Trial · NCT02619253
Phase I/Ib Study of Pembrolizumab With Vorinostat for Patients With Advanced Renal or Urothelial Cell Carcinoma
NCT02619253, Phase 1, Completed, Nabil Adra; results first posted 2024-11-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase I/Ib Study of Pembrolizumab With Vorinostat for Patients With Advanced Renal or Urothelial Cell Carcinoma. Trials, record NCT02619253. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02619253
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase I/Ib Study of Pembrolizumab With Vorinostat for Patients With Advanced Renal or Urothelial Cell Carcinoma
- NCT number
- NCT02619253
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 52 participants, actual
- Lead sponsor
- Nabil Adra
- Conditions
- Renal Cell Carcinoma, Urinary Bladder Neoplasms
- Interventions
- Pembrolizumab, Vorinostat
- First posted
- 2015-12-02
- Last updated
- 2024-11-18
- Results first posted
- 2024-11-18
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (Percentage of Patients With Complete Response or Partial Response) | Up to 4.5 years | Measured by RECIST v1.1 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 The percentage of patients with objective response and its 95% confidence interval will be provided. |
| Primary | Progression Free Survival | Up to 4.5 years | Progression free survival was determined from start date of treatment to date of progression for patients who progressed or date of death for patients who died without progressing. The observations of patients remaining alive and progression free were censored at the date of last disease evaluation. The Kaplan-Meier method was used to determine the median and 95% confidence interval. |
| Secondary | Safety and Tolerablity: Number of Patients Who Experienced Grade 3 or 4 Adverse Events | Up to 4.5 years | Number of unique patients who had a treatment-related (possible, probable, or definite) adverse event with grade 3 or greater using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. |
| Secondary | Number of Patients Experiencing a Dose Limiting Toxicity | Up to 21 days | Dose limiting toxicities (DLTs) are defined as Grade ≥ 3 hematological/non hematological toxicities attributable to vorinostat and/or pembrolizumab during the first 21 days of the combination treatment (days 1-21). If DLTs occur in 1 patient treated at the starting dose level a minimum of another 3 patients will be treated at this dose level. If a DLT occurs in more than 1 patient in the first 6 patients the study will be terminated. If a DLT occurs in \< 1/3 patients or ≤ 1/6 patients, 3 additional patients will be treated at the next dose level (level 2) with 200 mg vorinostat PO. If no DLTs occur at dose level 2, this dose level will be recommended for the expansion cohorts of the study. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (Percentage of Patients With Complete Response or Partial Response) | Up to 4.5 years | Patients were considered eligible for this analysis if they were in the expansion cohorts and had at least one follow-up assessment of disease status after completing one cycle of combination therapy. | percentage of participants | NUMBER |
| PRIMARY | Progression Free Survival | Up to 4.5 years | Patients were considered eligible for this analysis if they were in the expansion cohorts and had at least one follow-up assessment of disease status after completing one cycle of combination therapy. | months | MEDIAN |
| SECONDARY | Safety and Tolerablity: Number of Patients Who Experienced Grade 3 or 4 Adverse Events | Up to 4.5 years | Patients who received at least one dose of either study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients Experiencing a Dose Limiting Toxicity | Up to 21 days | Patients who completed one cycle of study therapy. | Participants | COUNT_OF_PARTICIPANTS |
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 |
|---|---|---|---|---|---|
| Objective Response Rate (Percentage of Patients With Complete Response or Partial Response) | Expansion Cohort A | 7.7 | 95% Confidence Interval 0.2 to 36.0 | percentage of participants | |
