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

Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Study ID
NCT06116578
Phase
PHASE2
Status
Withdrawn

Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 1, 2025
Status verified
Nov 2025
Primary completion
Jul 31, 2027
Completion
Jun 30, 2029

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: A: Pembrolizumab before surgery
    Before surgery: Pembrolizumab 200 mg two intravenous (IV) infusions q3w (2 injections: at C1D1 and C1D21)
  • Active Comparator: B: Pembrolizumab + olaparib before surgery
    Before surgery: Pembrolizumab 200 mg two IV infusions q3w (2 injections: at C1D1 and C1D21) + concomitant full dose olaparib (300 mg per os b.i.d) during four weeks

Primary Outcome Measure

Rate of CD8+ T-cell tumor infiltration density at surgery compare to baseline [ Time Frame: 1 year after the end of inclusions ]

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