Trial Outcomes & Findings for BLASST-1 (Bladder Cancer Signal Seeking Trial): Nivolumab, Gemcitabine, and Cisplatin in Treatment of Muscle Invasive Bladder Cancer (MIBC) Undergoing Cystectomy (NCT NCT03294304)
NCT ID: NCT03294304
Last Updated: 2021-12-16
Results Overview
Incidence of Measurable Disease "pT" in the TNM staging system refers to the size and extend of the primary tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. T's may be further divided to provide more detail, such as T3a and T3b. pTa refers to noninvasive papillary carcinoma. pTis refers to carcinoma in situ (CIS) or a "flat tumor" stage. pN refers to lymph nodes. N0 mans cancer has not spread to nearby lymph nodes.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
Surgery Day 1
Results posted on
2021-12-16
Participant Flow
Participant milestones
| Measure |
Nivolumab, Cisplatin, & Gemcitabine
Nivolumab: Nivolumab will be given at a fixed dose of 360 mg IV over 30 minutes on Day 8 every 21 days for 4 cycles.
Cisplatin: Cisplatin will be given at 70 mg/m2 IV over 30 minutes on Day 1 every 21 days, and based on treating physician's discretion, split-dose cisplatin can be given at 35 mg/m2 IV Day 1 and Day 8 every 21 days for 4 cycles.
Gemcitabine: Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1, 8, and every 21 days for 4 cycles.
|
|---|---|
|
Overall Study
STARTED
|
43
|
|
Overall Study
COMPLETED
|
43
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BLASST-1 (Bladder Cancer Signal Seeking Trial): Nivolumab, Gemcitabine, and Cisplatin in Treatment of Muscle Invasive Bladder Cancer (MIBC) Undergoing Cystectomy
Baseline characteristics by cohort
| Measure |
Nivolumab, Cisplatin, & Gemcitabine
n=43 Participants
Nivolumab: Nivolumab will be given at a fixed dose of 360 mg IV over 30 minutes on Day 8 every 21 days for 4 cycles.
Cisplatin: Cisplatin will be given at 70 mg/m2 IV over 30 minutes on Day 1 every 21 days, and based on treating physician's discretion, split-dose cisplatin can be given at 35 mg/m2 IV Day 1 and Day 8 every 21 days for 4 cycles.
Gemcitabine: Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1, 8, and every 21 days for 4 cycles.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
22 Participants
n=93 Participants
|
|
Sex/Gender, Customized
Male
|
15 Participants
n=93 Participants
|
|
Sex/Gender, Customized
Female
|
26 Participants
n=93 Participants
|
|
Sex/Gender, Customized
Unknown
|
2 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Surgery Day 1Population: 2 participants are not evaluable
Incidence of Measurable Disease "pT" in the TNM staging system refers to the size and extend of the primary tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. T's may be further divided to provide more detail, such as T3a and T3b. pTa refers to noninvasive papillary carcinoma. pTis refers to carcinoma in situ (CIS) or a "flat tumor" stage. pN refers to lymph nodes. N0 mans cancer has not spread to nearby lymph nodes.
Outcome measures
| Measure |
Nivolumab, Cisplatin, & Gemcitabine
n=41 Participants
Nivolumab: Nivolumab will be given at a fixed dose of 360 mg IV over 30 minutes on Day 8 every 21 days for 4 cycles.
Cisplatin: Cisplatin will be given at 70 mg/m2 IV over 30 minutes on Day 1 every 21 days, and based on treating physician's discretion, split-dose cisplatin can be given at 35 mg/m2 IV Day 1 and Day 8 every 21 days for 4 cycles.
Gemcitabine: Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1, 8, and every 21 days for 4 cycles.
|
|---|---|
|
Pathologic Response Rate (PaR) at Time of Radical Cystectomy. PaR is Defined as Absence of Residual MIBC at Cystectomy in the Surgical Specimen (Pathologic Down-staging to ≤pT1pN0 Which Includes pT0, pT1, pTa and pTis)
|
27 Participants
|
SECONDARY outcome
Timeframe: Treatment Day 1 of cycle 1Population: 2 participants were not evaluable
Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin
Outcome measures
| Measure |
Nivolumab, Cisplatin, & Gemcitabine
n=41 Participants
Nivolumab: Nivolumab will be given at a fixed dose of 360 mg IV over 30 minutes on Day 8 every 21 days for 4 cycles.
Cisplatin: Cisplatin will be given at 70 mg/m2 IV over 30 minutes on Day 1 every 21 days, and based on treating physician's discretion, split-dose cisplatin can be given at 35 mg/m2 IV Day 1 and Day 8 every 21 days for 4 cycles.
Gemcitabine: Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1, 8, and every 21 days for 4 cycles.
|
|---|---|
|
Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 1)
|
7 Participants
|
SECONDARY outcome
Timeframe: Treatment Day 8 of cycle 1Population: 2 participants are not evaluable
Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin
Outcome measures
| Measure |
Nivolumab, Cisplatin, & Gemcitabine
n=41 Participants
Nivolumab: Nivolumab will be given at a fixed dose of 360 mg IV over 30 minutes on Day 8 every 21 days for 4 cycles.
Cisplatin: Cisplatin will be given at 70 mg/m2 IV over 30 minutes on Day 1 every 21 days, and based on treating physician's discretion, split-dose cisplatin can be given at 35 mg/m2 IV Day 1 and Day 8 every 21 days for 4 cycles.
Gemcitabine: Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1, 8, and every 21 days for 4 cycles.
|
|---|---|
|
Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 1)
|
27 Participants
|
SECONDARY outcome
Timeframe: Treatment Day 1 of cycle 2Population: 2 participants are not evaluable
Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin
Outcome measures
| Measure |
Nivolumab, Cisplatin, & Gemcitabine
n=41 Participants
Nivolumab: Nivolumab will be given at a fixed dose of 360 mg IV over 30 minutes on Day 8 every 21 days for 4 cycles.
Cisplatin: Cisplatin will be given at 70 mg/m2 IV over 30 minutes on Day 1 every 21 days, and based on treating physician's discretion, split-dose cisplatin can be given at 35 mg/m2 IV Day 1 and Day 8 every 21 days for 4 cycles.
Gemcitabine: Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1, 8, and every 21 days for 4 cycles.
|
|---|---|
|
Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 2)
|
18 Participants
|
SECONDARY outcome
Timeframe: Treament day 8 of cycle 2Population: 2 participants are not evaluable
Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin
Outcome measures
| Measure |
Nivolumab, Cisplatin, & Gemcitabine
n=41 Participants
Nivolumab: Nivolumab will be given at a fixed dose of 360 mg IV over 30 minutes on Day 8 every 21 days for 4 cycles.
Cisplatin: Cisplatin will be given at 70 mg/m2 IV over 30 minutes on Day 1 every 21 days, and based on treating physician's discretion, split-dose cisplatin can be given at 35 mg/m2 IV Day 1 and Day 8 every 21 days for 4 cycles.
Gemcitabine: Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1, 8, and every 21 days for 4 cycles.
|
|---|---|
|
Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 2)
|
15 Participants
|
SECONDARY outcome
Timeframe: Treatment day 1 of cycle 3Population: 2 participants are not evaluable
Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin
Outcome measures
| Measure |
Nivolumab, Cisplatin, & Gemcitabine
n=41 Participants
Nivolumab: Nivolumab will be given at a fixed dose of 360 mg IV over 30 minutes on Day 8 every 21 days for 4 cycles.
Cisplatin: Cisplatin will be given at 70 mg/m2 IV over 30 minutes on Day 1 every 21 days, and based on treating physician's discretion, split-dose cisplatin can be given at 35 mg/m2 IV Day 1 and Day 8 every 21 days for 4 cycles.
Gemcitabine: Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1, 8, and every 21 days for 4 cycles.
|
|---|---|
|
Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 3)
|
16 Participants
|
SECONDARY outcome
Timeframe: Treatment day 8 of cycle 3Population: 2 participants are not evaluable
Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin
Outcome measures
| Measure |
Nivolumab, Cisplatin, & Gemcitabine
n=41 Participants
Nivolumab: Nivolumab will be given at a fixed dose of 360 mg IV over 30 minutes on Day 8 every 21 days for 4 cycles.
Cisplatin: Cisplatin will be given at 70 mg/m2 IV over 30 minutes on Day 1 every 21 days, and based on treating physician's discretion, split-dose cisplatin can be given at 35 mg/m2 IV Day 1 and Day 8 every 21 days for 4 cycles.
Gemcitabine: Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1, 8, and every 21 days for 4 cycles.
|
|---|---|
|
Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 3)
|
13 Participants
|
SECONDARY outcome
Timeframe: Treatment day 1 of cycle 4Population: 2 participants are not evaluable
Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin
Outcome measures
| Measure |
Nivolumab, Cisplatin, & Gemcitabine
n=41 Participants
Nivolumab: Nivolumab will be given at a fixed dose of 360 mg IV over 30 minutes on Day 8 every 21 days for 4 cycles.
Cisplatin: Cisplatin will be given at 70 mg/m2 IV over 30 minutes on Day 1 every 21 days, and based on treating physician's discretion, split-dose cisplatin can be given at 35 mg/m2 IV Day 1 and Day 8 every 21 days for 4 cycles.
Gemcitabine: Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1, 8, and every 21 days for 4 cycles.
|
|---|---|
|
Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 4)
|
8 Participants
|
SECONDARY outcome
Timeframe: Treatment day 8 of cycle 4Population: 2 participants are not evaluable
Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin
Outcome measures
| Measure |
Nivolumab, Cisplatin, & Gemcitabine
n=41 Participants
Nivolumab: Nivolumab will be given at a fixed dose of 360 mg IV over 30 minutes on Day 8 every 21 days for 4 cycles.
Cisplatin: Cisplatin will be given at 70 mg/m2 IV over 30 minutes on Day 1 every 21 days, and based on treating physician's discretion, split-dose cisplatin can be given at 35 mg/m2 IV Day 1 and Day 8 every 21 days for 4 cycles.
Gemcitabine: Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1, 8, and every 21 days for 4 cycles.
|
|---|---|
|
Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 4)
|
11 Participants
|
SECONDARY outcome
Timeframe: 30 Days +/- 7 Days after last chemotherapyPopulation: 2 participants are not evaluable
Incidence of Adverse Events
Outcome measures
| Measure |
Nivolumab, Cisplatin, & Gemcitabine
n=41 Participants
Nivolumab: Nivolumab will be given at a fixed dose of 360 mg IV over 30 minutes on Day 8 every 21 days for 4 cycles.
Cisplatin: Cisplatin will be given at 70 mg/m2 IV over 30 minutes on Day 1 every 21 days, and based on treating physician's discretion, split-dose cisplatin can be given at 35 mg/m2 IV Day 1 and Day 8 every 21 days for 4 cycles.
Gemcitabine: Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1, 8, and every 21 days for 4 cycles.
|
|---|---|
|
Safety of Nivolumab With Gemcitabine/Cisplatin
|
5 Participants
|
SECONDARY outcome
Timeframe: 4 weeks post radical cystectomyPopulation: 2 participants are not evaluable
Incidence of Adverse Events
Outcome measures
| Measure |
Nivolumab, Cisplatin, & Gemcitabine
n=41 Participants
Nivolumab: Nivolumab will be given at a fixed dose of 360 mg IV over 30 minutes on Day 8 every 21 days for 4 cycles.
