Trial · NCT04447755
A Study of Lenvatinib (MK-7902) in Pediatric Participants With Relapsed or Refractory Solid Malignancies (MK-7902-013/E7080)
NCT04447755, Phase 2, Completed, Merck Sharp & Dohme LLC; results first posted 2023-10-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Lenvatinib (MK-7902) in Pediatric Participants With Relapsed or Refractory Solid Malignancies (MK-7902-013/E7080). Trials, record NCT04447755. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04447755
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Lenvatinib (MK-7902) in Pediatric Participants With Relapsed or Refractory Solid Malignancies (MK-7902-013/E7080)
- NCT number
- NCT04447755
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 127 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Relapsed or Refractory Solid Tumors
- Interventions
- Lenvatinib
- First posted
- 2020-06-25
- Last updated
- 2025-10-03
- Other registries' IDs
- eudract:2019-004441-33
- Results first posted
- 2023-10-04
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) At Week 16 Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria (for High Grade Glioma [HGG] Only), by Investigator Assessment | Up to 16 weeks | ORR at Week 16 was defined as the percentage of participants with a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters \[SOD\] of target lesions, taking as reference the baseline SOD) as assessed by the investigator per RECIST 1.1 at 16 Weeks. For participants with HGG, response was assessed according to RANO criteria whereby overall response is based on both radiographic response (CR: disappearance of all target lesions, PR: sum of products of diameters \[SPD\] decreased by ≥ 50% from baseline value) and clinical performance status with steroid dose information. |
| Secondary | ORR Per RECIST 1.1 or RANO Criteria (for HGG Only), by Investigator Assessment | Up to approximately 21 months | ORR was defined as the percentage of participants with a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) as assessed by the investigator per RECIST 1.1. For participants with HGG, response was assessed according to RANO criteria whereby overall RANO response is based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value) and clinical performance status with steroid dose information. |
| Secondary | Progression Free Survival (PFS) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment | Up to approximately 21 months | PFS was defined as the time from the date of the first administration of study drug until the date of first documentation of progressive disease (PD) per RECIST 1.1 or RANO (for HGG) or death (whichever occurs first). |
| Secondary | Best Overall Response (BOR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment | Up to approximately 21 months | BOR is defined as the participant's best confirmed response (CR or PR) over the treatment period as assessed by the investigator per RECIST 1.1 or RANO. As per RECIST 1.1, CR is defined as disappearance of all target lesions and PR is defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. For participants with HGG, response will be assessed according to RANO criteria whereby overall RANO response is based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value) and clinical performance status with steroid dose information. |
| Secondary | Duration of Response (DOR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment | Up to approximately 21 months | DOR was defined as the time from the date of the first documented CR or PR to the date first documentation of progressive disease or death (whichever occurs first). As per RECIST 1.1, CR was defined as disappearance of all target lesions and PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. For participants with HGG, response will be assessed according to RANO criteria whereby overall RANO response is based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value) and clinical performance status with steroid dose information. |
| Secondary | Disease Control Rate (DCR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment | Up to approximately 21 months | DCR was defined as a BOR of CR or PR, or stable disease (SD). To be assigned a BOR of SD, the time from the first administration of study drug until the date of documented SD should be ≥7 weeks. As per RECIST 1.1, CR was defined as disappearance of all target lesions, PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For participants with HGG, response was assessed according to RANO criteria whereby overall response was based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value and SD: SPD \<50% decreased from baseline, but \<25% increased from nadir) and clinical performance status with steroid dose information. |
