Brief Report: Canadian Cancer Trials Group IND.227: A Phase 2 Randomized Study of Pembrolizumab in Patients With Advanced Malignant Pleural Mesothelioma (NCT02784171)

Maria Carmela Piccirillo¹, Quincy Chu², Penelope Bradbury³, Wei Tu⁴, Courtney H Coschi⁴, Federica Grosso⁵, Marie Florescu⁶, Manlio Mencoboni⁷, John R Goffin⁸, Maria Pagano⁹, Fortunato Ciardiello¹⁰, Fabiana Letizia Cecere¹¹, Mark Vincent¹², Roberto Ferrara¹³, David E Dawe¹⁴, Desiree Hao¹⁵, Christopher W Lee¹⁶, Alessandro Morabito¹⁷, Cesare Gridelli¹⁸, Luigi Cavanna¹⁹, Mussawar Iqbal²⁰, Normand Blais⁶, Natasha B Leighl³, Paul Wheatley-Price²¹, Ming-Sound Tsao³, Francesca Ugo⁵, Hazem El-Osta²², Piera Gargiulo¹, Pierre-Olivier Gaudreau⁴, Dongsheng Tu⁴, Joana Sederias⁴, Pamela Brown-Walker⁴, Francesco Perrone¹, Lesley Seymour²³, Scott A Laurie²¹

Affiliations

¹ Clinical Trials Unit, Istituto Nazionale Tumori Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Fondazione G Pascale, Napoli, Italy.
² Cross Cancer Institute, Edmonton, Alberta, Canada.
³ University Health Network, Toronto, Ontario, Canada.
⁴ Canadian Cancer Trials Group, Kingston, Ontario, Canada.
⁵ Mesothelioma Unit (FG) & Department of Integrated Activities Research and Innovation (FU), SS. Antonio e Biagio C. Arrigo Hospital, Alessandria, Italy.
⁶ Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, Quebec, Canada.
⁷ Oncology Unit ASL 3, Villa Scassi Hospital, Genova, Italy.
⁸ Juravinski Cancer Centre, Ontario, Canada.
⁹ Medical Oncology, Comprehensive Cancer Centre, AUSL Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) of Reggio Emilia, Reggio Emilia, Italy.
¹⁰ Oncology and Hematology Unit, University of Campania "Luigi Vanvitelli," Naples, Italy.
¹¹ Oncology Unit, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituti Fisioterapici Ospitalieri (IFO) Istituto Regina Elena, Rome, Italy.
¹² London Regional Cancer Program, London, Ontario, Canada.
¹³ Thoracic Oncology Unit, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale Tumori, Milano, Italy.
¹⁴ Department of Medical Oncology and Hematology, CancerCare Manitoba, Winnipeg, Canada.
¹⁵ Tom Baker Cancer Centre and Cumming School of Medicine, Calgary, Alberta, Canada.
¹⁶ British Columbia Cancer Agency, Surrey, British Columbia, Canada.
¹⁷ Thoracic Oncology Unit, Istituto Nazionale Tumori Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Fondazione G. Pascale, Napoli, Italy.
¹⁸ Oncology Unit, S. Giuseppe Moscati Hospital, Avellino, Italy.
¹⁹ Oncology and Hematology Department, USL Piacenza, Guglielmo da Saliceto Hospital, Piacenza, Italy.
²⁰ Allan Blair Cancer Centre, Regina, Saskatchewan, Canada.
²¹ Ottawa Hospital Research Institute and Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
²² Merck & Co, Inc., Rahway, New Jersey.
²³ Canadian Cancer Trials Group, Kingston, Ontario, Canada. Electronic address: lseymour@ctg.queensu.ca.

PMID: 36841541
DOI: 10.1016/j.jtho.2023.02.003

Free article

Clinical Trial

Brief Report: Canadian Cancer Trials Group IND.227: A Phase 2 Randomized Study of Pembrolizumab in Patients With Advanced Malignant Pleural Mesothelioma (NCT02784171)

Maria Carmela Piccirillo et al. J Thorac Oncol. 2023 Jun.

Free article

. 2023 Jun;18(6):813-819.

doi: 10.1016/j.jtho.2023.02.003. Epub 2023 Feb 24.

