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Safety and Efficacy of TTFields (150 kHz) Concomitant With Pemetrexed and Cisplatin or Carboplatin in Malignant Pleural Mesothelioma (STELLAR) A Phase II Study of PF-03446962 in Patients With Advanced Malignant Pleural Mesothelioma Direct Injection of Poly-ICLC (Hiltonol®) Vaccine In Malignant Pleural Mesothelioma A Phase I/II Study of First Line Vorinostat With Pemetrexed-cisplatin, in Patients With Malignant Pleural Mesothelioma ATREUS – Phase II Study on the Activity of Trabectedin in Patients With Malignant Pleural Mesothelioma (MPM) Accelerated Hypofractionated Radiotherapy in the Treatment of Malignant Pleural Mesothelioma Pembrolizumab + Defactinib In Pleural Mesothelioma Window of Opportunity Study of VS-6063 (Defactinib) in Surgical Resectable Malignant Pleural Mesothelioma Participants A Study of Atezolizumab in Unresectable or Advaced Malignant Pleural Mesothelioma A Clinical Trial of ADI-PEG 20TM in Patients With Malignant Pleural Mesothelioma Study of NGR-hTNF as Single Agent in Patients Affected by Advanced or Metastatic Malignant Pleural Mesothelioma Extrapleural Pneumonectomy /Pleurectomy Decortication, IHOC Cisplatin and Gemcitabine With Amifostine and Sodium Thiosulfate Cytoprotection for Resectable Malignant Pleural Mesothelioma Transarterial Chemoperfusion: Cisplatin, Methotrexate, Gemcitabine for Unresectable Pleural Mesothelioma Study of Carboplatin and Vinorelbine in Malignant Pleural Mesothelioma Vascularity Impact on the Treatment Outcome in Malignant Pleural Mesothelioma(VITMPM) Safety Confirmation Study of Pemetrexed Plus Cisplatin in Patients With Malignant Pleural Mesothelioma Intrapleural Administration of HSV1716 to Treat Patients With Malignant Pleural Mesothelioma. 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Brief Title

Pembrolizumab in Patients With Advanced Malignant Pleural Mesothelioma

Official Title

A Phase II/III Randomized Study of Pembrolizumab in Patients With Advanced Malignant Pleural Mesothelioma

Brief Summary

      Pembrolizumab is a new type of drug for mesothelioma (immunotherapy). Laboratory tests show
      that this drug works by helping improve the body's immune response to help fight cancer.
      Pembrolizumab may help the immune system to recognize cancer cells and slow down the growth
      and/or spreading of cancer.
    

Detailed Description

      The purpose of this study is to find out what effects a new drug, pembrolizumab has on this
      type of cancer and if it can offer better results than standard pemetrexed and platinum-based
      chemotherapy alone. This study will also look at side effects and how the treatments impact
      quality of life
    

Study Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

Phase II: Progression free survival measured as time from randomization to first observation of objective disease relapse or progression

Secondary Outcome

 Number and severity of adverse events

Condition

Mesothelioma

Intervention

Cisplatin

Study Arms / Comparison Groups

 Arm A - Cisplatin/Pemetrexed
Description:  Pemetrexed 500 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin 75 mg/m2 IV Day 1 every 21 days for 6 cycles

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

520

Start Date

October 7, 2016

Completion Date

December 31, 2022

Primary Completion Date

July 31, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must have histologically confirmed malignant pleural mesothelioma. Patients
             must be eligible to receive standard chemotherapy with pemetrexed and cisplatin and
             have no contraindications to standard chemotherapy.

          -  Patients must have unresectable advanced and/or metastatic disease, incurable by
             standard therapies.

          -  All patients must have a cellular tumour block from their primary or metastatic tumour
             available and consent to release the block/recently cut slides for correlative
             analyses (See Section 11.0) and the centre/pathologist must have agreed to the
             submission of the specimen(s).

          -  Presence of radiologically documented disease. At least one site of disease must be
             unidimensionally measurable as follows:

               -  CT scan (with slice thickness of ≤ 5 mm): ≥ 10 mm --> longest diameter

               -  Physical exam (using calipers): ≥ 10 mm

               -  Lymph nodes by CT scan ≥ 15 mm --> measured in short axis

          -  All radiology studies must be performed within 21 days prior to registration
             (exception: within 28 days if negative).

          -  Age ≥ 18 years.

          -  ECOG performance status 0 or 1.

        Previous Therapy

        Cytotoxic Chemotherapy:

          -  Patients must not have received prior chemotherapy for any stage of
             advanced/metastatic disease.

          -  Patients who received previous (neo)adjuvant cisplatin-based systemic chemotherapy
             must have received the last dose of chemotherapy at least 12 months before
             registration. Please contact CCTG PRIOR to randomization for such patients.

