Clinical Trials for Sarcoma

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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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

Disulfiram With Copper Gluconate and Liposomal Doxorubicin in Patients With Treatment-Refractory Sarcomas

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: Single-arm dose-escalation of oral disulfiram plus copper gluconate with liposomal doxorubicin for children and adults with relapsed/refractory sarcomas and measurable disease. Disulfiram (ALDH inhibitor) complexed with copper forms CuET that inhibits proteasome-associated pathways and cancer stem cell–like properties to potentially overcome anthracycline resistance; regimen includes a 7-day DSF/Cu lead-in and liposomal doxorubicin 30 mg/m2 IV Day 1 of 28-day cycles.

ClinicalTrials.gov ID: NCT05210374

A Phase I Study of Allogeneic Ex Vivo Expanded Gamma Delta (γδ) T Cells in Combination With Dinutuximab, Temozolomide, Irinotecan, and Zoledronate in Children With Refractory/ Relapsed, or Progressive Neuroblastoma or Refractory/ Relapsed 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.

TrialFetch AI summary: Pediatric patients ≥12 months with refractory/relapsed or progressive high-risk neuroblastoma/ganglioneuroblastoma or refractory/relapsed osteosarcoma receive dinutuximab plus temozolomide/irinotecan and zoledronate with added third‑party allogeneic ex vivo–expanded γδ T cells. γδ T cells are MHC-independent cytotoxic lymphocytes with potential ADCC synergy with anti-GD2 (dinutuximab) and activation by zoledronate; prior exposure to the backbone agents is allowed, but prior T‑cell therapy or allogeneic HSCT are excluded.

ClinicalTrials.gov ID: NCT05400603

A First-in-human, Phase 1/2, Multicenter, Open-label, Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of ADCE-D01, a Humanized Anti-human uPARAP Antibody Linked to a Topoisomerase I Inhibitor, in Patients With Metastatic and/or Unresectable Soft Tissue 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: Adults with metastatic or unresectable soft tissue sarcoma after 1–2 prior cytotoxic regimens receive ADCE-D01, a uPARAP-targeted antibody–drug conjugate delivering a topoisomerase I inhibitor. Single-arm dose escalation/expansion assesses safety, PK, and preliminary efficacy to establish the RP2D.

ClinicalTrials.gov ID: NCT06797999

Immunotherapy For Adults With GPC3-Positive Solid Tumors Using Interleukin-15 And -21 Armored Glypican-3-Specific Chimeric Antigen Receptor Expressing Autologous T Cells

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 GPC3-positive solid tumors (notably HCC; centrally confirmed by IHC) after standard therapies receive autologous GPC3-targeted CAR T cells armored with IL-15 and IL-21 to enhance expansion/persistence, incorporating an inducible caspase-9 safety switch, following cyclophosphamide/fludarabine lymphodepletion. Optional second infusion at 4 weeks if no progression.

ClinicalTrials.gov ID: NCT06198296

LINNOVATE: A Phase 1/2 Study of Safety/Efficacy Using LURBINECTEDIN, Combined With IPILIMUMAB, and NIVOLUMAB for Advanced Soft Tissue Sarcomas

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 unresectable or metastatic soft tissue sarcoma (ECOG 0–1); Phase 1 enrolls previously treated, Phase 2 previously untreated; excludes prior PD‑1/CTLA‑4 therapy and unstable CNS mets. Treatment combines lurbinectedin (DNA minor groove binder/transcription inhibitor with TAM modulation) every 3 weeks plus fixed-dose ipilimumab (anti–CTLA‑4) and nivolumab (anti–PD‑1).

ClinicalTrials.gov ID: NCT05876715

Phase Ib Trial Evaluating the Combination of CDK4 Inhibitor With Immunotherapy in Patients With 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: Single-arm study for adolescents and adults with locally advanced, unresectable, or metastatic PD-1–approved soft tissue sarcoma subtypes (e.g., UPS, myxofibrosarcoma, angiosarcoma, pleomorphic RMS/liposarcoma, ASPS) after ≥1 prior line; prior PD-1 allowed, ECOG 0–2. Patients receive a short palbociclib lead-in (CDK4/6 inhibitor) followed by pembrolizumab (anti–PD-1) to assess safety and early activity, with serial biopsies to evaluate immune modulation.

ClinicalTrials.gov ID: NCT06113809