorders
chest wall pain
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Injury, poisoning and procedural complications
iliacus/iliopsoas hematoma
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Psychiatric disorders
Altered Mental Status
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Gastrointestinal disorders
Clostridioides difficile
|
11.1%
2/18 • Number of events 2 • up to 100 days after last dose of nivolumab
|
|
Infections and infestations
Cellulitis
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Injury, poisoning and procedural complications
Chemotherapy Extravasation
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Infections and infestations
COVID-19 pneumonia
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Skin and subcutaneous tissue disorders
dermatologic toxicity c/w Stevens Johnson Syndrome
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Blood and lymphatic system disorders
Elevated Transaminases
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Infections and infestations
intra-abdominal infection
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
11.1%
2/18 • Number of events 5 • up to 100 days after last dose of nivolumab
|
|
Infections and infestations
Infected Biopsy Site
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Infections and infestations
neutropenic fever c/f SIRS
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Renal and urinary disorders
Pyelonephritis
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
16.7%
3/18 • Number of events 3 • up to 100 days after last dose of nivolumab
|
|
Infections and infestations
Sepsis
|
16.7%
3/18 • Number of events 4 • up to 100 days after last dose of nivolumab
|
|
Psychiatric disorders
Syncopal Episodes
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Infections and infestations
Urinary Tract Infection
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Renal and urinary disorders
Urinary Tract Infection
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
Other adverse events
| Measure |
Nivolumab and EPOCH
n=18 participants at risk
Patients will all receive nivolumab in combination with standard dose adjusted EPOCH for a planned 6 cycles, unless treatment is stopped early for disease progression or toxicity. Patients that have already received up to 1 cycle of standard of care chemotherapy will receive 5 cycles of experimental nivolumab + DA-EPOCH (dose adjusted, continuous infusion etoposide, prednisone, vincristine, doxorubicin, and bolus dosing of cyclophosphamide) for a total of 6 cycles of chemotherapy.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
27.8%
5/18 • Number of events 7 • up to 100 days after last dose of nivolumab
|
|
General disorders
Abdominal soft tissue nodules
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
General disorders
Abnormal Coordination
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
General disorders
activity change
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Renal and urinary disorders
Acute Kidney Injury
|
22.2%
4/18 • Number of events 4 • up to 100 days after last dose of nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
acute respiratory distress syndrome
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Skin and subcutaneous tissue disorders
acute skin pain 2/2 dermatologic toxicity
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Injury, poisoning and procedural complications
Acute tailbone (coccyx) pain
|
11.1%
2/18 • Number of events 4 • up to 100 days after last dose of nivolumab
|
|
Psychiatric disorders
Agitation
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
3/18 • Number of events 4 • up to 100 days after last dose of nivolumab
|
|
Investigations
Alkaline phosphatase increased
|
11.1%
2/18 • Number of events 3 • up to 100 days after last dose of nivolumab
|
|
Blood and lymphatic system disorders
Anemia
|
38.9%
7/18 • Number of events 23 • up to 100 days after last dose of nivolumab
|
|
Metabolism and nutrition disorders
Anorexia
|
11.1%
2/18 • Number of events 2 • up to 100 days after last dose of nivolumab
|
|
Investigations
Aspartate aminotransferase increased
|
11.1%
2/18 • Number of events 2 • up to 100 days after last dose of nivolumab
|
|
Cardiac disorders
asymptomatic bradycardia (intermittent)
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
11.1%
2/18 • Number of events 2 • up to 100 days after last dose of nivolumab
|
|
General disorders
autoimmune thyroiditis
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
3/18 • Number of events 4 • up to 100 days after last dose of nivolumab
|
|
Infections and infestations
Bacteremia
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
benign prostatic hyperplasia
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
biapical predominant ground glass opacities - chest
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Renal and urinary disorders
bilateral nephrolithiasis
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Infections and infestations
bilateral pneumonic infiltrates
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Renal and urinary disorders
bladder spasms
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
General disorders
blisters to feet c/w SJS
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
General disorders
blisters to palms c/w SJS
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Investigations
blood bilirubin increased
|
11.1%
2/18 • Number of events 2 • up to 100 days after last dose of nivolumab
|
|
Cardiac disorders
Elevated systolic blood pressure
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Infections and infestations
Cellulitis
|
16.7%
