Trial · NCT03049618
Recombinant EphB4-HSA Fusion Protein and Pembrolizumab, MK-3475
NCT03049618, Phase 2, Completed, University of Southern California; results first posted 2025-10-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Recombinant EphB4-HSA Fusion Protein and Pembrolizumab, MK-3475. Trials, record NCT03049618. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03049618
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Recombinant EphB4-HSA Fusion Protein and Pembrolizumab, MK-3475
- NCT number
- NCT03049618
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 42 participants, actual
- Lead sponsor
- University of Southern California
- Conditions
ALK Gene Mutation, BRAF Gene Mutation, EGFR Gene Mutation, Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Carcinoma, Recurrent Head and Neck Carcinoma, Recurrent Non-Small Cell Lung Carcinoma, ROS1 Gene Mutation, Stage III Non-Small Cell Lung Cancer, Stage IIIA Non-Small Cell Lung Cancer, Stage IIIB Non-Small Cell Lung Cancer, Stage IV Non-Small Cell Lung Cancer
- Interventions
- Laboratory Biomarker Analysis, Pembrolizumab, Recombinant EphB4-HSA Fusion Protein
- First posted
- 2017-02-10
- Last updated
- 2025-10-22
- Results first posted
- 2025-10-22
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) | Up to 22 months | Calculated based on the evaluable population of patients who received at least 1 dose of therapy. Overall response rate (ORR) is complete response (CR) + partial response (PR) recorded from study entry until disease progression based on RECIST v1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. |
| Secondary | Duration of Response | Up to 22 months | Duration of response is measured from date of first confirmed response until date of disease progression. |
| Secondary | Number of Participants With Adverse Events | Adverse events were collected from first dose of study treatment up to 30 days after last dose of treatment, up to 21 months (number of treatment given ranged from 1 cycle to 30 cycles). | The adverse events were graded as per common terminology criteria for adverse events(CTCAE) version 4.0. For a detailed list of adverse events refer to the adverse event module. |
| Secondary | Overall Survival (OS) | Up to 41 months | OS is the duration from study entry to death. Participants last known to be alive are censored at date of last contact. |
| Secondary | Progression Free Survival (PFS) | Up to 23 months | PFS was defined as duration of time from the first dose of study drug to the first documentation of Progressive Disease (PD) by investigator assessment using RECIST 1.1 or death on study due to any cause on or before the data cutoff date, whichever occurred first. PD: \>=20% increase (\>=5 mm absolute increase) in the sum of target lesion measurements, compared to the smallest sum on study (including baseline), or unequivocal progression of non-target lesions, evaluated as a whole, such that it is clear that treatment has failed, and disease is progressing, regardless of the status of the target lesions. |
| Other | Association of Biomarker With Overall Response Rate - HPV Status | Up to 22 months | Overall response rate (ORR) is complete response (CR) + partial response (PR) recorded from study entry until disease progression based on RECIST v1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. |
| Other | Association of Biomarker With Overall Response Rate - P16 Status | Up to 22 months | Overall response rate (ORR) is complete response (CR) + partial response (PR) recorded from study entry until disease progression based on RECIST v1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. |
| Other | Association of Biomarkers With Overall Response Rate - EphrinB2 Status | Up to 22 months | Overall response rate (ORR) is complete response (CR) + partial response (PR) recorded from study entry until disease progression based on RECIST v1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. |
| Other | Association of Biomarkers With Overall Response Rate - PD-L1 Status | Up to 22 months | Overall response rate (ORR) is complete response (CR) + partial response (PR) recorded from study entry until disease progression based on RECIST v1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. |
| Other | Association of Biomarkers With Overall Response Rate - EphrinB2 Positive/HPV-negative | Up to 22 months | Overall response rate (ORR) is complete response (CR) + partial response (PR) recorded from study entry until disease progression based on RECIST v1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) | Up to 22 months | Evaluable population of patients who received at least 1 dose of therapy. No statistical analysis is performed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response | Up to 22 months | Months | MEDIAN | |
| SECONDARY | Number of Participants With Adverse Events | Adverse events were collected from first dose of study treatment up to 30 days after last dose of treatment, up to 21 months (number of treatment given ranged from 1 cycle to 30 cycles). | All enrolled patients are included. No statistical analysis is performed. | participants | NUMBER |
| SECONDARY | Overall Survival (OS) | Up to 41 months | All enrolled patients are included. Statistical analysis was not performed. | Months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) | Up to 23 months | All patients were included in the analysis. Statistical analysis was not performed. | Months | MEDIAN |
