A Study of Lenvatinib (MK-7902) in Pediatric Participants With Relapsed or Refractory Solid Malignancies (MK-7902-013/E7080) (E7080-G000-231)

January 8, 2024 updated by: Merck Sharp & Dohme LLC

An Open-Label, Multicenter Phase 2 Basket Study to Evaluate the Antitumor Activity and Safety of Lenvatinib in Children, Adolescents, and Young Adults With Relapsed or Refractory Solid Malignancies

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 will be enrolled into initial tumor-specific cohorts which will be expanded based on observed response.

Study Overview

Status

Active, not recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

127

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Buenos Aires
      • Pilar, Buenos Aires, Argentina, B1629ODT
        • Hospital Universitario Austral ( Site 0126)
    • Caba
      • Ciudad Autonoma de Buenos Aires, Caba, Argentina, C1425EFD
        • Hospital de Niños Ricardo Gutiérrez ( Site 0125)
    • New South Wales
      • Randwick, New South Wales, Australia, 2031
        • Sydney Children's Hospital ( Site 0801)
    • Queensland
      • Brisbane, Queensland, Australia, 4101
        • Queensland Children s Hospital ( Site 0804)
    • Victoria
      • Parkville, Victoria, Australia, 3052
        • Royal Childrens Hospital Melbourne ( Site 0802)
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Perth Children s Hospital ( Site 0803)
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • UZ Gent ( Site 0250)
    • Primorsko-goranska Zupanija
      • Rijeka, Primorsko-goranska Zupanija, Croatia, 51000
        • Klinicki bolnicki centar Rijeka ( Site 0726)
    • Zagrebacka Zupanija
      • Zagreb, Zagrebacka Zupanija, Croatia, 10000
        • Klinika za djecje bolesti Zagreb ( Site 0725)
      • Praha 5, Czechia, 150 06
        • Fakultni nemocnice v Motole ( Site 0650)
    • Brno-mesto
      • Brno, Brno-mesto, Czechia, 613 00
        • Fakultni Nemocnice Brno Bohunice ( Site 0651)
      • Paris, France, 75005
        • Institut Curie ( Site 0325)
    • Auvergne
      • Lyon, Auvergne, France, 69008
        • Centre Leon-Berard ( Site 0326)
    • Bouches-du-Rhone
      • Marseille, Bouches-du-Rhone, France, 13005
        • Hopital La Timone ( Site 0328)
    • Val-de-Marne
      • Villejuif, Val-de-Marne, France, 94800
        • Gustave Roussy ( Site 0327)
      • Guatemala, Guatemala, 01011
        • Unidad Nacional de Oncologia Pediatrica ( Site 0176)
      • Guatemala, Guatemala, 01016
        • Medi-K Cayala ( Site 0177)
      • Budapest, Hungary, 1094
        • Semmelweis University ( Site 0675)
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont ( Site 0677)
    • Borsod-Abauj-Zemplen
      • Miskolc, Borsod-Abauj-Zemplen, Hungary, 3526
        • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi OktatoKorhaz ( Site 0678)
      • Ramat-Gan, Israel, 5265601
        • Chaim Sheba Medical Center ( Site 0500)
      • Genova, Italy, 16147
        • Istituto Giannina Gaslini ( Site 0411)
      • Milano, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0401)
      • Torino, Italy, 10126
        • Ospedale Infantile Regina Margherita ( Site 0412)
    • Roma
      • Rome, Roma, Italy, 00165
        • IRCCS Ospedale Pediatrico Bambino Gesu ( Site 0410)
    • Toscana
      • Firenze, Toscana, Italy, 50139
        • A.O.Universitaria Meyer-Oncology & Haematology Unit ( Site 0400)
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital ( Site 0875)
    • Seoul
      • Songpagu, Seoul, Korea, Republic of, 05505
        • Asan Medical Center ( Site 0876)
      • Auckland, New Zealand, 1023
        • Starship Childrens Hospital ( Site 0826)
    • Lima
      • San Isidro, Lima, Peru, 15073
        • Clinica Anglo Americana ( Site 0203)
    • Moskva
      • Moscow, Moskva, Russian Federation, 117198
        • Dmitry Rogachev National Research Center ( Site 0550)
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russian Federation, 197022
        • St.Petersburg State Medical Univ. n.a. acad. I.P.Pavlov ( Site 0554)
      • Saint-Petersburg, Sankt-Peterburg, Russian Federation, 197758
        • Clinical Research Center of specialized types medical care-Oncology ( Site 0553)
      • Beograd, Serbia, 11000
        • Univerzitetska decja klinika ( Site 0782)
    • Beograd
      • Belgrade, Beograd, Serbia, 11000
        • Institute for Oncology and Radiology of Serbia ( Site 0780)
    • Gauteng
      • Soweto, Gauteng, South Africa, 2013
        • Wits Clinical Research ( Site 0579)
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7700
        • Cancercare Rondebosch Oncology ( Site 0575)
      • Parow, Western Cape, South Africa, 7505
        • Tygerberg Hospital ( Site 0578)
      • Madrid, Spain, 28009
        • Hospital Nino Jesus ( Site 0477)
    • Barcelona
      • Esplugues de Llobregat, Barcelona, Spain, 08950
        • Hospital Universitario Sant Joan de Deu ( Site 0476)
    • Skane Lan
      • Lund, Skane Lan, Sweden, 221 85
        • Skanes Universitetssjukhus Lund. ( Site 0525)
      • Ankara, Turkey, 06100
        • Hacettepe Universitesi Tip Fakultesi ( Site 0603)
      • Istanbul, Turkey, 34093
        • Istanbul Universitesi Onkoloji Enstitusu ( Site 0600)
      • Izmir, Turkey, 35040
        • Ege Universitesi Tip Fakultesi ( Site 0601)
      • Izmir, Turkey, 35330
        • Dokuz Eylul Universitesi Arastirma Uygulama Hastanesi ( Site 0602)
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital of Colorado ( Site 0110)
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic ( Site 0119)
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Monroe Carell Jr. Children's Hospital at Vanderbilt ( Site 0102)
    • Texas
      • Dallas, Texas, United States, 75230
        • Mary Crowley Cancer Research Center ( Site 0107)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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 compound (open) bone fracture at the time of enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ewing Sarcoma
Participants with Ewing sarcoma will receive lenvatinib 14 mg/m^2 once daily (QD) orally until progressive disease or unacceptable toxicity.
Lenvatinib capsules administered orally at 14 mg/m^2 QD
Other Names:
  • E7080
  • MK-7902
  • LENVIMA
Experimental: Rhabdomyosarcoma
Participants with rhabdomyosarcoma will receive lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
Lenvatinib capsules administered orally at 14 mg/m^2 QD
Other Names:
  • E7080
  • MK-7902
  • LENVIMA
Experimental: High Grade Glioma
Participants with high grade glioma will receive lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
Lenvatinib capsules administered orally at 14 mg/m^2 QD
Other Names:
  • E7080
  • MK-7902
  • LENVIMA
Experimental: Diffuse Midline Glioma
Participants with diffuse midline glioma will receive lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
Lenvatinib capsules administered orally at 14 mg/m^2 QD
Other Names:
  • E7080
  • MK-7902
  • LENVIMA
Experimental: Medulloblastoma
Participants with medulloblastoma will receive lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
Lenvatinib capsules administered orally at 14 mg/m^2 QD
Other Names:
  • E7080
  • MK-7902
  • LENVIMA
Experimental: Ependymoma
Participants with ependymoma will receive lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
Lenvatinib capsules administered orally at 14 mg/m^2 QD
Other Names:
  • E7080
  • MK-7902
  • LENVIMA
Experimental: Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma
Participants with other solid tumors will receive lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
Lenvatinib capsules administered orally at 14 mg/m^2 QD
Other Names:
  • E7080
  • MK-7902
  • LENVIMA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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.
Up to 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR Per RECIST 1.1 or RANO Criteria (for HGG Only), by Investigator Assessment
Time Frame: 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.
Up to approximately 21 months
Progression Free Survival (PFS) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment
Time Frame: 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).
Up to approximately 21 months
Best Overall Response (BOR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment
Time Frame: 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.
Up to approximately 21 months
Duration of Response (DOR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment
Time Frame: 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.
Up to approximately 21 months
Disease Control Rate (DCR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment
Time Frame: 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.
Up to approximately 21 months
Clinical Benefit Rate (CBR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment
Time Frame: 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.
Up to approximately 21 months
Number of Participants Who Experienced an Adverse Event (AE)
Time Frame: Up to approximately 21 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.
Up to approximately 21 months
Number of Participants Who Discontinued Study Treatment Due to an AE
Time Frame: Up to approximately 20 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.
Up to approximately 20 months
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Taste Category
Time Frame: 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.
Cycle 1 Day 1 (cycle = 28 days)
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Appearance Category
Time Frame: Cycle 1 Day 1 (cycle = 28 days)
A hedonic 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 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 appearance category is presented.
Cycle 1 Day 1 (cycle = 28 days)
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Smell Category
Time Frame: Cycle 1 Day 1 (cycle = 28 days)
A hedonic 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 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 smell category is presented.
Cycle 1 Day 1 (cycle = 28 days)
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Mouth Feel Category
Time Frame: Cycle 1 Day 1 (cycle = 28 days)
A hedonic 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 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 mouth feel category is presented.
Cycle 1 Day 1 (cycle = 28 days)
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Overall Acceptability Category
Time Frame: Cycle 1 Day 1 (cycle = 28 days)
A hedonic 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 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 overall acceptability category is presented.
Cycle 1 Day 1 (cycle = 28 days)
Area Under the Concentration-Time Curve of Lenvatinib at Steady State (AUCss)
Time Frame: Cycle 1 Day 1 (0.5-4 and 6-10 hours post-dose), Cycle 1 Day 15 (pre-dose, 0.5-4, and 6-10 hours post-dose), and Cycle 2 Day 1 (pre-dose and 2-12 hours post-dose). A cycle is 28 days.
Blood samples were taken predose and at specified times postdose on Days 1-28 to determine the AUCss of Lenvatinib.
Cycle 1 Day 1 (0.5-4 and 6-10 hours post-dose), Cycle 1 Day 15 (pre-dose, 0.5-4, and 6-10 hours post-dose), and Cycle 2 Day 1 (pre-dose and 2-12 hours post-dose). A cycle is 28 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2020

Primary Completion (Actual)

September 16, 2022

Study Completion (Estimated)

February 19, 2025

Study Registration Dates

First Submitted

June 23, 2020

First Submitted That Met QC Criteria

June 23, 2020

First Posted (Actual)

June 25, 2020

Study Record Updates

Last Update Posted (Actual)

January 10, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 7902-013
  • MK-7902-013 (Other Identifier: Merck)
  • 2019-004441-33 (EudraCT Number)
  • HopSkip-013 (Other Identifier: Merck)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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