Trial · NCT06790706
IMMUNORARE5: A National Platform of 5 Academic Phase II Trials Coordinated by Lyon University Hospital to Assess the Safety and the Efficacy of the IMMUNOtherapy With Domvanalimab + Zimberelimab Combination in Patients With Advanced RARE Cancers
NCT06790706, Phase 2, Active not recruiting, Hospices Civils de Lyon
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. IMMUNORARE5: A National Platform of 5 Academic Phase II Trials Coordinated by Lyon University Hospital to Assess the Safety and the Efficacy of the IMMUNOtherapy With Domvanalimab + Zimberelimab Combination in Patients With Advanced RARE Cancers. Trials, record NCT06790706. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06790706
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
IMMUNORARE5: A National Platform of 5 Academic Phase II Trials Coordinated by Lyon University Hospital to Assess the Safety and the Efficacy of the IMMUNOtherapy With Domvanalimab + Zimberelimab Combination in Patients With Advanced RARE Cancers
- NCT number
- NCT06790706
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 27 participants, actual
- Lead sponsor
- Hospices Civils de Lyon
- Conditions
- Peritoneal Mesothelioma, Gestational Trophoblastic Tumor, Anaplastic Thyroid Carcinomas, Gastroenteropancreatic Neuroendocrine Tumor, Carcinoid Tumor, Thymic Carcinoma
- Interventions
- DOMVANALIMAB + ZIMBERELIMAB, DOMVANALIMAB + ZIMBERELIMAB + FOLFOX-4
- First posted
- 2025-01-24
- Last updated
- 2026-06-25
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free survival rate (cohort 1, 3 and 5) | At 24 weeks after the start of study treatments | Proportion of patients alive without disease progression at 24 weeks (in %). Progression is defined as followed: * Cohort 1: clinical progression OR radiological progression based on modified RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria * Cohort 3 and 5: radiological progression based on RECIST 1.1 criteria |
| Primary | Successful hCG normalization rate (cohort 2) | At 24 weeks after the start of study treatments | Proportion of patients experiencing a successful hCG-normalization within 24 weeks while on study treatment (in percent). The hCG normalization is defined as a hCG value that reach the institutional normal threshold . |
| Primary | Survival rate (cohort 4) | At 24 weeks after the start of study treatments | Proportion of patients alive at 24 weeks (percent). |
| Secondary | Overall response rate (cohorts 1, 3, 4 and 5) | Through treatment period, an average of 1 year | Overall response rate defined as the proportion of patients experiencing complete or partial radiological response as the best radiological tumor response on the study period according to RECIST 1.1 for cohorts 3-5 and mRECIST for cohort 1. |
| Secondary | Progression-free survival (cohorts 1, 3, 4 and 5) | Through study completion (maximum 6 years and 11 month) | Progression-free survival (PFS) defined as the time elapsed between inclusion and disease progression/death whichever occurs first, according to RECIST criteria (cohorts 3-5) or according to mRECIST criteria (cohort 1). Patients alive without progression will be censored at the last date of imaging assessment |
| Secondary | Resistance-free survival (cohort 2). | Through study completion (maximum 6 years and 11 month) | Resistance-free survival (RFS) calculated as the time elapsed between inclusion and disease resistance defined as the date of subsequent treatment start for lack of efficacy of study treatment (cohort 2). Patients without resistance will be censored at the date of last news. Disease resistance is defined as a rise (i.e ≥ 20% rise between 2 assays twice in three consecutive weekly assays) or a plateau (i.e. one or more of a ≤ 10% decrease between two assays three time in four consecutive weekly assays) in the hCG level. |
| Secondary | Overall survival (cohorts 1, 2, 3 and 5) | Through study completion (maximum 6 years and 11 month) | Overall survival defined as the time elapsed between inclusion and patients death regardless of the cause. Patients alive will be censored at the last date of last news. |
| Secondary | Duration of response (cohorts 1, 3, 4 and 5) | Through study completion (maximum 6 years and 11 month) | Duration of response defined as the delay (in days) between overall response and progression or death whichever occurs first. |
| Secondary | Tolerability : Adverse events | From patient inclusion, until 5 months after the end of treatment (i.e. an average of 17 months) | Tolerability of the combination of Domvanalimab and Zimberelimab will be assessed by a description of the adverse events (SAE, AE related to study treatment, AE of special interest) according to CI-CTCAE v5 criteria. |
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/NCT06790706
GET https://conductscience.org/api/trials/v1/NCT06790706/registered