Trial · NCT05078047
Study Comparing the Standard Administration of IO Versus the Same IO Administered Each 3 Months in Patients in Response After 6 Months of Standard IO
NCT05078047, Phase 3, Active not recruiting, UNICANCER
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study Comparing the Standard Administration of IO Versus the Same IO Administered Each 3 Months in Patients in Response After 6 Months of Standard IO. Trials, record NCT05078047. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05078047
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Comparing the Standard Administration of IO Versus the Same IO Administered Each 3 Months in Patients in Response After 6 Months of Standard IO
- NCT number
- NCT05078047
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 646 participants, estimated
- Lead sponsor
- UNICANCER
- Conditions
Lung Cancer Metastatic, Renal Cell Carcinoma, Head and Neck Cancer, Triple Negative Breast Cancer, Merkel Cell Carcinoma, Hepatocellular Carcinoma, Melanoma, Urothelial Carcinoma, Colorectal Carcinoma With Microsatellite Instability, Esophageal Squamous Cell Carcinoma, Endometrial Carcinoma, Cervical Cancer, Gastric/Gastro-esophageal Junction/Esophageal Adenocarcinoma, Basal Cell Carcinoma, Squamous Skin Carcinoma
- Interventions
- Reduced dose intensity of IO
- First posted
- 2021-10-14
- Last updated
- 2026-07-17
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free survival (PFS) | From randomization to disease progression or death, up to 3 years | The progression-free survival is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse. |
| Secondary | Cost-effectiveness analysis of the proposed therapeutic strategy | 3 years | Incremental cost-effectiveness ratio (ICER) expressed as a cost per quality-adjusted life year (QALY) gained at 36 months. |
| Secondary | Immune progression-free survival (iPFS) | From randomization to disease progression or death, up to 3 years | The progression-free survival is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse (Immune disease progression (iPD)). iPD will be determined locally by the investigator through the use of iRECIST in case of lesions identified at Baseline. |
| Secondary | Objective response rate (ORR) | From randomization to 12 and 24 months post-randomization | Objective response rate (ORR) defined as the percentage of patients with a confirmed complete response (CR) or partial response (PR) as assessed by the investigator using RECIST v1.1 at 12 and 24 months post-randomization. |
| Secondary | Overall survival (OS) | From randomization to death from any cause, up to 3 years | The overall survival is the length of time from randomization that patients enrolled in the study are still alive. |
| Secondary | Duration of response (DoR) | From randomization to disease progression or death, up to 3 years | Duration of response (DoR) defined as the time from randomization to first documented response until disease progression or death, whichever occurs first. |
| Secondary | Quality of life questionnaire - Core 30 (QLQ-C30) | At inclusion visit (pre-randomization) and 3, 6, 9, 12, 15, 18, 24, and 36 months post-randomization | Developed by the 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 | The Developed 5-level version of EQ-5D (EQ-5D-5L) questionnaire | At inclusion visit (pre-randomization) and 3, 6, 9, 12, 15, 18, 24, and 36 months post-randomization | Developed by the EuroQol group, the self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials consists of a descriptive system and a visual analogue scale (VAS). The EQ-5D-5L descriptive system comprises five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each dimension has 5 levels. This questionnaire provide a 5-digit score which generate a health state profile. The VAS records the patient's self-rated health on a vertical visual analogue scale where the score range from 100 (Best imaginable health state) to 0 (Worst imaginable health state). The VAS is used as a quantitative measure of health outcome that reflects the patient's own judgement. |
| Secondary | Hospital anxiety and depression scale (HADS) | At inclusion visit (pre-randomization) and 3, 6, 9, 12, 15, 18, 24, and 36 months post-randomization | The HADS is a 14 items questionnaire: 7 items related to anxiety and 7 items related to depression scored on a scale. Scores for items in each subscale of the HADS are summed to produce an anxiety score (HADS-A) or a depression score (HADS-D), or can be added to produce a total score corresponding to emotional distress (HADS-T). Each item is rated on a 4-point Likert scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), for a total score ranging from 0-21 for each subscale. The entire scale (emotional distress) range from 0 to 42, with higher scores indicating more distress. |
| Secondary | Fear of relapse questionnaire | At inclusion visit (pre-randomization) and 3, 6, 9, 12, 15, 18, 24, and 36 months post-randomization | The Fear of relapse questionnaire is a self-reported questionnaire aiming to better understand how these concerns of fear of relapse by patients manifest themselves. The questionnaire contains 32 items rated on a five-point Likert-type scale (0 = "never", 1 = "seldom ", 2 = "sometimes", 3 = "often", and 4 = "always"). For all items, higher scores indicate more severe fear of relapse. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
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 |
|---|---|
| 37131154 | 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/NCT05078047
GET https://conductscience.org/api/trials/v1/NCT05078047/registered