Trial · NCT04677504
A Study of Atezolizumab With or Without Bevacizumab in Combination With Cisplatin Plus Gemcitabine in Patients With Untreated, Advanced Biliary Tract Cancer
NCT04677504, Phase 2, Completed, Hoffmann-La Roche; results first posted 2023-06-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Atezolizumab With or Without Bevacizumab in Combination With Cisplatin Plus Gemcitabine in Patients With Untreated, Advanced Biliary Tract Cancer. Trials, record NCT04677504. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04677504
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Atezolizumab With or Without Bevacizumab in Combination With Cisplatin Plus Gemcitabine in Patients With Untreated, Advanced Biliary Tract Cancer
- NCT number
- NCT04677504
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 162 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Biliary Tract Cancer
- Interventions
- Atezolizumab, Bevacizumab, Placebo, Cisplatin, Gemcitabine
- First posted
- 2020-12-21
- Last updated
- 2024-07-03
- Results first posted
- 2023-06-29
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | Randomization to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first)(up to approximately 14 months) | PFS is defined as the time from randomization to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first) |
| Secondary | Overall Survival (OS) | Randomization to death from any cause (up to approximately 23 months) | OS is defined as the time from randomization to death from any cause. |
| Secondary | Confirmed Objective Response Rate (ORR) | Randomization up to approximately 14 months | Confirmed ORR is defined as the proportion of participants with Complete Response (CR) or Partial Response (PR) on two consecutive occasions \>=4 weeks apart, as determined by the investigator according to RECIST v1.1. |
| Secondary | Duration of Response (DOR) | First occurrence of a confirmed objective response to disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first)(up to approximately 14 months) | DOR is defined as the time from the first occurrence of a confirmed objective response to disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first). |
| Secondary | Disease Control Rate (DCR) | Randomization up to approximately 14 months | DCR is defined as the proportion of participants with a CR or a PR on two consecutive occasions \>= 4 weeks apart or SD with a minimum duration of 9weeks, as determined by the investigator according to RECIST v1.1 |
| Secondary | Time to Confirmed Deterioration (TTCD) | Randomization to the first clinically meaningful deterioration (up to approximately 14 months) | TTCD in patient-reported physical functioning, role functioning, and quality of life, as measured by the respective scales of the EORTC QLQ-C30 and/or EORTC IL77, and defined as the time from randomization to the first clinically meaningful deterioration that is either maintained for two consecutive assessments or followed by death from any cause within 3 weeks. |
| Secondary | Percentage of Participants With at Least One Adverse Event | Treatment start up to approximately 30 months. | Percentage of participants with at least one adverse event. |
| Secondary | Serum Concentration of Atezolizumab | Pre-Dose on Day 1 of Cycles 1, 2, 3, 4, 8, 12, and 16, and Post Dose Day 1 of Cycle 1 (cycle length=21 days) | Serum concentration of atezolizumab at specified timepoints. |
| Secondary | Prevalence of ADAs to Atezolizumab | Baseline | |
| Secondary | Incidence of ADAs to Atezolizumab | At pre-defined intervals from administration of study drug up to approximately 14 months |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) | Randomization to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first)(up to approximately 14 months) | Analysis was performed on the Intent-to-treat (ITT) population, defined as all randomized participants, regardless of whether they received the assigned treatment or not, were included for analyses with participants grouped according to the treatment assigned at randomization. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Randomization to death from any cause (up to approximately 23 months) | Analysis was performed on the Intent-to-treat (ITT) population, defined as all randomized participants, regardless of whether they received the assigned treatment or not, were included for analyses with participants grouped according to the treatment assigned at randomization. | Months | MEDIAN |
| SECONDARY | Confirmed Objective Response Rate (ORR) | Randomization up to approximately 14 months | Analysis was performed on the Intent-to-treat (ITT) population, defined as all randomized participants, regardless of whether they received the assigned treatment or not, were included for analyses with participants grouped according to the treatment assigned at randomization. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | First occurrence of a confirmed objective response to disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first)(up to approximately 14 months) | Analysis was performed on the Intent-to-treat (ITT) population, defined as all randomized participants, regardless of whether they received the assigned treatment or not, were included for analyses with participants grouped according to the treatment assigned at randomization. | Months | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) | Randomization up to approximately 14 months | Analysis was performed on the Intent-to-treat (ITT) population, defined as all randomized participants, regardless of whether they received the assigned treatment or not, were included for analyses with participants grouped according to the treatment assigned at randomization. | Percentage of participants | NUMBER |
| SECONDARY | Time to Confirmed Deterioration (TTCD) | Randomization to the first clinically meaningful deterioration (up to approximately 14 months) | Analysis was performed on the Intent-to-treat (ITT) population, defined as all randomized participants, regardless of whether they received the assigned treatment or not, were included for analyses with participants grouped according to the treatment assigned at randomization. | Months | MEDIAN |
| SECONDARY | Percentage of Participants With at Least One Adverse Event | Treatment start up to approximately 30 months. | Safety analyses will be performed on the safety-evaluable population, which is defined as all randomized participants who receive any amount of any component of protocol treatment. | Percentage of participants | NUMBER |
| SECONDARY | Serum Concentration of Atezolizumab | Pre-Dose on Day 1 of Cycles 1, 2, 3, 4, 8, 12, and 16, and Post Dose Day 1 of Cycle 1 (cycle length=21 days) | The PK analysis population consisted of all participants with at least 1 PK assessment. | μg/ mL | MEAN |
| SECONDARY | Prevalence of ADAs to Atezolizumab | Baseline | The immunogenicity analysis population consist of all participants with at least 1 postbaseline ADA assessment. Participants are grouped according to treatment received. No data were collected because the study was discontinued before any measurements were completed. | ||
| SECONDARY | Incidence of ADAs to Atezolizumab | At pre-defined intervals from administration of study drug up to approximately 14 months | The immunogenicity analysis population consist of all participants with at least 1 postbaseline ADA assessment. Participants are grouped according to treatment received. No data were collected because the study was discontinued before any measurements were completed. |
Source ClinicalTrials.gov
Results by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) | Arm B: Atezo+PBO+CisGem (Cycle*1-8), Followed by Atezo+PBO (Cycle*9 and Beyond) | 7.92 | 95% Confidence Interval 6.18 to 8.41 | Months | |
| Progression Free Survival (PFS) | Arm A: Atezo+Bev+CisGem (Cycle*1-8), Followed by Atezo+Bev (Cycle*9 and Beyond) | 8.35 | 95% Confidence Interval 6.83 to 9.96 | Months | |
| Overall Survival (OS) | Arm B: Atezo+PBO+CisGem (Cycle*1-8), Followed by Atezo+PBO (Cycle*9 and Beyond) | 14.59 | 95% Confidence Interval 11.17 to NA | Months | |
| Overall Survival (OS) | Arm A: Atezo+Bev+CisGem (Cycle*1-8), Followed by Atezo+Bev (Cycle*9 and Beyond) | 14.85 | 95% Confidence Interval 11.63 to 17.97 | Months | |
| Confirmed Objective Response Rate (ORR) | Arm B: Atezo+PBO+CisGem (Cycle*1-8), Followed by Atezo+PBO (Cycle*9 and Beyond) | 25.3 | Percentage of participants | ||
| Confirmed Objective Response Rate (ORR) | Arm A: Atezo+Bev+CisGem (Cycle*1-8), Followed by Atezo+Bev (Cycle*9 and Beyond) | 24.1 | Percentage of participants | ||
