Oncodistinct studies investigate existing and new therapies in all settings and are not dedicated to a specific trial phase or tumor type with a focus on:
Open-label, phase II, non-randomized basket trial assessing the efficacy of Abemaciclib in multiple platinum-resistant tumour types (cholangiocarcinoma, endometrial, urothelial carcinomas, oesophagal adeno- and squamous cell carcinomas)by using metabolic imaging (PERCIST) and RECIST v1.1 criteria.
Find more on the scientific rationale here: https://vimeo.com/351181211
American Association for Cancer Research: Abstract CT530 ; Crossref DOI link: https://doi.org/10.1158/1538-7445.AM2022-CT530
Open-label, phase II, prospective, multicentre, randomized, non-comparative trial assessing the safety and efficacy of Pembrolizumab in combination with standard chemotherapy in inflammatory breast cancer. Pembrolizumab was administered every 3 weeks during the neoadjuvant chemotherapy. The primary endpoint was the central evaluation of pathological complete response (pCR) of the resected breast specimen and all sampled ipsilateral lymph nodes following NACT with/without pembrolizumab.
The study, promoted by Institut Paoli-Calmettes (Marseille, France) was conducted in up to 21 centers (13 in France, 8 in Belgium).
Funding : MSD France provided financial support and the supply of the study drug for the trial.
Front. Oncol. 2020 Nov 25;10:575978. doi: 10.3389/fonc.2020.575978
The Open-label, phase II, interventional, multi-centre, randomized trial aimed to evaluate neoadjuvant Avelumab in combination with standard neoadjuvant chemotherapy or monotherapy in non-metastatic muscle invasive bladder cancer (MIBC) patients (both cisplatin eligible and ineligible. The primary endpoint was pathological complete response.
Find more here: https://vimeo.com/415416350 (Dutch version), and here https://vimeo.com/415419674 (French version) ESMO presentation can be found here. ASCO publications 2022 & 2024 (survival data).
The study, promoted by Institut Jules Bordet (Brussels, Belgium) was conducted in France and Belgium.
Funding : Merck provided financial support and the supply of the study drug for the trial.
Open-label, phase II, interventional, multi-centre, randomized trial.
The trial aims to evaluate Avelumab in combination with standard folfox chemotherapy following short course radiation therapy as neoadjuvant treatment for locally advanced rectal cancer patients. The primary endpoint is pathological complete response.
ESMO presentation can be found here.
Tackling the challenge of CNS metastases and Building a multidisciplinary Brain Metastases Clinical Research Platform.
The BrainStorm program focuses on patients with newly diagnosed non-CNS metastatic solid tumors with high risk of developing CNS metastases and allows building a large clinico pathological database for CNS metastases including ctDNA analyzes from CSF samples. Substudies are proposed at each time-period with the final objective to develop innovative treatment approaches and strategies.
A phase II trial of neoadjuvant Regorafenib in combination with Nivolumab and short-course radiotherapy in intermediate-risk, stage II-III rectal cancer.
The trial aims to evaluate the efficacy of the combination of nivolumab and regorafenib when administered before and after standard, pre-operative short-course radiation therapy.
A phase I first in human study of the anti CD73, IPH5301 in combination with chemotherapy with or without trastuzuman in patients with advanced solid tumors.
The trial aims to evaluate the occurrence of dose limiting toxicity (DLT) of IPH5301 in monotherapy in the dose escalation and in combination with paclitaxel and trastuzumab in the expansion cohort.
The trial is conducted in two parts, Part I- Dose escalation: This part aims to identify the maximum tolerated dose (MTD) of IPH5301 agent in monotherapy and recommended phase 2 dose (RP2D) for future trials, followed by a safety expansion study part cohort. Part II- Expansion cohort: A total of 12 HER2-expressing breast cancer patients is planned to be enrolled into the next expansion cohort to select a recommended dose of IPH5301 to be administered in combination with chemotherapy and trastuzumab for evaluation in future trials with selected advanced solid tumors.
The study is promoted by Institut Paoli-Calmettes (Marseille, France) and is conducted in France (2 center) and Belgium (1 center).
Project funded by Innate Pharma.
International, multicentre, single-arm study in chemo-refractory mCRC patients treated with standard chemotherapy, incorporating analysis of serial blood samples and archived tumour tissue for ctDNA to assess its dynamics and correlation with treatment outcomes and prognosis.
The study aims to identify the optimal timepoint and cut-off for early on-treatment ctDNA changes (assessed by F1LCDx and F1Monitor) that most accurately predict progressive disease as the best radiological response, with high specificity.
