The goal of this clinical trial is to etablish whether adding Mitazalimab to standard chemotherapy is more effective than standard chemotherapy alone in people with advanced bile duct cancer. It will also learn about the safety of Mitazalimab.
The main questions it aims to answer are:
* Does the addition of Mitazalimab enhance efficacy? * What medical problems do participants have when taking Mitazalimab + mFOLFOX?
Participants will:
* Take drug mFOLFOX every two weeks until disease progression or mFOLFOX every two weeks plus mitazalimab in addition to mFOLFOX, with a first injection 7 days before the first mFOLFOX chemotherapy and then 3 days after the start of each mFOLFOX cycle. * Visit the clinic once every 2 weeks for checkups and tests * Have a radiological assessment every 8 weeks during treatment. After stopping treatment, participants will be monitored at the hospital every 8 weeks if no progression is observed, or every 12 weeks after disease progression.
Age ≥18 years
Histologically-proven intrahepatic cholangiocarcinoma, extrahepatic (perihilar/distal) cholangiocarcinoma, or gallbladder carcinoma (ampullary carcinoma excluded)
Measurable tumor according to RECIST v1.1 classification
Non-resectable or metastatic disease or recurrent after surgery (if recurrence more than 6 months after adjuvant treatment stop)
Participants having received previous treatment with fluoropyrimidine, oxaliplatin or CD40 agonist, except for capecitabine given as adjuvant treatment (if last administered > 6 months).
Concurrent malignancy (other than BTC), with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for 3 years or more and are deemed at negligible risk for recurrence, are eligible for the trial
Known CNS metastases or carcinomatous meningitis
History of chronic diarrhea, inflammatory disease of the colon or rectum, or unresolved partial or complete intestinal obstruction
Parallel
mFOLFOX regimen
Drugoxaliplatin 85 mg/m² intravenous infusion (IV), folinic acid 400 mg/m² IV (or L-folinic acid 200 mg/m²), and fluorouracil (5-FU) 400 mg/m² IV bolus; followed by 5 FU 2400 mg/m² as a 46-hours continuous IV infusion: * every two week (14-day cycles) until disease progression on control arm * at D8 the first cycle and at D1 for subsequent cycles (14-day cycles) until disease progression on experimental arm
Mitazalimab
DrugThe first cycle of treatment (21-day cycle): Mitazalimab 900 µg/kg by intravenous infusion (IV) at D1 and D10 Subsequent cycles (14-day cycles): Mitazalimab 900 µg/kg by intravenous infusion (IV) at D3 of each cycle until disease progression
6 months overall survival rate of participants
Proportion of participant still alive 6 months after randomisation
Safety of the treatments
Adverse events will be collected and scored according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) common criteria v 6.0. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders.
Objective response rate of participants (ORR)
The objective response rate is defined as the percentage of participants with a complete response (CR) or a partial response (PR) on CT-scan for a given treatment
Disease control rate (DCR)
Proportion of participants with stable disease, or partial response or complete response on CT-Scan
Progression-free survival (PFS)
The Progression free survival is the lengh of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse
Click on the lead sponsor to view all of their trials.
UNICANCER
Lead sponsor
Alligator Bioscience AB
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
