810 Participants Needed

Durvalumab + Chemotherapy for Biliary Tract Cancer

(TOPAZ-1 Trial)

Recruiting at 111 trial locations
AC
AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: AstraZeneca
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)

Who Is on the Research Team?

GC

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

I am fully active or can carry out light work.
My disease was advanced or spread to other parts when first diagnosed and hasn't been treated yet.
My cancer is in the bile ducts or gallbladder and cannot be surgically removed.
See 1 more

Exclusion Criteria

I have cancer that has spread to my brain or spinal cord.
I haven't had major surgery in the last 28 days.
I have had another type of cancer in the past.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Durvalumab or Placebo in combination with Gemcitabine and Cisplatin

24 weeks
Tumor assessments every 6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

27 months
Tumor assessments every 8 weeks after the first 24 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Durvalumab
  • Placebo
Trial Overview The study tests Durvalumab (an immunotherapy drug) combined with Gemcitabine/Cisplatin chemotherapy versus a placebo plus the same chemotherapy in patients facing their first line of treatment for advanced biliary tract cancer.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment ArmExperimental Treatment1 Intervention
Group II: Placebo ArmPlacebo Group1 Intervention

Durvalumab is already approved in European Union, United States, Japan for the following indications:

🇪🇺
Approved in European Union as Imfinzi for:
🇺🇸
Approved in United States as Imfinzi for:
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Approved in Japan as Imfinzi for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

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

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