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 I/II, Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Vactosertib as a Single Agent in Adolescents and Adults With Recurrent, Refractory or Progressive Osteosarcoma

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.

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: Enrolling adolescents and adults (≥12) with measurable, recurrent/refractory or progressive osteosarcoma after standard therapy and ECOG 0–2 for oral vactosertib monotherapy. Vactosertib is a selective TGF-β type I receptor (ALK5) kinase inhibitor aimed at blocking TGF-β signaling to reduce tumor progression and immune evasion; excludes prior TGF-β inhibitors and significant cardiac/GI risks or strong CYP3A4 interactions.

ClinicalTrials.gov ID: NCT05588648

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

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.

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/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 Phase 2 Study Evaluating the Efficacy of Elacestrant in Patients With Estrogen Receptor Positive Uterine 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: Single-arm study for adults with locally advanced or metastatic, unresectable uterine sarcoma subtypes with strong ER expression (≥75% tumor cells), measurable disease, and ECOG 0–2, allowing prior chemotherapy/radiation. All patients receive once-daily oral elacestrant, a selective estrogen receptor degrader (SERD), in 28-day cycles until progression or discontinuation.

ClinicalTrials.gov ID: NCT07467772

Phase II Trial of Lung Chemoemobolization

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 unresectable, unablatable non-small cell lung cancer or lung metastases progressing on or intolerant to systemic therapy receive transarterial chemoembolization (TACE) with intra-arterial mitomycin (alkylating cytotoxic agent), lipiodol (contrast/drug carrier), and embospheres (arterial embolic microspheres). This trial targets patients not eligible for surgery, ablation, or radiation, assessing local disease control using a locoregional approach.

ClinicalTrials.gov ID: NCT05672108

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

Open-label, Non-randomized, Multi-cohort, Phase 1b/2 Trial Investigating the Safety, Tolerability, and Antitumor Activity of STC-15 (a METTL3 Inhibitor) as a Part of Combination Therapy With Toripalimab in Participants With Selected Advanced Cancers

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 with advanced or metastatic NSCLC, melanoma, endometrial cancer, or HNSCC who have progressed after standard therapies including prior anti-PD-1/L1 agents, and evaluates the combination of STC-15 (an oral METTL3 inhibitor targeting RNA methylation) plus toripalimab (anti-PD-1 antibody). Eligible patients must have measurable disease, ECOG 0–1, and no active CNS disease.

ClinicalTrials.gov ID: NCT06975293