Trial · NCT03552380
Study of Entinostat With Nivolumab Plus Ipilimumab in Previously Treated Renal Cell Carcinoma
NCT03552380, Phase 2, Terminated, Roberto Pili; results first posted 2024-09-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Entinostat With Nivolumab Plus Ipilimumab in Previously Treated Renal Cell Carcinoma. Trials, record NCT03552380. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03552380
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Entinostat With Nivolumab Plus Ipilimumab in Previously Treated Renal Cell Carcinoma
- NCT number
- NCT03552380
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- Roberto Pili
- Conditions
- Renal Cell Carcinoma
- Interventions
- Entinostat, Nivolumab, Ipilimumab
- First posted
- 2018-06-11
- Last updated
- 2024-09-03
- Results first posted
- 2024-09-03
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) Via RECIST 1.1 | From C1D1 until death or up to 31 months. | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: 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 | Number of Participants With Adverse Events | From C1D1 until death or up to 31 months | Assess adverse events according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4 |
| Secondary | Objective Response Rate Via Immune Related Response Criteria (irRC) | From C1D1 until death up to 31 months | Per immune-related response criteria (irRC): Complete Response(irCR), Disappearance of all target and nontarget lesions; Partial Reponse (irPR), ≥ 50% decrease in tumor burden compared with baseline; Progressive Disease (irPD), \>= 25% increase in tumour burden relative to nadir or the appearance new lesions; Stable Disease (irSD), not meeting criteria for irCR or irPR, in absence of irPD. Overall Response (OR) = irCR + irPR |
| Secondary | Progression Free Survival (PFS) Via RECIST 1.1 | Up to 31 months. | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. PFS is defined as time from starting treatment to disease progression met by RECIST 1.1 or death as a result of any cause. |
| Secondary | Progression Free Survival (PFS) Via irRC | Up to 31 months | Per immune-related response criteria (irRC): Complete Response(irCR), Disappearance of all target and nontarget lesions; Partial Reponse (irPR), ≥ 50% decrease in tumor burden compared with baseline; Progressive Disease (irPD), \>= 25% increase in tumour burden relative to nadir or the appearance new lesions; Stable Disease (irSD), not meeting criteria for irCR or irPR or irPD. PFS is defined as time from starting treatment to disease progression met by irRC or death as a result of any cause. |
| Secondary | Overall Survival (OS) | Up to a maximum of 59 months | OS is defined from Day 1 of treatment until death as a result of any cause |
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 | Objective Response Rate (ORR) Via RECIST 1.1 | From C1D1 until death or up to 31 months. | percentage of participants | NUMBER | |
| SECONDARY | Number of Participants With Adverse Events | From C1D1 until death or up to 31 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Objective Response Rate Via Immune Related Response Criteria (irRC) | From C1D1 until death up to 31 months | Percentage of participants | NUMBER | |
| SECONDARY | Progression Free Survival (PFS) Via RECIST 1.1 | Up to 31 months. | months | MEDIAN | |
| SECONDARY | Progression Free Survival (PFS) Via irRC | Up to 31 months | months | MEDIAN | |
| SECONDARY | Overall Survival (OS) | Up to a maximum of 59 months | months | MEDIAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) Via RECIST 1.1 | Phase II, Dose Level 1:Entinostat 5 mg With Nivolumab and Ipilimumab | 20 | 95% Confidence Interval 5.1 to 71.6 | percentage of participants | |
| Objective Response Rate (ORR) Via RECIST 1.1 | Phase II, Dose Level 2: Entinostat 3 mg With Nivolumab and Ipilimumab | 42.9 | 95% Confidence Interval 9.9 to 81.6 | percentage of participants | |
| Number of Participants With Adverse Events | Phase II, Dose Level 1: Entinostat 5 mg With Nivolumab and Ipilimumab | Number of patients had at least one adverse event of any grade. | 5 | Participants | |
| Number of Participants With Adverse Events | Phase II, Dose Level 2: Entinostat 3 mg With Nivolumab and Ipilimumab | Number of patients had at least one adverse event of any grade. | 7 | Participants | |
| Number of Participants With Adverse Events | Phase II, Dose Level 1: Entinostat 5 mg With Nivolumab and Ipilimumab | Number of patients had at least one grade 3 or greater adverse event. | 5 | Participants | |
| Number of Participants With Adverse Events | Phase II, Dose Level 2: Entinostat 3 mg With Nivolumab and Ipilimumab | Number of patients had at least one grade 3 or greater adverse event. | 3 | Participants | |
| Number of Participants With Adverse Events | Phase II, Dose Level 1: Entinostat 5 mg With Nivolumab and Ipilimumab | Number of patients had at least one grade 3 or greater treatment related adverse event | 5 | Participants | |
| Number of Participants With Adverse Events | Phase II, Dose Level 2: Entinostat 3 mg With Nivolumab and Ipilimumab | Number of patients had at least one grade 3 or greater treatment related adverse event | 2 | Participants | |
| Number of Participants With Adverse Events | Phase II, Dose Level 1: Entinostat 5 mg With Nivolumab and Ipilimumab | Number of patients having serious adverse event. | 3 | Participants | |
| Number of Participants With Adverse Events | Phase II, Dose Level 2: Entinostat 3 mg With Nivolumab and Ipilimumab | Number of patients having serious adverse event. | 3 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Study Treatment | STARTED | Phase II, Dose Level 1: Entinostat 5 mg With Nivolumab and Ipilimumab | 5 | |
| Study Treatment | STARTED | Phase II, Dose Level 2 : Entinostat 3 mg With Nivolumab and Ipilimumab | 7 | |
| Study Treatment | COMPLETED | Phase II, Dose Level 1: Entinostat 5 mg With Nivolumab and Ipilimumab | 0 | |
| Study Treatment | COMPLETED | Phase II, Dose Level 2 : Entinostat 3 mg With Nivolumab and Ipilimumab | 1 | |
| Study Treatment | NOT COMPLETED | Phase II, Dose Level 1: Entinostat 5 mg With Nivolumab and Ipilimumab | 5 | |
| Study Treatment | NOT COMPLETED | Phase II, Dose Level 2 : Entinostat 3 mg With Nivolumab and Ipilimumab | 6 | |
| Follow up | STARTED | Phase II, Dose Level 1: Entinostat 5 mg With Nivolumab and Ipilimumab | 5 | |
| Follow up | STARTED | Phase II, Dose Level 2 : Entinostat 3 mg With Nivolumab and Ipilimumab | 7 | |
| Follow up | COMPLETED | Phase II, Dose Level 1: Entinostat 5 mg With Nivolumab and Ipilimumab | 0 | |
| Follow up | COMPLETED | Phase II, Dose Level 2 : Entinostat 3 mg With Nivolumab and Ipilimumab | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events156
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 | Adrenal insufficiency | Endocrine disorders | Phase II, Dose Level 1: Entinostat 5 mg With Nivolumab and Ipilimumab | 1 | 5 | 1 |
| other | Adrenal insufficiency | Endocrine disorders | Phase II, Dose Level 2: Entinostat 3 mg With Nivolumab and Ipilimumab | 1 | 7 | 1 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Phase II, Dose Level 1: Entinostat 5 mg With Nivolumab and Ipilimumab | 1 | 5 | 1 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Phase II, Dose Level 2: Entinostat 3 mg With Nivolumab and Ipilimumab | 0 | 7 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Phase II, Dose Level 1: Entinostat 5 mg With Nivolumab and Ipilimumab | 1 | 5 | 4 |
| other | Anemia | Blood and lymphatic system disorders | Phase II, Dose Level 2: Entinostat 3 mg With Nivolumab and Ipilimumab | 2 | 7 | 2 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Phase II, Dose Level 1: Entinostat 5 mg With Nivolumab and Ipilimumab | 1 | 5 | 1 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Phase II, Dose Level 2: Entinostat 3 mg With Nivolumab and Ipilimumab | 1 | 7 | 1 |
| other | Creatinine increased | Investigations | Phase II, Dose Level 1: Entinostat 5 mg With Nivolumab and Ipilimumab | 1 | 5 | 2 |
| other | Creatinine increased | Investigations | Phase II, Dose Level 2: Entinostat 3 mg With Nivolumab and Ipilimumab | 1 | 7 | 1 |
1 to 10 of 156Source ClinicalTrials.gov
See all 156 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase II, Dose Level 1: Entinostat 5 mg With Nivolumab and Ipilimumab | 3 | 5 |
| Total, all-cause mortality | Phase II, Dose Level 2: Entinostat 3 mg With Nivolumab and Ipilimumab | 4 | 7 |
| Total, other adverse events | Phase II, Dose Level 1: Entinostat 5 mg With Nivolumab and Ipilimumab | 5 | 5 |
| Total, other adverse events | Phase II, Dose Level 2: Entinostat 3 mg With Nivolumab and Ipilimumab | 7 | 7 |
| Total, serious adverse events | Phase II, Dose Level 1: Entinostat 5 mg With Nivolumab and Ipilimumab | 3 | 5 |
| Total, serious adverse events | Phase II, Dose Level 2: Entinostat 3 mg With Nivolumab and Ipilimumab | 3 | 7 |
Source ClinicalTrials.gov
Papers0
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Phase II, Dose Level 1: Entinostat 5 mg With Nivolumab and Ipilimumab vs Phase II, Dose Level 2: Entinostat 3 mg With Nivolumab and Ipilimumab: deaths from any cause | Trial comparisons |
| Phase II, Dose Level 1: Entinostat 5 mg With Nivolumab and Ipilimumab vs Phase II, Dose Level 2: Entinostat 3 mg With Nivolumab and Ipilimumab: 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/NCT03552380
GET https://conductscience.org/api/trials/v1/NCT03552380/events?page=2