| Secondary | Clinical Benefit Rate (CBR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment | Up to approximately 21 months | CBR was defined as a BOR of CR or PR, or durable SD (Duration of SD should be ≥23 weeks since the first dose of the study treatment. As per RECIST 1.1, CR was defined as disappearance of all target lesions, PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For participants with HGG, response is assessed according to RANO criteria whereby overall response was based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value and SD: SPD \<50% decreased from baseline, but \<25% increased from nadir) and clinical performance status with steroid dose information. |
| Secondary | Number of Participants Who Experienced an Adverse Event (AE) | Up to approximately 50 months | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experienced at least one AE is reported. |
| Secondary | Number of Participants Who Discontinued Study Treatment Due to an AE | Up to approximately 38 months | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinued study treatment due to an AE is reported. |
| Secondary | Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Taste Category | Cycle 1 Day 1 (cycle = 28 days) | A hedonic Visual Analog Scale (VAS) was used to assess taste likability or "palatability" of a lenvatinib suspension formulated with water or apple juice. Participants scored each category on a scale from 1-7 ranging from super bad (score = 1) to super good (score = 7). As pre-specified by the supplemental Statistical Analysis Plan (sSAP), all participants who received suspension formulation were evaluated for palatability and acceptability of the suspension formulation, and data were summarized in an overall safety analysis set irrespective of tumor type. The palatability score based on the taste category is presented. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
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) At Week 16 Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria (for High Grade Glioma [HGG] Only), by Investigator Assessment | Up to 16 weeks | All participants who had measurable disease present at baseline and at least one efficacy assessment, unless they discontinued prior to the first efficacy assessment due to progressive disease. | Percentage of Participants | NUMBER |
| SECONDARY | ORR Per RECIST 1.1 or RANO Criteria (for HGG Only), by Investigator Assessment | Up to approximately 21 months | All participants who had measurable disease present at baseline and at least one efficacy assessment, unless they discontinued prior to the first efficacy assessment due to progressive disease. | Percentage of Participants | NUMBER |
| SECONDARY | Progression Free Survival (PFS) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment | Up to approximately 21 months | All participants who had measurable disease present at baseline and at least one efficacy assessment, unless they discontinued prior to the first efficacy assessment due to progressive disease. | Months | MEDIAN |
| SECONDARY | Best Overall Response (BOR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment | Up to approximately 21 months | All participants who had measurable disease present at baseline and at least one efficacy assessment, unless they discontinued prior to the first efficacy assessment due to progressive disease. | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Response (DOR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment | Up to approximately 21 months | All participants who had measurable disease present at baseline and at least one efficacy assessment, unless they discontinued prior to the first efficacy assessment due to progressive disease, and demonstrated CR or PR. | Months | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment | Up to approximately 21 months | All participants who had measurable disease present at baseline and at least one efficacy assessment, unless they discontinued prior to the first efficacy assessment due to progressive disease. | Percentage of Participants | NUMBER |
| SECONDARY | Clinical Benefit Rate (CBR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment | Up to approximately 21 months | All participants who had measurable disease present at baseline and at least one efficacy assessment, unless they discontinued prior to the first efficacy assessment due to progressive disease. | Percentage of Participants | NUMBER |
| SECONDARY | Number of Participants Who Experienced an Adverse Event (AE) | Up to approximately 50 months | All participants who received at least one dose of study treatment were analyzed. | Participants | NUMBER |
| SECONDARY | Number of Participants Who Discontinued Study Treatment Due to an AE | Up to approximately 38 months | All participants who received at least one dose of study treatment were analyzed. | Participants | NUMBER |
| SECONDARY | Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Taste Category | Cycle 1 Day 1 (cycle = 28 days) | Per protocol, all participants who received suspension formulation were analyzed. Data were summarized in an overall safety analysis set irrespective of tumor type. | Participants | NUMBER |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group98
