Trial · NCT03132038
Nivolumab in Recurrent or Metastatic Salivary Gland Carcinoma of the Head and Neck
NCT03132038, Phase 2, Completed, UNICANCER
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Nivolumab in Recurrent or Metastatic Salivary Gland Carcinoma of the Head and Neck. Trials, record NCT03132038. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03132038
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nivolumab in Recurrent or Metastatic Salivary Gland Carcinoma of the Head and Neck
- NCT number
- NCT03132038
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 98 participants, actual
- Lead sponsor
- UNICANCER
- Conditions
- Salivary Gland Carcinoma, Metastatic Cancer, Recurrent Cancer
- Interventions
- Nivolumab
- First posted
- 2017-04-27
- Last updated
- 2022-01-11
- Other registries' IDs
- eudract:2016-001794-32
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | non-progression rate | 6 months | The proportion of patients with a complete response (CR) or a partial response (PR) or a stable disease (SD) as per RECIST 1.1 after 6 months of treatment. |
| Secondary | progression free survival (PFS) | the time from the date of first Nivolumab administration until the date of event, assessed up to 84 months. | the time from the date of first Nivolumab administration until the date of event defined as the first progression according to RECIST 1.1, or death (by any cause in the absence of progression) |
| Secondary | Overall survival | the time from the date of first dose until the date of death due to any cause, assessed up to 84 months. | the time from the date of first dose until the date of death due to any cause |
| Secondary | Objective response rate (ORR) | the time from the date of first dose until the date of the initial objectively documented tumor progression per RECIST v1.1 or the date of subsequent therapy, assessed up to 84 months | ORR is defined as the number and percentage of patients with a Best Overall Response (BOR) of confirmed complete response (CR) or partial response (PR). |
| Secondary | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | the time from the date of first dose until the end of treatment, assessed up to 84 months. | incidence of all adverse events, serious adverse events, deaths and laboratory abnormalities |
| Secondary | Quality of life questionnaire - Core 30 (QLQ-C30) | the time from the date of first dose until the end of treatment, assessed up to 84 months. | Developed by the European Organisation for Research and Treatment of Cancer (EORTC), this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials. The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. |
| Secondary | Quality of Life Questionnaire - Head & Neck Cancer Module (QLQ-H&N35) | The time from the date of first dose until the end of treatment, assessed up to 84 months. | This EORTC head \& neck cancer specific questionnaire is intended to supplement the QLQ-C30. The head \& neck cancer module is a 35-item questionnaire designed for use among a wide range of patients with head \& neck cancer, varying in disease stage and treatment modality. It includes 7 multi-item scales that assess pain (4 items), swallowing (4 items), senses (2 items), speech (3 items), social eating (4 items), social contact (5 items), and sexuality (2 items). There are also 11 single items. Using a 4-point Likert scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), patients indicate the degree to which they have experienced symptoms. For all items and scales, high scores indicate more problems. |
| Secondary | Biomarkers (central PD-L1 assessment, PD-L2, tumor-infiltrating lymphocyte (TILs)) | after 2 months of treatment and at the end of treatment, assessed up to 12 months. | Correlations between expression of molecular targets and efficacy |
| Secondary | Growth Tumor rate | At each disease evaluation from baseline to last imagery, assessed up to 84 months. | The growth tumor rate will be assessed using RECIST 1.1 criteria before and under treatment for all eligible patients. |
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39886516 | 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 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/NCT03132038
GET https://conductscience.org/api/trials/v1/NCT03132038/registered