Trial · NCT03024437
Atezolizumab in Combination With Entinostat and Bevacizumab in Patients With Advanced Renal Cell Carcinoma
NCT03024437, Phase 1, Phase 2, Terminated, Roberto Pili; results first posted 2025-03-20
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Atezolizumab in Combination With Entinostat and Bevacizumab in Patients With Advanced Renal Cell Carcinoma. Trials, record NCT03024437. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03024437
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Atezolizumab in Combination With Entinostat and Bevacizumab in Patients With Advanced Renal Cell Carcinoma
- NCT number
- NCT03024437
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 31 participants, actual
- Lead sponsor
- Roberto Pili
- Conditions
- Metastatic Cancer, Renal Cancer
- Interventions
- Atezolizumab, Bevacizumab, Entinostat
- First posted
- 2017-01-18
- Last updated
- 2025-03-20
- Results first posted
- 2025-03-20
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase I: Recommended Phase II Dose of Entinostat | 21 days | Three dose levels of entinostat (1 mg, 3 mg and 5 mg) were tested according to the 3 + 3 standard design. The starting dose level of entinostat was 1 mg orally every 7 days. DLTs attributable to entinostat and/or bevacizumab and/or atezolizumab were evaluated during the first 21 days of the combination treatment. If a DLT occurs in 1 patient treated at the starting dose level, a minimum of 3 additional patients will be treated at this dose level. If DLTs occur in 2 or more of the first 6 patients, the study will be terminated. If a DLT occurs in 1 out of 6 patients, 3 additional patients will be treated at the next dose level (level 2). If no DLTs occur at the starting dose level 1, 3 additional patients will be treated at the next dose level (level 2). The process is repeated for dose level 2. If no DLTs occur at dose level 3 or if 1 DLT occurs out of 6 patients, then this dose level will be recommended for the Phase II portion of the study. |
| Primary | Phase II: Percentage of Patients With Objective Response | Up to 1 year | Percentage of patients who achieved a complete response or partial response to treatment as measured per RECIST 1.1. Complete response: Disappearance of all target lesions. Partial response: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. |
| Secondary | Phase I: Percentage of Patients With Objective Response | Up to 1 year | Percentage of patients who achieved a complete response or partial response to treatment as measured per RECIST 1.1. Complete response: Disappearance of all target lesions. Partial response: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. |
| Secondary | Phase II: Median Progression-free Survival | Up to 4.5 years | Progression free survival was defined as the time from on treatment date to date of recurrence of any type or death from any cause. Patients who did not experience recurrence or death were censored at their last evaluation date. The Kaplan-Meier method was used to determine the median and 95% confidence interval. |
| Secondary | Phase II: Median Overall Survival | Up to 5.5 years | Overall survival was defined as the time from on treatment date to death due to any cause. Patients who remained alive were censored at their last known alive date. The Kaplan-Meier method was used to determine the median and 95% confidence interval. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase I: Recommended Phase II Dose of Entinostat | 21 days | Patients who received at least one cycle of study drugs and had at least one post-baseline evaluation. | mg | NUMBER |
| PRIMARY | Phase II: Percentage of Patients With Objective Response | Up to 1 year | Patients who received at least one cycle of study drugs and had at least one post-baseline evaluation. Patients who were treated at Dose Level 3 in Phase I were assigned to the applicable Phase II cohort for efficacy analyses. | percentage of participants | NUMBER |
| SECONDARY | Phase I: Percentage of Patients With Objective Response | Up to 1 year | Patients who received at least one cycle of study drugs and had at least one post-baseline evaluation. | percentage of patients | NUMBER |
| SECONDARY | Phase II: Median Progression-free Survival | Up to 4.5 years | Patients who received at least one cycle of study drugs and had at least one post-baseline evaluation. Patients who were treated at Dose Level 3 in Phase I were assigned to the applicable Phase II cohort for efficacy analyses. | months | MEDIAN |