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Objective Response Rate (ORR) At Week 16 Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria (for High Grade Glioma [HGG] Only), by Investigator Assessment | Ewing Sarcoma | 22.2 | 95% Confidence Interval 2.8 to 60.0 | Percentage of Participants | |
Objective Response Rate (ORR) At Week 16 Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria (for High Grade Glioma [HGG] Only), by Investigator Assessment | Rhabdomyosarcoma | 11.8 | 95% Confidence Interval 1.5 to 36.4 | Percentage of Participants | |
Objective Response Rate (ORR) At Week 16 Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria (for High Grade Glioma [HGG] Only), by Investigator Assessment | High Grade Glioma | 0.0 | 95% Confidence Interval 0.0 to 45.9 | Percentage of Participants | |
Objective Response Rate (ORR) At Week 16 Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria (for High Grade Glioma [HGG] Only), by Investigator Assessment | Diffuse Midline Glioma | 0.0 | 95% Confidence Interval 0.0 to 33.6 | Percentage of Participants | |
Objective Response Rate (ORR) At Week 16 Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria (for High Grade Glioma [HGG] Only), by Investigator Assessment | Medulloblastoma | 0.0 | 95% Confidence Interval 0.0 to 33.6 | Percentage of Participants | |
Objective Response Rate (ORR) At Week 16 Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria (for High Grade Glioma [HGG] Only), by Investigator Assessment | Ependymoma | 0.0 | 95% Confidence Interval 0.0 to 33.6 | Percentage of Participants | |
Objective Response Rate (ORR) At Week 16 Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria (for High Grade Glioma [HGG] Only), by Investigator Assessment | Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma | 7.7 | 95% Confidence Interval 2.5 to 17.0 | Percentage of Participants | |
| ORR Per RECIST 1.1 or RANO Criteria (for HGG Only), by Investigator Assessment | Ewing Sarcoma | 22.2 | 95% Confidence Interval 2.8 to 60.0 | Percentage of Participants | |
| ORR Per RECIST 1.1 or RANO Criteria (for HGG Only), by Investigator Assessment | Rhabdomyosarcoma | 11.8 | 95% Confidence Interval 1.5 to 36.4 | Percentage of Participants | |
| ORR Per RECIST 1.1 or RANO Criteria (for HGG Only), by Investigator Assessment | High Grade Glioma | 0.0 | 95% Confidence Interval 0.0 to 45.9 | Percentage of Participants |
1 to 10 of 98Source ClinicalTrials.gov
See all 98 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ewing Sarcoma | 9 | |
| Overall Study | STARTED | Rhabdomyosarcoma | 17 | |
| Overall Study | STARTED | High Grade Glioma | 8 | |
| Overall Study | STARTED | Diffuse Midline Glioma | 9 | |
| Overall Study | STARTED | Medulloblastoma | 9 | |
| Overall Study | STARTED | Ependymoma | 9 | |
| Overall Study | STARTED | Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma | 66 | |
| Overall Study | COMPLETED | Ewing Sarcoma | 0 | |
| Overall Study | COMPLETED | Rhabdomyosarcoma | 0 | |
| Overall Study | COMPLETED | High Grade Glioma | 0 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events1,883
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 | Anaemia | Blood and lymphatic system disorders | Ewing Sarcoma | 0 | 9 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Rhabdomyosarcoma | 2 | 17 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | High Grade Glioma | 0 | 8 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Diffuse Midline Glioma | 0 | 9 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Medulloblastoma | 3 | 9 | 4 |
| other | Anaemia | Blood and lymphatic system disorders | Ependymoma | 0 | 9 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma | 13 | 66 | 15 |
| other | Neutropenia | Blood and lymphatic system disorders | Ewing Sarcoma | 1 | 9 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | Rhabdomyosarcoma | 1 | 17 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | High Grade Glioma | 1 | 8 | 1 |
1 to 10 of 1,883Source ClinicalTrials.gov
See all 1,883 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ewing Sarcoma | 9 | 9 |
| Total, all-cause mortality | Rhabdomyosarcoma | 17 | 17 |
| Total, all-cause mortality | High Grade Glioma | 8 | 8 |
| Total, all-cause mortality | Diffuse Midline Glioma | 9 | 9 |
| Total, all-cause mortality | Medulloblastoma | 8 | 9 |
| Total, all-cause mortality | Ependymoma | 9 | 9 |
| Total, all-cause mortality | Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma | 55 | 66 |
| Total, other adverse events | Ewing Sarcoma | 9 | 9 |
| Total, other adverse events | Rhabdomyosarcoma | 17 | 17 |
| Total, other adverse events | High Grade Glioma | 6 | 8 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34562750 | DERIVED |
Source PubMed
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.
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/NCT04447755
GET https://conductscience.org/api/trials/v1/NCT04447755/results?page=2