Today we’re going to look at the ongoing studies and clinical trials specific to soft tissue sarcomas in adults.
The below list was curated by assessing the ongoing Phase 3 trials for soft tissue sarcomas, specific to adults, and based in the United States. The dates provided are estimates, and subject to change. The list is primarily studies that have posted updates within 12 months or less.
This series is intended to provide a preview of what new innovations are to come on a given topic, and how might the results of those studies ultimately impact clinical guidelines on the topic(s).
Quick View Table of Soft Tissue Sarcoma Clinical Trials
Soft Tissue Sarcoma Clinical Trials:
A Study of Doxorubicin Plus Olaratumab (LY3012207) in Participants With Advanced or Metastatic Soft Tissue Sarcoma
- Sponsor: Eli Lilly and Company
- The main purpose of this study is to evaluate the efficacy of the combination of doxorubicin plus the study drug known as olaratumab versus doxorubicin plus placebo in participants with advanced or metastatic soft tissue sarcoma.
- Interventions: DRUG: Olaratumab|DRUG: Doxorubicin|DRUG: Placebo
- Primary Outcomes Measures: Overall Survival (OS), Overall survival was defined as the time from the date of randomization to the date of death due to any cause. For each participant, prior to data analysis, a reasonable effort was made to obtain the most up-to-date status (date of death or last date known to be alive). For any participant not known to have died as of the data cutoff date, OS was censored at the date the participant was last known to be alive. For any participant who withdrew consent for survival follow-up, OS was censored at the last date for which the participant provided consent for follow-up contact. The Kaplan-Meier method was used to estimate median parameters., Randomization to Date of Death Due to Any Cause (Up to 35.8 Months)|Overall Survival (OS) Leiomyosarcoma (LMS), Overall survival was defined as the time from the date of randomization to the date of death due to any cause. For each participant, prior to data analysis, a reasonable effort was made to obtain the most up-to-date status (date of death or last date known to be alive). For any participant not known to have died as of the data cutoff date, OS was censored at the date the participant was last known to be alive. For any participant who withdrew consent for survival follow-up, OS was censored at the last date for which the participant provided consent for follow-up contact. The Kaplan-Meier method was used to estimate median parameters., Randomization to Date of Death Due to Any Cause (Up to 35.8 Months).
A Study to Investigate Efficacy & Safety of INT230-6 Compared to US Standard of Care in Adults With Soft Tissue Sarcomas (INVINCIBLE-3)
- Sponsor: Intensity Therapeutics, Inc.
- To compare Overall Survival (OS) for INT230-6 vs United States (US) Standard of Care (SOC) in participants with unresectable or metastatic liposarcoma, undifferentiated pleomorphic sarcoma or leiomyosarcoma who have disease progression prior to study enrollment following no more than 2 standard therapies, which must have included an anthracycline-based regimen, unless contraindicated, and then a maximum of 1 additional regimen.
- Interventions: DRUG: INT230-6|DRUG: Eribulin|DRUG: Trabectedin|DRUG: Pazopanib
- Primary Outcomes Measures: Overall Survival (OS), To compare OS for INT230-6 vs US Standard of Care (SOC) in participants with unresectable or metastatic liposarcoma, undifferentiated pleomorphic sarcoma or leiomyosarcoma who have disease progression prior to study enrollment following no more than 2 standard therapies, which must have included an anthracycline-based regimen, unless contraindicated, and then a maximum of 1 additional regimen., From date of randomization until the documented date of death from any cause for a period of up to 2 years, unless superiority is demonstrated sooner or 80% of deaths during the study period.
Study of ADI-PEG 20 or Placebo Plus Gem and Doc in Previously Treated Subjects With Leiomyosarcoma (ARGSARC)
- Sponsor: Polaris Group
- To compare the efficacy and safety in subjects with advanced or metastatic LMS previously treated with an anthracycline.
- Interventions: DRUG: ADI PEG20|OTHER: Placebo
- Primary Outcomes Measures: Primary End Point of PFS, The primary objective is to compare the primary endpoint of PFS in subjects treated with the arginine degrading enzyme ADI-PEG 20 plus Gem and Doc (ADIGemDoc) or PBO plus Gem and Doc (PBOGemDoc) in the 2nd or 3rd line setting using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by blinded independent central review committee (BICR), Subjects will receive triplet combination treatment followed by weekly monotherapy ADI-PEG 20 or PBO (Each cycle is 21 days). Subjects tolerating chemotherapy may continue chemotherapy beyond 8 cycles and up to 104 weeks (~2 years).
Preoperative vs Postoperative IMRT for Extremity/Truncal STS
- Sponsor: Mount Sinai Hospital, Canada
- This study is designed to determine if preoperative image guided radiation therapy (IGRT) delivered using intensity modulated radiation therapy (IMRT) followed by surgery results in similar short-term wound healing complications as surgery followed by postoperative IGRT in patients with extremity or truncal soft tissue sarcoma. Half of the patients will receive preoperative radiotherapy, half will receive postoperative radiotherapy.
