Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06128863
Other study ID # EFTISARC-NEO/NIO-0004
Secondary ID 2022-003845-36
Status Recruiting
Phase Phase 2
First received
Last updated
Start date July 17, 2023
Est. completion date April 30, 2027

Study information

Verified date October 2023
Source Maria Sklodowska-Curie National Research Institute of Oncology
Contact Katarzyna Kozak
Phone +48225462051
Email katarzyna.kozak@nio.gov.pl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a phase II single-arm single-stage study evaluating efficacy and safety of pembrolizumab in combination with a soluble LAG-3 protein, eftilagimod alpha (Efti) and radiotherapy in neoadjuvant treatment of patients with soft tissue sarcomas. This study will determine the pathologic response rate (defined as percentage of tumor hyalinization/fibrosis) to the combination treatment.


Description:

Systemic therapy with pembrolizumab and eftilagimod alpha and radiotherapy are administered concurrently. Systemic treatment lasts for 9 weeks (study week 1-9). Radiation therapy lasts for 5 weeks (5 days per week) in weeks 2-6. Surgery takes place 5-6 weeks after completion of radiation therapy (week 11-12). Any adjuvant treatment (chemotherapy, immunotherapy, radiation therapy) after surgical treatment is not allowed. Patients will be then followed up regularly for a period of 24 months.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date April 30, 2027
Est. primary completion date April 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Primary or locally recurrent deep-seated extremities, girdles and/or superficial trunk (thoracic or abdominal wall) tumor; - One of the following histologies as defined in the World Health Organization (WHO) Classification of Soft Tissue Tumors: 1. undifferentiated pleomorphic sarcoma (UPS), 2. myxofibrosarcoma, 3. dedifferentiated liposarcoma (DDLPS), 4. myxoid and round cell liposarcoma (MRCLPS), 5. epithelioid sarcoma (ES), 6. angiosarcoma (AS) 7. soft tissue sarcoma not otherwise specified (NOS). - Grade 2 or 3 tumors according to Fédération Nationale des Centres de Lutte contre le Cancer (FNCLCC); - Size of the primary tumor >5 cm at instrumental staging (CT, MRI), or locally recurrent of any size; - Measurable disease based on RECIST 1.1; - Non-metastatic disease; Exclusion Criteria: - Previous treatment with eftilagimod alpha, anti-PD-1 or anti-PD-L1; - Prior radiotherapy to tumor-involved sites;

Study Design


Intervention

Drug:
Pembrolizumab, Eftilagimod alpha
Eftilagimod alpha 20 mg s.c. every 2 weeks (5 doses), Pembrolizumab 200 mg i.v. every 3 weeks (3 cycles), Radiotherapy 50 Gy (25 x 2 Gy)

Locations

Country Name City State
Poland Maria Sklodowska-Curie National Research Institute of Oncology Warsaw

Sponsors (2)

Lead Sponsor Collaborator
Maria Sklodowska-Curie National Research Institute of Oncology Immutep S.A.S.

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pathologic response The primary efficacy endpoint is a percent tumor hyalinization as a marker of response to treatment assessed at the time of surgical resection. At the time of definitive surgical treatment
Secondary Number of Participants Experiencing Adverse Events (AEs) Safety analyses will include all patients who received at least one dose of study drug. Safety will be assessed through summaries of adverse events, changes in laboratory test results, changes in vital signs.
Verbatim description of adverse events will be summarized and graded according to International Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. In addition, serious adverse events, severe adverse events (Grades 3, 4, and 5), and adverse events leading to study drug discontinuation or interruption will be summarized accordingly.
All adverse events will be documented from the enrolment of the first patient until 100 days after the surgical treatment of the last patient (2 years).
Secondary Number of participants completing neoadjuvant therapy Number of patients completing neoadjuvant treatment and having a curative surgery according to the protocol 2 years
Secondary Disease-free survival (DFS) Disease-free survival (DFS) is defined as the time from between the date of curative surgery and the date of disease recurrence defined as clinically diagnosed or biopsy-confirmed recurrent sarcoma at a site of the primary tumor, development of nodal metastasis, locoregional recurrence or distant metastases confirmed by imaging or clinical examination, or death without documented recurrence From the date of curative surgery to the date of first recurrence or death (whatever the cause), whichever occurs first
Secondary Local recurrence-free survival (LRFS) Local recurrence-free survival (LRFS) is defined as the time between the date of curative surgery and the date of local recurrence confirmed by imaging or clinical examination. Patients still alive and without signs of disease recurrence at the analysis cut-off date are censored at the last date known to be alive. From the date of curative surgery to the date of first local recurrence or date of death (whatever the cause), whichever occurs first
Secondary Distant metastasis-free survival (DMFS) Distant metastasis-free survival (DMFS) is defined as the time between the date of curative surgery to the date of diagnosis of distant metastases confirmed by imaging or clinical examination. Patients still alive and without signs of distant metastases at the analysis cut-off date are censored at the last date known to be alive. From the date of curative surgery to the date of first distant metastasis or date of death (whatever the cause), whichever occurs first
Secondary Overall survival (OS) Overall survival (OS) is defined as the time between the date of curative surgery and the date of death from any cause. For those without documentation of death, OS will be censored on the last date the participant was known to be alive. From the date of curative surgery up to the date of death or the last date the participant was known to be alive
Secondary Response rate Radiologic Response To Neoadjuvant Treatment using RECIST 1.1 From the date of the first dose of treatment to the date of curative surgery
See also
  Status Clinical Trial Phase
Recruiting NCT05848011 - A Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer Phase 2
Recruiting NCT05161572 - Perioperative Chemoimmunotherapy With/Without Preoperative Chemoradiation for Locally Advanced Gastric Cancer Phase 2
Recruiting NCT06165900 - Stereotactic Radiotherapy Combined With Adebrelimab and TCb (Nab-paclitaxel + Carboplatin) in Neoadjuvant Treatment of TNBC Phase 2
Recruiting NCT06120127 - Postoperative Chemotherapy With/Without Radiotherapy and Immunotherapy for Colorectal Liver Metastases With High Risk of Locally Recurrence Phase 2
Recruiting NCT06262581 - Neoadjuvant Tisleizumab(BGB-A317) for dMMR/MSI-H Non-late Stage CRC Patients Before Surgery Phase 2
Recruiting NCT05176002 - Camrelizumab in Combination With Radiotherapy for Neoadjuvant Esophageal Carcinoma. Phase 1/Phase 2
Not yet recruiting NCT05909137 - Omitting Clinical Target Volume in Radical Treatment of Unresectable Stage III Non-small Cell Lung Cancer
Recruiting NCT04500990 - MRI DWI None-Gaussian Model Predicting Early Response to Immunotherapy in Digestive System Malignancies: a Prospective Observational Study
Not yet recruiting NCT04372732 - Serum Autoantibodies in Predicting the Efficacy of Anti-PD-1 Treatment in Patients With Advanced NSCLC
Completed NCT02692976 - Natural Dendritic Cells for Immunotherapy of Chemo-naive Metastatic Castration-resistant Prostate Cancer Patients Phase 2
Completed NCT03763630 - MAPS & ITEC Cohorts: 6-8 Years Follow-up Phase 2
Not yet recruiting NCT06012318 - Dynamic Follow-up of Symptoms Based on Patient-reported Outcomes in Immunotherapy for Esophageal Cancer: a Prospective Multicentre Cohort Study (SPRING)
Not yet recruiting NCT05479240 - Neoadjuvant Chemoradiotherapy Combined With Tislelizumab in the Treatment of Locally Advanced Rectal Cancer Phase 2
Recruiting NCT05515796 - Multi-omics Sequencing in Neoadjuvant Immunotherapy of Gastrointestinal Tumors Phase 2
Recruiting NCT04711330 - Response and Toxicity Prediction by Microbiome Analysis After Concurrent Chemoradiotherapy
Recruiting NCT03701607 - Effect of Chemotherapy on PD-L1 in NSCLC
Recruiting NCT03683407 - Effect of Chemotherapy on TMB in NSCLC
Completed NCT03357861 - Cancer Patients Treated With Immunotherapy in Intensive Care Unit
Recruiting NCT05223088 - Tislelizumab Combined With Apatinib and Oxaliplatin Plus S1 as Neoadjuvant Therapy for Borrmann IV、Large Borrmann III Type and Bulky N Positive Advanced Gastric Cancer Phase 2
Completed NCT05657262 - Effect of Z Technıque on Pain, Comfort, Symptoms in Ummunotherapy Areas N/A