Clinical Trials for Sarcoma

Phase II Study of Enasidenib in IDH2-mutated Malignant Sinonasal and Skull Base 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: Adults with unresectable, recurrent, or metastatic sinonasal or skull base tumors harboring IDH2 R140/R172 mutations (e.g., SNUC, olfactory neuroblastoma, LCNEC, poorly differentiated sinonasal adenocarcinoma, chondrosarcoma) after prior systemic therapy receive enasidenib 100 mg PO daily. Enasidenib is a selective mutant IDH2 inhibitor that lowers 2-HG to promote differentiation; key exclusions include prior IDH inhibitor use and significant uncontrolled comorbidities.

ClinicalTrials.gov ID: NCT06176989

B7-H3-Specific Chimeric Antigen Receptor Autologous T-Cell Therapy for Pediatric Patients With Solid Tumors (3CAR)

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: Pediatric and young adult patients (≤21 years) with measurable, relapsed/refractory B7‑H3 (CD276)–positive solid tumors, including CNS involvement, receive lymphodepleting fludarabine/cyclophosphamide followed by a single IV infusion of autologous B7‑H3–targeted CAR T cells. The investigational therapy uses second‑generation CAR T cells engineered to recognize B7‑H3 to mediate antigen-directed cytotoxicity, with dose escalation to define safety and preliminary activity.

ClinicalTrials.gov ID: NCT04897321

A Phase II Study of All-Trans Retinoic Acid (ATRA) and Cemiplimab in Patients With Advanced 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 or unresectable leiomyosarcoma after prior systemic therapy (including allowable prior PD-1/PD-L1 exposure without severe irAEs) receive cemiplimab (anti–PD-1) every 3 weeks with short-course oral all-trans retinoic acid (ATRA) for the first three cycles, then cemiplimab alone until progression. ATRA, a retinoic acid receptor agonist that can reduce myeloid-derived suppressor cells, is paired with PD-1 blockade to potentially enhance antitumor immunity.

ClinicalTrials.gov ID: NCT06528769

A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of HH2853 in Patients with Relapsed/Refractory Non-Hodgkin's Lymphomas or Advanced 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 relapsed/refractory follicular lymphoma (≥2 prior lines), DLBCL not transplant candidates, PTCL (≥1 prior line), unresectable/metastatic epithelioid sarcoma, or advanced solid tumors enriched for PRC2 dependence (e.g., EZH2 mutation, INI1/SMARCA4 loss, ARID1A or BAP1 mutations) receive oral HH2853 (epsametostat), a dual EZH1/EZH2 inhibitor, given BID in 28‑day cycles. Single‑arm study assessing safety, PK/PD, and antitumor activity; prior EZH inhibitor exposure excluded and ECOG 0–1 required.

ClinicalTrials.gov ID: NCT04390737

A Randomized Phase III Trial of Doxorubicin + Pembrolizumab Versus Doxorubicin Alone for the Treatment of Dedifferentiated Liposarcoma (DDLPS), Undifferentiated Pleomorphic Sarcoma (UPS) and Related Poorly Differentiated 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 with metastatic or unresectable dedifferentiated liposarcoma, undifferentiated pleomorphic sarcoma, or related poorly differentiated sarcomas (ECOG 0–1, anthracycline‑naïve) are randomized to first-line doxorubicin plus pembrolizumab versus doxorubicin alone, with crossover to pembrolizumab at progression in the control arm. Pembrolizumab is an anti–PD-1 antibody designed to restore T‑cell antitumor activity; the study tests whether upfront addition improves PFS (with separate analyses for UPS-family tumors and DDLPS) and impacts OS versus reserving pembrolizumab for later.

ClinicalTrials.gov ID: NCT06422806

A Multicenter Phase II Study of Propranolol for the Treatment of Kaposi Sarcoma in Adults

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 biopsy-proven, measurable Kaposi sarcoma (HIV-positive on stable ART with progression or lack of regression, or HIV-negative without recent improvement) receive oral propranolol, a nonselective beta-adrenergic antagonist with anti-angiogenic/antiproliferative activity, using a brief titration then 12-week target dosing with response-guided continuation. Excludes patients with symptomatic visceral KS or urgent chemo needs and those with contraindications to beta-blockade (e.g., asthma/COPD, significant cardiac conduction disease, heart failure, hypotension, diabetes, or current beta-blocker use).

ClinicalTrials.gov ID: NCT06445166

A Pilot Trial of Autologous Tumor Infiltrating Lymphocytes (LN-144 or LN-145) for Patients With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, or Dedifferentiated Liposarcoma

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 metastatic uveal melanoma (any prior therapy) or unresectable/metastatic UPS or DDLPS refractory to ≥1 systemic regimen receive autologous tumor-infiltrating lymphocyte therapy lifileucel (LN-144/LN-145) after nonmyeloablative lymphodepleting chemotherapy and followed by IL-2. Lifileucel consists of ex vivo–expanded, tumor-specific T cells (adoptive cell therapy) and is being studied here for safety/feasibility in these populations.

ClinicalTrials.gov ID: NCT05607095

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