Clinical Trials for Sarcoma

A Phase 3, Randomized, Double-blind, Multicenter Study of MK-1084 in Combination With Pembrolizumab Compared With Pembrolizumab Plus Placebo as Firstline Treatment of Participants With KRAS G12C-Mutant, Metastatic NSCLC With PD-L1 TPS ≥50%

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: For patients with previously untreated, metastatic KRAS G12C-mutant NSCLC, PD-L1 TPS ≥50%, and ECOG performance status 0–1, this trial compares first-line pembrolizumab plus oral calderasib (MK-1084) with pembrolizumab plus placebo. Calderasib is an investigational covalent inhibitor of GDP-bound KRAS G12C.

ClinicalTrials.gov ID: NCT06345729

A Phase 2 Open-label Basket Study to Evaluate the Efficacy and Safety of Orally Administered Reversible Tyrosine Kinase Inhibitor BAY 2927088 in Participants With Metastatic or Unresectable Solid Tumors With HER2-activating Mutations

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with unresectable or metastatic solid tumors other than NSCLC that harbor an activating HER2 mutation are eligible after appropriate standard therapy or when no satisfactory alternative exists; prior HER2 tyrosine kinase inhibitor treatment and active brain metastases are excluded. All participants receive oral sevabertinib, a reversible HER2-directed tyrosine kinase inhibitor, 20 mg twice daily.

ClinicalTrials.gov ID: NCT06760819

A Single-Arm, Open-label Phase II Trial Testing the Activity of XL092 (Zanzalintinib) in Patients With Advanced Leiomyosarcoma

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with metastatic or unresectable, measurable leiomyosarcoma after more than two prior lines of therapy (including no more than two tyrosine kinase inhibitors) receive oral zanzalintinib until progression or unacceptable toxicity. Zanzalintinib is an investigational multikinase inhibitor targeting VEGFR2, MET, TYRO3, AXL, and MER.

ClinicalTrials.gov ID: NCT06571734

ADI-PEG 20 or Placebo Plus Gemcitabine and Docetaxel in Previously Treated Subjects With Leiomyosarcoma (ARGSARC): A Randomized, Double Blind, Multi-Center Phase 3 Trial

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with measurable, advanced or metastatic grade 2–3 uterine or non-uterine leiomyosarcoma previously treated with a doxorubicin-containing regimen receive gemcitabine and docetaxel plus either ADI-PEG 20 or placebo. ADI-PEG 20 (pegargiminase) depletes circulating arginine, potentially targeting ASS1-deficient tumors.

ClinicalTrials.gov ID: NCT05712694

A Phase 2 Trial of Zanzalintinib in Advanced/Metastatic Bone Sarcomas (ZAMBONE)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with unresectable locally advanced or metastatic osteosarcoma, Ewing sarcoma, grade 2–3 conventional chondrosarcoma, or another primary bone sarcoma receive zanzalintinib monotherapy, generally after at least one prior systemic therapy; prior VEGF-targeted tyrosine kinase inhibitors are excluded. Zanzalintinib is an oral multikinase inhibitor targeting VEGFR2, MET, and the TAM-family kinases TYRO3, AXL, and MER.

ClinicalTrials.gov ID: NCT07193550

Vonescimab for the Treatment of Previously Treated Advanced or Unresectable Leiomyosarcoma - a Phase II Trial

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with unresectable or metastatic leiomyosarcoma and measurable disease are eligible after 1–3 prior systemic therapy lines, or if they declined standard first-line therapy; prior PD-1/PD-L1 or VEGF inhibitor treatment is excluded. Participants receive ivonescimab, an investigational bispecific antibody targeting PD-1 and VEGF-A, intravenously every 3 weeks.

ClinicalTrials.gov ID: NCT07516925

Phase 2 Trial of Zanzalintinib and Pembrolizumab in Select Subtypes of Advanced/Metastatic Soft-tissue Sarcoma

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with measurable advanced or metastatic undifferentiated pleomorphic sarcoma, myxofibrosarcoma, high-grade pleomorphic sarcoma, or high-grade undifferentiated sarcoma who have not received prior checkpoint inhibitors or zanzalintinib receive zanzalintinib plus pembrolizumab. Zanzalintinib is an investigational oral inhibitor of VEGFR2, MET, and the TAM kinases TYRO3, AXL, and MER; pembrolizumab blocks PD-1.

ClinicalTrials.gov ID: NCT07283731

An Open-label, Single-arm, Multicohort, Phase 2 Study to Assess the Efficacy and Safety of Tabelecleucel in Subjects With Epstein-Barr Virus-associated Diseases (EBVision)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: This study enrolls patients aged ≥1 year with EBV-positive lymphoproliferative disease associated with immunodeficiency, CNS post-transplant lymphoproliferative disease, post-transplant lymphoproliferative disease for which rituximab or chemotherapy is inappropriate, or rapidly progressive EBV-positive sarcoma or smooth muscle tumors. Patients receive intravenous tabelecleucel, a donor-derived T-cell therapy that recognizes EBV peptides presented by specific HLA molecules and kills EBV-infected cells.

ClinicalTrials.gov ID: NCT04554914

A Phase IIa Open Label Study Evaluating the Preliminary Efficacy of Intratumoural Tigilanol Tiglate in Advanced and/or Metastatic Soft Tissue Sarcoma of the Extremities and Body Wall.

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with advanced or metastatic soft-tissue sarcoma of the extremities or body wall and an injectable lesion receive intratumoural tigilanol tiglate. This investigational protein kinase C activator is intended to cause local vascular disruption and tumour-cell death.

ClinicalTrials.gov ID: NCT05755113

KEYMAKER-U01 Substudy 01J: A Randomized Phase 2 Umbrella Study With Rolling Arms of Investigational Agents for First-line Treatment of Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: This trial enrolls previously untreated patients with advanced or metastatic nonsquamous NSCLC harboring a KRAS G12C mutation. It compares pembrolizumab plus carboplatin/pemetrexed with pembrolizumab plus investigational calderasib (MK-1084), a covalent KRAS G12C inhibitor, with or without cetuximab.

ClinicalTrials.gov ID: NCT07252739