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Clinical Trial Summary

Soft tissue sarcomas represent a subtype of cancer that is both rare and very heterogeneous. When they are organized, their current treatment is essentially based on tumor resection surgery, +/- associated with treatment by chemotherapy and/or radiotherapy. The aim of this treatment is to reduce the risk of local recurrence (appearance of a tumor in the same region where it was first detected) and/or distant (appearance of a tumor in other regions, organs where it was first detected). Currently, no immunotherapy treatment has been approved for the treatment of patients with sarcoma. This research is based on the hypothesis that soft tissue sarcomas in which "tertiary lymphoid structures" or "TLS" are found, recognizable by a cluster of specific immune cells within the tumor, would be likely to respond better to the immunotherapy. Furthermore, the combination of immunotherapy and certain drugs targeting DNA repair has demonstrated some effectiveness in other types of cancers. The research will therefore focus on two experimental drugs : - Pembrolizumab (immunotherapy) and - Olaparib (DNA repair inhibitor). This research will make it possible to evaluate the effectiveness and safety of use of the two drugs.

Clinical Trial Description

This study will allow: - To evaluate the ability of pembrolizumab (with or without olaparib) before surgery to trigger an immune reaction in order to kill tumor cells. - To evaluate the feasibility of therapy with pembrolizumab for 1 year (with or without radiotherapy) after surgery. The research is divided into two groups of patients, called "cohorts" depending on the type of soft tissue sarcoma you have: - Cohort 1: Undifferentiated pleomorphic sarcoma - Cohort 2: Dedifferentiated liposarcoma Before surgery, a group of patients will receive pembrolizumab combined with olaparib, a second group will receive only pembrolizumab. All patients will receive pembrolizumab after surgery (for up to 1 year). ;

Study Design

Related Conditions & MeSH terms

NCT number NCT06116578
Study type Interventional
Source Gustave Roussy, Cancer Campus, Grand Paris
Contact Sophie Postel-Vinay, MD.
Phone +33 (0)1 42 11 42 11
Status Not yet recruiting
Phase Phase 2
Start date September 2024
Completion date June 2028

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