DuRvalumab With chEmotherapy as First Line treAtment in Advanced Pleural Mesothelioma (DREAM3R)

• ClinicalTrials.gov Identifier: NCT04334759
• Recruitment Status: Recruiting
• First Posted: April 6, 2020
• Last Update Posted: May 11, 2023
• Sponsor: PrECOG, LLC.
• Collaborators: AstraZeneca; Thoracic Oncology Group Australasia (TOGA); University of Sydney
• Information provided by (Responsible Party): PrECOG, LLC.

Study Description

Brief Summary:

Patients with pleural mesothelioma (PM) that cannot be surgically removed will receive standard chemotherapy (cisplatin or carboplatin and pemetrexed) given with durvalumab, a type of immunotherapy, or a treatment chosen by the study doctor, which is either standard chemotherapy or immunotherapy combination (ipilimumab and nivolumab).

Durvalumab is an antibody (a type of human protein) that works by blocking a body substance called Programmed Death-Ligand 1 (PD-L1). Blocking PD-L1 helps the body's immune system attack cancer cells. Research has shown that durvalumab can slow tumor growth and shrink tumors in some people with cancer. Previous studies of combining durvalumab and chemotherapy showed that this combination is active in advanced mesothelioma.

The purpose of this study is to see whether adding durvalumab to standard chemotherapy will improve overall survival (OS) in patients with PM.

Condition or disease	Intervention/treatment	Phase
Mesothelioma; Pleural Mesothelioma; Malignant Pleural Mesothelioma	Drug: Durvalumab; Drug: Standard Chemotherapy; Drug: Ipilimumab and Nivolumab	Phase 3

Detailed Description:

Mesothelioma is a malignant tumor of the mesothelial surfaces primarily arising in the thoracic pleura. In the United Kingdom and USA the expected number of cases in the next few decades are 65,000 and 85,000, respectively. Once diagnosed, this disease is rarely cured with a median survival of less than a year.

This is an International, Open-Label, Multi-center, Phase III study. Patients will be randomized 1:1 to receive (a) chemotherapy given with durvalumab versus (b) physician's choice of either chemotherapy alone, or ipilimumab and nivolumab.

Experimental Arm:

- Durvalumab every 3 weeks + standard chemotherapy (cisplatin or carboplatin every 3 weeks + pemetrexed every 3 weeks) for 4 to 6 cycles, followed by durvalumab every 4 weeks until disease progression, unacceptable toxicity or patient withdrawal.

Control Arm: Physician Choice

• Standard chemotherapy (cisplatin or carboplatin every 3 weeks + pemetrexed every 3 weeks) for 4 to 6 cycles followed by observation
• Ipilimumab every 6 weeks and nivolumab every 2 or 3 weeks [physician discretion] for up to 2 years until disease progression, unacceptable toxicity or patient withdrawal .

Tumor assessments and Quality of Life (QOL) forms will be performed at baseline, then at weeks 6, 12, 18, 26, 34, 42, 50 and then every 12 weeks until disease progression. The QOL forms will also be repeated during the first visit after progression.

Mandatory pre-treatment tumor tissue sample (i.e., obtained during a previous procedure or biopsy) for research will also be required. Blood samples for research at 3 time points will be done.

The study is being led jointly by PrECOG as the US sponsor and University of Sydney as the international sponsor.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 480 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: First-line chemotherapy with cisplatin or carboplatin and pemetrexed + durvalumab OR physician's choice of either first-line chemotherapy alone, or ipilimumab and nivolumab.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: DREAM3R: DuRvalumab (MEDI4736) With chEmotherapy as First Line treAtment in Advanced Pleural Mesothelioma - A Phase 3 Randomised Trial
• Actual Study Start Date: February 18, 2021
• Estimated Primary Completion Date: April 2025
• Estimated Study Completion Date: December 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: Experimental Arm: Durvalumab + Chemotherapy, then Durvalumab Maintenance; Durvalumab + Standard Chemotherapy for 4 to 6 cycles, followed by Maintenance with Durvalumab	Drug: Durvalumab; Durvalumab 1500 milligrams (mg) intravenous (IV) every 3 weeks + Cisplatin 75 mg/m² or Carboplatin AUC 5 IV every 3 weeks + Pemetrexed 500 mg/m² IV every 3 weeks for 4 to 6 cycles, followed by maintenance with Durvalumab 1500 mg IV every 4 weeks; Other Names: MEDI4736; Imfinzi
Active Comparator: Control Arm: Chemotherapy, then Observation; Standard Chemotherapy for 4 to 6 cycles, followed by Observation	Drug: Standard Chemotherapy; Cisplatin 75 mg/m² or Carboplatin AUC 5 IV every 3 weeks + Pemetrexed 500 mg/m² IV every 3 weeks) for 4 to 6 cycles, followed by Observation; Other Name: Cisplatin or Carboplatin and Pemetrexed
Active Comparator: Control Arm: Ipilimumab and Nivolumab; Ipilimumab every 6 weeks and Nivolumab every 2 or 3 weeks for up to 2 years.	Drug: Ipilimumab and Nivolumab; Ipilimumab 1 mg/kg every 6 weeks and Nivolumab 360 mg every 3 weeks or 3 mg/kg every 2 weeks for up to 2 years; Other Name: Yervoy, Opdivo

Outcome Measures

Primary Outcome Measures :

1. Effects on Overall Survival [ Time Frame: Minimum follow-up is 24 months after randomisation. ]
   Defined as the time from randomisation to the date of death due to any cause.

Secondary Outcome Measures :

1. Progression-Free Survival (PFS) [ Time Frame: Performed at baseline, then at weeks 6, 12, 18, 26, 34, 42, 50 and then every 12 weeks until disease progression (minimum follow-up is 24 months after randomisation). ]
   Defined as the interval from date of randomisation to the date of first evidence of disease progression or death, whichever occurs first.
2. Objective Tumour Response Rate (OTRR) [ Time Frame: Performed at baseline, then at weeks 6, 12, 18, 26, 34, 42, 50 and then every 12 weeks until disease progression (minimum follow-up is 24 months after randomisation). ]
   Percentage of participants with either Complete Response (CR) or Partial Response (PR) assessed according to modified Response Criteria in Solid Tumors (RECIST) 1.1 for response in malignant pleural mesothelioma.
3. Classify and grade participants adverse events as assessed by CTCAE V5.0 [ Time Frame: 90 days after last dose of immunotherapy or 30 days after last dose of chemotherapy, whichever is longer. ]
   Classify and grade participants abnormal laboratory values and/or adverse events.
4. Health-Related Quality of Life (QOL): QLQ-C30 [ Time Frame: Performed at baseline, then at weeks 6, 12, 18, 26, 34, 42, 50, then every 12 weeks until disease progression and at first progression visit (minimum follow-up is 24 months after randomisation). ]
   European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30), Importance of QOL issues assessed using a four-point scale (1 = not at all, 4 = very much).
5. Health-Related QOL: LC29 [ Time Frame: Performed at baseline, then at weeks 6, 12, 18, 26, 34, 42, 50, then every 12 weeks until disease progression and at first progression visit (minimum follow-up is 24 months after randomisation). ]
   EORTC Quality of Life Lung Cancer Module (QLQ-LC29), Importance of QOL issues assessed using a four-point scale (1 = not at all, 4 = very much).
6. Health-Related QOL: EQ-5D-5L [ Time Frame: Performed at baseline, then at weeks 6, 12, 18, 26, 34, 42, 50, then every 12 weeks and at first progression visit until disease progression (minimum follow-up is 24 months after randomisation). ]
   Euro-Quality of Life (EuroQoL) 5 dimension 5 level (EQ-5D-5L) questionnaire, comprising of 5 questions with a score from 1 (no problem) to 5 (extreme problem) and a visual analog scale from 0 (worst) to 100 (best).
7. Health Care Usage Costs: Hospitalization [ Time Frame: Minimum follow-up is 24 months after randomisation. ]
   Australian Sites Only: Hospitalization costs calculated by applying Australian unit costs to Australian Refined Diagnostic Related Groups (AR DRG) costs for hospitalizations.
8. Health Care Usage Costs: Scheduled Visits to Health Professionals [ Time Frame: Minimum follow-up is 24 months after randomisation. ]
   Australian Sites Only: Scheduled costs for visits to health professionals collected via Medical Benefits Schedule (MBS).
9. Health Care Usage Costs: Medications [ Time Frame: Minimum follow-up is 24 months after randomisation. ]
   Australian Sites Only: Scheduled costs for medications collected via the Pharmaceutical Benefits Schedule (PBS).

