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Closed (no longer recruiting)Last updated:10 January 2023

SU2C-SARC032: This Phase II trial is trying to determine whether using immunotherapy and radiotherapy for the treatment of localised, high-risk soft tissue sarcoma is more effective than giving radiotherapy aloneA Phase II Randomized Controlled Trial of Neoadjuvant Pembrolizumab With Radiotherapy and Adjuvant Pembrolizumab in Patients With High-Risk, Localized Soft Tissue Sarcoma of the Extremity

Clinical summary

Summary

Participants will be randomised into an experimental or standard of care arm of the study. In the experimental arm, participants will receive neoadjuvant pembrolizumab with concurrent radiotherapy, followed by surgical resection and adjuvant pembrolizumab. In this study, standard of care will include neoadjuvant radiotherapy followed by surgical resection. This trial is recruiting patients with undifferentiated pleomorphic sarcoma or dedifferentiated/pleomorphic Liposarcoma of the extremity. Patients with non-melanomatous skin cancer, in situ carcinoma, or low-risk prostate cancer will also be considered for enrolment in this study.

Age

People12+

Phase

II

Trial Acronym

SU2C-SARC032

More information

Trial Identifiers

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Commercial Sponsor

Sarcoma Alliance for Research through Collaboration

Scientific Title

A Phase II Randomized Controlled Trial of Neoadjuvant Pembrolizumab With Radiotherapy and Adjuvant Pembrolizumab in Patients With High-Risk, Localized Soft Tissue Sarcoma of the Extremity

Eligibility

Inclusion

  • You have certain types of non-cancer medical conditions.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Exclusion

  • Your cancer has not spread to other parts of the body.
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Clinical trials have complex eligibility criteria.

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