Trial · NCT05492123
Nivolumab-ipilimumab and Chemoradiation for Cervical Cancer
NCT05492123, Phase 2, Recruiting, Hospital Israelita Albert Einstein
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Nivolumab-ipilimumab and Chemoradiation for Cervical Cancer. Trials, record NCT05492123. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05492123
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nivolumab-ipilimumab and Chemoradiation for Cervical Cancer
- NCT number
- NCT05492123
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 112 participants, estimated
- Lead sponsor
- Hospital Israelita Albert Einstein
- Conditions
- Uterine Cervical Neoplasms
- Interventions
- Nivolumab 40 mg in 4 ml Injection, Ipilimumab 200 MG in 40 ML Injection, Chemoradiation
- First posted
- 2022-08-08
- Last updated
- 2024-01-05
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 3-year progression-free survival | 3 years | No evidence of disease recurrence/regrowth after 3 years of follow-up |
| Secondary | 3-year overall survival | 3 years | Rate of survival 3 years after the end of chemoradiation |
| Secondary | Objective response rate | 90 days after the end of chemoradiation | RECIST response |
| Secondary | Response duration | Through study completion, an average of 3 year | Time from maximum response to disease progression |
| Secondary | To evaluate health related quality of life (HRQoL): defined as the change from baseline of disease-related symptoms and quality of life of patients undergoing treatment Nivolumab-ipilimumab and Chemoradiation for Cervical Cancer | Baseline (time from screening - before starting treatment) and at the end of treatment (56 days after the last dose of radiotherapy). | Evaluate health related quality of life using the instrument EORTC QLQ-C30 v3 based on European Organization for Research and Treatment of Cancer (EORTC). The EORTC QLQ-C30 v3 questionnaire, consisting of 30 questions covering 15 domains, divided into three distinct scales: state scale global health and quality of life (it has only one domain, global health measure); functional scale (physical function, role performance, emotional function, cognitive function and social function domains); and symptom scale (fatigue, nausea and vomiting, pain, dyspnea, insomnia, loss of appetite, constipation, diarrhea and financial difficulties). The scores on each scale range from 0 - 100. The global and functional health scales indicate better quality of life as their score approaches 100. For the symptoms scale, the analysis is inverse, with better performance for quality of life when the scores approach the score minimum (zero). |
| Secondary | Evaluate health related quality of life using supplemental cervical cancer module (EORTC CX24) to evaluate patients submitted to treatment with Nivolumab-ipilimumab and Chemoradiation for Cervical Cancer. | Baseline (time from screening - before starting treatment) and at the end of treatment (56 days after the last dose of radiotherapy). | The EORTC - CX24 questionnaire contains 24 questions, divided into three multiple-item scales and six single-item scales, of which 11 refer to symptoms (questions 31-37, 39 and 41-43), three about body image. (questions 45-47), four questions on sexual/vaginal function (questions 50-53), one on lymphedema (question 38), one for evaluation of peripheral neuropathy (question 40), one for evaluation of menopausal symptoms (question 44) ), one on sexual concerns (question 48), one on sexual activity (question 49) and one on sexual pleasure (question 54). The answers are transformed into a score from 0 - 100 and calculated separately for each scale. |
| Secondary | Treatment-related toxicity | Through study completion, an average of 3 year | Treatment-related toxicity according to CTCAE version 4.0 (Common Toxicity Criteria for Adverse Events ) |
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.
Papers3
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/NCT05492123
GET https://conductscience.org/api/trials/v1/NCT05492123/registered