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• Adults (18 years or over) with a histological diagnosis of epithelioid pleural mesothelioma that is not amenable to curative surgical resection. Histological diagnosis requires tumour tissue from an open biopsy, or a core biopsy with a needle of 19 gauge or wider.
• Measurable disease as per modified RECIST 1.1 (mRECIST 1.1) criteria for assessment of response in pleural mesothelioma, without prior radiotherapy to these sites.
• Body weight >30 kg,
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Tumour tissue (Formalin-Fixed Paraffin-Embedded [FFPE]) available from standard of care diagnostic biopsy for PD-L1 testing and other correlative biomarker testing at a central laboratory.
• Life expectancy of at least 12 weeks.

• Adequate blood tests (done within 14 days prior to randomisation) and with values within the ranges specified below. Blood transfusions are permissible if completed at least 7 days prior to treatment start.

  • Haemoglobin ≥ 9.0 g/L
  • Absolute neutrophil count ≥ 1.5 x 10^9/L
  • Platelets ≥ 100 x 10^9/L
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (except participants with Gilbert's Syndrome, who are eligible with bilirubin ≤ 2.5 ULN)
  • Alanine transaminase ≤ 2.5 x upper limit of normal (ULN), unless liver metastases or invasion are present, in which case it must be ≤ 5 x ULN
  • Aspartate aminotransferase ≤ 2.5 x ULN, unless liver metastases or invasion are present, in which case it must be ≤ 5 x ULN
  • Creatinine clearance (CrCl) ≥ 45 mL/min (Cockcroft-Gault formula). NOTE: Carboplatin AUC 5 must be the initial platinum agent of choice in patients with creatinine Cl <60 mL/min but ≥ 45 mL/min, or those with clinically reported hearing loss.
• Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient or legal representative must sign a consent form prior to enrolment in the trial to document their willingness to participate.
• Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.
• Women of childbearing potential must use a reliable means of contraception during treatment and for at least 90 days thereafter. Breastfeeding is not permissible during or for at least 90 days after the final study treatment. Men must have been surgically sterilised or use a barrier method of contraception if they are sexually active with a woman of child bearing potential.
• Evidence of post-menopausal status or negative serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.

Exclusion Criteria:

• Non-epithelioid histology (biphasic or sarcomatoid).
• Prior chemotherapy or other systemic anti-cancer or immunotherapy for PM.
• Diagnosis based only on cytology or aspiration biopsy with a needle narrower than 19 gauge.

• Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g. colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to this criterion:

  1. Patients with vitiligo or alopecia
  2. Patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement
  3. Any chronic skin condition that does not require systemic therapy
  4. Patients without active disease in the last 5 years may be included
  5. Patients with celiac disease controlled by diet alone
• Any condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone or equivalent dose of an alternative corticosteroid) or other immunosuppressive medications within 28 days of durvalumab or ipilimumab or nivolumab administration. Intranasal, inhaled or topical steroids or local steroid injections (e.g. intra-articular injection) are permitted in the absence of active autoimmune disease. Standard steroid premedication given prior to chemotherapy or as prophylaxis for imaging contrast allergy should not be counted for this criterion.
• Participants with symptomatic or uncontrolled brain metastases or leptomeningeal disease are excluded.
• Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathways.
• Current treatment or treatment within the last 12 months with any investigational anti-cancer products.
• Concurrent enrolment in another clinical study testing an anticancer treatment.
• Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 msec in screening ECG measured using standard institutional method or history of familial long QT syndrome.
• Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of study treatment on protocol. Note: Local surgery of isolated lesions for palliative intent is acceptable. Limited pleural biopsy procedures do not apply.
• No other malignancy that requires active treatment. Participants with a past history of adequately treated carcinoma in situ, non-melanoma skin cancer or lentigo maligna without evidence of disease or superficial transitional cell carcinoma of the bladder are eligible.
• Hearing loss or peripheral neuropathy considered by the investigators to contraindicate administration of either cisplatin, carboplatin or pemetrexed.
• History of allergy or hypersensitivity to investigational product, cisplatin, carboplatin, pemetrexed, ipilimumab, nivolumab or any excipient.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive cardiac failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, active peptic ulcer disease or gastritis, serious chronic gastrointestinal conditions associated with diarrhoea, active bleeding diatheses.
• Hepatitis B, hepatitis C or human immunodeficiency virus (HIV). Exceptions include past or resolved Hepatitis B (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) and patients positive for hepatitis C (HCV) antibody if polymerase chain reaction is negative for HCV RNA. HIV testing is not required in absence of clinical suspicion of HIV.
• Known history of primary immunodeficiency, allogeneic organ transplant, pneumonitis or active tuberculosis.
• Receipt of live attenuated vaccination within 30 days prior to enrolment or within 30 days of receiving durvalumab, ipilimumab, nivolumab.
• Specific comorbidities or conditions or concomitant medications which may interact with the investigational product(s).
• Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results.
• Serious medical or psychiatric conditions or social situation that might limit compliance with study requirements, substantially increase risk of incurring adverse events or compromise the ability of the patient to give written informed consent.

