Trial Outcomes & Findings for A Study Combining Eribulin Mesylate With Avelumab in Cisplatin Ineligible Metastatic Urothelial Cell Cancer Patients (NCT NCT03502681)
NCT ID: NCT03502681
Last Updated: 2022-07-01
Results Overview
Dose limiting toxicities (DLTs) experienced by subjects while being treated with the combination of eribulin+avelumab, by dose level.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
6 participants
Primary outcome timeframe
4-weeks
Results posted on
2022-07-01
Participant Flow
Participant milestones
| Measure |
Dose Level 0: Starting Cohort
Eribulin mesylate: 1.1mg/m2 on days 1,15 Avelumab 10 mg/kg on days 1,15
|
Dose Level 1
Eribulin mesylate 1.4mg/m2 days 1,15 Avelumab 10mg/kb on days 1,15
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
|
Overall Study
COMPLETED
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Dose Level 0: Starting Cohort
Eribulin mesylate: 1.1mg/m2 on days 1,15 Avelumab 10 mg/kg on days 1,15
|
Dose Level 1
Eribulin mesylate 1.4mg/m2 days 1,15 Avelumab 10mg/kb on days 1,15
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Disease Progression
|
2
|
1
|
Baseline Characteristics
A Study Combining Eribulin Mesylate With Avelumab in Cisplatin Ineligible Metastatic Urothelial Cell Cancer Patients
Baseline characteristics by cohort
| Measure |
Dose Level 0: Starting Cohort
n=3 Participants
Eribulin mesylate: 1.1mg/m2 on days 1,15 Avelumab 10 mg/kg on days 1,15
|
Dose Level 1
n=3 Participants
Eribulin mesylate 1.4mg/m2 days 1,15 Avelumab 10mg/kb on days 1,15
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
69.3 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
70.2 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Smoking Status
Never a smoker
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Smoking Status
Former smoker
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Histology
Urothelial(transitional cell) Carcinoma
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Histology
Urothelial(transitional cell) Carcinoma, Mixed
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4-weeksDose limiting toxicities (DLTs) experienced by subjects while being treated with the combination of eribulin+avelumab, by dose level.
Outcome measures
| Measure |
Dose Level 0: Starting Cohort
n=3 Participants
Eribulin mesylate: 1.1mg/m2 on days 1,15 Avelumab 10 mg/kg on days 1,15
|
Dose Level 1
n=3 Participants
Eribulin mesylate 1.4mg/m2 days 1,15 Avelumab 10mg/kb on days 1,15
|
|---|---|---|
|
Assess the Adverse Events of Combining Eribulin Mesylate With Avelumab - (MTD Cohort)
Febrile Neutropenia
|
0 participants
|
1 participants
|
|
Assess the Adverse Events of Combining Eribulin Mesylate With Avelumab - (MTD Cohort)
Neutrophil Count Decreased
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Data for this outcome measure was not collected or analyzed due to the early termination of the study.
Complete Response (CR) + Partial Response (PR)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at 3, 6 monthsPopulation: Data for this outcome measure was not collected or analyzed due to the early termination of the study.
Complete Response (CR) + Partial Response (PR) + Stable Disease (SD)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data for this outcome measure was not collected or analyzed due to the early termination of the study.
probability that a patient remains free of progression of disease by modified RECIST 1.1
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data for this outcome measure was not collected or analyzed due to the early termination of the study.
time from start of treatment, Day 1, to the date of death due to any cause
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data for this outcome measure was not collected or analyzed due to the early termination of the study.
measurement from the date of initiation of avelumab+ eribulin, D1 until the criteria for disease progression is met as defined by modified RECIST 1.1
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2.5 yearsPopulation: Data for this outcome measure was not collected or analyzed due to the early termination of the study.
time from start of treatment, Day 1, that half of the patients in the group with the disease are still alive.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2.5 yearsPopulation: Data for this outcome measure was not collected or analyzed due to the early termination of the study.
the period measured from the time that measurement criteria are met for complete or partial response (whichever status is recorded first) until the date that recurrent or progressive disease is objectively documented.
Outcome measures
Outcome data not reported
Adverse Events
All Subjects
Serious events: 3 serious events
Other events: 6 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
All Subjects
n=6 participants at risk
All subjects (6) from each dose level.
|
|---|---|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
16.7%
1/6 • Number of events 1 • Up to six cycles (6 months)
|
|
General disorders
FEVER
|
16.7%
1/6 • Number of events 1 • Up to six cycles (6 months)
|
|
Infections and infestations
INFECTIONS AND INFESTATIONS
|
16.7%
1/6 • Number of events 1 • Up to six cycles (6 months)
|
|
Infections and infestations
URINARY TRACT INFECTION
|
16.7%
1/6 • Number of events 1 • Up to six cycles (6 months)
|
Other adverse events
| Measure |
All Subjects
n=6 participants at risk
All subjects (6) from each dose level.
|
|---|---|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
33.3%
2/6 • Number of events 2 • Up to six cycles (6 months)
|
|
Respiratory, thoracic and mediastinal disorders
ALLERGIC RHINITIS
|
16.7%
1/6 • Number of events 1 • Up to six cycles (6 months)
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
33.3%
2/6 • Number of events 2 • Up to six cycles (6 months)
|
|
Blood and lymphatic system disorders
ANEMIA
|
50.0%
3/6 • Number of events 6 • Up to six cycles (6 months)
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
16.7%
1/6 • Number of events 2 • Up to six cycles (6 months)
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
33.3%
2/6 • Number of events 2 • Up to six cycles (6 months)
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
16.7%
1/6 • Number of events 1 • Up to six cycles (6 months)
|
|
Musculoskeletal and connective tissue disorders
BUTTOCK PAIN
|
16.7%
1/6 • Number of events 1 • Up to six cycles (6 months)
|
|
General disorders
CHILLS
|
50.0%
3/6 • Number of events 3 • Up to six cycles (6 months)
|
|
Investigations
CREATININE INCREASED
|
50.0%
3/6 • Number of events 3 • Up to six cycles (6 months)
|
|
Gastrointestinal disorders
DIARRHEA
|
16.7%
1/6 • Number of events 1 • Up to six cycles (6 months)
|
|
Nervous system disorders
DYSGEUSIA
|
16.7%
1/6 • Number of events 1 • Up to six cycles (6 months)
|
|
General disorders
EDEMA LIMBS
|
16.7%
1/6 • Number of events 2 • Up to six cycles (6 months)
|
|
General disorders
FATIGUE
|
33.3%
2/6 • Number of events 2 • Up to six cycles (6 months)
|
|
Gastrointestinal disorders
GASTROESOPHAGEAL REFLUX DISEASE
|
16.7%
1/6 • Number of events 1 • Up to six cycles (6 months)
|
|
Musculoskeletal and connective tissue disorders
GENERALIZED MUSCLE WEAKNESS
|
16.7%
1/6 • Number of events 1 • Up to six cycles (6 months)
|
|
Nervous system disorders
HEADACHE
|
16.7%
1/6 • Number of events 1 • Up to six cycles (6 months)
|
|
Renal and urinary disorders
HEMATURIA
|
16.7%
1/6 • Number of events 1 • Up to six cycles (6 months)
|
|
Metabolism and nutrition disorders
HYPERKALEMIA
|
16.7%
1/6 • Number of events 1 • Up to six cycles (6 months)
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
16.7%
1/6 • Number of events 3 • Up to six cycles (6 months)
|
|
Endocrine disorders
HYPOTHYROIDISM
|
16.7%
1/6 • Number of events 2 • Up to six cycles (6 months)
|
|
Infections and infestations
INFECTIONS AND INFESTATIONS
|
16.7%
1/6 • Number of events 2 • Up to six cycles (6 months)
|
|
General disorders
INFUSION RELATED REACTION
|
33.3%
2/6 • Number of events 2 • Up to six cycles (6 months)
|
|
General disorders
INFUSION SITE EXTRAVASATION
|
16.7%
1/6 • Number of events 2 • Up to six cycles (6 months)
|
|
Injury, poisoning and procedural complications
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
|
16.7%
1/6 • Number of events 1 • Up to six cycles (6 months)
|
|
Infections and infestations
KIDNEY INFECTION
|
16.7%
1/6 • Number of events 1 • Up to six cycles (6 months)
|
|
Investigations
LIPASE INCREASED
|
16.7%
1/6 • Number of events 1 • Up to six cycles (6 months)
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
50.0%
3/6 • Number of events 5 • Up to six cycles (6 months)
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER
|
16.7%
1/6 • Number of events 1 • Up to six cycles (6 months)
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
16.7%
1/6 • Number of events 1 • Up to six cycles (6 months)
|
|
Infections and infestations
NAIL INFECTION
|
16.7%
1/6 • Number of events 1 • Up to six cycles (6 months)
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
50.0%
3/6 • Number of events 8 • Up to six cycles (6 months)
|
|
Nervous system disorders
PARESTHESIA
|
16.7%
1/6 • Number of events 1 • Up to six cycles (6 months)
|
|
Respiratory, thoracic and mediastinal disorders
POSTNASAL DRIP
|
16.7%
1/6 • Number of events 1 • Up to six cycles (6 months)
|
|
Skin and subcutaneous tissue disorders
RASH ACNEIFORM
|
16.7%
1/6 • Number of events 1 • Up to six cycles (6 months)
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
16.7%
1/6 • Number of events 1 • Up to six cycles (6 months)
|
|
Investigations
SERUM AMYLASE INCREASED
|
16.7%
1/6 • Number of events 2 • Up to six cycles (6 months)
|
|
Nervous system disorders
SINUS PAIN
|
16.7%
1/6 • Number of events 1 • Up to six cycles (6 months)
|
|
Skin and subcutaneous tissue disorders
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
|
16.7%
1/6 • Number of events 1 • Up to six cycles (6 months)
|
|
Surgical and medical procedures
SURGICAL AND MEDICAL PROCEDURES
|
16.7%
1/6 • Number of events 1 • Up to six cycles (6 months)
|
|
Infections and infestations
URINARY TRACT INFECTION
|
16.7%
1/6 • Number of events 2 • Up to six cycles (6 months)
|
|
Gastrointestinal disorders
VOMITING
|
33.3%
2/6 • Number of events 2 • Up to six cycles (6 months)
|
|
Investigations
WHITE BLOOD CELL DECREASED
|
33.3%
2/6 • Number of events 8 • Up to six cycles (6 months)
|
Additional Information
Clinicaltrials.gov Results Coordinator
Hoosier Cancer Research Network
Phone: 317-921-2050
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place