| Objective Response Rate (Percentage of Patients With Complete Response or Partial Response) | Expansion Cohort B | 0 | 95% Confidence Interval 0 to 28.5 | percentage of participants | |
| Objective Response Rate (Percentage of Patients With Complete Response or Partial Response) | Expansion Cohort C | 16.7 | 95% Confidence Interval 2.1 to 48.4 | percentage of participants | |
| Progression Free Survival | Expansion Cohort A | 2.9 | 95% Confidence Interval 1.3 to 21.8 | months | |
| Progression Free Survival | Expansion Cohort B | 3.5 | 95% Confidence Interval 2.5 to 7.2 | months | |
| Progression Free Survival | Expansion Cohort C | 3.5 | 95% Confidence Interval 1.3 to 7.5 | months | |
| Safety and Tolerablity: Number of Patients Who Experienced Grade 3 or 4 Adverse Events | Dose Finding Cohort Dose Level 1 | 0 | Participants | ||
| Safety and Tolerablity: Number of Patients Who Experienced Grade 3 or 4 Adverse Events | Dose Finding Cohort Dose Level 2 | 0 | Participants | ||
| Safety and Tolerablity: Number of Patients Who Experienced Grade 3 or 4 Adverse Events | Expansion Cohort A | 5 | Participants | ||
| Safety and Tolerablity: Number of Patients Who Experienced Grade 3 or 4 Adverse Events | Expansion Cohort B | 3 | Participants |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose Finding Cohort Dose Level 1 | 4 | |
| Overall Study | STARTED | Dose Finding Cohort Dose Level 2 | 4 | |
| Overall Study | STARTED | Expansion Cohort A | 15 | |
| Overall Study | STARTED | Expansion Cohort B | 14 | |
| Overall Study | STARTED | Expansion Cohort C | 15 | |
| Overall Study | COMPLETED | Dose Finding Cohort Dose Level 1 | 0 | |
| Overall Study | COMPLETED | Dose Finding Cohort Dose Level 2 | 0 | |
| Overall Study | COMPLETED | Expansion Cohort A | 1 | |
| Overall Study | COMPLETED | Expansion Cohort B | 0 | |
| Overall Study | COMPLETED | Expansion Cohort C | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events900
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 | Dose Finding Cohort Dose Level 1 | 2 | 4 | 4 |
| other | Anemia | Blood and lymphatic system disorders | Dose Finding Cohort Dose Level 2 | 2 | 4 | 7 |
| other | Anemia | Blood and lymphatic system disorders | Expansion Cohort A | 10 | 15 | 16 |
| other | Anemia | Blood and lymphatic system disorders | Expansion Cohort B | 2 | 14 | 4 |
| other | Anemia | Blood and lymphatic system disorders | Expansion Cohort C | 3 | 15 | 8 |
| other | Fatigue | General disorders | Dose Finding Cohort Dose Level 1 | 2 | 4 | 5 |
| other | Fatigue | General disorders | Dose Finding Cohort Dose Level 2 | 1 | 4 | 3 |
| other | Fatigue | General disorders | Expansion Cohort A | 11 | 15 | 18 |
| other | Fatigue | General disorders | Expansion Cohort B | 4 | 14 | 6 |
| other | Fatigue | General disorders | Expansion Cohort C | 6 | 15 | 6 |
1 to 10 of 900Source ClinicalTrials.gov
See all 900 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Finding Cohort Dose Level 1 | 4 | 4 |
| Total, all-cause mortality | Dose Finding Cohort Dose Level 2 | 4 | 4 |
| Total, all-cause mortality | Expansion Cohort A | 11 | 15 |
| Total, all-cause mortality | Expansion Cohort B | 13 | 14 |
| Total, all-cause mortality | Expansion Cohort C | 11 | 15 |
| Total, other adverse events | Dose Finding Cohort Dose Level 1 | 4 | 4 |
| Total, other adverse events | Dose Finding Cohort Dose Level 2 | 4 | 4 |
| Total, other adverse events | Expansion Cohort A | 15 | 15 |
| Total, other adverse events | Expansion Cohort B | 13 | 14 |
| Total, other adverse events | Expansion Cohort C | 14 | 15 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40145367 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Dose Finding Cohort Dose Level 1 vs Dose Finding Cohort Dose Level 2: Number of Patients Experiencing a Dose Limiting Toxicity |
Source 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/NCT02619253
GET https://conductscience.org/api/trials/v1/NCT02619253/events?page=2