Trial · NCT02302339

A Study of Glembatumumab Vedotin as Monotherapy or in Combination With Immunotherapies in Patients With Advanced Melanoma

NCT02302339, Phase 2, Terminated, Celldex Therapeutics; results first posted 2019-09-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of Glembatumumab Vedotin as Monotherapy or in Combination With Immunotherapies in Patients With Advanced Melanoma. Trials, record NCT02302339. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02302339

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of Glembatumumab Vedotin as Monotherapy or in Combination With Immunotherapies in Patients With Advanced Melanoma
NCT number: NCT02302339
Status: Terminated
Phases: Phase 2
Enrollment: 132 participants, actual
Lead sponsor: Celldex Therapeutics
Conditions: Melanoma
Interventions: glembatumumab vedotin, glembatumumab vedotin and varlilumab, glembatumumab vedotin and PD-1 targeted checkpoint inhibitor (nivolumab OR pembrolizumab), glembatumumab vedotin and CDX-301
First posted: 2014-11-27
Last updated: 2019-09-06
Results first posted: 2019-09-06
Limitations and caveats: Study was discontinued early, leading to small number of subjects analyzed in Cohort 4 and minimal patient follow up in Cohorts 3 and 4.

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Objective Response Rate (ORR)	Every 6 to 9 weeks following treatment initiation until disease progression.	ORR is defined as the percentage of patients who achieved best overall response of complete or partial response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST version 1.1), Complete Response (CR) = disappearance of all target lesions and non-target lesions, Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions with no progression in non-target lesions and no new lesions. ORR was the primary outcome for Cohorts 1-3 and a secondary outcome for Cohort 4.
Primary	Adverse Events of the Combination of Glembatumumab Vedotin and CDX-301 (in Cohort 4).	Up to 18 months following the screening visit	The percentage of patients experiencing one or more adverse events.
Secondary	Duration of Response (DOR)	From start date of partial or complete response (whichever is achieved first) to first date that recurrent of progressive disease is objectively documented, assessed up to 18 months.	DOR is the number of months from the time criteria are first met for either CR or PR, until the first date that PD is objectively documented per RECIST 1.1.
Secondary	Progression-free Survival (PFS)	Evaluated every 6 to 9 weeks following treatment initiation until progression.	PFS is defined as the time from randomization to the earlier of disease progression or death due to any cause. Disease 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 progression in a non-target lesion, or the appearance of new lesions.
Secondary	Overall Survival (OS)	During treatment and every 3 months from end of treatment through death or end of study	Overall Survival (OS) is defined as the number of months from randomization to the date of death due to any cause.
Secondary	Correlation of Activity to gpNMB Expression	Up to 18 months following the screening visit	To investigate if the anti-cancer activity of glembatumumab vedotin as monotherapy or in combination with immunotherapies in advanced melanoma is dependent upon the degree of gpNMB expression in tumor tissue.
Secondary	Adverse Events	Following at least one dose of study treatment through 28 days after last dose of glembatumumab vedotin, or 70 calendar days after last administration of varlilumab, CDX-301 or PD-1 targeted checkpoint inhibitor (whichever occurs latest)	The percentage of patients experiencing one or more AEs will be summarized by relationship to study drug and severity.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Objective Response Rate (ORR)	Every 6 to 9 weeks following treatment initiation until disease progression.	Response evaluable (at least one dose and a post treatment disease assessment)	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Adverse Events of the Combination of Glembatumumab Vedotin and CDX-301 (in Cohort 4).	Up to 18 months following the screening visit		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Duration of Response (DOR)	From start date of partial or complete response (whichever is achieved first) to first date that recurrent of progressive disease is objectively documented, assessed up to 18 months.	Number of patients analyzed are the number of patients who achieved an objective response per Cohort. The response was observed at the last measurement without further follow up due to study closure.	months	MEDIAN
SECONDARY	Progression-free Survival (PFS)	Evaluated every 6 to 9 weeks following treatment initiation until progression.	Response evaluable (at least one dose and a post treatment disease assessment). The analysis was not completed for the glembatumumab + CDX-301 cohort because sufficient data were not collected to perform the analysis.	months	MEDIAN
SECONDARY	Overall Survival (OS)	During treatment and every 3 months from end of treatment through death or end of study	Response evaluable (at least one dose and a post treatment disease assessment). The analysis was not completed for the glembatumumab + CDX-301 cohort or the glembatumumab vedotin and PD-1 targeted checkpoint inhibitor cohort because sufficient data were not collected to perform the analysis.	months	MEDIAN
SECONDARY	Correlation of Activity to gpNMB Expression	Up to 18 months following the screening visit	Analysis not completed. gpNMB expression in tumor tissue was not done.
SECONDARY	Adverse Events	Following at least one dose of study treatment through 28 days after last dose of glembatumumab vedotin, or 70 calendar days after last administration of varlilumab, CDX-301 or PD-1 targeted checkpoint inhibitor (whichever occurs latest)		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group50

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Objective Response Rate (ORR)	Glembatumumab Vedotin		7	Participants
Objective Response Rate (ORR)	Glembatumumab Vedotin and Varlilumab		1	Participants
Objective Response Rate (ORR)	Glembatumumab Vedotin and PD-1 Targeted Checkpoint Inhibitor		4	Participants
Objective Response Rate (ORR)	Glembatumumab Vedotin and CDX-301		0	Participants
Adverse Events of the Combination of Glembatumumab Vedotin and CDX-301 (in Cohort 4).	Glembatumumab Vedotin and CDX-301	Leukopenia	1	Participants
Adverse Events of the Combination of Glembatumumab Vedotin and CDX-301 (in Cohort 4).	Glembatumumab Vedotin and CDX-301	Abdominal pain	1	Participants
Adverse Events of the Combination of Glembatumumab Vedotin and CDX-301 (in Cohort 4).	Glembatumumab Vedotin and CDX-301	Constipation	2	Participants
Adverse Events of the Combination of Glembatumumab Vedotin and CDX-301 (in Cohort 4).	Glembatumumab Vedotin and CDX-301	Dyspepsia	2	Participants
Adverse Events of the Combination of Glembatumumab Vedotin and CDX-301 (in Cohort 4).	Glembatumumab Vedotin and CDX-301	Nausea	1	Participants
Adverse Events of the Combination of Glembatumumab Vedotin and CDX-301 (in Cohort 4).	Glembatumumab Vedotin and CDX-301	Stomatitis	1	Participants

1 to 10 of 50Source ClinicalTrials.gov

See all 50 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Glembatumumab Vedotin	62
Overall Study	STARTED	Glembatumumab Vedotin and Varlilumab	34
Overall Study	STARTED	Glembatumumab Vedotin and PD-1 Targeted Checkpoint Inhibitor	29
Overall Study	STARTED	Glembatumumab Vedotin and CDX-301	7
Overall Study	COMPLETED	Glembatumumab Vedotin	61
Overall Study	COMPLETED	Glembatumumab Vedotin and Varlilumab	32
Overall Study	COMPLETED	Glembatumumab Vedotin and PD-1 Targeted Checkpoint Inhibitor	28
Overall Study	COMPLETED	Glembatumumab Vedotin and CDX-301	7
Overall Study	NOT COMPLETED	Glembatumumab Vedotin	1
Overall Study	NOT COMPLETED	Glembatumumab Vedotin and Varlilumab	2

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events724

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
other	Anemia	Blood and lymphatic system disorders	Glembatumumab Vedotin	15	62
other	Anemia	Blood and lymphatic system disorders	Glembatumumab Vedotin and Varlilumab	13	34
other	Anemia	Blood and lymphatic system disorders	Glembatumumab Vedotin and PD-1 Targeted Checkpoint Inhibitor	4	29
other	Anemia	Blood and lymphatic system disorders	Glembatumumab Vedotin and CDX-301	0	7
other	Leukopenia	Blood and lymphatic system disorders	Glembatumumab Vedotin	1	62
other	Leukopenia	Blood and lymphatic system disorders	Glembatumumab Vedotin and Varlilumab	1	34
other	Leukopenia	Blood and lymphatic system disorders	Glembatumumab Vedotin and PD-1 Targeted Checkpoint Inhibitor	1	29
other	Leukopenia	Blood and lymphatic system disorders	Glembatumumab Vedotin and CDX-301	1	7
other	Lymphopenia	Blood and lymphatic system disorders	Glembatumumab Vedotin	0	62
other	Lymphopenia	Blood and lymphatic system disorders	Glembatumumab Vedotin and Varlilumab	2	34

1 to 10 of 724Source ClinicalTrials.gov

See all 724 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Glembatumumab Vedotin	53	62
Total, all-cause mortality	Glembatumumab Vedotin and Varlilumab	26	34
Total, all-cause mortality	Glembatumumab Vedotin and PD-1 Targeted Checkpoint Inhibitor	8	29
Total, all-cause mortality	Glembatumumab Vedotin and CDX-301	1	7
Total, other adverse events	Glembatumumab Vedotin	61	62
Total, other adverse events	Glembatumumab Vedotin and Varlilumab	34	34
Total, other adverse events	Glembatumumab Vedotin and PD-1 Targeted Checkpoint Inhibitor	29	29
Total, other adverse events	Glembatumumab Vedotin and CDX-301	7	7
Total, serious adverse events	Glembatumumab Vedotin	19	62
Total, serious adverse events	Glembatumumab Vedotin and Varlilumab	14	34

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

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.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT02302339

GET https://conductscience.org/api/trials/v1/NCT02302339/results?page=2

API reference For AI assistants