Cancer Clinical Trial - Study Evaluating Pembrolizumab +/- Olaparib in TLS

Status Not yet recruiting

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

Cancer

Clinical Trial Details

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
Email	Sophie.postel-vinay@gustaveroussy.fr
Status	Not yet recruiting
Phase	Phase 2
Start date	September 2024
Completion date	June 2028

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms