Phase 2
N=127
A Study of Lenvatinib (MK-7902) in Pediatric Participants With Relapsed or Refractory Solid Malignancies (MK-7902-013/E7080)
Relapsed or Refractory Solid Tumors
Bottom Line
View on ClinicalTrials.gov: NCT04447755 ↗Enrolled (actual)
127
Serious AEs
52.0%
Results posted
Oct 2023
Primary outcome: 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 — 22.2; 11.8; 0.0; 0.0 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lenvatinib (Drug)
- Age
- Pediatric, Adult · 2+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
22.2; 11.8; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY ORR Per RECIST 1.1 or RANO Criteria (for HGG Only), by Investigator Assessment |
22.2; 11.8; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Progression Free Survival (PFS) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment |
3.0; 2.6; 1.9; 1.8; 3.4; 2.5 | — |
| SECONDARY Best Overall Response (BOR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment |
22.2; 11.8; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Duration of Response (DOR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment |
NA; 4.6; 4.6 | — |
| SECONDARY Disease Control Rate (DCR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment |
66.7; 52.9; 33.3; 22.2; 55.6; 55.6 | — |
| SECONDARY Clinical Benefit Rate (CBR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment |
33.3; 29.4; 0.0; 11.1; 44.4; 33.3 | — |
| SECONDARY Number of Participants Who Experienced an Adverse Event (AE) |
9; 17; 8; 9; 9; 8 | — |
| SECONDARY Number of Participants Who Discontinued Study Treatment Due to an AE |
1; 0; 0; 0; 1; 2 | — |
| SECONDARY Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Taste Category |
1; 0; 2; 5; 1; 0 | — |
| SECONDARY Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Appearance Category |
0; 0; 1; 5; 2; 0 | — |
| SECONDARY Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Smell Category |
0; 0; 0; 8; 1; 0 | — |
| SECONDARY Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Mouth Feel Category |
0; 1; 2; 4; 1; 2 | — |
| SECONDARY Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Overall Acceptability Category |
0; 1; 1; 3; 3; 1 | — |
| SECONDARY Area Under the Concentration-Time Curve of Lenvatinib at Steady State (AUCss) |
5896; 3915; 3660; 4990 | — |
Summary
The main purpose of this study is to evaluate the antitumor activity and safety of lenvatinib (MK-7902/E7080) in children, adolescents, and young adults with relapsed or refractory solid malignancies after administration. Participants were enrolled into Ewing sarcoma (EWS), rhabdomyosarcoma (RMS), high-grade glioma (HGG), diffuse midline glioma, medulloblastoma, ependymoma, and Other Solid Tumors Excluding Osteosarcoma, diffuse midline glioma, medulloblastoma, and ependymoma cohorts.
Eligibility Criteria
Inclusion Criteria
- Has histologically or cytologically documented relapsed, or refractory pediatric solid malignancy excluding osteosarcoma
- Has measurable disease as defined by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) for High Grade Glioma (HGG)
- Has a performance status defined as follows: 1) Lansky Play Score ≥50 for participants up to and including 16 years of age 2) Karnofsky performance status (KPS) ≥50 for participants >16 years of age 3) Neurologic deficits in participants with primary central nervous system (CNS) tumors must have been stable for at least 7 days prior to study enrollment
- Demonstrate adequate organ function
- No clinical evidence of nephrotic syndrome.
- Has adequate blood pressure (BP) control with or without antihypertensive medications
- Has adequate cardiac function
- Has adequate neurologic function
- Participant must have fully recovered to Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE v5.0) Grade ≤1 (except for alopecia, ototoxicity, and Grade ≤2 peripheral neuropathy) from the acute toxic effects of all prior anticancer therapy
- Male participants must agree to use approved contraception during the treatment period and for at least 7 days after the last dose of study intervention and refrain from donating sperm during this period
- Female participants are not pregnant and not breastfeeding, and are not a woman of childbearing potential (WOCBP) or are a WOCBP who agrees to follow contraceptive guidance during the treatment period and for at least 30 days after the last dose of study intervention
Exclusion Criteria
- Has had major surgery within 3 weeks prior to Cycle 1 Day 1 (C1D1)
- Has gastrointestinal (GI) bleeding or active hemoptysis (bright red blood of at least half teaspoon) within 21 days prior to enrollment
- Has CNS tumors with a history of symptomatic tumor hemorrhage
- Has evidence of new intracranial hemorrhage of more than punctate size on MRI assessment obtained within 28 days prior to study enrollment
- Has radiographic evidence of encasement or invasion of a major blood vessel or of intratumoral cavitation
- Has evidence of untreated CNS metastases (exception: participants with primary CNS tumors and leptomeningeal disease.
- Has GI malabsorption, GI anastomosis, or any other condition that in the opinion of the investigator might affect the absorption of lenvatinib
- Has preexisting ≥Grade 3 GI or non-GI fistula
- Has any active infection requiring systemic therapy
- Known to be Human immunodeficiency virus (HIV) positive
- Known active viral hepatitis (B or C) as demonstrated by positive serology. Testing for hepatitis B or hepatitis C is required at screening only when mandated by local health authority
- Is currently participating and receiving study therapy, or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the date of allocation
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
- Has known hypersensitivity to any component of the investigational product (lenvatinib or ingredients)
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the stud
- Has clinically significant cardiovascular disease within 6 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability
- Has non-healing wound, tumor ulceration, unhealed or incompletely healed fracture, or a compo
Data sourced from ClinicalTrials.gov (NCT04447755). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.