PHASE III STUDY WITH ATEZOLIZUMAB VERSUS PLACEBO IN MALIGNANT PLEURAL MESOTHELIOMA PATIENTS AFTER PLEURECTOMY/DECORTICATION

Who is this study for? Patients with malignant pleural mesothelioma
What treatments are being studied? Atezolizumab
Status: Recruiting
Location: See all (19) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This is a multicentric double-blind, placebo controlled, phase III trial. In this study, patients who underwent to a surgical resection of pleural mesothelioma and are without signs of macroscopic residual disease will be randomized 2:1 to receive atezolizumab or placebo. Patients will be treated for 12 months or until recurrence, unacceptable toxicity or patient/physician decision, whichever occurs first. Randomization will be done via a centralized system and patients will be stratified histology (epithelioid vs non epithelioid) and stage (I vs \>I). Patients will be radiologically evaluated after surgical procedure before starting therapy and then every 12 weeks for 24 months or until disease progression. At screening patients should be without macroscopic residual disease. Quality of life questionnaire will be administered to patient at baseline and every 12 weeks. During the study baseline tumor blocks will be centrally analyzed to determinate biological characteristics and gene expression.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Signed informed Consent Form

• Age ≥ 18 years on day of signing informed consent

• Histologically confirmed malignant pleural mesothelioma

• Surgical resection (P/D), without macroscopic residual. For stage I patient without visceral involvement a total pleurectomy is allowed

• Absence of measurable or non-measurable disease assessed with CT scan after surgery

• Patients must have received at least no 4 cycles of platinum/pemetrexed

• perioperative chemotherapy as per local practice (neoadjuvant or adjuvant or both). Less than 4 cycles of chemotherapy are allowed for clinical decisions

• \- In patients previously treated with neoadjuvant chemotherapy, randomization

• should occur within 50 days from surgical resection.

• \- In patients treated with adjuvant chemotherapy, randomization should occur

• within 30 ±7 days from last dose of adjuvant treatment.

• Performance status of 0-1 on the ECOG Performance Scale

• Availability of a representative tumor specimen for exploratory biomarker research (see Section 4.5.6 for information on tumor specimens) A formalin-fixed paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or at least 10 slides containing unstained, freshly cut, serial sections must be submitted along with an associated pathology report prior to study enrollment.

• Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment: ANC ³ 1.5 ´ 109/L (1500/mL) without granulocyte colony-stimulating factor support Lymphocyte count ³ 0.5 ´ 109/L (500/mL) Platelet count ³ 100 ´ 109/L (100,000/mL) without transfusion Hemoglobin 9 g/dL Patients may be transfused to meet this criterion. AST, ALT, and alkaline phosphatase (ALP) £ 2.5 ´ upper limit of normal (ULN)

⁃ Bilirubin £ 1.5 ´ ULN with the following exception:

⁃ Patients with known Gilbert disease: bilirubin level £ 3 ´ ULN. Creatinine £ 1.5 ´ ULN Albumin ³ 25 g/L (2.5 g/dL) For patients not receiving therapeutic anticoagulation: INR or aPTT £ 1.5 ´ ULN

⁃ • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, as defined below: Women must remain abstinent or use contraceptive methods with a failure rate of \< 1% per year during the treatment period and for 5 months after the final dose of atezolizumab. Women must refrain from donating eggs during this same period.

⁃ A woman is considered to be of childbearing potential if she is postmenarcheal, hasnot reached a postmenopausal state (³12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). Examples of contraceptive methods with a failure rate of \<1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.

⁃ The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) andn withdrawal are not acceptable methods of contraception. If required per local guidelines or regulations, locally recognized acceptable methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form.

⁃ Women with a positive pregnancy test at enrollment or prior to administration of study medication will be excluded.

Locations
Other Locations
Italy
Ospedaliera SS Antonio e Biagio e Cesare Arrigo di Alessandria
NOT_YET_RECRUITING
Alessandria
Istituto Tumori Bari
NOT_YET_RECRUITING
Bari
Azienda Ospedaliera Universitaria Policlinico- Vittorio Emanuele Catania
NOT_YET_RECRUITING
Catania
Ospedale Ss Annunziata
NOT_YET_RECRUITING
Chieti
Azienda Ospedaliero Universitaria di Ferrara
NOT_YET_RECRUITING
Ferrara
Villa Scassi
NOT_YET_RECRUITING
Genova
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori - Irccs
NOT_YET_RECRUITING
Meldola
Ospedale Dell'Angelo
NOT_YET_RECRUITING
Mestre
Azienda Ospedaliera Universitaria Di Modena
NOT_YET_RECRUITING
Modena
Aorn Ospedale Dei Colli
RECRUITING
Napoli
A.O.U. San Luigi Gonzaga
NOT_YET_RECRUITING
Orbassano
Istituto Oncologico Veneto
NOT_YET_RECRUITING
Padua
Azienda Ospedaliera Universitaria Di Parma
NOT_YET_RECRUITING
Parma
Policlinico San Matteo
NOT_YET_RECRUITING
Pavia
AUSL/IRCCS di Reggio Emilia
NOT_YET_RECRUITING
Reggio Emilia
IRCCS Regina Elena
RECRUITING
Roma
Humanitas Cancer Center, IRCCS
NOT_YET_RECRUITING
Rozzano
Ospedale S. G. Moscati
NOT_YET_RECRUITING
Taranto
Azientda Sanitaria Universitaria Giuliano Isontina
NOT_YET_RECRUITING
Trieste
Contact Information
Primary
Carmine Pinto, MD
carmine.pinto@ausl.re.it
0522296614
Backup
Erika Gervasi, BS
erika.gervasi@ausl.re.it
0522296858
Time Frame
Start Date: 2021-12-14
Estimated Completion Date: 2029-06-30
Participants
Target number of participants: 162
Treatments
Experimental: Arm A
atezolizumab 1200mg every 21 days
Placebo_comparator: Arm B
Placebo will be supplied by the sponsor and will be identical in appearance to atezolizumab and will comprise the same excipients but without atezolizumab every 21 days
Related Therapeutic Areas
Sponsors
Leads: Gruppo Oncologico Italiano di Ricerca Clinica

This content was sourced from clinicaltrials.gov