Trial Outcomes & Findings for Glembatumumab Vedotin in Treating Patients With Metastatic or Locally Recurrent Uveal Melanoma (NCT NCT02363283)
NCT ID: NCT02363283
Last Updated: 2020-08-21
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (PD); PD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years and 10 months
Results posted on
2020-08-21
Participant Flow
Recruitment period: October 2015 to January 2018
2 participants withdrew consents prior to starting therapy and 1 failed eligibility criteria.
Participant milestones
| Measure |
Treatment (Glembatumumab Vedotin)
Patients receive glembatumumab vedotin IV over 90 minutes every 3 weeks in the absence of disease progression or unacceptable toxicity.
Glembatumumab Vedotin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Treatment (Glembatumumab Vedotin)
Patients receive glembatumumab vedotin IV over 90 minutes every 3 weeks in the absence of disease progression or unacceptable toxicity.
Glembatumumab Vedotin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Not eligible due to transaminitis
|
1
|
Baseline Characteristics
Glembatumumab Vedotin in Treating Patients With Metastatic or Locally Recurrent Uveal Melanoma
Baseline characteristics by cohort
| Measure |
Treatment (Glembatumumab Vedotin)
n=35 Participants
Patients receive glembatumumab vedotin IV over 90 minutes every 3 weeks in the absence of disease progression or unacceptable toxicity.
Glembatumumab Vedotin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
35 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
|
35 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years and 10 monthsPopulation: participants who entered study and received treatment
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (PD); PD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions
Outcome measures
| Measure |
Treatment (Glembatumumab Vedotin)
n=35 Participants
Patients receive glembatumumab vedotin IV over 90 minutes every 3 weeks in the absence of disease progression or unacceptable toxicity.
Glembatumumab Vedotin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
Overall Response Rate Using Response Evaluation Criteria in Solid Tumors Version 1.1
Partial Response
|
2 Participants
|
|
Overall Response Rate Using Response Evaluation Criteria in Solid Tumors Version 1.1
Stable Disease
|
18 Participants
|
|
Overall Response Rate Using Response Evaluation Criteria in Solid Tumors Version 1.1
Disease Progression
|
14 Participants
|
|
Overall Response Rate Using Response Evaluation Criteria in Solid Tumors Version 1.1
Unknown
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to up to 21 daysPopulation: Of 32 enrolled participants, 26 had baseline tissue available and 24 had Day 21 tissue available leaving only 22 evaluable for the secondary outcome measure: change in tumor expression from baseline to Day 21. In other words, only 22 participants had tumor collected for both baseline and Day 21 GPNMB expression.
Target protein expression change from baseline to after 1 cycle of treatment.
Outcome measures
| Measure |
Treatment (Glembatumumab Vedotin)
n=22 Participants
Patients receive glembatumumab vedotin IV over 90 minutes every 3 weeks in the absence of disease progression or unacceptable toxicity.
Glembatumumab Vedotin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
The Number of Participants With Change in Glycoprotein NMB Expression on Tumor Tissue Via Immunohistochemistry
|
22 Participants
|
SECONDARY outcome
Timeframe: From consent to time of progression or death, whichever occurs first, assessed up to 2 years and 10 monthsPopulation: 37 participants signed consent 1 participant withdrew consent for survival follow up
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Treatment (Glembatumumab Vedotin)
n=36 Participants
Patients receive glembatumumab vedotin IV over 90 minutes every 3 weeks in the absence of disease progression or unacceptable toxicity.
Glembatumumab Vedotin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
Progression-free Survival
|
3.1 months
Interval 1.5 to 5.6
|
SECONDARY outcome
Timeframe: through 30 days post-treatment, up to 2 years and 10 monthsToxicity will be reported by type, frequency, and severity. Only adverse events toxicity with grade 3-4 severity.
Outcome measures
| Measure |
Treatment (Glembatumumab Vedotin)
n=35 Participants
Patients receive glembatumumab vedotin IV over 90 minutes every 3 weeks in the absence of disease progression or unacceptable toxicity.
Glembatumumab Vedotin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
Number of Participants With Grade 3-4 Adverse Events According to the National Cancer Institute Common Toxicity Criteria Version 4.0
Constipation
|
1 Participants
|
|
Number of Participants With Grade 3-4 Adverse Events According to the National Cancer Institute Common Toxicity Criteria Version 4.0
Neutropenia
|
19 Participants
|
|
Number of Participants With Grade 3-4 Adverse Events According to the National Cancer Institute Common Toxicity Criteria Version 4.0
Thrombocytopenia
|
1 Participants
|
|
Number of Participants With Grade 3-4 Adverse Events According to the National Cancer Institute Common Toxicity Criteria Version 4.0
Diarrhea
|
1 Participants
|
|
Number of Participants With Grade 3-4 Adverse Events According to the National Cancer Institute Common Toxicity Criteria Version 4.0
Vomiting
|
1 Participants
|
|
Number of Participants With Grade 3-4 Adverse Events According to the National Cancer Institute Common Toxicity Criteria Version 4.0
Rash, maculopapular
|
2 Participants
|
|
Number of Participants With Grade 3-4 Adverse Events According to the National Cancer Institute Common Toxicity Criteria Version 4.0
Pruritus
|
2 Participants
|
SECONDARY outcome
Timeframe: From consent to time of progression or death, whichever occurs first, assessed up to 2 years and 10 monthsPopulation: 37 participants signed consent 1 participant withdrew consent for survival follow up
Overall survival as measured from time of enrollment to time of death due to any cause.
Outcome measures
| Measure |
Treatment (Glembatumumab Vedotin)
n=36 Participants
Patients receive glembatumumab vedotin IV over 90 minutes every 3 weeks in the absence of disease progression or unacceptable toxicity.
Glembatumumab Vedotin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
Overall Survival
|
11.9 months
Interval 9.0 to 16.9
|
Adverse Events
Treatment (Glembatumumab Vedotin)
Serious events: 34 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment (Glembatumumab Vedotin)
n=35 participants at risk
Patients receive glembatumumab vedotin IV over 90 minutes every 3 weeks in the absence of disease progression or unacceptable toxicity.
Glembatumumab Vedotin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
60.0%
21/35 • through 30 days post-treatment, an average of 1 year
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.3%
5/35 • through 30 days post-treatment, an average of 1 year
|
|
Gastrointestinal disorders
Elevated ALT/AST
|
62.9%
22/35 • through 30 days post-treatment, an average of 1 year
|
|
Gastrointestinal disorders
Nausea
|
51.4%
18/35 • through 30 days post-treatment, an average of 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
31.4%
11/35 • through 30 days post-treatment, an average of 1 year
|
|
Gastrointestinal disorders
Constipation
|
22.9%
8/35 • through 30 days post-treatment, an average of 1 year
|
|
Blood and lymphatic system disorders
Mucositis, oral
|
17.1%
6/35 • through 30 days post-treatment, an average of 1 year
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
5/35 • through 30 days post-treatment, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
80.0%
28/35 • through 30 days post-treatment, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Rash, maculopapular
|
54.3%
19/35 • through 30 days post-treatment, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
51.4%
18/35 • through 30 days post-treatment, an average of 1 year
|
|
Blood and lymphatic system disorders
Leukopenia
|
68.6%
24/35 • through 30 days post-treatment, an average of 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
40.0%
14/35 • through 30 days post-treatment, an average of 1 year
|
|
Blood and lymphatic system disorders
Lymphopenia
|
17.1%
6/35 • through 30 days post-treatment, an average of 1 year
|
|
Gastrointestinal disorders
Elevated ALP
|
25.7%
9/35 • through 30 days post-treatment, an average of 1 year
|
|
Gastrointestinal disorders
Hyperbilirubinemia
|
11.4%
4/35 • through 30 days post-treatment, an average of 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
5.7%
2/35 • through 30 days post-treatment, an average of 1 year
|
|
Gastrointestinal disorders
Dry mouth
|
5.7%
2/35 • through 30 days post-treatment, an average of 1 year
|
|
Gastrointestinal disorders
Oral pain
|
5.7%
2/35 • through 30 days post-treatment, an average of 1 year
|
|
General disorders
Fatigue
|
57.1%
20/35 • through 30 days post-treatment, an average of 1 year
|
|
General disorders
Pain
|
17.1%
6/35 • through 30 days post-treatment, an average of 1 year
|
|
Gastrointestinal disorders
Chills
|
5.7%
2/35 • through 30 days post-treatment, an average of 1 year
|
|
General disorders
Flu like symptoms
|
5.7%
2/35 • through 30 days post-treatment, an average of 1 year
|
|
General disorders
Localized edema
|
5.7%
2/35 • through 30 days post-treatment, an average of 1 year
|
|
General disorders
Weight loss
|
5.7%
2/35 • through 30 days post-treatment, an average of 1 year
|
|
Nervous system disorders
Peripheral Neuropathy
|
42.9%
15/35 • through 30 days post-treatment, an average of 1 year
|
|
Nervous system disorders
Dysgeusia
|
22.9%
8/35 • through 30 days post-treatment, an average of 1 year
|
|
Nervous system disorders
Headache
|
8.6%
3/35 • through 30 days post-treatment, an average of 1 year
|
|
Nervous system disorders
Generalized muscle weakness
|
5.7%
2/35 • through 30 days post-treatment, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.7%
9/35 • through 30 days post-treatment, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
17.1%
6/35 • through 30 days post-treatment, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.6%
3/35 • through 30 days post-treatment, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.7%
2/35 • through 30 days post-treatment, an average of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.3%
5/35 • through 30 days post-treatment, an average of 1 year
|
|
Renal and urinary disorders
Hyponatremia
|
14.3%
5/35 • through 30 days post-treatment, an average of 1 year
|
|
Renal and urinary disorders
Hypophosphatemia
|
11.4%
4/35 • through 30 days post-treatment, an average of 1 year
|
|
Renal and urinary disorders
Hypokalemia
|
8.6%
3/35 • through 30 days post-treatment, an average of 1 year
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.7%
2/35 • through 30 days post-treatment, an average of 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
37.1%
13/35 • through 30 days post-treatment, an average of 1 year
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
8.6%
3/35 • through 30 days post-treatment, an average of 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.7%
2/35 • through 30 days post-treatment, an average of 1 year
|
|
Vascular disorders
Hot flashes
|
8.6%
3/35 • through 30 days post-treatment, an average of 1 year
|
|
Vascular disorders
Hypotension
|
8.6%
3/35 • through 30 days post-treatment, an average of 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Sapna Pradyuman Patel,MD/ Melanoma Medical Oncology
UT MD Anderson Cancer Center
Phone: 713-792-2921
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60