Trial · NCT03326258
Glembatumumab Vedotin, Nivolumab, and Ipilimumab in Treating Patients With Advanced Metastatic Solid Tumors That Cannot Be Removed by Surgery
NCT03326258, Phase 1, Phase 2, Withdrawn, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Glembatumumab Vedotin, Nivolumab, and Ipilimumab in Treating Patients With Advanced Metastatic Solid Tumors That Cannot Be Removed by Surgery. Trials, record NCT03326258. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03326258
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Glembatumumab Vedotin, Nivolumab, and Ipilimumab in Treating Patients With Advanced Metastatic Solid Tumors That Cannot Be Removed by Surgery
- NCT number
- NCT03326258
- Status
- Withdrawn
- Phases
- Phase 1, Phase 2
- Enrollment
- 0 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Advanced Malignant Solid Neoplasm, Estrogen Receptor Negative, GPNMB Positive, HER2/Neu Negative, Metastatic Malignant Solid Neoplasm, Metastatic Melanoma, Progesterone Receptor Negative, Stage III Breast Cancer AJCC v7, Stage III Cutaneous Melanoma AJCC v7, Stage III Uveal Melanoma AJCC v7, Stage IIIA Cutaneous Melanoma AJCC v7, Stage IIIB Cutaneous Melanoma AJCC v7, Stage IIIC Cutaneous Melanoma AJCC v7, Stage IV Breast Cancer AJCC v6 and v7, Stage IV Cutaneous Melanoma AJCC v6 and v7, Stage IV Uveal Melanoma AJCC v7, Triple-Negative Breast Carcinoma, Unresectable Solid Neoplasm
- Interventions
- Glembatumumab Vedotin, Ipilimumab, Laboratory Biomarker Analysis, Nivolumab, Pharmacological Study
- First posted
- 2017-10-31
- Last updated
- 2018-07-18
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recommended phase 2 dose for the combination of glembatumumab vedotin and nivolumab (Phase Ib) | Up to 21 days | All adverse events and toxicities will be tabulated and reported by type and grade for all dose levels of all treatment combinations and the proportions will be reported with exact 90% binomial confidence intervals. |
| Primary | Antitumor activity measured by Immune-Modified Response Evaluation Criteria in Solid Tumors (iRECIST)/Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (Phase II) | Up to 70 days | Descriptive statistics and graphical analysis will be used to summarize patients' demographic and clinicopathological characteristics, patient safety and efficacy outcomes and correlative markers. Overall response rates will be calculated and 2-sided 90% confidence intervals will also be provided for each cohort. |
| Secondary | Incidence of adverse events | Up to 70 days | Will be assessed by Common Terminology Criteria for Adverse Events version 4.03. Will be tabulated and reported by type and grade for each cohort and the proportions will be reported with exact 90% binomial confidence intervals. |
| Secondary | Overall response rate | Up to 70 days | Will be analyzed by the Kaplan-Meier method. The association between subgroups of interest and response to treatment will be assessed using Fisher's exact test. |
| Secondary | Clinical benefit rate | Up to 70 days | Will be analyzed by the Kaplan-Meier method. The association between subgroups of interest and response to treatment will be assessed using Fisher's exact test. |
| Secondary | Progression free survival | Up to 70 days | Will be analyzed by the Kaplan-Meier method. The association between subgroups of interest and response to treatment will be assessed using Fisher's exact test. |
| Secondary | Overall survival | Up to 70 days | Will be analyzed by the Kaplan-Meier method. The association between subgroups of interest and response to treatment will be assessed using Fisher's exact test. |
| Secondary | Pharmacokinetic parameters | Up to 70 days | The pharmacokinetics (PK) of glembatumumab vedotin and nivolumab in combination in serum and in mononuclear phagocyte system (MPS) cells in peripheral blood mononuclear cells will also be assessed descriptively. The descriptive statistics of plasma concentration-time data will first be tabulated. PK parameters will be estimated using both standard non-compartmental and compartmental methods. A repeated measurement statistical model will also be used to perform intra patient evaluation of changes in PK. |
| Secondary | Levels of plasma and tissue biomarkers | Up to 70 days | PD-L1 and other immune biomarkers including tumor infiltrating lymphocytes before and after treatment (after glembatumumab vedotin, and then after the combination) will be described using summary statistics. The change of immune markers will be assessed using linear mixed model for repeated measurement data. Data transformation will be performed if necessary to better satisfy the assumption of normality distribution. Univariate and multivariate logistic regression models will be used to evaluate predictive ability of these baseline biomarkers on the response to the combination of glembatumumab vedotin and nivolumab. Receiver operating characteristic (ROC) curves will be used to explore the optimal cut-off points for each biomarker to differentiate responders versus non-responders. The predictive ability will also be summarized using the area under ROC curves (AUC), and the 95% confidence intervals of AUC will be obtained using bootstrap resampling methods. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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 |
|---|---|---|---|---|---|
| UM1CA186704 | Duke-UNC-Wash U Partnership for Early Phase Clinical Trials in Cancer | ABBRUZZESE, JAMES L.; DEES, ELIZABETH CLAIRE; WANG-GILLAM, ANDREA | DUKE UNIVERSITY | NATIONAL CANCER INSTITUTE | 2014 to 2019 |
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/NCT03326258
GET https://conductscience.org/api/trials/v1/NCT03326258/registered