| SECONDARY | Phase II: Median Overall Survival | Up to 5.5 years | Patients who received at least one cycle of study drugs and had at least one post-baseline evaluation. Patients who were treated at Dose Level 3 in Phase I were assigned to the applicable Phase II cohort for efficacy analyses. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase I: Recommended Phase II Dose of Entinostat | Phase I - Dose Escalation | 5 | mg | ||
| Phase II: Percentage of Patients With Objective Response | Phase II - Cohort A | 62.5 | 95% Confidence Interval 35.4 to 84.8 | percentage of participants | |
| Phase II: Percentage of Patients With Objective Response | Phase II - Cohort B | 33.3 | 95% Confidence Interval 0.8 to 90.6 | percentage of participants | |
| Phase I: Percentage of Patients With Objective Response | Phase I - Dose Level 1 | 50 | 95% Confidence Interval 11.8 to 88.2 | percentage of patients | |
| Phase I: Percentage of Patients With Objective Response | Phase I - Dose Level 2 | 20 | 95% Confidence Interval 0.5 to 71.6 | percentage of patients | |
| Phase I: Percentage of Patients With Objective Response | Phase I - Dose Level 3 | 83.3 | 95% Confidence Interval 35.9 to 99.6 | percentage of patients | |
| Phase II: Median Progression-free Survival | Phase II - Cohort A | 13.7 | 95% Confidence Interval 8.7 to 21.3 | months | |
| Phase II: Median Progression-free Survival | Phase II - Cohort B | 9.8 | 95% Confidence Interval 1.3 to NA | months | |
| Phase II: Median Overall Survival | Phase II - Cohort A | 51.6 | 95% Confidence Interval 21.8 to NA | months | |
| Phase II: Median Overall Survival | Phase II - Cohort B | 31.2 | 95% Confidence Interval 22.8 to NA | months |
Source ClinicalTrials.gov
Participant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase I - Dose Level 1 | 6 | |
| Overall Study | STARTED | Phase I - Dose Level 2 | 6 | |
| Overall Study | STARTED | Phase I - Dose Level 3 | 6 | |
| Overall Study | STARTED | Phase II - Cohort A | 12 | |
| Overall Study | STARTED | Phase II - Cohort B | 1 | |
| Overall Study | COMPLETED | Phase I - Dose Level 1 | 0 | |
| Overall Study | COMPLETED | Phase I - Dose Level 2 | 0 | |
| Overall Study | COMPLETED | Phase I - Dose Level 3 | 0 | |
| Overall Study | COMPLETED | Phase II - Cohort A | 0 | |
| Overall Study | COMPLETED | Phase II - Cohort B | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events805
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 | Anemia | Blood and lymphatic system disorders | Phase I - Dose Level 1 | 2 | 6 | 3 |
| other | Anemia | Blood and lymphatic system disorders | Phase I - Dose Level 2 | 0 | 6 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Phase I - Dose Level 3 | 1 | 6 | 2 |
| other | Anemia | Blood and lymphatic system disorders | Phase II - Cohort A | 0 | 12 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Phase II - Cohort B | 0 | 1 | 0 |
| other | Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | Phase I - Dose Level 1 | 0 | 6 | 0 |
| other | Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | Phase I - Dose Level 2 | 0 | 6 | 0 |
| other | Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | Phase I - Dose Level 3 | 1 | 6 | 1 |
| other | Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | Phase II - Cohort A | 0 | 12 | 0 |
| other | Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | Phase II - Cohort B | 0 | 1 | 0 |
1 to 10 of 805Source ClinicalTrials.gov
See all 805 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase I - Dose Level 1 | 6 | 6 |
| Total, all-cause mortality | Phase I - Dose Level 2 | 5 | 6 |
| Total, all-cause mortality | Phase I - Dose Level 3 | 4 | 6 |
| Total, all-cause mortality | Phase II - Cohort A | 4 | 12 |
| Total, all-cause mortality | Phase II - Cohort B | 1 | 1 |
| Total, other adverse events | Phase I - Dose Level 1 | 6 | 6 |
| Total, other adverse events | Phase I - Dose Level 2 | 6 | 6 |
| Total, other adverse events | Phase I - Dose Level 3 | 6 | 6 |
| Total, other adverse events | Phase II - Cohort A | 12 | 12 |
| Total, other adverse events | Phase II - Cohort B | 1 | 1 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT03024437
GET https://conductscience.org/api/trials/v1/NCT03024437/events?page=2