Cisplatin: Cisplatin will be given at 70 mg/m2 IV over 30 minutes on Day 1 every 21 days, and based on treating physician's discretion, split-dose cisplatin can be given at 35 mg/m2 IV Day 1 and Day 8 every 21 days for 4 cycles.
Gemcitabine: Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1, 8, and every 21 days for 4 cycles.
|
|---|---|
|
Safety of Nivolumab With Gemcitabine/Cisplatin
|
24 Participants
|
SECONDARY outcome
Timeframe: Every 3 Months for 2 YearsPopulation: 2 participants are not evaluable
Count of participants experiencing Progression Free Survival (PFS)
Outcome measures
| Measure |
Nivolumab, Cisplatin, & Gemcitabine
n=41 Participants
Nivolumab: Nivolumab will be given at a fixed dose of 360 mg IV over 30 minutes on Day 8 every 21 days for 4 cycles.
Cisplatin: Cisplatin will be given at 70 mg/m2 IV over 30 minutes on Day 1 every 21 days, and based on treating physician's discretion, split-dose cisplatin can be given at 35 mg/m2 IV Day 1 and Day 8 every 21 days for 4 cycles.
Gemcitabine: Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1, 8, and every 21 days for 4 cycles.
|
|---|---|
|
Count of Participants Experiencing Progression Free Survival (PFS)
|
36 Participants
|
Adverse Events
Nivolumab, Cisplatin, & Gemcitabine
Serious events: 11 serious events
Other events: 42 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Nivolumab, Cisplatin, & Gemcitabine
n=43 participants at risk
Nivolumab: Nivolumab will be given at a fixed dose of 360 mg IV over 30 minutes on Day 8 every 21 days for 4 cycles.
Cisplatin: Cisplatin will be given at 70 mg/m2 IV over 30 minutes on Day 1 every 21 days, and based on treating physician's discretion, split-dose cisplatin can be given at 35 mg/m2 IV Day 1 and Day 8 every 21 days for 4 cycles.
Gemcitabine: Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1, 8, and every 21 days for 4 cycles.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Metabolism and nutrition disorders
Dehydration
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
General disorders
Fatigue
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
General disorders
Fever
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
4.7%
2/43 • Number of events 2 • 120 days after last dose nivolumab
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Investigations
Neutrophil count decreased
|
2.3%
1/43 • Number of events 2 • 120 days after last dose nivolumab
|
|
Investigations
Platelet count decreased
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Vascular disorders
Thromboembolic event
|
4.7%
2/43 • Number of events 3 • 120 days after last dose nivolumab
|
|
Renal and urinary disorders
Urinary retention
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Infections and infestations
Urinary tract infection
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
Other adverse events
| Measure |
Nivolumab, Cisplatin, & Gemcitabine
n=43 participants at risk
Nivolumab: Nivolumab will be given at a fixed dose of 360 mg IV over 30 minutes on Day 8 every 21 days for 4 cycles.
Cisplatin: Cisplatin will be given at 70 mg/m2 IV over 30 minutes on Day 1 every 21 days, and based on treating physician's discretion, split-dose cisplatin can be given at 35 mg/m2 IV Day 1 and Day 8 every 21 days for 4 cycles.