Multicentre, open-label, randomised, pragmatic clinical trial, comparing standard-of-care neoadjuvant treatment options for older (i.e., ≥70 years) subjects with high-risk stage II and stage III rectal cancer.
The primary objective is to assess whether SCRT is a better trade-off between efficacy and safety than TNT in an older RC population.
Sponsored by Institut Jules Bordet with 19 participating centers in Belgium.
Collaboration & funding from KCE (Belgian Health Care Knowledge Centre) : https://kce.fgov.be/en/kce-trials
ESMO Gastrolintestinal Oncology ; Published online June 5, 2024 DOI: 10.1016/j.esmogo.2024.100067
Retrospective cohort study conducted accross 7 centers in Belgium, Cyprus, Italy and France, including from January 2017 to December 2025, ER+/HER2- mBc patients treated with CDK4/6i in 1st- or 2nd-line who received at least >1 subsequent line of systemic therapy (LoT).
Primary objective:characterize the real-world effectiveness of the immediate next line of therapy after progression on CDK4/6i
ESMO Breast – May 2026 : poster 465P
Fundings : Novartis
Study chairs
Pr Ahmad AWADA, MD, PhD (Institut Jules Bordet, Brussels, Belgium)
François CHERIFI, MD (Centre François Baclesse, Caen, France)
Diogo MARTINS-BRANCO, MD (European Society for Medical Oncology, Switzerland)
First multicenter (14 European sites) retrospective analysis evaluating subsequent systemic therapies after cabozantinib-based treatment in metastatic renal cell carcinoma (mRCC). From August 2018 to December 2025, patients treated for mRCC that received at least one systemic treatment after progression under cabo.-based 1st (Group A) or 2nd line (Group B) were included.
Abstract 523000 : CABONEXT study confirms the antitumoral efficacy of second-generation TKI (mostly axitinib and lenvatinib) after 1st to 2nd line cabozantinib
Med. Sci. Forum 2025, 39(1), 2; https://doi.org/10.3390/msf2025039002
Study chair: Dr. Philippe Barthelemy Institut de Cancérologie Strasbourg Europe
International Real-World TNT Study Consortium : This international, multicenter study was conducted at 61 centers across 21 countries and included consecutive patients treated off trial with TNT for stage II/III rectal adenocarcinoma from September 2012 to December 2023. Data were analyzed between August and October 2024.
Nov 26, 2025 JAMA Oncology DOI:10.1001/jamaoncol.2025.5094 Comment & Response
July 10, 2025 JAMA Oncol DOI: 10.1001/jamaoncol.2025.2026 Case series study examines the use and outcomes of total neoadjuvant therapy in routine practice for patients with rectal cancer
This is a multicenter, international, retrospective study, including patients with localised gastric and gastro-oesophageal junction (GOJ) cancer eligible for a perioperative treatment based on FLOT4-AIO protocol.
Aim : This study will aim to report the landscape of HER2 overexpression in localised gastric/GOJ cancer.
Study chairs:
Dr. Georgios Tsironis (Consultant of Medical Oncology at the Bank of Cyprus Oncology Centre in Nicosia)
Dr. Demetris Papamichael (Director of Medical Oncology at the Bank of Cyprus Oncology Centre, Nicosia)
Retrospective observational study including patients diagnosed with stage II-III triple-negative breast cancer (TNBC) who underwent neoadjuvant chemotherapy (NACT) combined with immunotherapy (ICI) treated between April 2022 and June 2025 – currently 5 recruiting centres
Clinical data and pathology slides are collected at key timepoints, including baseline (pre-treatment) and at surgery (post-neoadjuvant treatment), while MRI data, when available, may include pre-treatment, mid-treatment, and post-treatment imaging. The primary objective is to develop a multimodal tool to predict pathological response in patients with TNBC treated with NACT + ICI according to the KN-522 regimen.
Study chairs:
Dr. GAndrea Gombos (Institut Jules Bordet, Brussels, Belgium)
Dr. Fatima Moujahid, MD (Institut Jules Bordet, Brussels, Belgium)
Collaborators : Roberto Salgado, MD, PhD – Pathologist ZAS-Hospitals, Antwerp, Belgium and TILs working group Peter Mac Callum Cancer Centre, Melbourne, Victoria, Australia ; Xavier Catteau, Pathologist Institut Jules Bordet & CurePath ; Stylianos Drisis, MD, PhD – Radiologist Institut Jules Bordet
