Trial · NCT07337447
Trial of FOLFIRI + Zimberelimab + Domvanalimab vs FOLFIRI With a Hybrid Synthetic Control Arm in Second Line Treatment of Neuroendocrine Carcinoma of Gastro-enteropancreatic or Unknown Origin (REWENEC 01)
NCT07337447, Phase 2, Not yet recruiting, Hospices Civils de Lyon
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial of FOLFIRI + Zimberelimab + Domvanalimab vs FOLFIRI With a Hybrid Synthetic Control Arm in Second Line Treatment of Neuroendocrine Carcinoma of Gastro-enteropancreatic or Unknown Origin (REWENEC 01). Trials, record NCT07337447. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07337447
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Trial of FOLFIRI + Zimberelimab + Domvanalimab vs FOLFIRI With a Hybrid Synthetic Control Arm in Second Line Treatment of Neuroendocrine Carcinoma of Gastro-enteropancreatic or Unknown Origin (REWENEC 01)
- NCT number
- NCT07337447
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 122 participants, estimated
- Lead sponsor
- Hospices Civils de Lyon
- Conditions
- Carcinoma, Neuroendocrine
- Interventions
- FOLFIRI + Zimberelimab + Domvanalimab, FOLFIRI (standard of care)
- First posted
- 2026-01-13
- Last updated
- 2026-01-13
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall survival (%) between FOLFIRI and FOLFIRI+Zimberelimab+Domvanalimab | 6 months after the start of treatment 12 months after the start of treatment | Length of time from randomization that patients included in the study are still alive. Analyzed in modified intention to treat |
| Secondary | Progression free survival (PFS) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months | Time from randomization to disease progression or death, whatever the cause. Alive and no progressive patients at last follow-up will be considered as censored |
| Secondary | Overall response rate (ORR) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months | local radiological evaluation using RECIST 1.1 |
| Secondary | Duration of response (DoR) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months | Time from response (complete or partial) to progression or death, estimated in patients who reached a response and are RECIST 1.1 evaluable |
| Secondary | Disease control rate | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months | Defined as the proportion of RECIST 1.1 evaluable patients in objective response or with stable disease. |
| Secondary | Evaluation of toxicity | At the Day 1 of each cycles (each cycle is 4 weeks) | assessed by NCI CTCAsE v5.0 |
| Secondary | Evaluation of toxicity | at the Day 15 of each cycles (each cycle is 4 weeks) | assessed by NCI CTCAsE v5.0 |
| Secondary | Questionnaire Quality of life QLQ-C30 | at the day 1 of Cycle 2 (1 cycle is 4 weeks) | Questionnaire QLQ-C30 |
| Secondary | Questionnaire Quality of life EQ 5D-5L | at the day 1 of Cycle 2 (1 cycle is 4 weeks) | Questionnaire EQ 5D-5L |
| Secondary | Questionnaire Quality of life | Every 8 weeks through study completion, an average of 2 years | Questionnaire QLQ-C30 |
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.
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/NCT07337447
GET https://conductscience.org/api/trials/v1/NCT07337447/registered