1845P - Exclusion of patients with psychiatric disorders from early phase oncology trials: A limited access to innovation?

Background

Psychiatric disorders (PD) are highly prevalent in patients with cancer and associated with poorer outcomes. This may be partly explained by a limited access to innovation since patients with PD are often underrepresented in oncology clinical trials. This study examines the frequency and the nature of exclusion criteria for patients with PD in a large sample of early phase oncology clinical trials (EPCT).

Methods

All protocols of EPCT opened to inclusion at the Drug Development Department at Gustave Roussy Cancer Centre in November 2022 were independently reviewed by 2 authors to identify exclusion criteria related to PD and classify them according to a 4-cluster classification (A: any PD, not specified; B: specific PD; C: pharmacology criteria and D: exclusion based on the clinician's judgment). The type of investigational drug, the route of administration and the type of cancer included in each trial were also collected.

Results

We analyzed a total of 117 protocols. The drugs most commonly studied included immune checkpoint blockers (44%), tyrosine kinase inhibitors (30%) and bispecific antibodies (15%). The most frequent route of administration was the intravenous route. A vast majority of ongoing studies (n=114, 97.4%) featured at least one criterion that could exclude patients with PD. Cluster D was the most prevalent (96.6%), followed by cluster C (14.5%), A (12.0%) and B (4.3%). Within cluster B, substance use disorder was the most frequently mentioned PD. In cluster C, all criteria concerned QT-prolonging drugs.

Conclusions

Nearly all the examined EPCT contained at least one criterion that could potentially result in the exclusion of patients with PD, most commonly based on subjective clinical judgment. Enhancing subjective clinical judgement with validated tools for evaluating consent capacity and future compliance may help in making more informed decisions and in reducing the impact of personal biases on the decision to exclude a patient with PD. Additionally, improved communication between psychiatry and oncology units engaged in clinical trials is also warranted.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

