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:

  • New drugs development from phase I to later phases trials
  • Innovative trial designs
  • Unmet medical need projects (e.g. rare tumors, oligometastasis, brain metastasis, inflammatory breast cancer…)
  • Development of immunotherapy and other new agents in the early setting (e.g. neoadjuvant…)
  • Biomarkers studies with high potential for clinical practice
  • “Proof of concept” studies

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.

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.
 

Short-course Radiation Followed by mFOLFOX-6 Plus Avelumab Locally-advanced Rectal Adenocarcinoma – 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.

Other studies to come shortly…