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Tyrosine Kinase Inhibitor

Lenvatinib + Pembrolizumab for Sarcoma

Phase 2

Waitlist Available

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

Must not have

Prior radiotherapy within 2 weeks of the start of study treatment

Serious non-healing wound, ulcer or bone fracture, not tumor related

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 27 weeks

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had radiotherapy in the last 2 weeks.

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I have a serious wound, ulcer, or bone fracture that is not healing and is not related to my tumor.

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I have an immune system disorder or am on medication that weakens my immune system.

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I am currently on dialysis for kidney failure.

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My brain cancer has not been treated.

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I am currently receiving treatment for another type of cancer.

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My high blood pressure is not under control.

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I have a condition that affects how my body absorbs medication.

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I have a specific heart condition.

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I haven't had severe bleeding in the specified timeframe.

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I am currently being treated for an infection.

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I have received an organ transplant from another person.

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I have had or currently have pneumonitis.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

best overall response rate

Secondary study objectives

progression-free survival (PFS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2017

Completed Phase 4

~2040

Pembrolizumab

2017

Completed Phase 3