Trial · NCT02363283
Glembatumumab Vedotin in Treating Patients With Metastatic or Locally Recurrent Uveal Melanoma
NCT02363283, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2020-08-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Glembatumumab Vedotin in Treating Patients With Metastatic or Locally Recurrent Uveal Melanoma. Trials, record NCT02363283. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02363283
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Glembatumumab Vedotin in Treating Patients With Metastatic or Locally Recurrent Uveal Melanoma
- NCT number
- NCT02363283
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 37 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Recurrent Uveal Melanoma, Stage IV Uveal Melanoma AJCC v7
- Interventions
- Glembatumumab Vedotin, Laboratory Biomarker Analysis, Pharmacological Study
- First posted
- 2015-02-16
- Last updated
- 2020-08-21
- Results first posted
- 2020-08-21
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate Using Response Evaluation Criteria in Solid Tumors Version 1.1 | 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 | 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 |
| Secondary | The Number of Participants With Change in Glycoprotein NMB Expression on Tumor Tissue Via Immunohistochemistry | Baseline to up to 21 days | Target protein expression change from baseline to after 1 cycle of treatment. |
| Secondary | Progression-free Survival | From consent to time of progression or death, whichever occurs first, assessed up to 2 years and 10 months | 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 |
| Secondary | Number of Participants With Grade 3-4 Adverse Events According to the National Cancer Institute Common Toxicity Criteria Version 4.0 | through 30 days post-treatment, up to 2 years and 10 months | Toxicity will be reported by type, frequency, and severity. Only adverse events toxicity with grade 3-4 severity. |
| Secondary | Overall Survival | From consent to time of progression or death, whichever occurs first, assessed up to 2 years and 10 months | Overall survival as measured from time of enrollment to time of death due to any cause. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate Using Response Evaluation Criteria in Solid Tumors Version 1.1 | 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 | participants who entered study and received treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Number of Participants With Change in Glycoprotein NMB Expression on Tumor Tissue Via Immunohistochemistry | Baseline to up to 21 days | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-free Survival | From consent to time of progression or death, whichever occurs first, assessed up to 2 years and 10 months | 37 participants signed consent 1 participant withdrew consent for survival follow up | months | MEDIAN |
| SECONDARY | Number of Participants With Grade 3-4 Adverse Events According to the National Cancer Institute Common Toxicity Criteria Version 4.0 | through 30 days post-treatment, up to 2 years and 10 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Survival | From consent to time of progression or death, whichever occurs first, assessed up to 2 years and 10 months | 37 participants signed consent 1 participant withdrew consent for survival follow up | months | MEDIAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate Using Response Evaluation Criteria in Solid Tumors Version 1.1 | Treatment (Glembatumumab Vedotin) | Partial Response | 2 | Participants | |
| Overall Response Rate Using Response Evaluation Criteria in Solid Tumors Version 1.1 | Treatment (Glembatumumab Vedotin) | Stable Disease | 18 | Participants | |
| Overall Response Rate Using Response Evaluation Criteria in Solid Tumors Version 1.1 | Treatment (Glembatumumab Vedotin) | Disease Progression | 14 | Participants | |
| Overall Response Rate Using Response Evaluation Criteria in Solid Tumors Version 1.1 | Treatment (Glembatumumab Vedotin) | Unknown | 1 | Participants | |
| The Number of Participants With Change in Glycoprotein NMB Expression on Tumor Tissue Via Immunohistochemistry | Treatment (Glembatumumab Vedotin) | 22 | Participants | ||
| Progression-free Survival | Treatment (Glembatumumab Vedotin) | 3.1 | 95% Confidence Interval 1.5 to 5.6 | months | |
| Number of Participants With Grade 3-4 Adverse Events According to the National Cancer Institute Common Toxicity Criteria Version 4.0 | Treatment (Glembatumumab Vedotin) | Neutropenia | 19 | Participants | |
| Number of Participants With Grade 3-4 Adverse Events According to the National Cancer Institute Common Toxicity Criteria Version 4.0 | Treatment (Glembatumumab Vedotin) | Thrombocytopenia | 1 | Participants | |
| Number of Participants With Grade 3-4 Adverse Events According to the National Cancer Institute Common Toxicity Criteria Version 4.0 | Treatment (Glembatumumab Vedotin) | Diarrhea | 1 | Participants | |
| Number of Participants With Grade 3-4 Adverse Events According to the National Cancer Institute Common Toxicity Criteria Version 4.0 | Treatment (Glembatumumab Vedotin) | Constipation | 1 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Glembatumumab Vedotin) | 37 | |
| Overall Study | COMPLETED | Treatment (Glembatumumab Vedotin) | 35 | |
| Overall Study | NOT COMPLETED | Treatment (Glembatumumab Vedotin) | 2 |
Source ClinicalTrials.gov
Adverse events43
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Neutropenia | Blood and lymphatic system disorders | Treatment (Glembatumumab Vedotin) | 21 | 35 | |
| serious | Thrombocytopenia | Blood and lymphatic system disorders | Treatment (Glembatumumab Vedotin) | 5 | 35 | |
| serious | Elevated ALT/AST | Gastrointestinal disorders | Treatment (Glembatumumab Vedotin) | 22 | 35 | |
| serious | Nausea | Gastrointestinal disorders | Treatment (Glembatumumab Vedotin) | 18 | 35 | |
| serious | Diarrhea | Gastrointestinal disorders | Treatment (Glembatumumab Vedotin) | 11 | 35 | |
| serious | Constipation | Gastrointestinal disorders | Treatment (Glembatumumab Vedotin) | 8 | 35 | |
| serious | Mucositis, oral | Blood and lymphatic system disorders | Treatment (Glembatumumab Vedotin) | 6 | 35 | |
| serious | Vomiting | Gastrointestinal disorders | Treatment (Glembatumumab Vedotin) | 5 | 35 | |
| serious | Alopecia | Skin and subcutaneous tissue disorders | Treatment (Glembatumumab Vedotin) | 28 | 35 | |
| serious | Rash, maculopapular | Skin and subcutaneous tissue disorders | Treatment (Glembatumumab Vedotin) | 19 | 35 |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Glembatumumab Vedotin) | 1 | 35 |
| Total, other adverse events | Treatment (Glembatumumab Vedotin) | 0 | 35 |
| Total, serious adverse events | Treatment (Glembatumumab Vedotin) | 34 | 35 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UM1CA186712 | The Ohio State University as a Lead Academic Organization (LAO) for the Experimental Therapeutics Clinical Trials Network | CARSON, WILLIAM E.; ARNOLD, SUSANNE M; EPPERLA, NARENDRANATH | OHIO STATE UNIVERSITY | NATIONAL CANCER INSTITUTE | 2014 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02363283
GET https://conductscience.org/api/trials/v1/NCT02363283/events?page=2