A. Hollebecque: Financial Interests, Personal, Invited Speaker: Servier, Incyte, Eisai; Financial Interests, Personal, Advisory Board: Basilea, Taiho, Relay Theraeutics, QED Therapeutics, Debiopharm, MSD, Boehringer Ingelheim; Financial Interests, Institutional, Funding: Incyte; Financial Interests, Institutional, Research Grant: AstraZeneca; Non-Financial Interests, Principal Investigator, M19-345: AbbVie; Non-Financial Interests, Principal Investigator, CO42216; WP42627; CO40939: Roche; Non-Financial Interests, Principal Investigator, MCLA-158: Merus; Non-Financial Interests, Principal Investigator, SGNB6A: Seatle Genetics; Non-Financial Interests, Principal Investigator, TAS-120-202: Taiho; Non-Financial Interests, Principal Investigator, Krystal-10: Mirati; Non-Financial Interests, Principal Investigator, ADP-0033: Adaptimmune; Non-Financial Interests, Principal Investigator, ACT16902: Sanofi; Non-Financial Interests, Principal Investigator, C4201002: Pfizer; Non-Financial Interests, Principal Investigator, RLY-4008: Relay Therapeutics; Non-Financial Interests, Principal Investigator, CC-90011: Celgene/BMS; Non-Financial Interests, Principal Investigator, Loxo-IDH: Loxo/Lilly; Non-Financial Interests, Principal Investigator: AstraZeneca; Non-Financial Interests, Principal Investigator, SN-201 study: Sotio; Non-Financial Interests, Principal Investigator, Tropics-03: Gilead; Non-Financial Interests, Principal Investigator, BI1403: Boehringer Ingelheim. J. Michot: Non-Financial Interests, Personal and Institutional, Local PI: AbbVie, Agios, Amgen, Argen-x, Astex, AstraZeneca, BeiGene, Blueprint, BMS, Boeringer Ingelheim, Celgene, Chugai, Clovis, Daiichi Sankyo, Debiopharm, Eisai, Eos, Axelixis, Forma, Gamamabs, Gortec, GSK, H3 biomedecine, Incyte, Innate Pharma, Janssen, Kura Oncology, Kyowa, Lilly, Loxo, Lysarc, Lytix Biopharma, Medimmune, Menarini, Merus, MSD, Nanobiotix, Nektar Therapeutics, Novartis, Octimet, Oncoethix, Oncopeptides AB, Orion, Pfizer, PharmaMar, Pierre Fabre, Roche, Sanofi, Seattle Genetics, Servier, Sierra Oncology, Taiho, Takeda, Tesaro, Xencor; Financial Interests, Personal, Advisory Board: Roche, AstraZeneca, Amgen; Non-Financial Interests, Personal, Other: Celgene, BMS, GSK. A. Marabelle: Financial Interests, Personal, Advisory Board: Gritstone, Innate Pharma, Neogene, Deka Biosciences, Hotspot Therapeutics, Johnson & Johnson, Departmenth Charge, Bioline Rx, Clover Biopharmaceuticals, Grey Wolf Therapeutics, Lytix Biopharma, RedX Pharma, HiFiBiO Therapeutics, ImCheck Therapeutics, Shattuck Labs, Marengo Therapeutics, PegaOne; Financial Interests, Personal, Other, Associate Editor: European Journal of Cancer; Financial Interests, Personal, Stocks/Shares: HiFiBiO Therapeutics, Deka Biosciences, HotSpot Therapeutics, Shattuck Labs; Financial Interests, Institutional, Research Grant: BMS, AstraZeneca, Sanofi; Financial Interests, Institutional, Coordinating PI: IMCheck, SOTIO, Roche/Genentech, MSD, BMS, OSE Immunotherapeutics, Eisai, Pierre Fabre, Adlai Nortye, Molecular Partners; Financial Interests, Steering Committee Member: Roche; Financial Interests, Institutional, Funding: Transgene; Non-Financial Interests, Other, Associate Editor: IOTECH Journal; Non-Financial Interests, Institutional, Product Samples: BMS, Idera, MSD, Transgene; Non-Financial Interests, Leadership Role: Société Française d'Immunothérapie des Cancers; Non-Financial Interests, Member: Society for Immunotherapy of Cancer, American Association for Cancer Research, American Society for Clinical Oncology; Other, Other, Consultant: Third Rock Ventures, Guidepoint; Other, Advisor: Medicxi. S. Champiat: Financial Interests, Personal, Invited Speaker: Amgen, Astellas, AstraZeneca, BMS, Eisai, Genmab, Janssen, Merck, Merck Serono, Novartis and Roche; Financial Interests, Personal, Other, Principal Investigator of Clinical Trials: AbbVie, Amgen, Boehringer Ingelheim, Cytovation, Eisai, Imcheck Therapeutics, Molecular Partners Ag, Merck, Ose Pharma, Pierre Fabre, Sanofi Aventis, Sotio A.S, Transgene; Financial Interests, Personal, Advisory Board: Alderaan Biotechnology, Amgen, AstraZeneca, Avacta, Celanese, Domain Therapeutics, Ellipses Pharma, Genmab, Immunicom, Inc., Nanobiotix, Nextcure, Oncovita, Pierre Fabre, Seagen, Tatum Bioscience, Tollys SAS, UltraHuman8; Financial Interests, Personal, Other, Travel and congress: Amgen, AstraZeneca, BMS, Merck, Ose Pharma, Roche, Sotio; Financial Interests, Institutional, Other, As part of the Drug Development Department (DITEP) =Principal/sub-Investigator of Clinical Trials: Adaptimmune, Adlai Nortye USA Inc, Aduro Biotech, Agios Pharmaceuticals, Amgen, Adaptimmune, AdlaiAstex Pharmaceuticals, AstraZeneca Ab, Aveo, Basilea Pharmaceutica International Ltd, Bayer Healthcare Ag, Bbb Technologies Bv, BeiGene, BicycleTx Ltd, Blueprint Medicines, Boehringer Ingelheim, Boston Pharmaceuticals, BMS, Ca, Casi Pharmaceuticals, Inc, Celgene Corporation, Cellcentric, Chugai Pharmaceutical Co, Cullinan-Apollo, Curevac, Daiichi Sankyo, Debiopharm, Eisai, Eisai Limited, Eli Lilly, Exelixis, Faron Pharmaceuticals Ltd, Forma Tharapeutics, Gamamabs, Genentech, GSK, H3 Biomedicine, Hoffmann La Roche Ag, Imcheck Therapeutics, Incyte Corporation, Imcheck Therapeutics, Incyte Corporation, Innate Pharma, Institut De Recherche Pierre Fabre, Iris Servier, Iteos Belgium SA, Janssen Cilag, Janssen Research Foundation, Janssen R&D LLC, Kura Oncology, Kyowa Kirin Pharm. Dev, Lilly France, Loxo Oncology, Medimmune, Menarini Ricerche, Merck Sharp & Dohme Chibret, Merrimack Pharmaceuticals, Merus, Molecular Partners Ag, Nanobiotix, Nektar Therapeutics, Novartis Pharma, Octimet Oncology Nv, Oncoethix, Oncopeptides, Orion Pharma, Genomics, Ose Pharma, Pfizer, PharmaMar, Pierre Fabre Medicament, Relay Therapeutics, Inc, Roche, Sanofi Aventis, Seattle Genetics, Sotio A.S, Syros Pharmaceuticals, Taiho Pharma, Tesaro, Transgene S.A, Turning Point Therapeutics, Xencor; Financial Interests, Institutional, Research Grant, As part of the Drug Development Department (DITEP) =Research Grants: AstraZeneca, BMS, Boehringer Ingelheim, GSK, INCA, Janssen Cilag, Merck, Pfizer, Roche, Sanofi; Non-Financial Interests, Institutional, Product Samples, As part of the Drug Development Department (DITEP) =Non-financial support (drug supplied): AstraZeneca, BMS, Boehringer Ingelheim, GSK, Medimmune, Merck, NH TherAGuiX, Pfizer, Roche. Y. Loriot: Financial Interests, Personal, Advisory Board: Merck Kga, Pfizer, Gilead, seattle genetics, Taiho; Financial Interests, Personal, Other, lectures, advisory boards: MSD, AstraZeneca, Astellas, Janssen; Financial Interests, Personal, Other, lectures, advisroy boards: Roche, BMS; Financial Interests, Institutional, Research Grant: Janssen, Sanofi, MSD, Roche, Celsius; Financial Interests, Institutional, Steering Committee Member: Janssen; Financial Interests, Steering Committee Member: MSD, Astellas, Gilead/immunomedics, Taiho; Financial Interests, Institutional, Local PI: Pfizer, MSD, Pfizer, Janssen, Exelexis, AstraZeneca, Merck Kga, BMS, Astellas, Gilead, Incyte; Financial Interests, Personal, Steering Committee Member: Basilea; Financial Interests, Institutional, Coordinating PI: Janssen; Non-Financial Interests, Other, scientific committee: ARC; Non-Financial Interests, Member: ESMO, ASCO, AACR. P. Rouby: Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Training: Pfizer, MSD, BMS, Pierre Fabre, Novartis, AstraZeneca, Lilly. C. Baldini: Financial Interests, Personal, Funding: BMS, Sanofi; Financial Interests, Personal, Financially compensated role: BMS, AstraZeneca, AbbVie. All other authors have declared no conflicts of interest.