Abstract 1350P
Background
In the past few years several adaptive, multi-drug, multi-stage, pan-cancer trials have been launched based on the concept of the Drug Rediscovery Protocol (DRUP). These trials independently study the effect of existing medicines on specific genomic aberrations outside their approved label. Because these are rare cancers with uncommon mutations, patient accrual is slow.
Methods
To address this problem, we have adopted a prospective multiplatform recruitment approach. The first cohort that will be jointly and simultaneously rolled out in several international DRUP-like studies, investigates the effect of the PARP inhibitor olaparib, across all histologic tumour types with biallelic BRCA loss, outside of EMA-approved indications.
Results
In a joint effort across all accruing DRUP-like studies (i.c. IMPRESS, ProTarget, FINPROVE, MEGALiT), investigators have shared all the essential documents and templates of the trial (protocol, eCRF, informed consent) to facilitate data aggregation and joint analysis. Scientific advice has been solicited from EMA for potential regulatory approval. Also, relevant HTA bodies and payers from each country will be consulted to ensure timely assessment and reimbursement.
Conclusions
Adequate and rapid patient recruitment is vital to the success of each clinical trial. A multiplatform accrual for rare tumours will also facilitate inclusion of patients with these rare cancers and hence improve opportunities for better treatment by speeding up recruitment, analysis of the data and translation of the results. Furthermore, the total trial costs will be divided between the platforms. This is especially important as academic-led studies have limited financial resources. Unlike pharmaceutical-sponsored trials our platforms are independent and have no marketing objectives. Our main focus is improving cancer care for all patients, including those with more severe symptoms or comorbidities. Bridging the platforms of the adaptive clinical trials empowers cancer research and enables timely accrual for rare indications.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
K.S. Rohrberg: Financial Interests, Personal, Invited Speaker: Bayer, Amgen; Financial Interests, Institutional, Invited Speaker, Compensation for conduction of clinical trial.: Lilly, Roche/Genentech, Bristol-Myers Squibb, Symphogen, Pfizer, Novartis, Alligator Bioscience, Genmab, Bioinvent, Monta Bioscience; Financial Interests, Institutional, Other, Compensation for conduction of clinical trial: Bayer, Incyte, Puma Biotechnology, Orion Clinical. K. Peltola: Financial Interests, Personal, Advisory Board: MSD, Ipsen, Roche, BMS, Pfizer, Lilly, Novartis; Financial Interests, Personal, Stocks/Shares: Faron Pharmaceuticals; Financial Interests, Institutional, Invited Speaker, Conduct of sponsored clinical trial: Novartis; Financial Interests, Institutional, Invited Speaker, Sponsored clinical trial: Exelixis; Financial Interests, Institutional, Invited Speaker, Several clinical trials: BMS, MSD, Roche; Financial Interests, Institutional, Invited Speaker, clinical trials: Incyte; Financial Interests, Institutional, Invited Speaker, Conduct of clinical trials: Pfizer. M.V.J. Mustonen: Financial Interests, , Stocks/Shares: Orion Corporation. U.N. Lassen: Financial Interests, Personal, Advisory Board: Bayer, Novartis; Financial Interests, Institutional, Research Grant: Roche, BMS, Pfizer, GSK. A. Helland: Financial Interests, Institutional, Advisory Board, Advisory boards: Jansen, Takeda, AstraZeneca, Abbvie, Roche, BMS, Pfizer, MSD, Bayer, Lilly; Financial Interests, Institutional, Invited Speaker, talks at meetings: AstraZeneca, Roche, Abbvie, Pfizer; Financial Interests, Institutional, Invited Speaker, BMS provides drug to patients in an investigator initiated clinical trial: BMS; Financial Interests, Institutional, Invited Speaker, Ultimovacs provides drug and funds for investigator initiated clinical trial: Ultimovacs; Financial Interests, Institutional, Invited Speaker, AstraZeneca provides drug and funds for investigator initiated clinical trial: AstraZeneca; Financial Interests, Institutional, Invited Speaker, Roche provides drug and funds for investigator initiated clinical trial: Roche; Financial Interests, Institutional, Invited Speaker, Novartis provides drug and funds for clinical trial: Novartis; Financial Interests, Institutional, Invited Speaker, Eli Lilly provides drug and funds for clinical stduy: Eli Lilly; Financial Interests, Institutional, Invited Speaker, Incyte provides drug and funds for clinical stduy: Incyte; Non-Financial Interests, Other, Board member in the patient organisation. Provides advice and gives talks: The lung cancer patients organisation. H. Gelderblom: Financial Interests, Institutional, Invited Speaker: Daiichi, Deciphera, Novartis, Boehringer Ingelheim, AmMax Bio, Debiopharm, Cytovation. E.E. Voest: Financial Interests, Personal, Advisory Board, Hourly rate, to charity: Biogeneration Ventures; Financial Interests, Institutional, Advisory Board, Hourly rate, no compensation in 2019-2020: InteRNA; Financial Interests, Institutional, Invited Speaker, DRUP trial: Amgen, AstraZeneca, Boehringer Ingelheim, BMS, Clovis Oncology, Eisai, Ipsen, MSD, Novartis, Pfizer, GSK, Seattle Genetics; Financial Interests, Institutional, Invited Speaker, DRUP trialDRUG Access Protocol: Bayer, Roche; Financial Interests, Institutional, Invited Speaker, DRUG Access Protocol: Sanofi; Non-Financial Interests, Other, Supervisory Board: HMF – Hartwig Medical Foundation; Non-Financial Interests, , Principal Investigator, Senior group leader: Oncode Institute; Non-Financial Interests, Advisory Role, Editorial Board: JAMA Oncology; Non-Financial Interests, Leadership Role, Board of Directors: Cancer Core Europe. All other authors have declared no conflicts of interest.