Trial · NCT04357873
Efficacy of Immunotherapy Plus a Drug in Patients With Progressive Advanced Mucosal Cancer of Different Locations
NCT04357873, Phase 2, Completed, UNICANCER
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of Immunotherapy Plus a Drug in Patients With Progressive Advanced Mucosal Cancer of Different Locations. Trials, record NCT04357873. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04357873
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Immunotherapy Plus a Drug in Patients With Progressive Advanced Mucosal Cancer of Different Locations
- NCT number
- NCT04357873
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 112 participants, actual
- Lead sponsor
- UNICANCER
- Conditions
- Squamous Cell Lung Cancer, Vulvar Cancer, Penile Cancer, Cervix Cancer, Head and Neck Squamous Cell Carcinoma, Anal Cancer
- Interventions
- pembrolizumab; vorinostat
- First posted
- 2020-04-22
- Last updated
- 2025-02-19
- Other registries' IDs
- eudract:2019-003839-33
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR), investigator assessment | From inclusion to first and subsequent tumor assesment or progression, up to 24 months | Investigators will assess the ORR. The ORR is defined in each cohort as the percentage of evaluable patients for ORR, designate as the proportion of patients with best response of complete response (CR) or a partial response (PR) during treatment according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1). |
| Secondary | Objective Response Rate (ORR), central assessment | From inclusion to first and subsequent tumor assesment or progression, up to 36 months | ORR defined as the proportion of patients with best response of CR or PR during treatment, as assessed by a central radiological panel according to RECIST v1.1. |
| Secondary | immune Objective Response Rate (iORR), central assessment | From inclusion to first and subsequent tumor assesment or progression, up to 36 months | ORR defined as the proportion of patients with best response of CR or PR during treatment, as assessed by a central radiological panel according to immune-specific response criteria. |
| Secondary | Duration Of Response (DOR) | From the first assessment of a CR or PR until the date of the first occurrence of PD or death from any cause | DOR will be evaluated in patients with either CR or PR. DOR is defined as the time from the first assessment of a CR or PR until the date of the first occurrence of progressive disease (PD) or death from any cause (if death occurred within predefined period), whichever occurs first. |
| Secondary | Progression Free Survival (PFS) | From inclusion to disease progression or death, up to 36 months | PFS is defined per RECIST v1.1 as the time from inclusion until disease progression (per RECIST v1.1) or death from any cause, whichever occurs first. At the time of analysis, a patient alive and without disease progression will be censored at the date of the last tumor assessment. Patients alive without disease progression who started a new anticancer therapy will be censored at the date of the last tumor assessment prior to the start of the new anticancer therapy. |
| Secondary | immune Progression Free Survival (iPFS) | From inclusion to disease progression or death, up to 36 months | iPFS is defined per immune-specific response evaluation criteria in solid tumors (iRECIST) as the time from inclusion until confirmed disease progression (per iRECIST), or death from any cause, whichever occurs first. At the time of analysis, a patient alive and without progression will be censored at the date of the last tumor assessment. Patients alive without disease progression who started a new anti-cancer therapy will be censored at the date of the last tumor assessment prior to the start of the new anticancer therapy. |
| Secondary | Overall Survival (OS) | From inclusion to death from any cause, up to 36 months | OS is defined as the time from inclusion until death from any cause. Patients who are alive at last follow-up news will be censored at this date. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT04357873
GET https://conductscience.org/api/trials/v1/NCT04357873/registered