NCT04784247

A Pilot Study of Lenvatinib Plus Pembrolizumab in Patients With Advanced Sarcoma

Active, enrolled Phase 2 Last updated 20 April 2026

What this trial tests

Phase 2 trial testing Lenvatinib in Advanced Sarcoma in 52 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

18 March 2021

Primary endpoint
1 March 2027

1 March 2027

Quick facts

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	52
Start date	18 March 2021
Primary completion	1 March 2027
Estimated completion	1 March 2027
Sites	7 locations across United States

Drugs / interventions tested

• Lenvatinib (LENVATINIB) — full drug profile →
• Pembrolizumab (pembrolizumab) — full drug profile →

Conditions studied

• Advanced Sarcoma — all drugs for Advanced Sarcoma →

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

18 and older, any sex, with Advanced Sarcoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• best overall response rate
  Time frame: at 27 weeks
  Response and progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)

Sponsor's own description

The purpose of this study is to find out whether combining the study drugs, lenvatinib and pembrolizumab, is a safe and effective treatment for metastatic soft tissue sarcomas that cannot be removed with surgery.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. A Rationale for the Activity of Bone Target Therapy and Tyrosine Kinase Inhibitor Combination in Giant Cell Tumor of Bone and Desmoplastic Fibroma: Translational Evidences.
   De Vita A, Vanni S, Miserocchi G, Fausti V, et al · · 2022 · cited 45× · PMID 35203581 · DOI 10.3390/biomedicines10020372
2. Soft Tissue Sarcoma: An Insight on Biomarkers at Molecular, Metabolic and Cellular Level.
   Pillozzi S, Bernini A, Palchetti I, Crociani O, et al · · 2021 · cited 29× · PMID 34207243 · DOI 10.3390/cancers13123044
3. Biomarkers for immune checkpoint inhibition in sarcomas - are we close to clinical implementation?
   Yiong CS, Lin TP, Lim VY, Toh TB, et al · · 2023 · cited 26× · PMID 37612756 · DOI 10.1186/s40364-023-00513-5
4. Fibroblast Growth Factor Receptor (FGFR) Signaling in GIST and Soft Tissue Sarcomas.
   Napolitano A, Ostler AE, Jones RL, Huang PH. · · 2021 · cited 24× · PMID 34204560 · DOI 10.3390/cells10061533
5. Trial Watch: combination of tyrosine kinase inhibitors (TKIs) and immunotherapy.
   Petrazzuolo A, Maiuri MC, Zitvogel L, Kroemer G, et al · · 2022 · cited 23× · PMID 35655707 · DOI 10.1080/2162402x.2022.2077898
6. Cutaneous angiosarcoma: A review of current evidence for treatment with checkpoint inhibitors.
   Guan L, Palmeri M, Groisberg R. · · 2023 · cited 19× · PMID 36993810 · DOI 10.3389/fmed.2023.1090168
7. Mesenchymal Chondrosarcoma from Diagnosis to Clinical Trials.
   Dudzisz-Śledź M, Kondracka M, Rudzińska M, Zając AE, et al · · 2023 · cited 17× · PMID 37760551 · DOI 10.3390/cancers15184581
8. Immunological and Genomic Analysis Reveals Clinically Relevant Distinctions between Angiosarcoma Subgroups.
   van Ravensteijn SG, Versleijen-Jonkers YMH, Hillebrandt-Roeffen MHS, Weidema ME, et al · · 2022 · cited 15× · PMID 36497420 · DOI 10.3390/cancers14235938