Gemcitabine: Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1, 8, and every 21 days for 4 cycles.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
4.7%
2/43 • Number of events 3 • 120 days after last dose nivolumab
|
|
Investigations
Activated partial thromboplastin time prolonged
|
4.7%
2/43 • Number of events 2 • 120 days after last dose nivolumab
|
|
Renal and urinary disorders
Acute kidney injury
|
7.0%
3/43 • Number of events 12 • 120 days after last dose nivolumab
|
|
Endocrine disorders
Adrenal insufficiency
|
4.7%
2/43 • Number of events 2 • 120 days after last dose nivolumab
|
|
Psychiatric disorders
Agitation
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Investigations
Alanine aminotransferase increased
|
27.9%
12/43 • Number of events 18 • 120 days after last dose nivolumab
|
|
Investigations
Alkaline phosphatase increased
|
14.0%
6/43 • Number of events 6 • 120 days after last dose nivolumab
|
|
Immune system disorders
Allergic reaction
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
4.7%
2/43 • Number of events 2 • 120 days after last dose nivolumab
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.3%
4/43 • Number of events 4 • 120 days after last dose nivolumab
|
|
Blood and lymphatic system disorders
Anemia
|
58.1%
25/43 • Number of events 61 • 120 days after last dose nivolumab
|
|
Metabolism and nutrition disorders
Anorexia
|
16.3%
7/43 • Number of events 8 • 120 days after last dose nivolumab
|
|
Psychiatric disorders
Anxiety
|
18.6%
8/43 • Number of events 8 • 120 days after last dose nivolumab
|
|
Investigations
Aspartate aminotransferase increased
|
25.6%
11/43 • Number of events 16 • 120 days after last dose nivolumab
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.7%
2/43 • Number of events 2 • 120 days after last dose nivolumab
|
|
Renal and urinary disorders
Bladder spasm
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Gastrointestinal disorders
Bloating
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Eye disorders
Blurred vision
|
9.3%
4/43 • Number of events 4 • 120 days after last dose nivolumab
|
|
Injury, poisoning and procedural complications
Bruising
|
4.7%
2/43 • Number of events 2 • 120 days after last dose nivolumab
|
|
Investigations
Cardiac troponin I increased
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
General disorders
Chills
|
9.3%
4/43 • Number of events 4 • 120 days after last dose nivolumab
|
|
Investigations
Cholesterol high
|
7.0%
3/43 • Number of events 3 • 120 days after last dose nivolumab
|
|
Congenital, familial and genetic disorders
Congenital, familial and genetic disorders - Other, specify
|
4.7%
2/43 • Number of events 2 • 120 days after last dose nivolumab
|
|
Gastrointestinal disorders
Constipation
|
55.8%
24/43 • Number of events 24 • 120 days after last dose nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.6%
8/43 • Number of events 8 • 120 days after last dose nivolumab
|
|
Investigations
Creatinine increased
|
11.6%
5/43 • Number of events 6 • 120 days after last dose nivolumab
|
|
Metabolism and nutrition disorders
Dehydration
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Psychiatric disorders
Depression
|
7.0%
3/43 • Number of events 3 • 120 days after last dose nivolumab
|
|
Gastrointestinal disorders
Diarrhea
|
16.3%
7/43 • Number of events 8 • 120 days after last dose nivolumab
|
|
Nervous system disorders
Dizziness
|
7.0%
3/43 • Number of events 3 • 120 days after last dose nivolumab
|
|
Nervous system disorders
Dysgeusia
|
23.3%
10/43 • Number of events 12 • 120 days after last dose nivolumab
|
|
Gastrointestinal disorders
Dyspepsia
|
11.6%
5/43 • Number of events 5 • 120 days after last dose nivolumab
|
|
Gastrointestinal disorders
Dysphagia
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.3%
4/43 • Number of events 5 • 120 days after last dose nivolumab
|
|
General disorders
Edema limbs
|
16.3%
7/43 • Number of events 8 • 120 days after last dose nivolumab
|
|
Nervous system disorders
Extrapyramidal disorder
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Eye disorders
Eye disorders - Other, specify
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Eye disorders
Eyelid function disorder
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
General disorders
Fatigue
|
69.8%
30/43 • Number of events 37 • 120 days after last dose nivolumab
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
General disorders
Fever
|
11.6%
5/43 • Number of events 5 • 120 days after last dose nivolumab
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Vascular disorders
