NCT06116578

Study Evaluating Pembrolizumab +/- Olaparib in TLS Positive Selected Resectable STS Followed by Adjuvant Pembrolizumab

A Window of Opportunity (WoO) Study Evaluating Pembrolizumab With or Without Olaparib in Tertiary Lymphoid Structures (TLS)-Positive Selected Resectable Soft Tissue Sarcoma (STS) Followed by Adjuvant Pembrolizumab

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. Trial population :Adult patients with suspected / diagnosed soft tissue sarcoma of the extremities or trunk (Cohort 1: Undifferentiated pleomorphic sarcoma / Cohort 2: Dedifferentiated liposarcoma) 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.

Detailed 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).

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab	cf Arm A
DRUG	Pembrolizumab and Olaparib	cf Arm B
DRUG	Pembrolizumab adjuvant	After surgery (adjuvant phase), all patients (Arm A and B) will receive pembrolizumab 200 mg two intravenous (IV) infusions q3w for one-year

Timeline

• Start date: 2025-01-01
• Primary completion: 2027-07-01
• Completion: 2029-06-01
• First posted: 2023-11-03
• Last updated: 2025-12-01

Locations

1 site across 1 country: France