Durvalumab + Chemotherapy for Biliary Tract Cancer
(TOPAZ-1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment for individuals with advanced biliary tract cancer, including cancers of the bile ducts and gallbladder. The researchers aim to determine if adding Durvalumab (an immunotherapy) to standard chemotherapy (Gemcitabine and Cisplatin) is more effective than chemotherapy alone. Participants will receive either the Durvalumab combination or a placebo with the chemotherapy. The trial seeks individuals with advanced or metastatic biliary tract cancer that cannot be surgically removed and who have not received prior treatment for it. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that durvalumab, when combined with gemcitabine and cisplatin, is generally well-tolerated by patients. One study found that this combination helped patients with advanced biliary tract cancer live longer compared to standard chemotherapy alone. Previous studies on durvalumab have demonstrated that its side effects are manageable, with no unexpected reactions.
Earlier research indicated that patients taking durvalumab experienced side effects similar to those from other treatments in its category, such as fatigue, nausea, and reduced appetite. Serious side effects were rare. Notably, durvalumab is already approved for treating other types of cancer, indicating that its safety profile is well understood.
Overall, these findings suggest that combining durvalumab with chemotherapy offers a promising and relatively safe option for treating advanced biliary tract cancer.12345Why do researchers think this study treatment might be promising for biliary tract cancer?
Researchers are excited about Durvalumab for biliary tract cancer because it works differently from standard treatments. While traditional therapies like gemcitabine and cisplatin focus on killing cancer cells directly, Durvalumab is an immunotherapy that helps the immune system recognize and attack cancer cells. This unique approach could potentially enhance the body's natural defenses to fight the cancer more effectively and with fewer side effects than conventional chemotherapy alone.
What evidence suggests that this trial's treatments could be effective for biliary tract cancer?
In this trial, participants will receive either durvalumab or a placebo alongside the usual chemotherapy drugs, gemcitabine and cisplatin. Research has shown that adding durvalumab to gemcitabine and cisplatin can greatly benefit people with advanced biliary tract cancer. Studies have found that this combination can help patients live longer and delay the progression of their cancer. Specifically, one study showed that fewer patients died when treated with durvalumab compared to those who received a placebo. These findings suggest that using durvalumab with chemotherapy might be more effective than chemotherapy alone for treating this type of cancer.14567
Who Is on the Research Team?
Gordon Cohen
Principal Investigator
AstraZeneca
Are You a Good Fit for This Trial?
This trial is for adults with advanced biliary tract cancer, including cholangiocarcinoma and gallbladder carcinoma. They should be in good physical condition (WHO/ECOG PS of 0 or 1) and have not been treated before if their disease was inoperable or metastatic at diagnosis. Those who had surgery or adjuvant therapy must have completed it over six months ago.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Durvalumab or Placebo in combination with Gemcitabine and Cisplatin
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Durvalumab
- Placebo
Durvalumab is already approved in European Union, United States, Japan for the following indications:
- Locally advanced, unresectable non-small cell lung cancer (NSCLC)
- Extensive-stage small cell lung cancer (ES-SCLC)
- Limited-stage small cell lung cancer (LS-SCLC)
- Locally advanced or metastatic urothelial carcinoma
- Not specified in provided sources
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology