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Studio di fase 2 di Pembrolizumab in pazienti con osteosarcoma in ricaduta o metastatici non suscettibile di trattamento chirurgico con intento curativo - PROMO

Studio Clinico

Patologia: Sarcomi dei tessuti molli e gist

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Monocentrico

Randomizzato: No

Fase di studio: II

Richiesta mandatoria di tessuto: 

Linee di trattamento: Seconda linea, Terza/N linea

Criteri di inclusione: 

1. Histologically confirmed osteosarcoma.
2. Disease relapse or progression after at least one line of systemic treatment.
    a. First-line systemic treatment should include cytotoxic chemotherapy according to local practice.
    b. The patient can be eligible if he/she is considered medically unfit for chemotherapy, as assessed by the sarcoma centre in charge of the patient’s treatment.
3. Surgical resection with curative intent not possible.
4. Be willing and able to provide written informed consent/assent for the trial.
5. Be ≥ 18 years of age on day of signing informed consent.
6. Have measurable disease based on RECIST, version 1.1.
7. Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen.
8. Have a performance status of 0 or 1 on the ECOG Performance Scale.
9. Demonstrate adequate organ function
10. Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
11. Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication (Reference Section 5.7.2). Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
12. Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.

Criteri di esclusione: 

1. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
2. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
3. Has a known history of active TB (Bacillus Tuberculosis)
4. Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
5. Hypersensitivity to pembrolizumab or any of its excipients.
6. Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
7. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
    - Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
    - Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
8. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
9. Has known active central nervous system (CNS) metastases and/or sarcomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include sarcomatous meningitis which is excluded regardless of clinical stability.
10. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
11. Has known history of, or any evidence of active, non-infectious pneumonitis.
12. Has an active infection requiring systemic therapy.
13. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator.
14. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
15. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
16. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
17. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
18. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
19. Has received a live vaccine within 30 days of planned start of study therapy.

Numero di pazienti previsti: 

25

Schema di trattamento: 

200 mg EV ogni 3 settimane

Trattamento sperimentale: 

Pembrolizumab

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

Valutare la percentuale di pazienti che raggiunge risposta clinica a settimana 18, valutata secondo criteri RECIST 1.1

Obiettivi secondari dello studio: 

• Overall response rate (ORR), Beneficio Clinico (CBR), durata della risposta e PFS
• Valutare la percentuale di pazienti che raggiugne la risposta valutata con 18F-FDG PET/CT misurata in termini di cambiamenti di SUVmax, MTV e/o TLG.
• Valutare la sopravvivenza globale
• Valutare la sicurezza e tollerabilità di pembrolizumab in pazienti con osteosarcoma
• Valutare gli effetti del trattamento in termini di qualità della vita

Note generali: 

Data di inizio arruolamento: Gennaio 2017
Data di fine arruolamento: Agosto 2019

Periodo previsto di arruolamento: 18 mesi

Centri partecipanti

Nord Italia

Istituto Ortopedico Rizzoli
Via Pupilli 1 - 40136 Bologna - BO
SSD Chemioterapia dei Tumori dell'apparato Locomotore

Riferimento: Dr.ssa Emanuela Palmerini
Telefono: 0516366199
Email: emanuela.palmerini@ior.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2016-001676-29

Data di inserimento: 12.12.2018

Promotore

CRO

NA

Principal Investigator ITALIA

Istituto Ortopedico Rizzoli, Bologna

Riferimento: Dr.ssa Emanuela Palmerini

Telefono: 0516366199

Email: emanuela.palmerini@ior.it

Localita: Bologna

Principal Investigator INTERNAZIONALE

University of Oslo - Department of Oncology Norwegian Radium Hospital

Riferimento: Dr. Kjetil Boye

Telefono: 004722781852

Email: kjetil.boye@rr-research.no

Localita: Oslo

Nazione: NO

 

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