Trial · NCT04091217
Atezolizumab in Combination With Bevacizumab in Patients With Unresectable Locally Advanced or Metastatic Mucosal Melanoma
NCT04091217, Phase 2, Completed, Hoffmann-La Roche; results first posted 2024-10-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Atezolizumab in Combination With Bevacizumab in Patients With Unresectable Locally Advanced or Metastatic Mucosal Melanoma. Trials, record NCT04091217. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04091217
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Atezolizumab in Combination With Bevacizumab in Patients With Unresectable Locally Advanced or Metastatic Mucosal Melanoma
- NCT number
- NCT04091217
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 43 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Melanoma
- Interventions
- Atezolizumab, Bevacizumab
- First posted
- 2019-09-16
- Last updated
- 2024-10-24
- Results first posted
- 2024-10-24
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) in the Full Analysis Set Analysis Population | Up to approximately 32 months | ORR was defined as the percentage of participants with a complete response (CR) defined as disappearance of all target lesions, or partial response (PR) defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR, on two consecutive occasions \>= 4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). |
| Secondary | Progression-Free Survival (PFS) | Up to approximately 32 months | PFS was defined as the time from the date of first treatment to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1. |
| Secondary | Overall Survival (OS) | Up to approximately 32 months | Overall survival was defined as the time from the date of first treatment to death from any cause. |
| Secondary | Duration of Objective Response (DOR) | Up to approximately 32 months | DOR was defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1 |
| Secondary | Disease Control Rate (DCR) | Up to approximately 32 months | DCR was defined as the sum of a complete or partial response or stable disease rates as determined by the investigator according to RECIST v1.1. |
| Secondary | Percentage of Participants With Adverse Events | From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months) | The percentage of participants who experienced an Adverse Event (AE) or Serious Adverse Event (SAE). Incidence, nature, and severity of Adverse Events (AE), are reported per the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0). |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Progression-Free Survival (PFS) | Up to approximately 32 months | Full Analysis Set (FAS) is defined as all enrolled participants who receive any amount of study treatment and evaluable for efficacy endpoints. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Up to approximately 32 months | Full Analysis Set (FAS) was defined as all enrolled participants who receive any amount of study treatment and evaluable for efficacy endpoints. | Months | MEDIAN |
| SECONDARY | Duration of Objective Response (DOR) | Up to approximately 32 months | Only responders (CR/PR) assessed by investigator were included in the analysis. | Months | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) | Up to approximately 32 months | Full Analysis Set (FAS) was defined as all enrolled participants who receive any amount of study treatment and evaluable for efficacy endpoints. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Adverse Events | From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months) | Safety analysis set is defined as all enrolled participants who receive any amount of least one dose of any study treatment. | Percentage of participants | NUMBER |
| PRIMARY | Objective Response Rate (ORR) in the Full Analysis Set Analysis Population | Up to approximately 32 months | Full Analysis Set (FAS) is defined as all enrolled participants who receive any amount of study treatment and evaluable for efficacy endpoints. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group13
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) | Atezolizumab + Bevacizumab | 8.21 | 95% Confidence Interval 4.07 to 9.59 | Months | |
| Overall Survival (OS) | Atezolizumab + Bevacizumab | 24.77 | 95% Confidence Interval 14.88 to NA | Months | |
| Duration of Objective Response (DOR) | Atezolizumab + Bevacizumab | 12.42 | 95% Confidence Interval 5.59 to 14.03 | Months | |
| Disease Control Rate (DCR) | Atezolizumab + Bevacizumab | 65.0 | 95% Confidence Interval 48.32 to 79.37 | Percentage of Participants | |
| Percentage of Participants With Adverse Events | Atezolizumab + Bevacizumab | Percentage of participants with at least 1 AE | 95.3 | Percentage of participants | |
| Percentage of Participants With Adverse Events | Atezolizumab + Bevacizumab | Percentage of participants with at least one Grade 3-5 AE | 25.6 | Percentage of participants | |
| Percentage of Participants With Adverse Events | Atezolizumab + Bevacizumab | Percentage of participants with at least one AE by worst grade - Grade 1 | 41.9 | Percentage of participants | |
| Percentage of Participants With Adverse Events | Atezolizumab + Bevacizumab | Percentage of participants with at least one AE by worst grade - Grade 2 | 27.9 | Percentage of participants | |
| Percentage of Participants With Adverse Events | Atezolizumab + Bevacizumab | Percentage of participants with at least one AE by worst grade - Grade 3 | 23.3 | Percentage of participants | |
| Percentage of Participants With Adverse Events | Atezolizumab + Bevacizumab | Percentage of participants with at least one AE by worst grade - Grade 4 | 0 | Percentage of participants |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Atezolizumab + Bevacizumab | 43 | |
| Overall Study | Stage I Analysis Population | Atezolizumab + Bevacizumab | 22 | |
| Overall Study | Stage II Analysis Population | Atezolizumab + Bevacizumab | 38 | |
| Overall Study | COMPLETED | Atezolizumab + Bevacizumab | 41 | |
| Overall Study | NOT COMPLETED | Atezolizumab + Bevacizumab | 2 |
Source ClinicalTrials.gov
Adverse events46
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 | Blood lactate dehydrogenase increased | Investigations | Atezolizumab + Bevacizumab | 16 | 43 | |
| other | Blood cholesterol increased | Investigations | Atezolizumab + Bevacizumab | 11 | 43 | |
| other | Aspartate aminotransferase increased | Investigations | Atezolizumab + Bevacizumab | 10 | 43 | |
| other | Alanine aminotransferase increased | Investigations | Atezolizumab + Bevacizumab | 9 | 43 | |
| other | Blood triglycerides increased | Investigations | Atezolizumab + Bevacizumab | 9 | 43 | |
| other | Blood bilirubin increased | Investigations | Atezolizumab + Bevacizumab | 8 | 43 | |
| other | Blood creatine phosphokinase increased | Investigations | Atezolizumab + Bevacizumab | 7 | 43 | |
| other | Blood uric acid increased | Investigations | Atezolizumab + Bevacizumab | 7 | 43 | |
| other | Gamma-glutamyltransferase increased | Investigations | Atezolizumab + Bevacizumab | 6 | 43 | |
| other | Blood glucose increased | Investigations | Atezolizumab + Bevacizumab | 5 | 43 |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Atezolizumab + Bevacizumab | 20 | 43 |
| Total, other adverse events | Atezolizumab + Bevacizumab | 34 | 43 |
| Total, serious adverse events | Atezolizumab + Bevacizumab | 9 | 43 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36044526 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT04091217
GET https://conductscience.org/api/trials/v1/NCT04091217/events?page=2