- Interventions: RADIATION: Preoperative intensity modulated radiation therapy|RADIATION: Postoperative intensity modulated radiation therapy
- Primary Outcomes Measures: “Incidence of acute wound healing complications, * Secondary operations required for wound treatment (debridement, secondary closure procedures such as rotationplasty, free flaps or skin grafts).
Phase III Trial of Anlotinib, Catequentinib in Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma, Synovial Sarcoma (APROMISS)
- Sponsor: Advenchen Laboratories, LLC
- “THIS STUDY IS CURRENTLY RECRUITING PATIENTS WITH ALVEOLAR SOFT PART SARCOMA ONLY AND IS NO LONGER RECRUITING PATIENTS WITH SYNOVIAL SARCOMA OR LEIOMYOSARCOMA.
- This study evaluates the safety and efficacy of AL3818 (anlotinib) hydrochloride in the treatment of metastatic or advanced alveolar soft part sarcoma (ASPS), leiomyosarcoma (LMS), and synovial sarcoma (SS). All participants with ASPS will receive open-label AL3818. In participants with LMS or SS, AL3818 will be compared to IV dacarbazine. Two-thirds of the participants will receive AL3818, one-third of the participants will receive IV dacarbazine.”
- Interventions: DRUG: AL3818|DRUG: Dacarbazine|DRUG: AL3818 or placebo
- Primary Outcomes Measures: Objective Response Rate (ORR) (ASPS), To determine ORR in subjects with ASPS, defined as percentage of subjects who achieve a Complete Response (CR) or Partial Response (PR) as best responses according to RECIST 1.1 as evaluated by a blinded independent radiological review (BICR)., Up to 48 months|Progression Free Survival (PFS) (LMS/SS), To compare PFS in subjects with LMS or SS randomized to AL3818 versus dacarbazine, defined a median number of months from the date of randomization until the first documented sign of disease progression or death due to any causes, whichever occurs earlier as evaluated by a blinded independent radiologic review (BICR)., From time of randomization to the date of disease progression or death from any cause, up to 48 months.
Tazemetostat in Combination With Doxorubicin as Frontline Therapy for Advanced Epithelioid Sarcoma
- Sponsor: Epizyme, Inc.
- “The participants of this study will have advanced epithelioid sarcoma. Sarcoma is a cancer of the connective tissues, such as nerves, muscles and bones. Epithelioid sarcoma is an ultra-rare sarcoma of the soft-tissue.
- Part 1 of this trial will evaluate the safety and the level of the study drug that the study drug combinations can be tolerated (known as tolerability). It is also designed to establish a recommended study drug dosage for the next part of the study.
- Part 2 will evaluate and compare for each of the study drug combinations how long participants live without their disease getting worse.
- The study drug is called tazemetostat. The study will test tazemetostat in combination with doxorubicin compared to placebo (dummy treatment) in combination with doxorubicin. Doxorubicin is a current front line treatment for epithelioid sarcoma”
- Interventions: DRUG: Tazemetostat|DRUG: Doxorubicin HCl|DRUG: Tazemetostat|DRUG: Placebo|DRUG: Doxorubicin HCl
- Primary Outcomes Measures: Dose Limiting Toxicities (DLTs), Determined by Adverse Events (AEs) and clinical laboratory tests., 1 Cycle/21 days|Progression free survival (PFS), Phase 3: Assessed by Independent Review Committee., Through study completion, an average of two years.
Phase 3 Study to Treat Patients With Soft Tissue Sarcomas
- Sponsor: ImmunityBio, Inc.
- The purpose of this study is to determine the efficacy and safety of aldoxorubicin in subjects with metastatic, locally advanced, or unresectable soft tissue sarcomas.
- Interventions: DRUG: Aldoxorubicin|DRUG: Investigator’s Choice Treatment (Darcabazine, Pazopanib, Gemcitabine + Docetaxel, Doxorubicin, Ifosfamide)
- Primary Outcomes Measures: “Progression-Free Survival (PFS), PFS is defined as the time from the date of randomization to first documentation of objective tumor progression, according to RECIST 1.1 Criteria, or to death due to any cause in the absence of previous documentation of objective tumor progression. For subjects without documentation of objective tumor progression, who started other anti-tumor treatment, or lost to follow up/withdrew consent prior to confirmed progression, PFS is censored at the date of the last tumor assessment. PFS is defined as the interval from the date of randomization to the earliest date of documented evidence of recurrent or progressive disease, or the date of death due to any cause, whichever occurs first. PD is defined as: 20% increase in the sum of the longest diameter of target lesions from the smallest sum of the longest diameter recorded since the treatment started; the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 new lesion is also considered PD., 24 months”
Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
- Sponsor: National Cancer Institute (NCI)
- This phase II trial compares the effect of immunotherapy (pembrolizumab) plus chemotherapy (doxorubicin) to chemotherapy (doxorubicin) alone in treating patients with undifferentiated pleomorphic sarcoma (UPS) or a related poorly differentiated sarcoma that has spread from where it first started to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell’s DNA and may kill tumor cells. It also blocks a certain enzyme needed for cell division and DNA repair. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding immunotherapy (pembrolizumab) to the standard chemotherapy (doxorubicin) may help patients with metastatic or unresectable UPS or a related poorly differentiated sarcoma live longer without having disease progression.
