Trial · NCT06983210
Clinical Trial of AM80 in Combination With Gemcitabine, Cisplatin, and Nivolumab in Patients With Urothelial Carcinoma
NCT06983210, Phase 2, Recruiting, Nagoya University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Trial of AM80 in Combination With Gemcitabine, Cisplatin, and Nivolumab in Patients With Urothelial Carcinoma. Trials, record NCT06983210. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06983210
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Trial of AM80 in Combination With Gemcitabine, Cisplatin, and Nivolumab in Patients With Urothelial Carcinoma
- NCT number
- NCT06983210
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 43 participants, estimated
- Lead sponsor
- Nagoya University
- Conditions
- Urothelial Carcinoma Bladder, Urothelial Carcinoma of the Renal Pelvis and Ureter, Urothelial Carcinoma Urethra, Urothelial Carcinoma Recurrent
- Interventions
- Add-on effect of adding tamivarotene (AM80) to gemcitabine, cisplatin, and nivolumab combination therapy
- First posted
- 2025-05-21
- Last updated
- 2025-08-14
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response rate (RR) | Time from the start of treatment (day 1) to the confirmation of complete response (CR: complete disappearance of tumor) or partial response (PR: reduction of tumor by a certain percentage or more). (Average 18 weeks) | Response rate (RR): determined by the investigator or sub-investigator at the site. Tumor shrinkage by the best overall response based on the RECIST criteria will be determined by CT scan at each time point. For the same subject, the same imaging method used to evaluate measurable lesions at screening (e.g., the same contrast method) will be used during the study period in principle. The evaluation on each visit day should be performed by the same evaluator as much as possible to ensure internal consistency between each visit day. The response rate is calculated as the ratio of the total number of subjects with complete response (CR) and partial response (PR). CR or PR shall require "confirmation of efficacy". |
| Secondary | Overall survival | Time from day 1 of AM80 administration to death. (Average 49 weeks) | Overall survival is defined as the period beginning on the date of AM80 administration and ending on the date of death from any cause. For cases that are alive at the cutoff point, the last date of confirmed survival is used as the cutoff date. In the case of untraceable cases, the cutoff date is the last date of confirmed survival before the cutoff. |
| Secondary | Progression free survival | Time from day 1 of AM80 administration to the date of confirmed progression. (Average 49 weeks) | Progression" in the evaluation of progression-free survival is defined as Progressive Disease (PD) in the overall efficacy. Progression-free survival is defined as the time to the cut-off point for survivors who have not experienced progression by the time the last patient completes the imaging evaluation at 49 weeks post-treatment (cut-off point). Unfollow-up will be terminated on the date of the last confirmation that there was no progression. For subjects who have started post-treatment without progression, the cut-off date is the date of the last confirmation that there was no progression before the start of post-treatment. However, if nivolumab is continued after completion of study treatment, it will be treated as post-treatment, but will not be censored in the calculation of progression-free survival. If post-treatment other than nivolumab is subsequently started, it will be censored on the last date of confirmation that no progression occurred before that date. |
| Secondary | Duration of Response | Time since initiation of treatment from the time PR or CR was first identified to the date of tumor recurrence. (Average 49 weeks) | The duration of response is the period from the start of AM80 administration to the first date of objective confirmation of tumor recurrence or progression of disease from the time of first confirmation of CR or PR in the evaluation of overall efficacy from the start of AM80 administration in cases in which the best overall response was evaluated as CR or PR. The duration of complete response is the period from the start of AM80 administration and the first confirmed CR in the assessment of overall response to the first objectively confirmed date of tumor recurrence. Duration of response and duration of complete response will be evaluated based on the determination by RECIST evaluation, respectively. If no progression of disease is observed at the cut-off time point, the study is terminated on the last date when disease progression is confirmed. For subjects who have started post-treatment without progression, the cut-off date will be the last date of confirmation that there was no p |
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 |
|---|---|
| 38849479 | RESULT |
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/NCT06983210
GET https://conductscience.org/api/trials/v1/NCT06983210/registered