        Other Anti-Cancer Therapy:

          -  Patients may not have received targeted small molecule therapy, immunotherapies and
             viral therapies, biologic therapies and angiogenesis inhibitors for
             advanced/metastatic disease, or any prior immunotherapy for any stage of disease.

        Radiation:

          -  Patients may have had prior radiation therapy, but NOT to the thorax unless clear
             disease progression has been demonstrated and confirmed with CCTG. A minimum of 28
             days must have elapsed between the end of radiotherapy and registration onto the
             study. Radiation must have involved < 30% of functioning bone marrow and there must be
             measurable disease outside the previously irradiated area (patients whose sole site of
             disease (for example pleural rind) is in a previously irradiated area are ineligible
             UNLESS there is evidence of progression, or new lesions have been documented, in the
             irradiated field). Please contact CCTG PRIOR to randomization if the patient has
             received prior thoracic radiation. Patients must have recovered from any acute toxic
             effects from radiation prior to registration.

        Previous Surgery:

          -  Previous major surgery is permitted provided that it has been at least 28 days prior
             to patient registration and that wound healing has occurred.

          -  Lab Requirements:

               -  Absolute neutrophils ≥ 1.5 x 10^9/L

               -  Platelets ≥ 100 x 10^9/L

               -  Hemoglobin ≥ 90 g/L

               -  Bilirubin ≤ 1.5 x ULN (upper limit of normal)

               -  AST and ALT ≤ 2.5 x ULN

               -  Serum creatinine < 1.25 x ULN or Creatinine clearance ≥ 50 mL/min

          -  Patient consent must be appropriately obtained in accordance with applicable local and
             regulatory requirements.

          -  Patients must be accessible for treatment, response assessment and follow-up. Patients
             registered on this trial must be treated and followed at the participating centre.

          -  In accordance with CCTG policy, protocol treatment is to begin within 2 working days
             of patient randomization.

          -  Women/men of childbearing potential must have agreed to use two highly effective
             contraceptive methods during the study and for six months after discontinuation.

          -  Patient must be able (i.e. sufficiently fluent) and willing to complete the quality of
             life questionnaires.

        Exclusion Criteria:

          -  Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (at doses
             more than 10 mg prednisone or equivalent) or any other form of immunosuppressive
             therapy within 7 days prior to the first and any dose of trial treatment.

          -  Has active autoimmune disease that has required systemic treatment in the past 3 years
             (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive
             drugs) or history of allogeneic transplantation. Replacement therapy (e.g. thyroxine,
             insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary
             insufficiency, etc.) is not considered a form of systemic treatment.

          -  Must not have received a live vaccine within 30 days of planned start of study
             therapy.

          -  Patients with known active central nervous system (CNS) metastases and/or
             carcinomatous 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 carcinomatous meningitis which is excluded regardless
             of clinical stability.

          -  Patients who have experienced untreated and/or uncontrolled cardiovascular conditions
             and/or have symptomatic cardiac dysfunction including cardiac ventricular arrhythmias
             requiring medication, history of 2nd or 3rd degree atrioventricular conduction
             defects) or who have had unstable angina congestive heart failure or myocardial
             infarction within the previous year. Patients with a significant cardiac history, this
             includes hypertension, even if controlled, should have a LVEF ≥ 50%.

          -  Patients with a history of other malignancies unless having undergone curative therapy
             (i.e. resection, radiation, etc) and do not require concurrent anticancer therapy.

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to pembrolizumab or any of the other chemotherapy agents.

          -  Concurrent treatment with other investigational drugs or anti0cancer therapy.

          -  Patients with serious illness or medical condition that would not permit the patient
             to be managed according to the protocol including, but not limited to:

               -  History of significant neurologic or psychiatric disorder which would impair the
                  ability to obtain consent or limit compliance with study requirements.

               -  Active infection requiring systemic therapy; (including any patient known to have
                  active hepatitis B, hepatitis C or human immunodeficiency virus (HIV) [note:
                  testing in asymptomatic patients is not required] or tuberculosis).

               -  Known history of, or any evidence of active, non-infectious pneumonitis.

               -  Any other medical conditions that might be aggravated by treatment.

               -  Serious or non-healing wound, ulcer, or bone fracture.

          -  Patients with evidence of interstitial lung disease.

          -  Patients with severe/uncontrollable tumor pain that requires radiation prior to
             starting on systemic therapy.

          -  Pregnant or lactating women. (N.B.: All women of childbearing potential must have a
             negative pregnancy test within 72 hours prior to registration).
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Quincy Chu, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT02784171

Organization ID

I227

Secondary IDs

2016-002286-60

Responsible Party

Sponsor

Study Sponsor

Canadian Cancer Trials Group

Collaborators

 National Cancer Institute, Naples

Study Sponsor

Quincy Chu, Study Chair, Cross Cancer Institute, Edmonton Alberta Canada


Verification Date

January 2021