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Tyrosine Kinase Inhibitor

Lenvatinib + Pembrolizumab for Sarcoma

Phase 2

Recruiting

Led By Sujana Movva, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have a performance status ECOG 0-1

Participants must be able to swallow and retain oral medication or have a functioning G-tube in place

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 27 weeks

Awards & highlights

Study Summary

This trial will test whether combining two drugs, lenvatinib and pembrolizumab, is a safe and effective treatment for a type of cancer called metastatic soft tissue sarcoma.

Who is the study for?

Adults with advanced soft tissue sarcoma that can't be surgically removed, who've had 1-3 prior systemic therapies (but not specific drugs like lenvatinib or PD-1/PD-L1 inhibitors), and are able to swallow pills. They must have good organ function, no untreated brain metastases, no recent serious bleeding or infections, and agree to effective contraception.Check my eligibility

What is being tested?

The trial is testing the combination of two drugs: Lenvatinib and Pembrolizumab for treating metastatic soft tissue sarcomas. The goal is to see if this drug duo is safe and works better together than when used separately.See study design

What are the potential side effects?

Possible side effects include fatigue, high blood pressure, reduced thyroid gland activity (hypothyroidism), nausea, inflammation in organs such as lungs (pneumonitis), liver issues, kidney problems, increased risk of infection due to immune system effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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I can swallow pills or have a working feeding tube.

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I have had 1 to 3 treatments for my condition.

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I agree to use effective birth control methods.

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My soft tissue sarcoma cannot be removed by surgery and/or has spread.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 27 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~27 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 27 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

best overall response rate

Secondary outcome measures

progression-free survival (PFS)

Trial Design

5Treatment groups

Experimental Treatment

Group I: Vascular sarcomas (including angiosarcoma and epithelioid hemangioendothelioma)Experimental Treatment2 Interventions

Patients enrolled in the study will be treated initially with a 2 week run-in of lenvatinib 20 mg orally daily. Subsequently, they will start pembrolizumab 200 mg intravenously every 3 weeks (21-day cycles). Treatment will continue until progression or other indications for study withdrawal. Otherwise, treatment will be discontinued after a maximum of 35 cycles of pembrolizumab (approximately 2 years) or after achieving CR. RECIST v1.1 tumor assessments will be made at baseline (CT or MRI) and approximately every 3 cycles (or every 9 weeks +/- 1 week) for the first 9 cycles (27 weeks), then every 4 cycles (or every 12 weeks +/- 1week). Patients who progress after having discontinued therapy after completing 2 years of treatment or after achieving confirmed CR may be eligible to reinitiate therapy for an additional 1 year (approximately 17 cycles).

Group II: Other soft tissue sarcomas (including synovial sarcoma and malignant peripheral nerve sheath tumorExperimental Treatment2 Interventions

Group III: LeiomyosarcomaExperimental Treatment2 Interventions

Patients enrolled in the study will be treated initially with a 2 week run-in of lenvatinib 20 mg orally daily. Subsequently, they will start pembrolizumab 200 mg intravenously every 3 weeks (21-day cycles). Treatment will continue until progression or other indications for study withdrawal Otherwise, treatment will be discontinued after a maximum of 35 cycles of pembrolizumab (approximately 2 years) or after achieving CR. RECIST v1.1 tumor assessments will be made at baseline (CT or MRI) and approximately every 3 cycles (or every 9 weeks +/- 1 week) for the first 9 cycles (27 weeks), then every 4 cycles (or every 12 weeks +/- 1week). Patients who progress after having discontinued therapy after completing 2 years of treatment or after achieving confirmed CR may be eligible to reinitiate therapy for an additional 1 year (approximately 17 cycles).

Group IV: High grade undifferentiated pleomorphic sarcomaExperimental Treatment2 Interventions

Patients enrolled in the study will be treated initially with a 2 week run-in of lenvatinib 20 mg orally daily. Subsequently, they will start pembrolizumab 200 mg intravenously every 3 weeks (21-day cycles). Treatment will continue until progression or other indications for study withdrawal . Otherwise, treatment will be discontinued after a maximum of 35 cycles of pembrolizumab (approximately 2 years) or after achieving CR. RECIST v1.1 tumor assessments will be made at baseline (CT or MRI) and approximately every 3 cycles (or every 9 weeks +/- 1 week) for the first 9 cycles (27 weeks), then every 4 cycles (or every 12 weeks +/- 1week). Patients who progress after having discontinued therapy after completing 2 years of treatment or after achieving confirmed CR may be eligible to reinitiate therapy for an additional 1 year (approximately 17 cycles).

Group V: Bone sarcomas (including osteosarcoma and chondrosarcoma)Experimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lenvatinib

2005

Completed Phase 4

~2690

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor

3,886 Previous Clinical Trials

5,054,521 Total Patients Enrolled

31 Trials studying Sarcoma

3,877 Patients Enrolled for Sarcoma

Parker Institute for Cancer ImmunotherapyOTHER

9 Previous Clinical Trials

390 Total Patients Enrolled

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,570 Total Patients Enrolled

70 Trials studying Sarcoma

13,717 Patients Enrolled for Sarcoma

Media Library

Lenvatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04784247 — Phase 2

Sarcoma Research Study Groups: High grade undifferentiated pleomorphic sarcoma, Other soft tissue sarcomas (including synovial sarcoma and malignant peripheral nerve sheath tumor, Bone sarcomas (including osteosarcoma and chondrosarcoma), Vascular sarcomas (including angiosarcoma and epithelioid hemangioendothelioma), Leiomyosarcoma

Sarcoma Clinical Trial 2023: Lenvatinib Highlights & Side Effects. Trial Name: NCT04784247 — Phase 2

Lenvatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04784247 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Pembrolizumab been accepted by the FDA?

"Pembrolizumab is still being studied in Phase 2 clinical trials, so its safety rating is currently a 2."

Answered by AI

Can patients sign up for this experiment at this time?

"Yes, this study is still looking for participants and recent updates have been made to the clinicaltrials.gov listing. The trial was initially posted on March 18th, 2021 with September 21st, 2022 being the most recent edit date."

Answered by AI

What are some previous studies in which Pembrolizumab has been used?

"Pembrolizumab is being trialled in 1076 clinical studies, 134 of which are currently active. These trials are being conducted all over the world, with 37368 different locations participating. However, many of these live trials for Pembrolizumab originate from Sacramento, California."

Answered by AI

What is Pembrolizumab used to treat?

"Pembrolizumab is often used to treat malignant neoplasms, but it can also be effective for treating other conditions like unresectable melanoma and microsatellite instability high."

Answered by AI

How many guinea pigs are a part of this medical study?

"Data from clinicaltrials.gov does show that this study is open and admitting patients at the moment. This trial was first posted on March 18th, 2021 and has since been updated September 21st, 2022. The research requires 50 individuals total, which will be gathered from 7 different locations."

Answered by AI

If a patient were to participate in this research, how many different city locations would they have to visit?

"There are 7 recruiting patients for this trial such as Memorial Sloan Kettering Bergen (Limited Protocol Activities) in Montvale, Memorial Sloan Kettering Monmouth (Limited Protocol Activities) in Middletown, and Memorial Sloan Kettering Cancer Commack (Limited Protocol Activities) in Commack,to name a few other locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Lenvatinib and Pembrolizumab in People With Advanced Soft Tissue Sarcoma

2021. "Lenvatinib and Pembrolizumab in People With Advanced Soft Tissue Sarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04784247.

All > Soft Tissue Sarcoma