We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pembrolizumab in Patients With Advanced Malignant Pleural Mesothelioma

This study is currently recruiting participants.
Verified March 2017 by Canadian Cancer Trials Group
Sponsor:
ClinicalTrials.gov Identifier:
NCT02784171
First Posted: May 26, 2016
Last Update Posted: November 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
National Cancer Institute, Naples
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Canadian Cancer Trials Group
  Purpose
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.

Condition Intervention Phase
Mesothelioma Drug: Cisplatin Drug: Pemetrexed Drug: Pembrolizumab Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Randomized Study of Pembrolizumab in Patients With Advanced Malignant Pleural Mesothelioma

Resource links provided by NLM:


Further study details as provided by Canadian Cancer Trials Group:

Primary Outcome Measures:
  • Progression free survival measured as time from randomization to first observation of objective disease relapse or progression [ Time Frame: 32 months ]

Secondary Outcome Measures:
  • Number and severity of adverse events [ Time Frame: 32 months ]
  • Overall Survival [ Time Frame: 32 months ]
  • Quality of Life using EORTC QLQ-C30 [ Time Frame: 32 months ]
  • Response rate compared using Fisher's exact test [ Time Frame: 32 months ]

Estimated Enrollment: 126
Study Start Date: October 7, 2016
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm A - Cisplatin/Pemetrexed
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
Drug: Cisplatin Drug: Pemetrexed
Active Comparator: Arm B - Cisplatin/Pemetrexed/Pembrolizumab
Pembrolizumab 200 mg* IV Day 1 over 30 min every 21 days for a total of 2 years 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
Drug: Cisplatin Drug: Pemetrexed Drug: Pembrolizumab
Active Comparator: Arm C - Pembrolizumab
Pembrolizumab 200 mg* IV 30 min Day 1 every 21 days for a total of 2 years
Drug: Pembrolizumab

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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.

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. 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 is in a previously irradiated area are ineligible UNLESS there is evidence of progression, or new lesions have been documented, in the irradiated field). (Exceptions may be made however, for low dose, palliative radiotherapy - please call the CCTG at 613-533-6430 PRIOR to registration if questions arise about the interpretation of this criterion). 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 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). 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 (unstable angina, congestive heart failure, myocardial infarction within the previous year or cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects). Patients with a significant cardiac history, even if controlled, should have a LVEF ≥ 50%.
  • Patients with a history of other malignancies requiring 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.
  • Patients receiving concurrent treatment with other anti-cancer therapy or other investigational anti-cancer agents.
  • 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.
  • Pregnant or lactating women. (N.B.: All women of childbearing potential must have a negative pregnancy test within 72 hours prior to registration).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02784171


Contacts
Contact: Lesley Seymour 613-533-6430

Locations
Canada, Alberta
Tom Baker Cancer Centre Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Desiree Hao    403 521-3706      
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Quincy Chu    780 432-8248      
Canada, British Columbia
BCCA - Cancer Centre for the Southern Interior Recruiting
Kelowna, British Columbia, Canada, V1Y 5L3
Contact: Delia Sauciuc    250 712-3900 ext 683930      
BCCA - Fraser Valley Cancer Centre Recruiting
Surrey, British Columbia, Canada, V3V 1Z2
Contact: Christopher Lee    604 930-4017      
Canada, Manitoba
CancerCare Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: David Dawe    204 787-8644      
Canada, Ontario
Juravinski Cancer Centre at Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: John Goffin    905 387-9495      
London Regional Cancer Program Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Mark D. Vincent    519 685-8640      
Ottawa Hospital Research Institute Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Paul Wheatley-Price    613 737-7700 ext 79859      
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Penelope A. Bradbury    416 946-4501 ext 3544      
Canada, Quebec
CHUM - Hopital Notre-Dame Recruiting
Montreal, Quebec, Canada, H2L 4M1
Contact: Marie Florescu    514 890-8444      
The Research Institute of the McGill University Suspended
Montreal, Quebec, Canada, H4A 3J1
Canada, Saskatchewan
Allan Blair Cancer Centre Recruiting
Regina, Saskatchewan, Canada, S4T 7T1
Contact: Mussawar Iqbal    306 766-2691      
Italy
Oncologia SS Antonio e Biagio Alessandria Recruiting
Alessandria, AL, Italy, 15121
Contact: Federica Grosso         
Azienda Ospedaliera San Giuseppe Moscati Recruiting
Avellino, AV, Italy, 83100
Contact: Gridelli Cesare         
Oncologia Medica IRCCS Arcispedale Maria Recruiting
Reggio Emilia, RE, Italy, 42123
Contact: Maria Pagano         
Istituti Fisioterapici Ospitalieri IFO Istituto Recruiting
Rome, RM, Italy, 00144
Contact: Fabiana Letizia Cecere         
U.O. di Oncologia Ospedale Villa Scassi Recruiting
Genova, Sampierdarena, Italy, 16149
Contact: Manlio Mencoboni    010 410-2639      
PO A Perrino ASL Brindisi - UOC Oncologia Medica Recruiting
Brindisi, Italy, 72100
Contact: Saverio Cinieri         
AOU Policlinico Vittorio Emanuele UOC di Oncologia Not yet recruiting
Catania, Italy, 95125
Contact: Hector Jose Soto Parra    2 8224-4459      
Intstituto Scientifico Romangnolo Recruiting
Meldola, Italy, 47014
Contact: Marco Angelo Burgio    054 373-9100      
Instituto Nazionale Tumori Recruiting
Milan, Italy
Contact: Maria Chiara Garassino         
U.O.C. di Oncologia U.L.S.S. 13 Recruiting
Mirano, Italy, 30035
Contact: Francesco Rosetti    3904 1579-4002      
Azienda Ospedaliera di Rilievo Nazionale Not yet recruiting
Napoli, Italy, 80131
Contact: Giacomo Carteni         
Dott. Fortunato Ciardiello,Cattedra Oncologia Medica Recruiting
Napoli, Italy, 80131
Contact: Fortunato Ciardiello    081 566-6745      
Unita Sperimentazioni Cliniche Istituto per lo Recruiting
Napoli, Italy, 80131
Contact: Alessandro Morabito    081 590-3571      
Azienda USL di Piacenza, Ospedale Gugliemimo Salieto Recruiting
Piacenza, Italy, 29100
Contact: Luigi Cavanna    052 330-2697      
Sponsors and Collaborators
Canadian Cancer Trials Group
National Cancer Institute, Naples
Merck Sharp & Dohme Corp.
Investigators
Study Chair: Quincy Chu Cross Cancer Institute, Edmonton Alberta Canada
Study Chair: Francesco Perrone National Cancer Institute of Naples, Italy
  More Information

Responsible Party: Canadian Cancer Trials Group
ClinicalTrials.gov Identifier: NCT02784171     History of Changes
Other Study ID Numbers: I227
2016-002286-60 ( EudraCT Number )
First Submitted: May 24, 2016
First Posted: May 26, 2016
Last Update Posted: November 15, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Pembrolizumab
Cisplatin
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors