Trial Outcomes & Findings for Nivolumab in Treating Patients With Primary Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis, or Post-Polycythemia Vera Myelofibrosis (NCT NCT02421354)
NCT ID: NCT02421354
Last Updated: 2019-05-15
Results Overview
Responses will be categorized according to the revised International Working Group-Myeloproliferative Neoplasms Research and Treatment and European LeukmiaNet consensus criteria for myelofibrosis.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
14 weeks (after 8 doses of therapy)
Results posted on
2019-05-15
Participant Flow
Recruitment Period: May 2015 to October 2017
Participant milestones
| Measure |
Treatment (Nivolumab)
Patients receive nivolumab IV over 60 minutes once every 2 weeks for 8 doses and then once every 12 weeks thereafter. Treatment may continue for up to 4 years in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nivolumab in Treating Patients With Primary Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis, or Post-Polycythemia Vera Myelofibrosis
Baseline characteristics by cohort
| Measure |
Treatment (Nivolumab)
n=8 Participants
Patients receive nivolumab IV over 60 minutes once every 2 weeks for 8 doses and then once every 12 weeks thereafter. Treatment may continue for up to 4 years in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
74 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 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
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 weeks (after 8 doses of therapy)Responses will be categorized according to the revised International Working Group-Myeloproliferative Neoplasms Research and Treatment and European LeukmiaNet consensus criteria for myelofibrosis.
Outcome measures
| Measure |
Treatment (Nivolumab)
n=8 Participants
Patients receive nivolumab IV over 60 minutes once every 2 weeks for 8 doses and then once every 12 weeks thereafter. Treatment may continue for up to 4 years in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Objective Response Rate, Defined as Complete Remission + Partial Remission + Clinical Improvement
|
0 Participants
|
Adverse Events
Treatment (Nivolumab)
Serious events: 6 serious events
Other events: 7 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Treatment (Nivolumab)
n=8 participants at risk
Patients receive nivolumab IV over 60 minutes once every 2 weeks for 8 doses and then once every 12 weeks thereafter. Treatment may continue for up to 4 years in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
General disorders
Abdominal Pain
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
Renal and urinary disorders
Acute Kidney Injury
|
12.5%
1/8 • Number of events 2 • 2 years, 5 months
|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
2/8 • Number of events 2 • 2 years, 5 months
|
|
General disorders
Back Pain
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
General disorders
Chest Pain
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
Gastrointestinal disorders
Esophageal Varices Hemorrhage
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
Nervous system disorders
Facial Nerve Disorder
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
Injury, poisoning and procedural complications
Fall
|
12.5%
1/8 • Number of events 2 • 2 years, 5 months
|
|
General disorders
Fever
|
12.5%
1/8 • Number of events 2 • 2 years, 5 months
|
|
Gastrointestinal disorders
Gastric Hemorrhage
|
25.0%
2/8 • Number of events 4 • 2 years, 5 months
|
|
General disorders
Headache
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
Infections and infestations
Infection
|
12.5%
1/8 • Number of events 2 • 2 years, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
Infections and infestations
Urinary Tract Infection
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
Other adverse events
| Measure |
Treatment (Nivolumab)
n=8 participants at risk
Patients receive nivolumab IV over 60 minutes once every 2 weeks for 8 doses and then once every 12 weeks thereafter. Treatment may continue for up to 4 years in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
General disorders
Pain
|
37.5%
3/8 • Number of events 5 • 2 years, 5 months
|
|
Infections and infestations
Neutropenic Fever
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
Blood and lymphatic system disorders
Leptomeningeal disease
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
General disorders
Fever
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
Vascular disorders
Hypertension
|
25.0%
2/8 • Number of events 2 • 2 years, 5 months
|
|
Infections and infestations
Infection
|
37.5%
3/8 • Number of events 4 • 2 years, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
Renal and urinary disorders
Acute Kidney Injury
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
Nervous system disorders
Peripheral Neuropathy
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
Investigations
Increased Transaminases
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
Gastrointestinal disorders
Mucositis
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
Investigations
Hyperbilirubinemia
|
37.5%
3/8 • Number of events 3 • 2 years, 5 months
|
|
Blood and lymphatic system disorders
Anemia
|
12.5%
1/8 • Number of events 2 • 2 years, 5 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
2/8 • Number of events 3 • 2 years, 5 months
|
|
Cardiac disorders
Cardiomegaly
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
General disorders
Edema
|
37.5%
3/8 • Number of events 3 • 2 years, 5 months
|
|
Gastrointestinal disorders
Constipation
|
50.0%
4/8 • Number of events 4 • 2 years, 5 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
2/8 • Number of events 2 • 2 years, 5 months
|
|
Gastrointestinal disorders
Abdominal distention
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
General disorders
Bruising
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
General disorders
Chills
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
Investigations
Elevated Alkaline Phophatase
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
Investigations
Elevated Creatinine
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
Gastrointestinal disorders
Esophageal Varicies
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
Ear and labyrinth disorders
Hemotympanum
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
Hepatobiliary disorders
Hepatobiliary disorder
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
Psychiatric disorders
Insomnia
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
Nervous system disorders
Memory Impairment
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
Nervous system disorders
Hemorrhage
|
25.0%
2/8 • Number of events 2 • 2 years, 5 months
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
Renal and urinary disorders
Renal lesion
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
Infections and infestations
Sinusitis
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
Skin and subcutaneous tissue disorders
Skin discoloration
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
Additional Information
Dr. Srdan Verstovsek, MD. Professor
The University of Texas MD Anderson Cancer Center
Phone: 713-745-3429
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place