Flushing
|
4.7%
2/43 • Number of events 2 • 120 days after last dose nivolumab
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
16.3%
7/43 • Number of events 7 • 120 days after last dose nivolumab
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
4.7%
2/43 • Number of events 3 • 120 days after last dose nivolumab
|
|
Gastrointestinal disorders
Gastroparesis
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
30.2%
13/43 • Number of events 29 • 120 days after last dose nivolumab
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Nervous system disorders
Headache
|
23.3%
10/43 • Number of events 11 • 120 days after last dose nivolumab
|
|
Ear and labyrinth disorders
Hearing impaired
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Cardiac disorders
Heart failure
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Vascular disorders
Hematoma
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Renal and urinary disorders
Hematuria
|
9.3%
4/43 • Number of events 4 • 120 days after last dose nivolumab
|
|
Investigations
Hemoglobin increased
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
7.0%
3/43 • Number of events 4 • 120 days after last dose nivolumab
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.0%
3/43 • Number of events 20 • 120 days after last dose nivolumab
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
4.7%
2/43 • Number of events 2 • 120 days after last dose nivolumab
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
9.3%
4/43 • Number of events 4 • 120 days after last dose nivolumab
|
|
Endocrine disorders
Hyperparathyroidism
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Vascular disorders
Hypertension
|
34.9%
15/43 • Number of events 24 • 120 days after last dose nivolumab
|
|
Endocrine disorders
Hyperthyroidism
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
9.3%
4/43 • Number of events 4 • 120 days after last dose nivolumab
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
11.6%
5/43 • Number of events 5 • 120 days after last dose nivolumab
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
23.3%
10/43 • Number of events 15 • 120 days after last dose nivolumab
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.0%
6/43 • Number of events 9 • 120 days after last dose nivolumab
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
27.9%
12/43 • Number of events 22 • 120 days after last dose nivolumab
|
|
Metabolism and nutrition disorders
Hyponatremia
|
23.3%
10/43 • Number of events 16 • 120 days after last dose nivolumab
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
11.6%
5/43 • Number of events 7 • 120 days after last dose nivolumab
|
|
Endocrine disorders
Hypothyroidism
|
16.3%
7/43 • Number of events 9 • 120 days after last dose nivolumab
|
|
Immune system disorders
Immune system disorders - Other, specify
|
4.7%
2/43 • Number of events 2 • 120 days after last dose nivolumab
|
|
Infections and infestations
Infections and infestations - Other, specify
|
4.7%
2/43 • Number of events 2 • 120 days after last dose nivolumab
|
|
General disorders
Infusion related reaction
|
4.7%
2/43 • Number of events 3 • 120 days after last dose nivolumab
|
|
General disorders
Infusion site extravasation
|
4.7%
2/43 • Number of events 2 • 120 days after last dose nivolumab
|
|
General disorders
Injection site reaction
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Psychiatric disorders
Insomnia
|
11.6%
5/43 • Number of events 5 • 120 days after last dose nivolumab
|
|
Investigations
Investigations - Other, specify
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
General disorders
Localized edema
|
4.7%
2/43 • Number of events 2 • 120 days after last dose nivolumab
|
|
Investigations
Lymphocyte count decreased
|
14.0%
6/43 • Number of events 8 • 120 days after last dose nivolumab
|
|
Nervous system disorders
Memory impairment
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Infections and infestations
Mucosal infection
|
2.3%
1/43 • Number of events 2 • 120 days after last dose nivolumab
|
|
Gastrointestinal disorders
Mucositis oral
|
11.6%
5/43 • Number of events 6 • 120 days after last dose nivolumab
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.0%
3/43 • Number of events 3 • 120 days after last dose nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.0%
3/43 • Number of events 4 • 120 days after last dose nivolumab
|
|
Gastrointestinal disorders
Nausea
|
72.1%
31/43 • Number of events 37 • 120 days after last dose nivolumab
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Investigations
Neutrophil count decreased
|
46.5%
20/43 • Number of events 40 • 120 days after last dose nivolumab
|
|
General disorders
Pain
|
4.7%
2/43 • Number of events 2 • 120 days after last dose nivolumab
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.0%
3/43 • Number of events 4 • 120 days after last dose nivolumab
|
|
Infections and infestations
Papulopustular rash
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Nervous system disorders
Paresthesia
|
4.7%
2/43 • Number of events 2 • 120 days after last dose nivolumab
|
|
Reproductive system and breast disorders
Pelvic pain
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Nervous system disorders
Peripheral motor neuropathy
|
4.7%
2/43 • Number of events 2 • 120 days after last dose nivolumab
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.6%
5/43 • Number of events 5 • 120 days after last dose nivolumab
|
|
Vascular disorders
Phlebitis
|
4.7%
2/43 • Number of events 2 • 120 days after last dose nivolumab
|
|
Investigations
Platelet count decreased
|
30.2%
13/43 • Number of events 19 • 120 days after last dose nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.7%
2/43 • Number of events 2 • 120 days after last dose nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Nervous system disorders
Presyncope
|
2.3%
1/43 • Number of events 2 • 120 days after last dose nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
4.7%
2/43 • Number of events 2 • 120 days after last dose nivolumab
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.7%
2/43 • Number of events 2 • 120 days after last dose nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
2.3%
1/43 • Number of events 2 • 120 days after last dose nivolumab
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
4.7%
2/43 • Number of events 2 • 120 days after last dose nivolumab
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
30.2%
13/43 • Number of events 13 • 120 days after last dose nivolumab
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
4.7%
2/43 • Number of events 2 • 120 days after last dose nivolumab
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
2.3%
1/43 • Number of events 2 • 120 days after last dose nivolumab
|
|
Gastrointestinal disorders
Salivary duct inflammation
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Infections and infestations
Skin infection
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Gastrointestinal disorders
Stomach pain
|
4.7%
2/43 • Number of events 2 • 120 days after last dose nivolumab
|
|
Vascular disorders
Superficial thrombophlebitis
|
7.0%
3/43 • Number of events 3 • 120 days after last dose nivolumab
|
|
Nervous system disorders
Syncope
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Vascular disorders
Thromboembolic event
|
11.6%
5/43 • Number of events 6 • 120 days after last dose nivolumab
|
|
Ear and labyrinth disorders
Tinnitus
|
23.3%
10/43 • Number of events 10 • 120 days after last dose nivolumab
|
|
Gastrointestinal disorders
Toothache
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Infections and infestations
Upper respiratory infection
|
4.7%
2/43 • Number of events 2 • 120 days after last dose nivolumab
|
|
Renal and urinary disorders
Urinary frequency
|
16.3%
7/43 • Number of events 7 • 120 days after last dose nivolumab
|
|
Renal and urinary disorders
Urinary retention
|
4.7%
2/43 • Number of events 2 • 120 days after last dose nivolumab
|
|
Infections and infestations
Urinary tract infection
|
20.9%
9/43 • Number of events 10 • 120 days after last dose nivolumab
|
|
Renal and urinary disorders
Urinary tract obstruction
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Renal and urinary disorders
Urinary tract pain
|
7.0%
3/43 • Number of events 4 • 120 days after last dose nivolumab
|
|
Reproductive system and breast disorders
Uterine pain
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Cardiac disorders
Ventricular arrhythmia
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Gastrointestinal disorders
Vomiting
|
18.6%
8/43 • Number of events 10 • 120 days after last dose nivolumab
|
|
Eye disorders
Watering eyes
|
2.3%
1/43 • Number of events 1 • 120 days after last dose nivolumab
|
|
Investigations
Weight loss
|
11.6%
5/43 • Number of events 5 • 120 days after last dose nivolumab
|
|
Investigations
White blood cell decreased
|
41.9%
18/43 • Number of events 29 • 120 days after last dose nivolumab
|
Additional Information
Dr. Konety Badrinath
Masonic Cancer Center, University of Minnesota
Phone: 612-625-1655
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place