RecruitingPhase 2NCT05451043

Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)

A Study to Evaluate the Efficacy of Propranolol in Boosting Immunotherapy in Hepatocellular Carcinoma, Cholangiocarcinoma and Pancreatic Adenocarcinoma

Sponsor

AHS Cancer Control Alberta

Enrollment

62 participants

Start Date

Jul 5, 2023

Study Type

INTERVENTIONAL

Conditions

Pancreatic Cancer Biliary Tract Cancer Cholangiocarcinoma Hepatocellular Cancer

Summary

A single-arm, interventional study combining Immunotherapy and propranolol with/without chemotherapy and propranolol 1. Pancreatic Cancer Durvalumab will be administered once every 4 weeks, in combination with gemcitabine + nab-paclitaxel (day 1/8/15) and continuous propranolol. Tremelimumab will be given on day 1 of cycle 1, which may be repeated at the time of progression in eligible patients. 2. HCC Durvalumab will be administered once every 4 weeks in combination with continuous propranolol. Tremelimumab will be given on day 1 of cycle 1, which may be repeated at the time of progression in eligible patients. 3. Biliary Tract Cancer (BTC, Cholangiocarcinoma of the gallbladder or bile ducts) Durvalumab will be administered once every 3 weeks, in combination with cisplatin + gemcitabine (day 1/8) and continuous propranolol. Tremelimumab will be given on day 1 of cycle 1, which may be repeated at the time of progression in eligible patients.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests adding two immunotherapy drugs (durvalumab and tremelimumab) plus a blood pressure medication (propranolol, which may have anti-cancer properties) to standard chemotherapy for people with advanced breast cancer that has spread to other parts of the body. **You may be eligible if...** - You have metastatic (spread) breast cancer - You are starting or about to start chemotherapy - Your general health is adequate for combination treatment - You are 18 or older **You may NOT be eligible if...** - You have active autoimmune disease that immunotherapy could worsen - You have severe asthma or breathing problems (propranolol is not safe in these cases) - You have uncontrolled heart rhythm problems or very low heart rate (propranolol lowers heart rate) - You are pregnant or breastfeeding - You have received prior immunotherapy that caused serious side effects Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALDurvalumab

It is a human immunoglobulin G1 kappa monoclonal antibody that blocks the interaction of programmed cell death ligand 1 with the PD-1. Durvalumab is known as a checkpoint inhibitor drug

DRUGGemcitabine

Gemcitabine is a nucleoside analog and a chemotherapeutic agent. As a prodrug, gemcitabine is transformed into its active metabolites that work by replacing the building blocks of nucleic acids during DNA elongation, arresting tumour growth and promoting apoptosis of malignant cells

DRUGNab paclitaxel

Nanoparticle albumin-bound (nab) paclitaxel is a form of paclitaxel which works as an antimicrotubule agent. Paclitaxel, the active ingredient in nab-paclitaxel promotes the assembly of microtubules from tubulin dimers and stabilizes microtubules by preventing depolymerization. This interferes with the normal dynamic reorganization of the microtubule network required for interphase and mitotic functions

BIOLOGICALTremelimumab

Tremelimumab is a fully human monoclonal antibody against CTLA-4. It is an immune checkpoint blocker.

DRUGPropranolol

Competitively blocks both β1 and β2 adrenergic receptors.

DRUGCisplatin

cisplatin has been associated with ability to crosslink with the urine bases on the DNA to form DNA adducts, preventing repair of the DNA leading to DNA damage and subsequently induces apoptosis within cancer cells.