3/18 • Number of events 4 • up to 100 days after last dose of nivolumab
|
|
Blood and lymphatic system disorders
Pancytopenia
|
11.1%
2/18 • Number of events 2 • up to 100 days after last dose of nivolumab
|
|
Cardiac disorders
chest pain
|
11.1%
2/18 • Number of events 2 • up to 100 days after last dose of nivolumab
|
|
General disorders
Chills
|
38.9%
7/18 • Number of events 9 • up to 100 days after last dose of nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
chronic hypercapnic respiratory failure
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
General disorders
chronic pain syndrome
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
General disorders
Chronic venous stasis
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Skin and subcutaneous tissue disorders
erythema
|
11.1%
2/18 • Number of events 2 • up to 100 days after last dose of nivolumab
|
|
General disorders
Concentration impairment
|
11.1%
2/18 • Number of events 2 • up to 100 days after last dose of nivolumab
|
|
Psychiatric disorders
Confusion
|
27.8%
5/18 • Number of events 6 • up to 100 days after last dose of nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
27.8%
5/18 • Number of events 6 • up to 100 days after last dose of nivolumab
|
|
Gastrointestinal disorders
Constipation
|
50.0%
9/18 • Number of events 11 • up to 100 days after last dose of nivolumab
|
|
Injury, poisoning and procedural complications
costovertebral angle pain - left
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.8%
5/18 • Number of events 5 • up to 100 days after last dose of nivolumab
|
|
Infections and infestations
COVID-19
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Musculoskeletal and connective tissue disorders
deconditioning
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Metabolism and nutrition disorders
decreased calorie intake
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Vascular disorders
Thromboembolic event
|
16.7%
3/18 • Number of events 3 • up to 100 days after last dose of nivolumab
|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Psychiatric disorders
Delirium
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Psychiatric disorders
Depression
|
11.1%
2/18 • Number of events 2 • up to 100 days after last dose of nivolumab
|
|
Skin and subcutaneous tissue disorders
dermatologic toxicity c/w Stevens Johnson Syndrome
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
9/18 • Number of events 13 • up to 100 days after last dose of nivolumab
|
|
Vascular disorders
Disseminated intravascular coagulation
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Nervous system disorders
Dizziness
|
27.8%
5/18 • Number of events 8 • up to 100 days after last dose of nivolumab
|
|
Eye disorders
Dry eye
|
16.7%
3/18 • Number of events 3 • up to 100 days after last dose of nivolumab
|
|
General disorders
Dry mouth
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Dry nose
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Nervous system disorders
Dysgeusia
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Metabolism and nutrition disorders
dyslipidemia
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
2/18 • Number of events 2 • up to 100 days after last dose of nivolumab
|
|
Gastrointestinal disorders
Dysphagia
|
11.1%
2/18 • Number of events 2 • up to 100 days after last dose of nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
38.9%
7/18 • Number of events 8 • up to 100 days after last dose of nivolumab
|
|
Nervous system disorders
dystonia
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Renal and urinary disorders
Dysuria
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Skin and subcutaneous tissue disorders
ecchymosis
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
General disorders
ECOG increase
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
General disorders
Edema
|
55.6%
10/18 • Number of events 22 • up to 100 days after last dose of nivolumab
|
|
General disorders
elevated lactate
|
11.1%
2/18 • Number of events 3 • up to 100 days after last dose of nivolumab
|
|
Blood and lymphatic system disorders
elevated LDH (intermittent)
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
General disorders
Elevated PSA
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Nervous system disorders
Encephalopathy
|
11.1%
2/18 • Number of events 3 • up to 100 days after last dose of nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.1%
2/18 • Number of events 2 • up to 100 days after last dose of nivolumab
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
16.7%
3/18 • Number of events 3 • up to 100 days after last dose of nivolumab
|
|
Injury, poisoning and procedural complications
Fall
|
16.7%
3/18 • Number of events 7 • up to 100 days after last dose of nivolumab
|
|
General disorders
Fatigue
|
44.4%
8/18 • Number of events 10 • up to 100 days after last dose of nivolumab
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
11.1%
2/18 • Number of events 3 • up to 100 days after last dose of nivolumab
|
|
General disorders
Fever
|
44.4%
8/18 • Number of events 12 • up to 100 days after last dose of nivolumab
|
|
General disorders
Fluid Overload
|
16.7%
3/18 • Number of events 3 • up to 100 days after last dose of nivolumab
|
|
Nervous system disorders
Foot Drop
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Renal and urinary disorders
frequent urination
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Musculoskeletal and connective tissue disorders
Gait disturbance
|
11.1%
2/18 • Number of events 4 • up to 100 days after last dose of nivolumab
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
16.7%
3/18 • Number of events 3 • up to 100 days after last dose of nivolumab
|
|
General disorders
gum oozing and bleeding
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
General disorders
gum soreness
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Psychiatric disorders
Hallucinations
|
11.1%
2/18 • Number of events 2 • up to 100 days after last dose of nivolumab
|
|
General disorders
Headache
|
38.9%
7/18 • Number of events 8 • up to 100 days after last dose of nivolumab
|
|
Cardiac disorders
heart failure with preserved ejection fraction
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Blood and lymphatic system disorders
Hematuria
|
11.1%
2/18 • Number of events 2 • up to 100 days after last dose of nivolumab
|
|
Blood and lymphatic system disorders
Hemophagocytic lymphohistiocytosis (HLH)
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
General disorders
Hemrrohoids
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
General disorders
Hiccups
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Infections and infestations
enteritis
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
General disorders
Hoarseness
|
11.1%
2/18 • Number of events 2 • up to 100 days after last dose of nivolumab
|
|
Reproductive system and breast disorders
Hot flashes
|
11.1%
2/18 • Number of events 2 • up to 100 days after last dose of nivolumab
|
|
Investigations
hyperbilirubinemia
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.6%
1/18 • Number of events 3 • up to 100 days after last dose of nivolumab
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.7%
3/18 • Number of events 3 • up to 100 days after last dose of nivolumab
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Vascular disorders
Hypertension
|
22.2%
4/18 • Number of events 8 • up to 100 days after last dose of nivolumab
|
|
Endocrine disorders
Hyperthyroidism
|
11.1%
2/18 • Number of events 2 • up to 100 days after last dose of nivolumab
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
11.1%
2/18 • Number of events 2 • up to 100 days after last dose of nivolumab
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
16.7%
3/18 • Number of events 4 • up to 100 days after last dose of nivolumab
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
6/18 • Number of events 21 • up to 100 days after last dose of nivolumab
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
16.7%
3/18 • Number of events 15 • up to 100 days after last dose of nivolumab
|
|
Metabolism and nutrition disorders
Hyponatremia
|
22.2%
4/18 • Number of events 6 • up to 100 days after last dose of nivolumab
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
22.2%
4/18 • Number of events 9 • up to 100 days after last dose of nivolumab
|
|
Vascular disorders
hypotension
|
22.2%
4/18 • Number of events 9 • up to 100 days after last dose of nivolumab
|
|
Endocrine disorders
Hypothyroidism
|
16.7%
3/18 • Number of events 3 • up to 100 days after last dose of nivolumab
|
|
General disorders
hypovolemia
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
33.3%
6/18 • Number of events 8 • up to 100 days after last dose of nivolumab
|
|
Vascular disorders
hypervolemia
|
16.7%
3/18 • Number of events 3 • up to 100 days after last dose of nivolumab
|
|
General disorders
immunocompromised
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Cardiac disorders
non st elevation myocardial infarction (NSTEMI)
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
General disorders
influenza A
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Investigations
INR increased
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Psychiatric disorders
Insomnia
|
27.8%
5/18 • Number of events 5 • up to 100 days after last dose of nivolumab
|
|
Skin and subcutaneous tissue disorders
right side tongue sore
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Musculoskeletal and connective tissue disorders
rigors
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Nervous system disorders
sensory deficit
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Musculoskeletal and connective tissue disorders
left-sided parasthesia in groin area
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Skin and subcutaneous tissue disorders
Lesion
|
16.7%
3/18 • Number of events 4 • up to 100 days after last dose of nivolumab
|
|
Nervous system disorders
Lethargy
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Blood and lymphatic system disorders
Leukocytosis
|
27.8%
5/18 • Number of events 6 • up to 100 days after last dose of nivolumab
|
|
Injury, poisoning and procedural complications
Liver Injury
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Blood and lymphatic system disorders
low absolute lymphocyte
|
11.1%
2/18 • Number of events 4 • up to 100 days after last dose of nivolumab
|
|
Metabolism and nutrition disorders
Malnutrition
|
11.1%
2/18 • Number of events 2 • up to 100 days after last dose of nivolumab
|
|
Skin and subcutaneous tissue disorders
maxillary sinus nodular mucosal thickening
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Psychiatric disorders
Memory impairment
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Infections and infestations
Methicillin-resistant Staphylococcus aureus (MRSA)
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Skin and subcutaneous tissue disorders
mouth sore
|
11.1%
2/18 • Number of events 2 • up to 100 days after last dose of nivolumab
|
|
Skin and subcutaneous tissue disorders
Mucositis
|
27.8%
5/18 • Number of events 8 • up to 100 days after last dose of nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
multifocal infection of the lungs
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
small bilateral pleural effusions
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Gastrointestinal disorders
Nausea
|
55.6%
10/18 • Number of events 12 • up to 100 days after last dose of nivolumab
|
|
Nervous system disorders
Neuralgia
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Nervous system disorders
neuropathy
|
61.1%
11/18 • Number of events 22 • up to 100 days after last dose of nivolumab
|
|
Investigations
Neutrophil count decreased
|
5.6%
1/18 • Number of events 8 • up to 100 days after last dose of nivolumab
|
|
Skin and subcutaneous tissue disorders
oral aphthous ulcerations
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Infections and infestations
oral candidiasis
|
11.1%
2/18 • Number of events 2 • up to 100 days after last dose of nivolumab
|
|
General disorders
Pain
|
50.0%
9/18 • Number of events 18 • up to 100 days after last dose of nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
parenchymal lung abnormality
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Nervous system disorders
Paresthesia
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Infections and infestations
Pharyngitis
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Investigations
Platelet count decreased
|
11.1%
2/18 • Number of events 14 • up to 100 days after last dose of nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
11.1%
2/18 • Number of events 2 • up to 100 days after last dose of nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
27.8%
5/18 • Number of events 7 • up to 100 days after last dose of nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
11.1%
2/18 • Number of events 3 • up to 100 days after last dose of nivolumab
|
|
Skin and subcutaneous tissue disorders
posterior oropharyngeal erythema
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
22.2%
4/18 • Number of events 4 • up to 100 days after last dose of nivolumab
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
22.2%
4/18 • Number of events 4 • up to 100 days after last dose of nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary nodules
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Skin and subcutaneous tissue disorders
Rash
|
27.8%
5/18 • Number of events 7 • up to 100 days after last dose of nivolumab
|
|
Eye disorders
Retroperitoneal hemorrhage
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Infections and infestations
rhinovirus
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
General disorders
right parotid mass with slight drainage and erythema
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Infections and infestations
Sepsis
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Cardiac disorders
Sinus tachycardia
|
33.3%
6/18 • Number of events 7 • up to 100 days after last dose of nivolumab
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Infections and infestations
Skin infection
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Skin and subcutaneous tissue disorders
Skin Sloughing
|
5.6%
1/18 • Number of events 2 • up to 100 days after last dose of nivolumab
|
|
Gastrointestinal disorders
small bowel ileus
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
General disorders
small lump on right wrist
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
General disorders
Sore throat
|
16.7%
3/18 • Number of events 4 • up to 100 days after last dose of nivolumab
|
|
Vascular disorders
splenic artery thrombosis
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Nervous system disorders
Syncope
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
General disorders
Syndrome of inappropriate antidiuretic hormone secretion (SIADH)
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
General disorders
throat tightening
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Infections and infestations
Thrush
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Gastrointestinal disorders
Transaminitis
|
11.1%
2/18 • Number of events 2 • up to 100 days after last dose of nivolumab
|
|
Nervous system disorders
Tremor
|
11.1%
2/18 • Number of events 2 • up to 100 days after last dose of nivolumab
|
|
Renal and urinary disorders
uretal stone
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Renal and urinary disorders
urinary incontinence
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Renal and urinary disorders
Urinary retention
|
11.1%
2/18 • Number of events 2 • up to 100 days after last dose of nivolumab
|
|
Renal and urinary disorders
Urinary tract infection
|
11.1%
2/18 • Number of events 3 • up to 100 days after last dose of nivolumab
|
|
Renal and urinary disorders
urolithiasis
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Gastrointestinal disorders
Vomiting
|
22.2%
4/18 • Number of events 4 • up to 100 days after last dose of nivolumab
|
|
General disorders
weakness
|
33.3%
6/18 • Number of events 9 • up to 100 days after last dose of nivolumab
|
|
Metabolism and nutrition disorders
Weight loss
|
16.7%
3/18 • Number of events 3 • up to 100 days after last dose of nivolumab
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
11.1%
2/18 • Number of events 3 • up to 100 days after last dose of nivolumab
|
|
Musculoskeletal and connective tissue disorders
wrist dislocation
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Skin and subcutaneous tissue disorders
tenderness
|
11.1%
2/18 • Number of events 2 • up to 100 days after last dose of nivolumab
|
|
Nervous system disorders
Unstable balance
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
|
Eye disorders
watering eyes
|
5.6%
1/18 • Number of events 1 • up to 100 days after last dose of nivolumab
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place