Durvalumab + Chemotherapy for Biliary Tract Cancer

(TOPAZ-1 Trial)

Recruiting at 111 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AstraZeneca

Disqualifiers: Other malignancy, Brain metastases, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 14

Duration: 24 weeks

810 Participants Needed

Trial Summary

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)

Research Team

Gordon Cohen

Principal Investigator

AstraZeneca

Eligibility Criteria

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.

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Treatment Arm Experimental Treatment 1 Intervention

Durvalumab + Gemcitabine + Cisplatin

Group II: Placebo Arm Placebo Group 1 Intervention

Placebo + Gemcitabine + Cisplatin

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

Approved in European Union as Imfinzi for:

• Locally advanced, unresectable non-small cell lung cancer (NSCLC)

Approved in United States as Imfinzi for:

• Extensive-stage small cell lung cancer (ES-SCLC)
• Limited-stage small cell lung cancer (LS-SCLC)
• Locally advanced or metastatic urothelial carcinoma

Approved in Japan as Imfinzi for:

• Not specified in provided sources

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