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CancerPhase 2NeoSarcNCT06116578

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

A Phase 2 study testing Pembrolizumab, Pembrolizumab and Olaparib and Pembrolizumab adjuvant in people with Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
Pembrolizumab, Pembrolizumab and Olaparib and Pembrolizumab adjuvant
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteFrance
Study dates
1 Jan 2025to Jun 2029
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients aged ≥ 18 years at time of informed consent signature
  • Histologically confirmed diagnosis of high grade (FNCLCC grade 2 or 3) extremity, retroperitoneal, or trunk wall STS of selected histotypes as defined below. Diagnosis must be stated in a pathology report and confirmed by the physician investigator:
  • Cohort 1: Undifferentiated Pleomorphic Sarcoma (UPS) Cohort 2: Dedifferentiated Liposarcoma (ddLPS)
  • R0 resectability at time of enrollment according to expert STS surgeon
  • Absence of distant metastasis on screening CT-scan (or equivalent appropriate imaging technique)
  • Patients with local relapse after an initial surgical resection can be enrolled if no perioperative chemotherapy or radiation has been previously performed Identification of Tertiary Lymphoid Structures (TLSs) on tumor archival FFPE sample, as assessed by a registered STS expert senior pathologist
Show all 21Show fewer
  • Primary tumor site measurable according to RECIST v1.1 as ≥10 mm in the longest diameter (except lymph nodes which must have short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and suitable for repeated assessment.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no deterioration from registration date
  • Adequate hematologic and organ function, defined by the following laboratory results obtained within 3 days prior to the first study treatment (Cycle 0 Day 1): Absolute neutrophil count (ANC) ≥ 1500 cells/μL, Platelet count ≥ 100.000/μL, Hemoglobin ≥ 10 g/dL, Total bilirubin ≤ 1.5 ULN (subjects with documented/suspected Gilbert's disease may be enrolled with bilirubin ≤ 3 × ULN), Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x upper normal limit (ULN), Albumin ≥ 28g/L, Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 30 mL/min (according to Cockcroft and Gault formula), International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN. This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation (such as low-molecular weight heparin or warfarin) should be on stable dose.
  • Hepatitis B and C, and HIV screening tests are not required unless
  • Known history of HBV, HCV or HIV infection
  • As mandated by local health authority
  • A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
  • Not a woman of childbearing potential (WOCBP) OR
  • A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for 120 to 180 days (corresponding to time needed to eliminate any study treatment(s) plus the duration of a menstruation cycle: 120 days for pembrolizumab and/or 180 days for olaparib) after the last dose of study treatment.
  • Male participants:
  • A male participant must agree to use a contraception - Contraceptive Guidance and Pregnancy Testing of this protocol during the treatment period and for at least 180 to 240 days, corresponding to time needed to eliminate any study treatment(s) plus the duration of a spermatogenesis cycle: 180 for pembrolizumab and/or 240 days for olaparib) after the last dose of study treatment and refrain from donating sperm during this period.
  • Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment.
  • Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed.
  • Patient should be able and willing to comply with baseline mandatory biopsy, as well as study visits and procedures as per protocol.
  • Patients must be affiliated to a social security system or beneficiary of an equivalent system.

Who cannot join

  • Has a visceral STS primary site.
  • Has a non-resectable or marginally resectable locally advanced STS, as assessed by expert STS surgeon.
  • Has evidence of metastatic disease on CT-scan (or equivalent imaging technique).
  • Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to randomization.
  • Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids.
  • Has had previous exposure to anti-PD-1, anti-PD-L1, anti-PD-L2 agent or with an agent directed to another stimulatory or co inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).
Show all 28Show fewer
  • Had had previous exposure to olaparib or any other PARP inhibitor.
  • Has received a live vaccine or live-attenuated vaccine received within 4 weeks prior to Cycle 0 Day 1 or anticipation that such a live attenuated vaccine will be required during the study. Administration of killed vaccines is allowed.
  • Has received treatment with systemic immunostimulatory agents (e.g., IFN and IL-2) within 4 weeks prior to Cycle 0 Day 1.
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
  • Has had an administration of colony stimulating factors (e.g., granulocyte colony-stimulating factor, granulocyte macrophage colony stimulating factor, or recombinant erythropoietin) within 4 weeks prior to Cycle 0 Day 1.
  • A WOCBP who has a positive urine pregnancy test within 72 hours prior to randomization (see Appendix 3 - Contraceptive Guidance and Pregnancy Testing). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.
  • Has a history of severe allergic, anaphylactic, or other hypersensitivity reactions to the components of excipients in pembrolizumab and/or olaparib.
  • Has any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) or immunodeficiency
  • Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (e.g.., thyroxine, insulin, or physiologic corticosteroid)
  • Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  • Has a history of allogeneic tissue/organ or hematopoietic stem cell transplantation.
  • Has a history of another primary malignancy within 2 years prior to Cycle 0 Day 1
  • Has a serious, uncontrolled medical disorder
  • Is unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (e.g., gastrectomy, partial bowel obstruction, and malabsorption).
  • Has concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA), Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection, HIV (defined as detectable viral load)
  • Has any active infection requiring systemic therapy.
  • Major surgical procedure within 20 days prior ty Cycle 0 Day 1 or anticipation of need for a major surgical procedure during the course of the study.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Participant is currently receiving either strong (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate (e.g., ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil) inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration of the study. The required washout period prior to starting olaparib is 2 weeks. The medication can be restarted as soon as olaparib has been halted.
  • Participant is currently receiving either strong (phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate (e.g., bosentan, efavirenz, modafinil) inducers of CYP3A4 that cannot be discontinued for the duration of the study. The required washout period prior to starting olaparib is 5 weeks for phenobarbital and 3 weeks for other agents. The medication can be restarted as soon as olaparib has been halted.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Gustave Roussy

    Villejuif, Val De Marne, 94800

Other trials in France

About this study

Official title: 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

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.

Read more

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.

Read the 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
Being tested
Pembrolizumab, Pembrolizumab and Olaparib, Pembrolizumab adjuvant
Keywords
sarcoma, TLS, Liposarcoma, immunotherapy, PARP
Medical subject headings
Neoplasms, Sarcoma, Liposarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabDrug

    Also called WOO (Windows of opportunity)

    cf Arm A

  • Pembrolizumab and OlaparibDrug

    Also called WOO (Windows of opportunity)

    cf Arm B

  • Pembrolizumab adjuvantDrug

    Also called Adjuvant

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

Study groups in NCT06116578
Study groupRoleWhat they receive
A: Pembrolizumab before surgeryActive comparatorBefore surgery: Pembrolizumab 200 mg two intravenous (IV) infusions q3w (2 injections: at C1D1 and C1D21)
Receives: Drug: Pembrolizumab; Drug: Pembrolizumab adjuvant
B: Pembrolizumab + olaparib before surgeryActive comparatorBefore 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
Receives: Drug: Pembrolizumab and Olaparib; Drug: Pembrolizumab adjuvant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of CD8+ T-cell tumor infiltration density at surgery compare to baseline

    50% increase in CD8+ T-cell tumor infiltration density between baseline biopsy and resection surgery specimen as defined by expert pathologist who will be blinded for treatment arm and patient outcome

    Measured: 1 year after the end of inclusions

Secondary outcomes (10)

  1. Proportion of patients with 70% pathological response

    Proportion of patients with 70% pathological response on the resection surgery specimen as assessed by expert pathologist after WoO treatment

    Measured: Through study completion, an average of 1 year

  2. Surgery evaluation: Quality of resection as defined by Hemanek and Wittekind (R0 the best / R1 / R2 the worst)

    Quality of resection is defined at time of resection surgery as follows, as initially defined by Hemanek and Wittekind according to both clinical and pathological findings: R0 corresponds to resection for cure or complete remission. R1 to microscopic residual tumor, R2 to macroscopic residual tumor.

    Measured: Through study completion, an average of 1 year

  3. Surgery evaluation : amputation rate

    Measured: Through study completion, an average of 1 year

  4. Surgery evaluation : Incidence of acute wound complications up to 120 days after surgery

    Measured: 120 days after surgery

  5. Objective Response Rate (ORR)

    Objective Response Rate (ORR) at 4 weeks of WoO treatment defined as the rate of patients with Complete Response (CR) or Partial Response (PR) according to RECIST v1.1

    Measured: At 4 weeks of WoO treatment

  6. Time To Relapse (TTR)

    Measured: From date of randomization until the date of first documented Progression or date of death from any cause, whichever came first, assessed up to 75 months

  7. Local Recurrence Rate (LRR)

    Local Recurrence Rate (LRR) at 2-year post-surgery

    Measured: 2-year post-surgery

  8. Disease Free Survival (DFS) at 2-year post-surgery

    Disease Free Survival (DFS) at 2-year post-surgery

    Measured: 2-year post-surgery

  9. Overall Survival (OS)

    Measured: Through study completion, an average of 1 year

  10. Disease Control Rate (DCR)

    Disease Control Rate (DCR) at 4 weeks of WoO according to RECIST v1.1

    Measured: At 4 weeks of WoO treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2023
  2. Study start1 Jan 2025
  3. Primary completionJul 2027 (estimated)
  4. Study completionJun 2029 (estimated)

Why it stopped: Abandon of the study by the partenair (MSD)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06116578
Sponsor's protocol ID
2024-513469-38-00
Other IDs
2023/3610
Acronym
NeoSarc
Status last verified
Nov 2025
First submitted
18 Oct 2023
Last updated
1 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab, Pembrolizumab and Olaparib and Pembrolizumab adjuvant in people with Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06116578.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.

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