Contacts and Locations

Contacts

Contact: Deb Riordan- US Sites, BSN, RN; 267-271-4884; DREAM3R@precogllc.org

Contact: Stephanie Winata- International Sites; 61-2-9562-5000; DREAM3R.study@sydney.edu.au

Locations

United States, California

University of California San Diego; Recruiting

La Jolla, California, United States, 92093

Principal Investigator: Lyudmila Bazhenova, MD

United States, Florida

University of Miami; Recruiting

Miami, Florida, United States, 33136

Principal Investigator: Chukwuemeka Ikpeazu, MD

Moffitt Cancer Center; Recruiting

Tampa, Florida, United States, 18054

Principal Investigator: Tawee Tanvetyanon, MD

United States, Georgia

Emory University; Recruiting

Atlanta, Georgia, United States, 30322

Principal Investigator: Conor Steuer, MD

United States, Illinois

University of Chicago; Recruiting

Chicago, Illinois, United States, 60637

Principal Investigator: Hedy Kindler, MD

NorthShore University Health System/Kellogg Cancer Center; Recruiting

Evanston, Illinois, United States, 60201

Principal Investigator: Nicholas Campbell, MD

United States, Maryland

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center; Recruiting

Baltimore, Maryland, United States, 21287

Principal Investigator: Patrick Forde, MD

United States, Massachusetts

Massaschusetts General Hospital; Recruiting

Boston, Massachusetts, United States, 02114

Principal Investigator: Ibiayi Dagogo-Jack, MD

Dana Farber Cancer Institute; Recruiting

Boston, Massachusetts, United States, 02215

Principal Investigator: David Kwiatkowski, MD, PhD

United States, Michigan

University of Michigan; Recruiting

Ann Arbor, Michigan, United States, 48109

Principal Investigator: Angel Qin, MD

United States, Minnesota

Metro Minnesota Community Oncology Research Consortium; Recruiting

Saint Louis Park, Minnesota, United States, 55416

Principal Investigator: Yan Ji, MD

United States, New Jersey

Morristown Medical/Atlantic Health; Recruiting

Morristown, New Jersey, United States, 07960

Principal Investigator: Charles Farber, MD

Jersey Shore University Medical Center; Recruiting

Neptune, New Jersey, United States, 07753

Principal Investigator: Thomas Bauer, MD

Rutgers Cancer Institute of New Jersey; Recruiting

New Brunswick, New Jersey, United States, 08903

Principal Investigator: Missak Haigentz, MD

United States, New York

Memorial Sloan Kettering; Recruiting

New York, New York, United States, 10065

Principal Investigator: Majorie Zauderer, MD

United States, Ohio

University of Cincinnati; Recruiting

Cincinnati, Ohio, United States, 45267

Principal Investigator: Muhammad Riaz, MD

Cleveland Clinic Foundation; Recruiting

Cleveland, Ohio, United States, 44195

Principal Investigator: James Stevenson, MD

The Ohio State University; Recruiting

Columbus, Ohio, United States, 43210

Principal Investigator: Asrar Alahmadi, MD

United States, Pennsylvania

Penn State Cancer Institute; Recruiting

Hershey, Pennsylvania, United States, 17033

Principal Investigator: Patrick MA, MD

Abramson Cancer Cener at Penn Presbyterian Medical Center; Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator: Melina Marmarelis, MD

Fox Chase Cancer Center; Recruiting

Philadelphia, Pennsylvania, United States, 19111

Principal Investigator: Hossein Borghaei, MD

Allegheny Cancer Center; Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Principal Investigator: Gene Finley, MD

United States, Tennessee

Vanderbilt-Ingram Cancer Center; Recruiting

Nashville, Tennessee, United States, 37232

Principal Investigator: Erin Gillaspie, MD

United States, Texas

University of Texas Southwestern Medical Center; Recruiting

Dallas, Texas, United States, 75390

Principal Investigator: Jonathan E Dowell, MD

Baylor College of Medicine; Recruiting

Houston, Texas, United States, 77030

Principal Investigator: Meera Patel, MD

MD Anderson Cancer Center; Recruiting

Houston, Texas, United States, 77030

Principal Investigator: Anne Tsao, MD

United States, Virginia

University of Virginia; Recruiting

Charlottesville, Virginia, United States, 22903

Principal Investigator: Richard Hall, MD

Australia, Australian Capital Territory

Canberra Hospital; Recruiting

Garran, Australian Capital Territory, Australia, 2605

Principal Investigator: Geoffrey Peters, MBBS FRACP

Australia, New South Wales

Blacktown Hospital; Recruiting

Blacktown, New South Wales, Australia, 2148

Principal Investigator: Adnan Nagrial, MBBS, PhD

Chris O'Brien Lifehouse; Recruiting

Camperdown, New South Wales, Australia, 2050

Principal Investigator: Steven Kao, MBChB PhD

Coffs Harbour Health Campus; Recruiting

Coffs Harbour, New South Wales, Australia, 2450

Principal Investigator: Karen Briscoe, MBBS, FRACP

Gosford Hospital; Recruiting

Gosford, New South Wales, Australia, 2250

Principal Investigator: Matthew Chan, MBBS, FRACP

Wyong Hospital; Recruiting

Hamlyn Terrace, New South Wales, Australia, 2259

Principal Investigator: Matthew Chan, MBBS, FRACP

Nepean Hospital; Recruiting

Kingswood, New South Wales, Australia, 2747

Principal Investigator: Deme Karikios, MBBS, PhD

Liverpool Hospital; Recruiting

Liverpool, New South Wales, Australia, 2170

Principal Investigator: Victoria Bray, MBBS PhD

Orange Health Service; Recruiting

Orange, New South Wales, Australia, 2800

Principal Investigator: Robert Zielinski, MBBS FRACP

Northern Cancer Institute (GenesisCare); Recruiting

Saint Leonards, New South Wales, Australia, 2065

Principal Investigator: Nick Pavlakis, MMed, PhD

Calvary Mater Newcastle; Recruiting

Waratah, New South Wales, Australia, 2298

Principal Investigator: Hiren Mandaliya, MBBS, MD

Westmead Hospital; Recruiting

Westmead, New South Wales, Australia, 2145

Principal Investigator: Rina Hui, MBBS, PhD

Australia, Queensland

Icon Cancer Care Wesley; Recruiting

Auchenflower, Queensland, Australia, 4066

Principal Investigator: Adam Stirling, MBBS FRACP

Sunshine Coast University Hospital; Recruiting

Birtinya, Queensland, Australia, 4575

Principal Investigator: Bryan Chan, BPharm, MBBS

Icon Cancer Care Chermside; Recruiting

Chermside, Queensland, Australia, 4032

Principal Investigator: Adam Stirling, MBBS FRACP

The Prince Charles Hospital; Recruiting

Chermside, Queensland, Australia, 4032

Principal Investigator: Brett Hughes, MBBS, FRACP

Townsville University Hospital; Recruiting

Douglas, Queensland, Australia, 4814

Principal Investigator: Suresh Varma, MBBS FRACP

Icon Cancer Care South Brisbane; Recruiting

South Brisbane, Queensland, Australia, 4101

Principal Investigator: Adam Stirling, MBBS FRACP

Princess Alexandra Hospital; Recruiting

Woolloongabba, Queensland, Australia, 4102

Principal Investigator: Kenneth O'Byrne, MB, BCh, PhD

Australia, South Australia

Flinders Medical Centre; Recruiting

Bedford Park, South Australia, Australia, 5042

Principal Investigator: Shawgi Sukumaran, MBBS, DM

The Queen Elizabeth Hospital; Recruiting

Woodville South, South Australia, Australia, 5011

Principal Investigator: Rachel Roberts-Thomson, MBBS, FRACP