| OTHER_PRE_SPECIFIED | Association of Biomarker With Overall Response Rate - HPV Status | Up to 22 months | Only the Head and Neck cancer cohort is being reported. No specimens were collected for the non-small cell lung cancer cohort. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Association of Biomarker With Overall Response Rate - P16 Status | Up to 22 months | Only the Head and Neck cancer cohort is being reported. No specimens were collected in the non-small cell lung cancer cohort. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Association of Biomarkers With Overall Response Rate - EphrinB2 Status | Up to 22 months | Only the Head and Neck cancer cohort is being reported. No specimens were collected in the non-small cell lung cancer cohort. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Association of Biomarkers With Overall Response Rate - PD-L1 Status | Up to 22 months | Only the Head and Neck cancer cohort is being reported. No specimens were collected in the non-small cell lung cancer cohort. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Association of Biomarkers With Overall Response Rate - EphrinB2 Positive/HPV-negative | Up to 22 months | Only the Head and Neck cancer cohort is being reported. No statistical analysis performed. No specimens were collected in the non-small cell lung cancer cohort. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group39
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) | Head and Neck Cancer Cohort | 6 | Participants | ||
| Overall Response Rate (ORR) | Non-Small Cell Lung Cancer Cohort | 3 | Participants | ||
| Duration of Response | Head and Neck Cancer Cohort | 3.7 | 95% Confidence Interval 1.8 to 8.9 | Months | |
| Duration of Response | Non-Small Cell Lung Cancer Cohort | 7.6 | 95% Confidence Interval 1.6 to 28.0 | Months | |
| Number of Participants With Adverse Events | Head and Neck Cancer Cohort | CTCAE grade 1 or 2 | 25 | participants | |
| Number of Participants With Adverse Events | Non-Small Cell Lung Cancer Cohort | CTCAE grade 1 or 2 | 17 | participants | |
| Number of Participants With Adverse Events | Head and Neck Cancer Cohort | CTCAE grade 3 or 4 | 23 | participants | |
| Number of Participants With Adverse Events | Non-Small Cell Lung Cancer Cohort | CTCAE grade 3 or 4 | 17 | participants | |
| Overall Survival (OS) | Head and Neck Cancer Cohort | 8.6 | 95% Confidence Interval 3.2 to 13.7 | Months | |
| Overall Survival (OS) | Non-Small Cell Lung Cancer Cohort | 11.8 | 95% Confidence Interval 4.2 to 30.1 | Months |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Head and Neck Cancer Cohort | 25 | |
| Overall Study | STARTED | Non-Small Cell Lung Cancer Cohort | 17 | |
| Overall Study | COMPLETED | Head and Neck Cancer Cohort | 23 | |
| Overall Study | COMPLETED | Non-Small Cell Lung Cancer Cohort | 15 | |
| Overall Study | NOT COMPLETED | Head and Neck Cancer Cohort | 2 | |
| Overall Study | NOT COMPLETED | Non-Small Cell Lung Cancer Cohort | 2 |
Source ClinicalTrials.gov
Adverse events90
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 |
|---|---|---|---|---|---|---|
| other | Hypertension | Vascular disorders | Head and Neck Cancer Cohort | 7 | 25 | |
| other | Hypertension | Vascular disorders | Non-Small Cell Lung Cancer Cohort | 5 | 17 | |
| other | Fatigue | General disorders | Head and Neck Cancer Cohort | 3 | 25 | |
| other | Fatigue | General disorders | Non-Small Cell Lung Cancer Cohort | 5 | 17 | |
| other | Alanine Aminotransferase Increased | Investigations | Head and Neck Cancer Cohort | 2 | 25 | |
| other | Alanine Aminotransferase Increased | Investigations | Non-Small Cell Lung Cancer Cohort | 2 | 17 | |
| other | Constipation | Gastrointestinal disorders | Head and Neck Cancer Cohort | 1 | 25 | |
| other | Constipation | Gastrointestinal disorders | Non-Small Cell Lung Cancer Cohort | 3 | 17 | |
| other | Nausea | Gastrointestinal disorders | Head and Neck Cancer Cohort | 1 | 25 | |
| other | Nausea | Gastrointestinal disorders | Non-Small Cell Lung Cancer Cohort | 6 | 17 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Head and Neck Cancer Cohort | 12 | 25 |
| Total, all-cause mortality | Non-Small Cell Lung Cancer Cohort | 6 | 17 |
| Total, other adverse events | Head and Neck Cancer Cohort | 16 | 25 |
| Total, other adverse events | Non-Small Cell Lung Cancer Cohort | 11 | 17 |
| Total, serious adverse events | Head and Neck Cancer Cohort | 12 | 25 |
| Total, serious adverse events | Non-Small Cell Lung Cancer Cohort | 8 | 17 |
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 |
|---|---|---|---|---|---|
| P30CA014089 | University of Southern California Norris Comprehensive Cancer Center Support Grant (CCSG) | LERMAN, CARYN | UNIVERSITY OF SOUTHERN CALIFORNIA | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Head and Neck Cancer Cohort vs Non-Small Cell Lung Cancer Cohort: Overall Response Rate (ORR) | Trial comparisons |
| Head and Neck Cancer Cohort vs Non-Small Cell Lung Cancer Cohort: deaths from any cause | Trial comparisons |
| Head and Neck Cancer Cohort vs Non-Small Cell Lung Cancer Cohort: serious adverse events | Trial comparisons |
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/NCT03049618
GET https://conductscience.org/api/trials/v1/NCT03049618/results?page=2