Authors

Affiliations

¹ Clinical Trials Unit, Istituto Nazionale Tumori Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Fondazione G Pascale, Napoli, Italy.
² Cross Cancer Institute, Edmonton, Alberta, Canada.
³ University Health Network, Toronto, Ontario, Canada.
⁴ Canadian Cancer Trials Group, Kingston, Ontario, Canada.
⁵ Mesothelioma Unit (FG) & Department of Integrated Activities Research and Innovation (FU), SS. Antonio e Biagio C. Arrigo Hospital, Alessandria, Italy.
⁶ Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, Quebec, Canada.
⁷ Oncology Unit ASL 3, Villa Scassi Hospital, Genova, Italy.
⁸ Juravinski Cancer Centre, Ontario, Canada.
⁹ Medical Oncology, Comprehensive Cancer Centre, AUSL Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) of Reggio Emilia, Reggio Emilia, Italy.
¹⁰ Oncology and Hematology Unit, University of Campania "Luigi Vanvitelli," Naples, Italy.
¹¹ Oncology Unit, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituti Fisioterapici Ospitalieri (IFO) Istituto Regina Elena, Rome, Italy.
¹² London Regional Cancer Program, London, Ontario, Canada.
¹³ Thoracic Oncology Unit, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale Tumori, Milano, Italy.
¹⁴ Department of Medical Oncology and Hematology, CancerCare Manitoba, Winnipeg, Canada.
¹⁵ Tom Baker Cancer Centre and Cumming School of Medicine, Calgary, Alberta, Canada.
¹⁶ British Columbia Cancer Agency, Surrey, British Columbia, Canada.
¹⁷ Thoracic Oncology Unit, Istituto Nazionale Tumori Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Fondazione G. Pascale, Napoli, Italy.
¹⁸ Oncology Unit, S. Giuseppe Moscati Hospital, Avellino, Italy.
¹⁹ Oncology and Hematology Department, USL Piacenza, Guglielmo da Saliceto Hospital, Piacenza, Italy.
²⁰ Allan Blair Cancer Centre, Regina, Saskatchewan, Canada.
²¹ Ottawa Hospital Research Institute and Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
²² Merck & Co, Inc., Rahway, New Jersey.
²³ Canadian Cancer Trials Group, Kingston, Ontario, Canada. Electronic address: lseymour@ctg.queensu.ca.

PMID: 36841541
DOI: 10.1016/j.jtho.2023.02.003

Erratum in

Erratum to "Brief Report: Canadian Cancer Trials Group IND.227: A Phase II randomized study of pembrolizumab in patients with advanced malignant pleural mesothelioma (NCT02784171). [Journal of Thoracic Oncology Vol. 18 No. 6: 813-819]".
Piccirillo MC, Chu Q, Bradbury P, Tu W, Coschi CH, Grosso F, Florescu M, Mencoboni M, Goffin JR, Pagano M, Ciardiello F, Cecere FL, Vincent M, Ferrara R, Dawe DE, Hao D, Lee CW, Morabito A, Gridelli C, Cavanna L, Iqbal M, Blais N, Leighl NB, Wheatley-Price P, Tsao MS, Ugo F, El-Osta H, Gargiulo P, Gaudreau PO, Tu D, Sederias J, Brown-Walker P, Perrone F, Seymour L, Laurie SA. Piccirillo MC, et al. J Thorac Oncol. 2024 Nov;19(11):1578-1579. doi: 10.1016/j.jtho.2024.08.017. Epub 2024 Aug 24. J Thorac Oncol. 2024. PMID: 39186030 No abstract available.

Abstract

Immune checkpoint inhibitors have activity in mesothelioma. IND.227 was a phase 2 trial (120 patients planned) comparing progression-free survival of standard platinum and pemetrexed (CP) versus CP + pembrolizumab (pembro) versus pembro. Accrual to the pembro arm was discontinued on the basis of interim analysis (IA-16 wk disease control rate). CP + pembro was tolerable, with progression-free survival similar between arms and median survival and overall response rate higher than those of CP alone (19.8 mo [95% confidence interval or CI: 8.4-41.36] versus 8.9 mo [95% CI: 5.3-12.8] and 47% [95% CI: 24%-71%] versus 19% [95% CI: 5%-42%], respectively). The subsequent phase 3 trial has completed accrual; results are expected in 2023.

Keywords: Chemoimmunotherapy; Mesothelioma; Phase II; Randomized.

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Comment in

"Brief Report: Canadian Cancer Trials Group IND.227": Unpacking the Clinical Potential of Single-Agent Pembrolizumab in Advanced Malignant Pleural Mesothelioma.
Gemelli M. Gemelli M. J Thorac Oncol. 2023 Jun;18(6):e67-e68. doi: 10.1016/j.jtho.2023.03.009. J Thorac Oncol. 2023. PMID: 37210188 No abstract available.
Response to a Letter Received Entitled: "'Brief Report: Canadian Cancer Trials Group IND.227': Unpacking the Clinical Potential of Single-Agent Pembrolizumab in Advanced Malignant Pleural Mesothelioma".
Piccirillo MC, Chu Q, Bradbury P, Seymour L. Piccirillo MC, et al. J Thorac Oncol. 2023 Jun;18(6):e68-e69. doi: 10.1016/j.jtho.2023.03.003. J Thorac Oncol. 2023. PMID: 37210189 No abstract available.

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Brief Report: Canadian Cancer Trials Group IND.227: A Phase 2 Randomized Study of Pembrolizumab in Patients With Advanced Malignant Pleural Mesothelioma (NCT02784171)

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Brief Report: Canadian Cancer Trials Group IND.227: A Phase 2 Randomized Study of Pembrolizumab in Patients With Advanced Malignant Pleural Mesothelioma (NCT02784171)

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