Trial Outcomes & Findings for DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, Decitabine, and Nivolumab in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia (NCT NCT03358719)
NCT ID: NCT03358719
Last Updated: 2026-02-27
Results Overview
Will evaluate the proportion of n=8 evaluable patients in the expansion cohort experiencing a dose-limiting toxicity. Toxicity rates will be described using upper 1-sided 95% Jeffreys binomial confidence intervals.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
8 participants
Primary outcome timeframe
Up to 180 days
Results posted on
2026-02-27
Participant Flow
Participant milestones
| Measure |
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)
Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401 intracutaneously and poly ICLC SC on day -14, on day 15 of courses 1-4, and then on day 1 of every 4 courses thereafter. Patients also receive nivolumab IV over 30 minutes on days 1 and 15 and decitabine IV over 1 hour on days 1-5. Courses with nivolumab and decitabine repeat every 4 weeks in the absence of disease progression or unaccepted toxicity.
DEC-205/NY-ESO-1 Fusion Protein CDX-1401: Given intracutaneously
Decitabine: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Poly ICLC: Given SC
The study originally provided for the possibility of dose de-escalation for the treatment arms, but as we had no dose limiting toxicities, the dose level 1 was declared the maximum administered dose and all patients were enrolled and treated at dose level 1.
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)
Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401 intracutaneously and poly ICLC SC on day -14, on day 15 of courses 1-4, and then on day 1 of every 4 courses thereafter. Patients also receive nivolumab IV over 30 minutes on days 1 and 15 and decitabine IV over 1 hour on days 1-5. Courses with nivolumab and decitabine repeat every 4 weeks in the absence of disease progression or unaccepted toxicity.
DEC-205/NY-ESO-1 Fusion Protein CDX-1401: Given intracutaneously
Decitabine: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Poly ICLC: Given SC
The study originally provided for the possibility of dose de-escalation for the treatment arms, but as we had no dose limiting toxicities, the dose level 1 was declared the maximum administered dose and all patients were enrolled and treated at dose level 1.
|
|---|---|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Adverse Event
|
2
|
Baseline Characteristics
DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, Decitabine, and Nivolumab in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)
n=8 Participants
Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401 intracutaneously and poly ICLC SC on day -14, on day 15 of courses 1-4, and then on day 1 of every 4 courses thereafter. Patients also receive nivolumab IV over 30 minutes on days 1 and 15 and decitabine IV over 1 hour on days 1-5. Courses with nivolumab and decitabine repeat every 4 weeks in the absence of disease progression or unaccepted toxicity.
DEC-205/NY-ESO-1 Fusion Protein CDX-1401: Given intracutaneously
Decitabine: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Poly ICLC: Given SC
The study originally provided for the possibility of dose de-escalation for the treatment arms, but as we had no dose limiting toxicities, the dose level 1 was declared the maximum administered dose and all patients were enrolled and treated at dose level 1.
|
|---|---|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=24 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=24 Participants
|
|
Age, Continuous
|
72.2 years
STANDARD_DEVIATION 8.6 • n=24 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Up to 180 daysPopulation: All treated and eligible patients
Will evaluate the proportion of n=8 evaluable patients in the expansion cohort experiencing a dose-limiting toxicity. Toxicity rates will be described using upper 1-sided 95% Jeffreys binomial confidence intervals.
Outcome measures
| Measure |
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)
n=8 Participants
Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401 intracutaneously and poly ICLC SC on day -14, on day 15 of courses 1-4, and then on day 1 of every 4 courses thereafter. Patients also receive nivolumab IV over 30 minutes on days 1 and 15 and decitabine IV over 1 hour on days 1-5. Courses with nivolumab and decitabine repeat every 4 weeks in the absence of disease progression or unaccepted toxicity.
DEC-205/NY-ESO-1 Fusion Protein CDX-1401: Given intracutaneously
Decitabine: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Poly ICLC: Given SC
The study originally provided for the possibility of dose de-escalation for the treatment arms, but as we had no dose limiting toxicities, the dose level 1 was declared the maximum administered dose and all patients were enrolled and treated at dose level 1.
|
|---|---|
|
Proportion or Participants Experiencing a Dose-limiting Toxicity
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 180 daysPopulation: All treated and eligible patients
Descriptive statistics will be used to evaluate the Immune cell profile in the peripheral blood and bone marrow following combination therapy using mass cytometry.
Outcome measures
| Measure |
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)
n=6 Participants
Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401 intracutaneously and poly ICLC SC on day -14, on day 15 of courses 1-4, and then on day 1 of every 4 courses thereafter. Patients also receive nivolumab IV over 30 minutes on days 1 and 15 and decitabine IV over 1 hour on days 1-5. Courses with nivolumab and decitabine repeat every 4 weeks in the absence of disease progression or unaccepted toxicity.
DEC-205/NY-ESO-1 Fusion Protein CDX-1401: Given intracutaneously
Decitabine: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Poly ICLC: Given SC
The study originally provided for the possibility of dose de-escalation for the treatment arms, but as we had no dose limiting toxicities, the dose level 1 was declared the maximum administered dose and all patients were enrolled and treated at dose level 1.
|
|---|---|
|
Immune Cell Profile
Pre Conventional dendritic cells type 1 (Cycle 1)
|
0.0030201667 percentage of CD45⁺ leukocytes
Standard Deviation 0.0050996289
|
|
Immune Cell Profile
Pre Conventional dendritic cells type 2 (Cycle 2)
|
0.152785 percentage of CD45⁺ leukocytes
Standard Deviation 0.1900236337
|
|
Immune Cell Profile
Pre Plasmacytoid dendritic cells (Cycle 1)
|
0.1246616667 percentage of CD45⁺ leukocytes
Standard Deviation 0.1795932594
|
|
Immune Cell Profile
Post Conventional dendritic cells type 1 (Cycle1)
|
0.0038176667 percentage of CD45⁺ leukocytes
Standard Deviation 0.0054418615
|
|
Immune Cell Profile
Post Conventional dendritic cells type 2 (Cycle 2)
|
0.1421666667 percentage of CD45⁺ leukocytes
Standard Deviation 0.1900236337
|
|
Immune Cell Profile
Post Plasmacytoid dendritic cells (Cycle 2)
|
0.0837116667 percentage of CD45⁺ leukocytes
Standard Deviation 0.1795932594
|
SECONDARY outcome
Timeframe: Cycle 1- 4 weekly to EOT (up to 180 days from baseline)Population: All treated and eligible patients
The degree of DNA methylation at CpG sites within the promoter of the tumor antigen NY-ESO-1 was quantified. Results are reported as the percentage of methylated cytosines relative to the total cytosines at the analyzed CpG sites.
Outcome measures
| Measure |
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)
n=8 Participants
Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401 intracutaneously and poly ICLC SC on day -14, on day 15 of courses 1-4, and then on day 1 of every 4 courses thereafter. Patients also receive nivolumab IV over 30 minutes on days 1 and 15 and decitabine IV over 1 hour on days 1-5. Courses with nivolumab and decitabine repeat every 4 weeks in the absence of disease progression or unaccepted toxicity.
DEC-205/NY-ESO-1 Fusion Protein CDX-1401: Given intracutaneously
Decitabine: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Poly ICLC: Given SC
The study originally provided for the possibility of dose de-escalation for the treatment arms, but as we had no dose limiting toxicities, the dose level 1 was declared the maximum administered dose and all patients were enrolled and treated at dose level 1.
|
|---|---|
|
Peripheral Blood and Bone Marrow Cells Responses
Cycle 1 Week 3 (approximately 3 weeks from baseline)
|
73.5 percentage of methylated cytosines
Standard Deviation 0.71
|
|
Peripheral Blood and Bone Marrow Cells Responses
Cycle 1 Week 4 (approximately 4 weeks from baseline)
|
76.6 percentage of methylated cytosines
Standard Deviation 6.8
|
|
Peripheral Blood and Bone Marrow Cells Responses
Cycle 2 Week 1 (approximately 5 weeks from baseline)
|
85.1 percentage of methylated cytosines
Standard Deviation 5.5
|
|
Peripheral Blood and Bone Marrow Cells Responses
Cycle 2 Week 2 (approximately 6 weeks from baseline)
|
62.3 percentage of methylated cytosines
Standard Deviation 13.7
|
|
Peripheral Blood and Bone Marrow Cells Responses
Baseline (Day 0)
|
84.5 percentage of methylated cytosines
Standard Deviation 4.9
|
|
Peripheral Blood and Bone Marrow Cells Responses
Cycle 1 Week 1 (approximately 1 week from baseline)
|
81 percentage of methylated cytosines
Standard Deviation 7.8
|
|
Peripheral Blood and Bone Marrow Cells Responses
Cycle 1 Week 2 (approximately 2 weeks from baseline)
|
70.2 percentage of methylated cytosines
Standard Deviation 9.3
|
|
Peripheral Blood and Bone Marrow Cells Responses
Cycle 2 Week 3 (approximately 7 weeks from baseline)
|
72 percentage of methylated cytosines
Standard Deviation 9.3
|
|
Peripheral Blood and Bone Marrow Cells Responses
Cycle 2 Week 4 (approximately 8 weeks from baseline)
|
76.9 percentage of methylated cytosines
Standard Deviation 8.5
|
|
Peripheral Blood and Bone Marrow Cells Responses
Cycle 3 Week 1 (approximately 9 weeks from baseline)
|
82.5 percentage of methylated cytosines
Standard Deviation .71
|
|
Peripheral Blood and Bone Marrow Cells Responses
Cycle 3 Week 2 (approximately 10 weeks from baseline)
|
54.1 percentage of methylated cytosines
Standard Deviation 24.3
|
|
Peripheral Blood and Bone Marrow Cells Responses
Cycle 3 Week 3 (approximately 11 weeks from baseline)
|
74.3 percentage of methylated cytosines
Standard Deviation 2.8
|
|
Peripheral Blood and Bone Marrow Cells Responses
Cycle 4 Week 1 (approximately 12 weeks from baseline)
|
72.4 percentage of methylated cytosines
Standard Deviation 12.4
|
|
Peripheral Blood and Bone Marrow Cells Responses
Cycle 4 Week 2 (approximately 13 weeks from baseline)
|
59.7 percentage of methylated cytosines
Standard Deviation 12.4
|
|
Peripheral Blood and Bone Marrow Cells Responses
Cycle 4 Week 3 (approximately 14 weeks from baseline)
|
76 percentage of methylated cytosines
Standard Deviation 5.5
|
|
Peripheral Blood and Bone Marrow Cells Responses
Cycle 4 Week 4 (approximately 15 weeks from baseline)
|
76.3 percentage of methylated cytosines
Standard Deviation 11.7
|
|
Peripheral Blood and Bone Marrow Cells Responses
End of Treatment (up to 180 days from baseline)
|
85.7 percentage of methylated cytosines
Standard Deviation 1.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 180 daysWill be assessed by complete response (CR), using results of blood counts on day 1 of each cycle.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 180 daysWill be assessed by partial response (PR) using results of blood counts on day 1 of each cycle.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 180 daysWill be assessed by Hematologic Improvement using results of blood counts on day 1 of each cycle
Outcome measures
Outcome data not reported
Adverse Events
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)
Serious events: 6 serious events
Other events: 6 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)
n=8 participants at risk
Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401 intracutaneously and poly ICLC SC on day -14, on day 15 of courses 1-4, and then on day 1 of every 4 courses thereafter. Patients also receive nivolumab IV over 30 minutes on days 1 and 15 and decitabine IV over 1 hour on days 1-5. Courses with nivolumab and decitabine repeat every 4 weeks in the absence of disease progression or unaccepted toxicity.
DEC-205/NY-ESO-1 Fusion Protein CDX-1401: Given intracutaneously
Decitabine: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Poly ICLC: Given SC
The study originally provided for the possibility of dose de-escalation for the treatment arms, but as we had no dose limiting toxicities, the dose level 1 was declared the maximum administered dose and all patients were enrolled and treated at dose level 1.
|
|---|---|
|
Infections and infestations
Sepsis
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Infections and infestations
Sinusitis
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Infections and infestations
Skin infection
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Nervous system disorders
Presyncope
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Vascular disorders
Embolism
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Vascular disorders
Haematoma
|
0.00%
0/8 • 180 days after the last treatment
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
25.0%
2/8 • Number of events 8 • 180 days after the last treatment
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/8 • 180 days after the last treatment
|
|
General disorders
Death
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Immune system disorders
Immune system disorder
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/8 • 180 days after the last treatment
|
|
Infections and infestations
Lung infection
|
12.5%
1/8 • Number of events 8 • 180 days after the last treatment
|
Other adverse events
| Measure |
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)
n=8 participants at risk
Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401 intracutaneously and poly ICLC SC on day -14, on day 15 of courses 1-4, and then on day 1 of every 4 courses thereafter. Patients also receive nivolumab IV over 30 minutes on days 1 and 15 and decitabine IV over 1 hour on days 1-5. Courses with nivolumab and decitabine repeat every 4 weeks in the absence of disease progression or unaccepted toxicity.
DEC-205/NY-ESO-1 Fusion Protein CDX-1401: Given intracutaneously
Decitabine: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Poly ICLC: Given SC
The study originally provided for the possibility of dose de-escalation for the treatment arms, but as we had no dose limiting toxicities, the dose level 1 was declared the maximum administered dose and all patients were enrolled and treated at dose level 1.
|
|---|---|
|
Eye disorders
Dry eye
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Eye disorders
Vitreous floaters
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Gastrointestinal disorders
Ascites
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Gastrointestinal disorders
Colitis ulcerative
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Gastrointestinal disorders
Constipation
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • 180 days after the last treatment
|
|
Gastrointestinal disorders
Flatulence
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Gastrointestinal disorders
Stomatitis
|
12.5%
1/8 • Number of events 12 • 180 days after the last treatment
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
General disorders
Asthenia
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
General disorders
Chest pain
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
General disorders
Chills
|
12.5%
1/8 • Number of events 8 • 180 days after the last treatment
|
|
General disorders
Fatigue
|
25.0%
2/8 • Number of events 12 • 180 days after the last treatment
|
|
General disorders
Injection site pain
|
0.00%
0/8 • 180 days after the last treatment
|
|
General disorders
Injection site reaction
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
General disorders
Malaise
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
General disorders
Mucosal inflammation
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
General disorders
Oedema peripheral
|
37.5%
3/8 • Number of events 24 • 180 days after the last treatment
|
|
General disorders
Pain
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
General disorders
Pyrexia
|
0.00%
0/8 • 180 days after the last treatment
|
|
Infections and infestations
Candida infection
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Infections and infestations
Fungal infection
|
0.00%
0/8 • 180 days after the last treatment
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/8 • 180 days after the last treatment
|
|
Injury, poisoning and procedural complications
Fall
|
37.5%
3/8 • Number of events 23 • 180 days after the last treatment
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
2/8 • Number of events 8 • 180 days after the last treatment
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
2/8 • Number of events 8 • 180 days after the last treatment
|
|
Investigations
Blood alkaline phosphatase increased
|
12.5%
1/8 • Number of events 8 • 180 days after the last treatment
|
|
Investigations
Blood creatinine increased
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Investigations
Platelet count decreased
|
0.00%
0/8 • 180 days after the last treatment
|
|
Investigations
Troponin increased
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Investigations
Weight decreased
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Investigations
White blood cell count decreased
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Metabolism and nutrition disorders
Decreased appetite
|
37.5%
3/8 • Number of events 12 • 180 days after the last treatment
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
37.5%
3/8 • Number of events 16 • 180 days after the last treatment
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
25.0%
2/8 • Number of events 8 • 180 days after the last treatment
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/8 • 180 days after the last treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
12.5%
1/8 • Number of events 12 • 180 days after the last treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Musculoskeletal and connective tissue disorders
Soft tissue necrosis
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Nervous system disorders
Dysgeusia
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Nervous system disorders
Lethargy
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Psychiatric disorders
Confusional state
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Psychiatric disorders
Insomnia
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Renal and urinary disorders
Acute kidney injury
|
25.0%
2/8 • Number of events 8 • 180 days after the last treatment
|
|
Renal and urinary disorders
Micturition urgency
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Renal and urinary disorders
Urinary retention
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
37.5%
3/8 • Number of events 12 • 180 days after the last treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
25.0%
2/8 • Number of events 8 • 180 days after the last treatment
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/8 • 180 days after the last treatment
|
|
Skin and subcutaneous tissue disorders
Panniculitis lobular
|
0.00%
0/8 • 180 days after the last treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
1/8 • Number of events 12 • 180 days after the last treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
25.0%
2/8 • Number of events 12 • 180 days after the last treatment
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Vascular disorders
Embolism
|
0.00%
0/8 • 180 days after the last treatment
|
|
Vascular disorders
Hypotension
|
0.00%
0/8 • 180 days after the last treatment
|
|
Blood and lymphatic system disorders
Neutropenia
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
|
Cardiac disorders
Tachycardia
|
12.5%
1/8 • Number of events 8 • 180 days after the last treatment
|
|
Blood and lymphatic system disorders
Anaemia
|
37.5%
3/8 • Number of events 20 • 180 days after the last treatment
|
|
Blood and lymphatic system disorders
Leukopenia
|
12.5%
1/8 • Number of events 4 • 180 days after the last treatment
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Comprehensive Cancer Center
Phone: 716-845-2300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place