Trial · NCT03201458
Atezolizumab With or Without Cobimetinib in Treating Patients With Metastatic Bile Duct Cancer That Cannot Be Removed by Surgery or Gallbladder Cancer
NCT03201458, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2023-07-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Atezolizumab With or Without Cobimetinib in Treating Patients With Metastatic Bile Duct Cancer That Cannot Be Removed by Surgery or Gallbladder Cancer. Trials, record NCT03201458. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03201458
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Atezolizumab With or Without Cobimetinib in Treating Patients With Metastatic Bile Duct Cancer That Cannot Be Removed by Surgery or Gallbladder Cancer
- NCT number
- NCT03201458
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 86 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Gallbladder Carcinoma, Metastatic Cholangiocarcinoma, Stage III Intrahepatic Cholangiocarcinoma AJCC v8, Stage IV Intrahepatic Cholangiocarcinoma AJCC v8, Unresectable Cholangiocarcinoma
- Interventions
- Atezolizumab, Biopsy, Biospecimen Collection, Cobimetinib, Computed Tomography, Magnetic Resonance Imaging
- First posted
- 2017-06-28
- Last updated
- 2024-04-05
- Results first posted
- 2023-07-11
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | From date of randomization to time of progression or death, assessed up to 1 year | PFS within each treatment arm will be summarized descriptively and compared between groups, under the assumption of Cox proportional hazards, using the stratified log-rank test to account for tumor site. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Secondary | Number of Participants With Adverse Events | Up to 1 year | Will be assessed using National Cancer Institute's Common Terminology Criteria for Adverse Events version 5.0. The incidence of AEs will be tabulated by subgroups of interest (e.g. grade 3 or higher, organ class, relationship to study drug). For analyses at the individual level, the highest grade and relationship to study drug will be assumed if multiple events have occurred. Toxicity will be tabulated by type and grade and will be summarized with descriptive statistics. |
| Secondary | Objective Response Rate | Up to 1 year | Defined as the proportion of response evaluable subjects who have a complete response or partial response and will be assessed by Response Evaluation Criteria in Solid Tumors version 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
| Secondary | Overall Survival | From date of randomization to time of death, assessed up to 1 year | Results will be summarized descriptively and compared between groups, under the assumption of proportional hazards, using the stratified log-rank test to account for tumor site. |
| Secondary | Change in CD8+ Density Within the Tumor | Day 21 | Change between the pre-treatment tumor biopsy to the on-treatment biopsy collected on day 21. |
| Other | Number of Participants With PD-L1 Expression | Up to 1 year | The number of participants with tumors expressing PD-L1 by 1 percent or more. |
Source ClinicalTrials.gov
Outcomes6
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) | From date of randomization to time of progression or death, assessed up to 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Adverse Events | Up to 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Objective Response Rate | Up to 1 year | Evaluable population excluded patients removed from study prior to the first radiographic evaluation time point for clinical progression or death from tumor progression. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival | From date of randomization to time of death, assessed up to 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change in CD8+ Density Within the Tumor | Day 21 | Participants with paired high-quality biopsies (fold change pre- and post-treatment). | cells per millimeter squared | MEAN |
| OTHER_PRE_SPECIFIED | Number of Participants With PD-L1 Expression | Up to 1 year | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group26
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 A (Atezolizumab) | Progression free at 1 Year after Randomization | 0 | Participants | |
| Progression Free Survival (PFS) | Arm B (Atezolizumab, Cobimetinib) | Progression free at 1 Year after Randomization | 3 | Participants | |
| Progression Free Survival (PFS) | Arm A (Atezolizumab) | Progressed or Off Treatment by 1 Year after Randomization | 39 | Participants | |
| Progression Free Survival (PFS) | Arm B (Atezolizumab, Cobimetinib) | Progressed or Off Treatment by 1 Year after Randomization | 35 | Participants | |
| Number of Participants With Adverse Events | Arm A (Atezolizumab) | Grade 3 or higher adverse event considered at least possibly related to the study drug(s) | 15 | Participants | |
| Number of Participants With Adverse Events | Arm B (Atezolizumab, Cobimetinib) | Grade 3 or higher adverse event considered at least possibly related to the study drug(s) | 17 | Participants | |
| Number of Participants With Adverse Events | Arm A (Atezolizumab) | No grade 3 or higher adverse events considered at least possibly related to the study drug(s) | 24 | Participants | |
| Number of Participants With Adverse Events | Arm B (Atezolizumab, Cobimetinib) | No grade 3 or higher adverse events considered at least possibly related to the study drug(s) | 21 | Participants | |
| Objective Response Rate | Arm A (Atezolizumab) | Complete Response | 0 | Participants | |
| Objective Response Rate | Arm B (Atezolizumab, Cobimetinib) | Complete Response | 0 | Participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 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 A (Atezolizumab) | 43 | |
| Overall Study | STARTED | Arm B (Atezolizumab, Cobimetinib) | 43 | |
| Overall Study | COMPLETED | Arm A (Atezolizumab) | 39 | |
| Overall Study | COMPLETED | Arm B (Atezolizumab, Cobimetinib) | 38 | |
| Overall Study | NOT COMPLETED | Arm A (Atezolizumab) | 4 | |
| Overall Study | NOT COMPLETED | Arm B (Atezolizumab, Cobimetinib) | 5 |
Source ClinicalTrials.gov
Adverse events308
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 | Abdominal distension | Gastrointestinal disorders | Arm A (Atezolizumab) | 2 | 43 | |
| other | Abdominal distension | Gastrointestinal disorders | Arm B (Atezolizumab, Cobimetinib) | 3 | 43 | |
| other | Abdominal pain | Gastrointestinal disorders | Arm A (Atezolizumab) | 14 | 43 | |
| other | Abdominal pain | Gastrointestinal disorders | Arm B (Atezolizumab, Cobimetinib) | 15 | 43 | |
| other | Alanine aminotransferase (ALT) increased | Investigations | Arm A (Atezolizumab) | 10 | 43 | |
| other | Alanine aminotransferase (ALT) increased | Investigations | Arm B (Atezolizumab, Cobimetinib) | 9 | 43 | |
| other | Alkaline phosphatase increased | Investigations | Arm A (Atezolizumab) | 12 | 43 | |
| other | Alkaline phosphatase increased | Investigations | Arm B (Atezolizumab, Cobimetinib) | 17 | 43 | |
| other | Allergic reaction | Immune system disorders | Arm A (Atezolizumab) | 3 | 43 | |
| other | Allergic reaction | Immune system disorders | Arm B (Atezolizumab, Cobimetinib) | 0 | 43 |
1 to 10 of 308Source ClinicalTrials.gov
See all 308 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A (Atezolizumab) | 35 | 43 |
| Total, all-cause mortality | Arm B (Atezolizumab, Cobimetinib) | 35 | 43 |
| Total, other adverse events | Arm A (Atezolizumab) | 38 | 43 |
| Total, other adverse events | Arm B (Atezolizumab, Cobimetinib) | 36 | 43 |
| Total, serious adverse events | Arm A (Atezolizumab) | 32 | 43 |
| Total, serious adverse events | Arm B (Atezolizumab, Cobimetinib) | 31 | 43 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34907910 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UM1CA186691 | The Johns Hopkins Translational Science Team and Consortium for ETCTN Studies | CARDUCCI, MICHAEL A; BEUMER, JAN HENDRIK; GENTZLER, RYAN; LIU, GLENN; MESSERSMITH, WELLS A.; RUIZ, JIMMY | JOHNS HOPKINS UNIVERSITY | NATIONAL CANCER INSTITUTE | 2014 to 2025 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A (Atezolizumab) vs Arm B (Atezolizumab, Cobimetinib): deaths from any cause | Trial comparisons |
| Arm A (Atezolizumab) vs Arm B (Atezolizumab, Cobimetinib): 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/NCT03201458
GET https://conductscience.org/api/trials/v1/NCT03201458/results?page=2