Clinical Trials for Sarcoma

Randomized, Controlled, Open-label, Phase III Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Patients With Metastatic Leiomyosarcoma

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, unresectable leiomyosarcoma, ECOG 0–1, no prior systemic therapy for metastatic disease and no prior anthracycline exposure are randomized to doxorubicin alone versus doxorubicin plus lurbinectedin, a DNA minor-groove binder that inhibits oncogenic transcription and induces double-strand breaks. Prior non-anthracycline adjuvant/neoadjuvant therapy and hormone therapy are allowed; key exclusions include low-grade LMS, significant cardiac disease, active viral hepatitis/HIV, strong CYP3A4 inducers, and need for rapid tumor shrinkage.

ClinicalTrials.gov ID: NCT06088290

A Multi-Center Phase II Study of Selinexor in Treating Recurrent or Refractory Wilms Tumor and Other Pediatric Solid Tumors

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: Enrolling children and young patients (≥12 months) with relapsed/refractory solid tumors—Wilms tumor; rhabdoid tumors (ATRT, MRTK, soft tissue/liver rhabdoid, SCUH, SCCOHT); MPNST; or other solid tumors with evidence of XPO1 dependence/selinexor sensitivity—who have measurable disease and prior therapy. Patients receive oral selinexor monotherapy, a selective XPO1 (exportin 1) inhibitor that blocks nuclear export of tumor suppressors and oncoprotein mRNAs.

ClinicalTrials.gov ID: NCT05985161

A Phase 2 Trial of Atezolizumab and Cabozantinib in Adolescents and Young Adults With Recurrent/Metastatic Osteosarcoma (TACOS)

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: Single-arm study for adolescents and young adults (≥12) with histologically confirmed recurrent/metastatic or unresectable osteosarcoma after standard chemotherapy, requiring measurable disease and ECOG 0–2. Treatment is atezolizumab (anti–PD-L1) plus cabozantinib (oral multi–TKI targeting MET/VEGFR2/AXL) given in 21-day cycles until progression or intolerance.

ClinicalTrials.gov ID: NCT05019703

A Phase 1/2a, Open-Label, Dose Escalation and Expansion Study of the Safety and Tolerability of T3011 Administered Via Intratumoral Injection as a Single Agent and in Combination With Intravenous Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors

Active drug

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

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.

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: Adults with advanced/metastatic solid tumors requiring at least one injectable lesion (ECOG 0–1) receive intratumoral T3011—an engineered oncolytic HSV‑1 expressing IL‑12 and an anti‑PD‑1 antibody—either as monotherapy in melanoma, HNSCC post‑platinum/PD‑(L)1, sarcoma, or cSCC, or combined with IV pembrolizumab in previously treated metastatic NSCLC without EGFR/ALK alterations. Excludes patients with uninjectable disease, high‑risk injection sites, active autoimmune disease requiring immunosuppression, active HSV, significant cardiopulmonary disease, CNS metastases, or active viral infections.

ClinicalTrials.gov ID: NCT04370587

A Dose Finding Study of MiniBeam RadioTherapy for Skin and Superficial Soft Tissue Tumors (MBRT1)

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 primary, recurrent, or metastatic skin or superficial soft tissue tumors suitable for palliative orthovoltage RT receive MiniBeam Radiation Therapy delivered via a tungsten slit collimator in 2–3 fractions, which spatially fractionates dose into high “peaks” and low “valleys” to spare normal tissue. Excludes lesions likely to fully respond to standard palliative RT, prior overlapping RT, recent/planned BRAF/VEGF-targeted therapy or cytotoxic chemo during the DLT window, and lesions with unavoidable spinal cord exposure.

ClinicalTrials.gov ID: NCT07062003

URSa-1: A Minibasket Study of Pembrolizumab in Ultra-Rare Sarcomas

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 (≥18) with recurrent or metastatic, measurable pleomorphic liposarcoma, PEComa, epithelioid sarcoma, CIC-rearranged sarcoma, or sclerosing epithelioid fibrosarcoma/low-grade fibromyxoid sarcoma who have progressed after their most recent therapy (ECOG 0–1; 1–3 prior systemic lines allowed; treated/stable brain metastases allowed; no prior PD-1/PD-L1/PD-L2 therapy). Single-arm cohorts receive pembrolizumab IV every 6 weeks, an anti–PD-1 monoclonal antibody checkpoint inhibitor that blocks PD-1/PD-L1/PD-L2 interactions to restore antitumor T-cell activity.

ClinicalTrials.gov ID: NCT07089992

A Feasibility Multicenter Phase I Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

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 adults (ECOG 0-2) with locally advanced or metastatic cancers eligible for atezolizumab, investigating therapeutic drug monitoring-based personalized dosing of atezolizumab (anti-PD-L1 immune checkpoint inhibitor) as monotherapy or combined with other approved agents. Patients initially receive standard dosing, then transition to adaptive, lower-frequency fixed dosing based on plasma levels.

ClinicalTrials.gov ID: NCT06066138

Phase 2 Study of Avapritinib in Patients With CKIT or PDGFRA Mutation-Positive Malignant Solid Tumors

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 trial enrolls adults with locally advanced or metastatic non-GIST solid tumors (such as melanoma, sarcoma, or primary CNS tumors) harboring activating mutations in CKIT or PDGFRA, who have no effective standard therapy options. Patients receive avapritinib, an oral tyrosine kinase inhibitor selective for CKIT and PDGFRA mutations.

ClinicalTrials.gov ID: NCT04771520

Adopting a Functional Precision Medicine Approach For Individualized Pediatric Cancer Treatments

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: Children, adolescents, and young adults (≤21 years) with relapsed or refractory solid or hematologic malignancies and accessible tumor tissue undergo ex vivo drug sensitivity testing integrated with genomic profiling to guide individualized therapy selection. Treating physicians may use matched, typically approved monotherapies or combinations based on predicted sensitivity; outcomes are compared with contemporaneous patients receiving non–FPM standard-of-care therapy.

ClinicalTrials.gov ID: NCT05857969

A Phase 1/2, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Recommended Phase 2 Dose (RP2D), and Efficacy of Lurbinectedin Monotherapy in Pediatric Participants With Previously Treated Solid Tumors Followed by Expansion to Assess Efficacy and Safety in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma.

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: Open-label dose-escalation/expansion of lurbinectedin monotherapy for pediatric patients with previously treated solid tumors (≥2 to <18 years) to establish RP2D, followed by treatment of pediatric/young adult patients (≥2 to ≤30 years) with relapsed/refractory Ewing sarcoma. Lurbinectedin is a DNA minor-groove binder that inhibits oncogenic transcription and induces DNA double-strand breaks; key exclusions include significant QTc prolongation, active CNS disease requiring steroids, prior lurbinectedin/trabectedin, and recent intensive therapy.

ClinicalTrials.gov ID: NCT05734066