Trial · NCT03012581
Secured Access to Nivolumab for Adult Patients With Selected Rare Cancer Types
NCT03012581, Phase 2, Completed, UNICANCER
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Secured Access to Nivolumab for Adult Patients With Selected Rare Cancer Types. Trials, record NCT03012581. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03012581
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Secured Access to Nivolumab for Adult Patients With Selected Rare Cancer Types
- NCT number
- NCT03012581
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 269 participants, actual
- Lead sponsor
- UNICANCER
- Conditions
- Carcinoma, Renal Cell, Head and Neck Neoplasm, Skin Neoplasms, Microsatellite Instability, Penile Neoplasms, Cancer With POLE Exonucleasic Domain Mutation
- Interventions
- Nivolumab
- First posted
- 2017-01-06
- Last updated
- 2024-02-28
- Other registries' IDs
- eudract:2016-002257-37
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective response rate | measured at the first scheduled disease assessment following study treatment initiation (Day 84, ± 7 days) | ORR will be assessed per cohort by an IRC according to RECIST v1.1. |
| Secondary | Progression-free survival | From date of inclusion until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 36 months | Assessed according to RECIST v1.1 |
| Secondary | Overall survival | From date of inclusion until the date of death from any cause, assessed up to 36 months | |
| Secondary | Best response | From inclusion up to 36 months | Assessed according to RECIST v1.1 |
| Secondary | Response duration | from first observation of objective response until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 36 months | Assessed according to RECIST v1.1 |
| Secondary | Time to response | from inclusion first observation of objective response, assessed up to 36 months | Assessed according to RECIST v1.1 |
| Secondary | Frequency and severity of adverse events | from inclusion until 100 days after last dose of investigational product | assessed according to the NCI-CTCAE v4 |
| Secondary | Objective response rate in subgroups of subjects with high versus low expression (cutoff set at the median for the population measured) of different immune markers (PD-L1, CD4+, FOXP3+, Fas-L, OX40, VEGF, CD31; CD34) | measured at the first scheduled disease assessment following study treatment initiation (Day 84, ± 7 days) | ORR will be assessed per cohort by an IRC according to RECIST v1.1. |
| Secondary | Progression-free survival in subgroups of subjects with high versus low expression (cutoff set at the median for the population measured) of different immune markers (PD-L1, CD4+, FOXP3+, Fas-L, OX40, VEGF, CD31; CD34) | From date of inclusion until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 36 months | Assessed according to RECIST v1.1. |
| Secondary | Overall survival in subgroups of subjects with high versus low expression (cutoff set at the median for the population measured) of different immune markers (PD-L1, CD4+, FOXP3+, Fas-L, OX40, VEGF, CD31; CD34) | From date of inclusion until the date of death from any cause, assessed up to 36 months |
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.
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 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/NCT03012581
GET https://conductscience.org/api/trials/v1/NCT03012581/registered