Clinical Trials for Sarcoma

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART): Adaptive Clinical Treatment (ACT)

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.

HealthScout AI summary: This trial enrolls adults with advanced sarcoma, prostate, breast, ovarian, or pancreatic cancers who have progressed after prior systemic therapy, assigning individualized regimens—including targeted agents like CDK4/6 inhibitors (abemaciclib), PARP inhibitors (olaparib), EGFR inhibitors (gefitinib, osimertinib), endocrine therapies, and chemotherapeutics—based on serial molecular profiling and multidisciplinary tumor board review. Patients may switch treatments upon progression or toxicity according to ongoing molecular and proteomic data.

ClinicalTrials.gov ID: NCT06630325

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.

HealthScout 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

Lurbinectedin in FET-Fusion Tumors (LIFFT)

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.

HealthScout AI summary: Enrolling patients ≥10 years with recurrent/relapsed solid tumors harboring FET fusions (EWSR1, FUS, TAF15), including an efficacy cohort for EWS-FLI1–positive relapsed/refractory Ewing sarcoma, to receive lurbinectedin IV on days 1 and 4 of 28-day cycles. Lurbinectedin is a selective inhibitor of oncogenic transcription that binds the DNA minor groove, suppressing fusion-driven transcription (e.g., EWS-FLI1) and tumor-associated macrophages.

ClinicalTrials.gov ID: NCT05918640

Allogeneic Stem Cell Transplantation Utilizing Alpha/Beta T Cell and CD19+ B Cell Depletion With Zoledronic Acid in Combination to Treat Pediatric, Adolescent, and Young Adult Patients With Relapsed/Refractory Solid Tumors

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.

HealthScout AI summary: Pediatric, adolescent, and young adult patients (6 months–25 years) with relapsed/refractory high-risk solid tumors undergo haploidentical allogeneic HSCT using αβ T-cell and CD19+ B-cell–depleted grafts, with adjunct zoledronic acid. Zoledronic acid, a nitrogen-containing bisphosphonate that inhibits farnesyl pyrophosphate synthase and activates γδ T cells, is used to enhance graft-versus-tumor effects.

ClinicalTrials.gov ID: NCT06625190

A Phase 1/2 Open Label, Basket Study to Assess the Safety, Tolerability and Anti-Tumor Activity of Afamitresgene Autoleucel in Pediatric Subjects With MAGE-A4 Positive Tumors

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.

HealthScout AI summary: Pediatric and young adult patients (2–17 with synovial sarcoma; 2–21 with MPNST, neuroblastoma, or osteosarcoma) with HLA‑A*02 positivity and centrally confirmed MAGE‑A4–expressing, measurable disease receive leukapheresis, fludarabine/cyclophosphamide lymphodepletion, and a single infusion of afamitresgene autoleucel. Afami‑cel is an autologous TCR-engineered T‑cell therapy targeting MAGE‑A4 presented by HLA‑A*02, with expected T‑cell therapy toxicities including CRS and cytopenias.

ClinicalTrials.gov ID: NCT05642455

A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

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.

HealthScout AI summary: For patients <50 years with histologically confirmed osteosarcoma and resectable oligometastatic pulmonary disease (≤4 nodules/lung, 3 mm–3 cm) at initial presentation or first pulmonary relapse, this trial randomizes to open thoracotomy versus video-assisted thoracoscopic surgery (VATS) for metastasectomy. Key exclusions include unresectable primary tumor, central lesions needing anatomic resection, extrapulmonary metastases, significant pleural effusion, or prior therapeutic pulmonary metastasectomy.

ClinicalTrials.gov ID: NCT05235165

Phase 1b Trial of Atezolizumab in Combination With Stereotactic Body Radiation Therapy (SBRT) and Surgery in Patients With Pulmonary Recurrence of Osteosarcoma

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.

HealthScout AI summary: Single-arm study for children through adults with osteosarcoma limited to the lungs in first or later pulmonary relapse, with all nodules resectable and at least one SBRT-eligible lesion. Patients receive atezolizumab (anti–PD-L1) combined with SBRT to a selected lung lesion, followed by complete surgical resection of all pulmonary metastases, with perioperative atezolizumab per unilateral or bilateral disease schema.

ClinicalTrials.gov ID: NCT06492954

VITAS: Atezolizumab in Combination With Chemotherapy for Pediatric Relapsed/Refractory Solid Tumors: An Open-label, Phase II, Single-arm, Multi-center Trial

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.

HealthScout AI summary: Pediatric and young adult patients (6 months–30 years) with relapsed/refractory solid tumors (excluding lymphoma), including a dedicated efficacy cohort for PD-L1–enriched, measurable rhabdomyosarcoma, eligible if adequate organ function and no prior PD-1/PD-L1 therapy. Treatment is atezolizumab (anti–PD-L1) combined with vincristine, irinotecan, and temozolomide in 21-day cycles until progression/toxicity.

ClinicalTrials.gov ID: NCT04796012

A Phase I/II Study of Abemaciclib in Patients With HIV-associated and HIV-negative Kaposi Sarcoma

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.

HealthScout AI summary: Adults with histologically confirmed Kaposi sarcoma (HIV-positive or HIV-negative) requiring systemic therapy, including previously treated, treatment-naive, and Stage T1 cohorts; requires measurable disease and ECOG 0–2. Single-arm abemaciclib (oral CDK4/6 inhibitor) given continuously in 28-day cycles to assess safety and antitumor activity, with cohorts stratified by prior therapy status.

ClinicalTrials.gov ID: NCT04941274

A Phase II Study of Concurrent Systemic Pembrolizumab and Isolated Limb Infusion (ILI) With Melphalan and Dactinomycin for Patients With Locally Advanced or Metastatic Extremity Sarcoma

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.

HealthScout AI summary: For adolescents and adults with locally advanced or metastatic extremity sarcoma eligible for limb-directed therapy after ≥1 prior systemic regimen (or declining standard options), this single-arm study pairs isolated limb infusion (melphalan+dactinomycin) with systemic pembrolizumab (anti–PD‑1) to enhance local control and systemic immune activity. Excludes active CNS disease (unless treated/stable), significant immunosuppression/autoimmunity, and those unable to undergo ILI/anesthesia.

ClinicalTrials.gov ID: NCT04332874