| Duration of Response (DOR) | Arm B: Atezo+PBO+CisGem (Cycle*1-8), Followed by Atezo+PBO (Cycle*9 and Beyond) | 5.78 | 95% Confidence Interval 4.27 to 6.70 | Months | |
| Duration of Response (DOR) | Arm A: Atezo+Bev+CisGem (Cycle*1-8), Followed by Atezo+Bev (Cycle*9 and Beyond) | NA | 95% Confidence Interval 6.44 to NA | Months | |
| Disease Control Rate (DCR) | Arm B: Atezo+PBO+CisGem (Cycle*1-8), Followed by Atezo+PBO (Cycle*9 and Beyond) | 75.9 | Percentage of participants | ||
| Disease Control Rate (DCR) | Arm A: Atezo+Bev+CisGem (Cycle*1-8), Followed by Atezo+Bev (Cycle*9 and Beyond) | 78.5 | Percentage of participants |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm B: Atezo+PBO+CisGem (Cycle*1-8), Followed by Atezo+PBO (Cycle*9 and Beyond) | 83 | |
| Overall Study | STARTED | Arm A: Atezo+Bev+CisGem (Cycle*1-8), Followed by Atezo+Bev (Cycle*9 and Beyond) | 79 | |
| Overall Study | COMPLETED | Arm B: Atezo+PBO+CisGem (Cycle*1-8), Followed by Atezo+PBO (Cycle*9 and Beyond) | 0 | |
| Overall Study | COMPLETED | Arm A: Atezo+Bev+CisGem (Cycle*1-8), Followed by Atezo+Bev (Cycle*9 and Beyond) | 0 | |
| Overall Study | NOT COMPLETED | Arm B: Atezo+PBO+CisGem (Cycle*1-8), Followed by Atezo+PBO (Cycle*9 and Beyond) | 83 | |
| Overall Study | NOT COMPLETED | Arm A: Atezo+Bev+CisGem (Cycle*1-8), Followed by Atezo+Bev (Cycle*9 and Beyond) | 79 |
Source ClinicalTrials.gov
Adverse events306
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Arm B: Atezo+PBO+CisGem (Cycle*1-8), Followed by Atezo+PBO (Cycle*9 and Beyond) | 51 | 81 | 88 |
| other | Anaemia | Blood and lymphatic system disorders | Arm A: Atezo+Bev+CisGem (Cycle*1-8), Followed by Atezo+Bev (Cycle*9 and Beyond) | 37 | 78 | 59 |
| other | Neutropenia | Blood and lymphatic system disorders | Arm B: Atezo+PBO+CisGem (Cycle*1-8), Followed by Atezo+PBO (Cycle*9 and Beyond) | 17 | 81 | 31 |
| other | Neutropenia | Blood and lymphatic system disorders | Arm A: Atezo+Bev+CisGem (Cycle*1-8), Followed by Atezo+Bev (Cycle*9 and Beyond) | 17 | 78 | 37 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Arm B: Atezo+PBO+CisGem (Cycle*1-8), Followed by Atezo+PBO (Cycle*9 and Beyond) | 6 | 81 | 13 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Arm A: Atezo+Bev+CisGem (Cycle*1-8), Followed by Atezo+Bev (Cycle*9 and Beyond) | 7 | 78 | 18 |
| other | Hypothyroidism | Endocrine disorders | Arm B: Atezo+PBO+CisGem (Cycle*1-8), Followed by Atezo+PBO (Cycle*9 and Beyond) | 6 | 81 | 6 |
| other | Hypothyroidism | Endocrine disorders | Arm A: Atezo+Bev+CisGem (Cycle*1-8), Followed by Atezo+Bev (Cycle*9 and Beyond) | 6 | 78 | 6 |
| other | Abdominal pain | Gastrointestinal disorders | Arm B: Atezo+PBO+CisGem (Cycle*1-8), Followed by Atezo+PBO (Cycle*9 and Beyond) | 13 | 81 | 16 |
| other | Abdominal pain | Gastrointestinal disorders | Arm A: Atezo+Bev+CisGem (Cycle*1-8), Followed by Atezo+Bev (Cycle*9 and Beyond) | 15 | 78 | 16 |
1 to 10 of 306Source ClinicalTrials.gov
See all 306 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm B: Atezo+PBO+CisGem (Cycle*1-8), Followed by Atezo+PBO (Cycle*9 and Beyond) | 51 | 83 |
| Total, all-cause mortality | Arm A: Atezo+Bev+CisGem (Cycle*1-8), Followed by Atezo+Bev (Cycle*9 and Beyond) | 49 | 79 |
| Total, other adverse events | Arm B: Atezo+PBO+CisGem (Cycle*1-8), Followed by Atezo+PBO (Cycle*9 and Beyond) | 81 | 81 |
| Total, other adverse events | Arm A: Atezo+Bev+CisGem (Cycle*1-8), Followed by Atezo+Bev (Cycle*9 and Beyond) | 77 | 78 |
| Total, serious adverse events | Arm B: Atezo+PBO+CisGem (Cycle*1-8), Followed by Atezo+PBO (Cycle*9 and Beyond) | 43 | 81 |
| Total, serious adverse events | Arm A: Atezo+Bev+CisGem (Cycle*1-8), Followed by Atezo+Bev (Cycle*9 and Beyond) | 36 | 78 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm B: Atezo+PBO+CisGem (Cycle*1-8), Followed by Atezo+PBO (Cycle*9 and Beyond) vs Arm A: Atezo+Bev+CisGem (Cycle*1-8), Followed by Atezo+Bev (Cycle*9 and Beyond): deaths from any cause | Trial comparisons |
| Arm B: Atezo+PBO+CisGem (Cycle*1-8), Followed by Atezo+PBO (Cycle*9 and Beyond) vs Arm A: Atezo+Bev+CisGem (Cycle*1-8), Followed by Atezo+Bev (Cycle*9 and Beyond): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04677504
GET https://conductscience.org/api/trials/v1/NCT04677504/results?page=2