Phase II study evaluating the efficacy and safety of preoperative immunotherapy (pembrolizumab with eftilagimod alfa) in combination with radiotherapy in patients with operable soft tissue sarcomas.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

17 Jul 2023 → ongoing

Decision date (initial)

2024-10-30

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Agencja Badań Medycznych

External identifiers

EU CT number

2024-515971-37-00

EudraCT number

2022-003845-36

ClinicalTrials.gov

NCT06128863

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

Evaluation of the efficacy of pembrolizumab and eftilagimod alfa in combination with preoperative radiotherapy in patients with resectable soft tissue sarcomas by analyzing the pathological response in the postoperative material.

Secondary objectives 5

1. Assessment of the pathological response according to EORTC-STBSG criteria
2. Assessment of radiological response according to RECIST 1.1 criteria
3. Assessment of disease-free survival (DFS), local relapse-free survival (LRFS) and distant metastasis free survival (DMFS) and overall survival (OS)
4. Evaluation of the safety of the combination of pembrolizumab with eftilagimod alfa
5. Assessment of patients' quality of life (EORTC QLQ-C30 scale and FACT G)

Conditions and MedDRA coding

Resectable soft tissue sarcomas

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Willing and able to provide written informed consent for the trial.
2. Be ≥ 18 years of age on day of signing informed consent.
3. Performance status of 0 to 1 on the ECOG Performance Scale.
4. Primary or locally recurrent deep-seated extremities, girdles and/or superficial trunk (thoracic or abdominal wall) soft tissue sarcoma
5. Size of the primary tumor >5 cm at instrumental staging (CT, MRI), or locally recurrent of any size
6. Measurable disease based on RECIST 1.1
7. Non-metastatic disease.
8. No previous systemic treatment for sarcoma.
9. Grade 2 or 3 tumors according FNCLCC.

Exclusion criteria 5

1. Ewing sarcoma, Alveolar and embryonal rhabdomyoarcoma
2. Previous treatment with eftilagimod alpha, anty-PD-1 or ant-PD-L1.
3. Prior radiotherapy to tumor-involved sites.
4. Subjects with active, known or suspected autoimmune disease or inflammatory bowel disease, which, in the opinion of the investigator, might impair the subject's tolerance of trial treatment. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring replacement therapy, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
5. A concomitant disease that, in the opinion of the investigator, poses an unacceptable risk to the patient if he or she participates in the study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The pathological response, defined as percentage of fibrosis and hyalinization found in the surgical specimen after completion of preoperative treatment.

Secondary endpoints 8

1. Treatment safety profile
2. Number of patients completing neoadjuvant treatment and having a curative surgery according to the protocol.
3. Disease-free survival time (DFS)
4. Local recurrence-free survival (LRFS)
5. Distant metastasis-free survival (DMFS)
6. Overall survival (OS)
7. Overall response rate (ORR) by RECIST 1.1 criteria
8. Exploratory endpoints include the search for biomarkers and correlations between their occurrence and response to treatment

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Sponsor organisation

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Address

Ul. Wilhelma Konrada Roentgena 5

City

Warsaw

Postcode

02-781

Country

Poland

Scientific contact point

Organisation

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Contact name

Katarzyna Kozak

Public contact point

Organisation

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Contact name

Katarzyna Kozak

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications