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Monoclonal Antibodies

Atezolizumab for Biliary Tract Cancer

Phase 2
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No prior systemic therapy for advanced BTC
Adequate biliary drainage with no evidence of ongoing infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomization up to approximately 3-5 years
Awards & highlights

Study Summary

This trial will test if adding atezolizumab and bevacizumab to cisplatin and gemcitabine will work better than just adding atezolizumab to cisplatin and gemcitabine to treat advanced biliary tract cancer in people who haven't had prior systemic therapy.

Eligible Conditions
  • Biliary Tract Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have not received any previous treatment for advanced biliary tract cancer.
Select...
Your bile ducts are draining properly and you don't have any signs of ongoing infection.
Select...
You are expected to live for more than 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomization up to approximately 3-5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization up to approximately 3-5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
Confirmed Objective Response Rate (ORR)
Disease Control Rate (DCR)
Duration of Response (DOR)
+6 more

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227
27%
Fatigue
25%
Decreased appetite
24%
Cough
19%
Dyspnoea
19%
Asthenia
18%
Constipation
18%
Pyrexia
18%
Nausea
16%
Diarrhoea
13%
Arthralgia
12%
Vomiting
12%
Anaemia
11%
Back pain
11%
Musculoskeletal pain
11%
Rash
10%
Headache
9%
Oedema peripheral
9%
Weight decreased
9%
Chest pain
9%
Insomnia
9%
Pruritus
9%
Pain in extremity
8%
Dizziness
7%
Upper respiratory tract infection
7%
Aspartate aminotransferase increased
7%
Myalgia
7%
Haemoptysis
6%
Influenza like illness
6%
Nasopharyngitis
6%
Alanine aminotransferase increased
6%
Bronchitis
6%
Productive cough
5%
Musculoskeletal chest pain
5%
Depression
5%
Dry skin
4%
Abdominal pain
4%
Urinary tract infection
4%
Neuropathy peripheral
4%
Paraesthesia
3%
Stomatitis
3%
Dysgeusia
3%
Pneumonia
2%
Malaise
2%
Pleural effusion
2%
Neutropenia
1%
Lacrimation increased
1%
Respiratory tract infection
1%
Sepsis
1%
Pneumonitis
1%
Mucosal inflammation
1%
Bone pain
1%
Pulmonary embolism
1%
Peripheral sensory neuropathy
1%
Alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Atezolizumab
Docetaxel

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A: Atezo+Bev+CisGem, followed by Atezo+BevExperimental Treatment4 Interventions
Participants will receive atezolizumab intravenously on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, and clinical status. Participants will receive bevacizumab intravenously on Day 1 of each 21-day cycle. Participants will receive cisplatin intravenously followed by gemcitabine on Days 1 and 8 of each 21-day cycle for Cycles 1-8.
Group II: Arm B: Atezo+PBO+CisGem, followed by Atezo+PBOActive Control4 Interventions
Participants will receive atezolizumab intravenously on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, and clinical status. Participants will receive placebo matching bevacizumab intravenously on Day 1 of each 21-day cycle. Participants will receive cisplatin intravenously followed by gemcitabine on Days 1 and 8 of each 21-day cycle for Cycles 1-8.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~2070
Atezolizumab
2016
Completed Phase 3
~6040
Bevacizumab
2013
Completed Phase 4
~5280
Cisplatin
2013
Completed Phase 3
~1940

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,426 Previous Clinical Trials
1,089,007 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,197 Previous Clinical Trials
888,435 Total Patients Enrolled

Media Library

Atezolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04677504 — Phase 2
Biliary Tract Cancer Research Study Groups: Arm A: Atezo+Bev+CisGem, followed by Atezo+Bev, Arm B: Atezo+PBO+CisGem, followed by Atezo+PBO
Biliary Tract Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT04677504 — Phase 2
Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04677504 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential risks does Atezolizumab pose to people?

"Atezolizumab is deemed to be moderately safe, as it has been graded a 2 out of 3. This rating acknowledges the existing safety data from this phase two trial without any efficacy evidence yet available."

Answered by AI

Can you elucidate any prior research projects involving Atezolizumab?

"Currently, 1527 studies are conducting analysis on Atezolizumab with 452 of them at the final phase 3. While most trials take place in Shanghai, there is a total number of 77605 locations running investigative research on this drug."

Answered by AI

How many participants are being monitored in this research endeavor?

"At this moment, the clinical trial is not taking on new patients. Initially posted in February 2021 and last updated in September 2022, it appears to be closed for enrollment. Should you seek other trials related to biliary tract cancer or Atezolizumab, there are presently 104 and 1527 studies actively looking for participants respectively."

Answered by AI

How many medical centers have implemented this clinical trial?

"11 medical centres are currently conducting this trial, including University of Virginia in Charlottesville, Uni of Southern California; Norris Comprehensive Cancer Ctr in Los Angeles and Centre Universitaire de sante de l'Estrie (CHUS) in Sherbrooke. Additionally, several other locations have been approved to participate as well."

Answered by AI

What medical conditions is Atezolizumab regularly used to address?

"Atezolizumab is often used to abate recurrent platinum-sensitive epithelial ovarian cancer, but has also been found to be beneficial for metastatic ureter urothelial carcinoma, malignant neoplasms, and chronic cervical cancer."

Answered by AI

Are there any vacancies available in this study for participants?

"This experiment, which was initially posted on February 23rd 2021, is not currently accepting patients. The study's most recent update occured on September 29th 2022 and as of now there are no more recruitment needs. However, 1631 other studies remain in search for test subjects."

Answered by AI
~40 spots leftby Mar 2025