Trial Outcomes & Findings for Phase II Trial of Nivolumab Plus Ipilimumab in Patients With Renal Medullary Carcinoma (NCT NCT03274258)
NCT ID: NCT03274258
Last Updated: 2026-08-20
Results Overview
To determine the objective response rate (ORR) of patients with locally advanced or metastatic renal medullary carcinoma (RMC) treated with combination of nivolumab plus ipilimumab.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
2 years and 6 months
Results posted on
2026-08-20
Participant Flow
From March 2018 to November 2020, patients were recruited from the outpatient clinics for Genitourinary Medical Oncology at MD Anderson Cancer Center in Houston, Texas who have been diagnosed with cancer and currently undergoing outpatient treatment at the cancer center that are immunotherapy-naïve with ccRCC refractory to prior antiangiogenic therapies.
10 participants were treated on trial
Participant milestones
| Measure |
Nivolumab IV Combination With Ipilimumab IV
nivolumab IV and ipilimumab IV
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Nivolumab IV Combination With Ipilimumab IV
nivolumab IV and ipilimumab IV
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
Radiographic Progression
|
7
|
Baseline Characteristics
Phase II Trial of Nivolumab Plus Ipilimumab in Patients With Renal Medullary Carcinoma
Baseline characteristics by cohort
| Measure |
Nivolumab IV Combination With Ipilimumab IV
n=10 Participants
nivolumab IV and ipilimumab IV
|
|---|---|
|
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
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 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
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 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
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 years and 6 monthsTo determine the objective response rate (ORR) of patients with locally advanced or metastatic renal medullary carcinoma (RMC) treated with combination of nivolumab plus ipilimumab.
Outcome measures
| Measure |
Nivolumab IV Combination With Ipilimumab IV
n=10 Participants
nivolumab IV and ipilimumab IV
|
|---|---|
|
Objective Response Rate (ORR)
|
0 Participants
|
PRIMARY outcome
Timeframe: 2 years and 6 monthsTo determine the efficacy and safety of the combination of nivolumab plus ipilimumab in patients with RMC. Efficacy will be measured by overall survival (OS) and progression-free survival (PFS).
Outcome measures
| Measure |
Nivolumab IV Combination With Ipilimumab IV
n=10 Participants
nivolumab IV and ipilimumab IV
|
|---|---|
|
Overall Survival (OS), Progression-free Survival (PFS), and the Disease Control Rate (DCR)
OS
|
8.23 months
Interval 3.45 to
Upper confidence interval was not estimable because the required number of events had not occurred.
|
|
Overall Survival (OS), Progression-free Survival (PFS), and the Disease Control Rate (DCR)
PFS
|
1.38 months
Interval 1.28 to 1.6
|
PRIMARY outcome
Timeframe: 2 years and 6 monthsTo determine the efficacy and safety of the combination of nivolumab plus ipilimumab in patients with RMC. Efficacy will be measured by disease control rate (DCR).
Outcome measures
| Measure |
Nivolumab IV Combination With Ipilimumab IV
n=10 Participants
nivolumab IV and ipilimumab IV
|
|---|---|
|
Disease Control Rate (DCR)
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 years and 6 monthsPopulation: No participants were included in the analysis for this outcome because the study was terminated early for futility before the planned exploratory biomarker analyses for this endpoint were completed.
Exploratory analyses of tumor and immune biomarkers associated with treatment response, including antibody and T-cell immune responses, were planned using protocol-specified laboratory assays.
Outcome measures
Outcome data not reported
Adverse Events
Nivolumab IV Combination With Ipilimumab IV
Serious events: 4 serious events
Other events: 10 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Nivolumab IV Combination With Ipilimumab IV
n=10 participants at risk
nivolumab IV and ipilimumab IV
|
|---|---|
|
Vascular disorders
Hypotension
|
10.0%
1/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Gastrointestinal disorders
Abdominal Pain
|
10.0%
1/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
General disorders
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Disease Progression
|
10.0%
1/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Cardiac disorders
Pericardial Tamponade
|
10.0%
1/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
General disorders
Pain
|
10.0%
1/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
Other adverse events
| Measure |
Nivolumab IV Combination With Ipilimumab IV
n=10 participants at risk
nivolumab IV and ipilimumab IV
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
30.0%
3/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
20.0%
2/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
2/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Investigations
Alkaline phosphatase increased
|
20.0%
2/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Immune system disorders
Allergic reaction
|
10.0%
1/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
20.0%
2/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Blood and lymphatic system disorders
Anemia
|
90.0%
9/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Metabolism and nutrition disorders
Anorexia
|
60.0%
6/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Psychiatric disorders
Anxiety
|
30.0%
3/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
2/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Investigations
Aspartate aminotransferase increased
|
30.0%
3/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Cardiac disorders
Atrial fibrillation
|
10.0%
1/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
60.0%
6/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
10.0%
1/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
20.0%
2/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Infections and infestations
Bronchial infection
|
10.0%
1/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Cardiac disorders
Chest pain - cardiac
|
10.0%
1/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Investigations
Cholesterol high
|
40.0%
4/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Gastrointestinal disorders
Constipation
|
40.0%
4/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
60.0%
6/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Investigations
Creatinine increased
|
80.0%
8/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Psychiatric disorders
Depression
|
10.0%
1/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
1/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Nervous system disorders
Dizziness
|
30.0%
3/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Gastrointestinal disorders
Dysphagia
|
20.0%
2/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
40.0%
4/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
1/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Injury, poisoning and procedural complications
Fall
|
10.0%
1/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
General disorders
Fatigue
|
80.0%
8/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
10.0%
1/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
General disorders
Gait disturbance
|
20.0%
2/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
30.0%
3/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Nervous system disorders
Headache
|
40.0%
4/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Renal and urinary disorders
Hematuria
|
30.0%
3/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Blood and lymphatic system disorders
Hemolytic uremic syndrome
|
10.0%
1/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
10.0%
1/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Vascular disorders
Hot flashes
|
20.0%
2/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
10.0%
1/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
70.0%
7/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
10.0%
1/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Vascular disorders
Hypertension
|
10.0%
1/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
20.0%
2/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
10.0%
1/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.0%
1/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
10.0%
1/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.0%
1/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Vascular disorders
Hypotension
|
10.0%
1/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
10.0%
1/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Investigations
INR increased
|
20.0%
2/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Psychiatric disorders
Insomnia
|
50.0%
5/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Investigations
Lipase increased
|
30.0%
3/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Investigations
Lymphocyte count decreased
|
30.0%
3/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Gastrointestinal disorders
Mucositis oral
|
10.0%
1/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.0%
1/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
5/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
10.0%
1/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Investigations
Neutrophil count decreased
|
30.0%
3/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
General disorders
Non-cardiac chest pain
|
20.0%
2/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
General disorders
Pain
|
30.0%
3/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Cardiac disorders
Palpitations
|
10.0%
1/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Nervous system disorders
Paresthesia
|
10.0%
1/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Cardiac disorders
Pericardial tamponade
|
10.0%
1/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
10.0%
1/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Investigations
Platelet count decreased
|
10.0%
1/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
20.0%
2/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
10.0%
1/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Renal and urinary disorders
Proteinuria
|
40.0%
4/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
20.0%
2/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
10.0%
1/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Investigations
Serum amylase increased
|
40.0%
4/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
20.0%
2/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Investigations
Weight loss
|
10.0%
1/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
|
Investigations
White blood cell decreased
|
20.0%
2/10 • 90 days after last dose of study treatment, up to 3 years.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
|
Additional Information
Pavlos Msaouel, MD, PHD, PHD
The University of Texas MD Anderson Cancer Center
Phone: (713) 563-4585
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place