- Interventions: PROCEDURE: Biospecimen Collection|PROCEDURE: Diagnostic Imaging|DRUG: Doxorubicin|PROCEDURE: Echocardiography|PROCEDURE: Multigated Acquisition Scan|BIOLOGICAL: Pembrolizumab
- Primary Outcomes Measures: Progression free survival (PFS), Will be compared between the treatment arms (doxorubicin + pembrolizumab versus \[vs\] doxorubicin alone). The comparison of PFS between treatment arms will be done using a stratified (on Eastern Cooperative Oncology group performance status \[0 vs 1\]) log-rank test with a 5% type I error (1-sided)., From randomization to documented progression (per Response Evaluation Criteria in Solid Tumors version 1.1) or death from any cause without prior progression, up to 5 years.
Radiation Therapy With or Without Combination Chemotherapy or Pazopanib Before Surgery in Treating Patients With Newly Diagnosed Non-rhabdomyosarcoma Soft Tissue Sarcomas That Can Be Removed by Surgery
- Sponsor: National Cancer Institute (NCI)
- This randomized phase II/III trial studies how well pazopanib, when combined with chemotherapy and radiation therapy or radiation therapy alone, work in the treatment of patients with newly diagnosed non-rhabdomyosarcoma soft tissue sarcomas that can eventually be removed by surgery. Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as ifosfamide and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Pazopanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether these therapies can be safely combined and if they work better when given together in treating patients with non-rhabdomyosarcoma soft tissue sarcomas.
- Interventions: DRUG: Doxorubicin|DRUG: Doxorubicin Hydrochloride|DRUG: Ifosfamide|DRUG: Pazopanib|DRUG: Pazopanib Hydrochloride|RADIATION: Radiation Therapy|PROCEDURE: Therapeutic Conventional Surgery
- Primary Outcomes Measures: Feasible Dose: Pediatric, The dose of pazopanib that is feasible when given in combination with radiation or chemoradiation in pediatric unresected intermediate- and high-risk NRSTS patients. Initially, up to 10 patients (minimum of 3 patients ≥ 2 and \< 18 years of age and 3 patients ≥ 18 years of age) eligible for each of the two study cohorts were non-randomly assigned (to generate 8 patients evaluable for toxicity) to receive treatment with pazopanib at dose level 1. A protocol-defined list of pazopanib-associated adverse events were defined as dose-limiting toxicities. The pazopanib dose determined to be feasible was based on the number of patient-reported dose-limiting toxicities encountered., After the first 6 weeks of Induction|Feasible Dose: Adult, The dose of pazopanib that is feasible when given in combination with radiation or chemoradiation in adult unresected intermediate- and high-risk NRSTS patients. Initially, up to 10 patients (minimum of 3 patients ≥ 2 and \< 18 years of age and 3 patients ≥ 18 years of age) eligible for each of the two study cohorts were non-randomly assigned (to generate 8 patients evaluable for toxicity) to receive treatment with pazopanib at dose level 1. A protocol-defined list of pazopanib-associated adverse events were defined as dose-limiting toxicities. The pazopanib dose determined to be feasible was based on the number of patient-reported dose-limiting toxicities encountered., After the first 6 weeks of Induction|Percentage of Chemoradiotherapy Patients With Positive Pathologic Response at Week 13, A responder is defined by more than (90% tumor necrosis at week 13). A non-responder has less than 90% necrosis or progressive disease before week 13., Week 13 after induction|Percentage of Radiotherapy Patients With Positive Pathologic Response at Week 10, A responder is defined by more than 90% tumor necrosis at week 10. A non-responder has less than 90% necrosis or progressive disease before week 10., Week 10 after induction|Percentage of Radiotherapy Patients Failure Free at 5 Years Following Study Entry, Time to the first occurrence of relapse, progression, secondary cancer or death from any cause., From enrollment to up to 60 months.
Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcomaa
- Sponsor: European Organisation for Research and Treatment of Cancer – EORTC
- “This is a multicenter, randomized, open label phase lll trial to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of high risk DDLPS (dedifferentiated Liposarcoma) and LMS (Leiomyosarcoma) patients as measured by disease free survival.
- After confirmation of eligibility criteria, patients will be randomized to either the standard arm or experimental arm.”
- Interventions: PROCEDURE: Surgery|DRUG: Preoperative chemotherapy
- Primary Outcomes Measures: Disease free survival, Disease free survival will be measured from the date of randomization (as reference) to the date of recurrence or death, whichever occurs first.
Potential Guideline That May Be Affected Includes:
- Soft Tissue Sarcoma
- National Comprehensive Cancer Network (NCCN)
- Published: July 2022
- Radiation Therapy for Treatment of Soft Tissue Sarcoma in Adults
- American Society for Radiation Oncology (ASTRO)
- Publication: July 2021
There you have it – a list of Clinical Trials for Soft Tissue Sarcoma as of July 2024. Stay tuned, for our next Guidelines+ Trials Rundown. Sign up for alerts and stay informed on the latest published guidelines and articles.