Clinical Trials

Oncodistinct trials investigate existing and new therapies in all settings and are not dedicated to a specific trial phase or tumor type with a focus on:

trials & studies

Ongoing Oncodistinct studies

Multiorgan Metabolic Imaging Response Assessment of Abemaciclib (MiMe-A) – Oncodistinct 002

Open-label, phase II, non-randomized basket trial.
Basket trial to assess the efficacy of abemaciclib in multiple platinum-resistant tumour types by using metabolic imaging (PERCIST) and RECIST v1.1 criteria.

Find more on the scientific rationale here: https://vimeo.com/351181211

Study of Immunotherapy in Combination With Chemotherapy in HER2-negative Inflammatory Breast Cancer (PELICAN) – Oncodistinct 003

Open-label, phase II, multicentre, randomized trial.
This trial aims to assess the safety and efficacy of Pembrolizumab in combination with standard chemotherapy in inflammatory breast cancer. Pembrolizumab is administered every 3 weeks during the neoadjuvant chemotherapy. The primary endpoint is pathological complete response.

Avelumab as Neoadjuvant Therapy in Subjects With Urothelial Muscle Invasive Bladder Cancers (AURA) – Oncodistinct 004

Open-label, phase II, interventional, multi-centre, randomized trial.

The trial aims 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 is 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.

Short-course Radiation Followed by mFOLFOX-6 Plus Compound 2055269 for Locally-advanced Rectal Adenocarcinoma (AVERECTAL) – Oncodistinct 005

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.

A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours (BrainStorm) – Oncodistinct 006

Tackling the challenge of CNS metastases 

Building a multidisciplinary Brain Metastases Clinical Research Platform called BrainStorm. The BrainStorm program will focus on patients with newly diagnosed non-CNS metastatic solid tumors with high risk of developing CNS metastases and will allow building a large clinico pathological database for CNS metastases including ctDNA analyzes from CSF samples. Substudies will be proposed at each time-period with the final objective to develop innovative treatment approaches and strategies.

Neoadjuvant Regorafenib in Combination With Nivolumab and Short-course Radiotherapy in Intermediate-risk, Stage II-III Rectal Cancer (REGINA) – Oncodistinct 009

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.

Study of the Anti-CD73 IPH5301 Alone or in Combination With Chemotherapy and Trastuzumab in Patients With Advanced Solid Tumors (CHANCES) – Oncodistinct 011

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.

Other studies to come shortly…