Australia, Tasmania

Royal Hobart Hospital; Recruiting

Hobart, Tasmania, Australia, 7000

Principal Investigator: Rebecca Tay, MBBS FRACP

Launceston General Hospital; Recruiting

Launceston, Tasmania, Australia, 7250

Principal Investigator: Axel Durieux, MBBS FRACP

Australia, Victoria

Monash Health; Recruiting

Clayton, Victoria, Australia, 3168

Principal Investigator: Muhammad Alamgeer, MBBS FRACP

Peninsula & South Eastern Haematology and Oncology Group; Recruiting

Frankston, Victoria, Australia, 3199

Principal Investigator: Vinod Ganju, MBBS FRACP

Austin Hospital; Recruiting

Heidelberg, Victoria, Australia, 3084

Principal Investigator: Paul Mitchell, MBBS FRACP

Peter MacCallum Cancer Centre; Recruiting

Melbourne, Victoria, Australia, 3000

Principal Investigator: Thomas John, MBBS, PhD

Epworth HealthCare - Richmond; Recruiting

Richmond, Victoria, Australia, 3121

Principal Investigator: Ross Jennens, MBBS FRACP

Sunshine Hospital (Western Health); Recruiting

Saint Albans, Victoria, Australia, 3021

Principal Investigator: Suzanne Kosmider, MBBS FRACP

Goulburn Valley Health; Recruiting

Shepparton, Victoria, Australia, 3630

Principal Investigator: Myron Klevansky, MBBS, FRACP

Australia, Western Australia

Sir Charles Gairdner Hospital (SCGH); Recruiting

Nedlands, Western Australia, Australia, 6009

Principal Investigator: Anna Nowak, MBBS, PhD

New Zealand

Auckland City Hospital; Recruiting

Grafton, Auckland, New Zealand, 1023

Principal Investigator: Aileen Ludlow, MBBS FRACP

Sponsors and Collaborators

PrECOG, LLC.

AstraZeneca

Thoracic Oncology Group Australasia (TOGA)

University of Sydney

Investigators

• Study Chair: Patrick Forde, MD; Johns Hopkins University
• Study Chair: Anna Nowak, MD; Faculty of Health and Medical Sciences University of Western Australia

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kok PS, Forde PM, Hughes B, Sun Z, Brown C, Ramalingam S, Cook A, Lesterhuis WJ, Yip S, O'Byrne K, Pavlakis N, Brahmer J, Anagnostou V, Ford K, Fitzpatrick K, Bricker A, Cummins MM, Stockler M, Nowak AK; Thoracic Oncology Group of Australasia (TOGA) and PrECOG, USA. Protocol of DREAM3R: DuRvalumab with chEmotherapy as first-line treAtment in advanced pleural Mesothelioma-a phase 3 randomised trial. BMJ Open. 2022 Jan 25;12(1):e057663. doi: 10.1136/bmjopen-2021-057663.

Kindler HL. Understanding the new therapeutic options for mesothelioma. Lancet Oncol. 2021 Oct;22(10):1353-1355. doi: 10.1016/S1470-2045(21)00520-9. Epub 2021 Sep 6. No abstract available.

Uprety D. CheckMate 743: A Glimmer of Hope for Malignant Pleural Mesothelioma. Clin Lung Cancer. 2021 Mar;22(2):71-73. doi: 10.1016/j.cllc.2020.11.009. Epub 2020 Dec 2. No abstract available.

• Responsible Party: PrECOG, LLC.
• ClinicalTrials.gov Identifier: NCT04334759
• Other Study ID Numbers: DREAM3R; PrE0506 ( Other Identifier: PrECOG, LLC ); TOGA 18/001 ( Other Identifier: Thoracic Oncology Group Australasia ); CTC 0231 ( Other Identifier: NHMRC Clinical Trials Centre, University of Sydney )
• First Posted: April 6, 2020
• Last Update Posted: May 11, 2023
• Last Verified: May 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Data is proprietary

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by PrECOG, LLC.:

Unresectable Mesothelioma; Durvalumab; Anti-Programmed Death-Ligand 1 Antibody; Immune Checkpoint Inhibitor; Ipilimumab; Nivolumab

Additional relevant MeSH terms:

Mesothelioma; Mesothelioma, Malignant; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases; Cisplatin; Carboplatin; Nivolumab; Pemetrexed; Ipilimumab; Durvalumab; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors