Trial · NCT03595124
A Study to Compare Treatments for a Type of Kidney Cancer Called TFE/Translocation Renal Cell Carcinoma (tRCC)
NCT03595124, Phase 2, Active not recruiting, National Cancer Institute (NCI); results first posted 2025-10-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Compare Treatments for a Type of Kidney Cancer Called TFE/Translocation Renal Cell Carcinoma (tRCC). Trials, record NCT03595124. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03595124
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Compare Treatments for a Type of Kidney Cancer Called TFE/Translocation Renal Cell Carcinoma (tRCC)
- NCT number
- NCT03595124
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Metastatic Renal Cell Carcinoma, Stage III Renal Cell Cancer AJCC v8, Stage IV Renal Cell Cancer AJCC v8, TFE3-Rearranged Renal Cell Carcinoma, Unresectable Renal Cell Carcinoma
- Interventions
- Axitinib, Nivolumab
- First posted
- 2018-07-23
- Last updated
- 2026-10-22
- Results first posted
- 2025-10-10
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | Up to 1 year from study entry | The Kaplan-Meier method will be used to estimate 1-year PFS, defined as the time from randomization to disease progression or death due to any cause. The 70% confidence interval was chosen to match the one-sided significance level of alpha = 0.15 specified in the protocol analysis plan. |
| Secondary | Overall Survival (OS) | Up to 1 year from study entry | The Kaplan-Meier method will be used to estimate 1-year OS, defined as the time from study entry until death. The 70% confidence interval was chosen to match the one-sided significance level of alpha = 0.15 specified in the protocol analysis plan. |
| Secondary | Overall Response Rate (ORR) | Up to 1 year from study entry | The ORR will be defined as the proportion of patients that achieve a complete or partial response according to RECIST version 1.1 among patients who initiated protocol therapy and completed at least one subsequent imaging assessment. The 70% confidence interval was chosen to match the one-sided significance level of alpha = 0.15 specified in the protocol analysis plan. |
| Secondary | Percentage of Patients Experiencing Adverse Events (AEs) | Up to 2 years from study entry | Percentage of patients experiencing grade 3+ non-hematologic and all grade 4-5 AEs occurring during protocol therapy or within 30 days of treatment will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The 70% confidence interval was chosen to match the one-sided significance level of alpha = 0.15 specified in the protocol analysis plan. |
| Other | Translocation Morphology Renal Cell Carcinoma Clinical Behavior | Up to 2 years from study entry | Site(s) of disease at presentation (including extent of lymph node involvement), site(s) of relapse, surgical and radiotherapy practices on protocol therapy. |
| Other | Type of Antitumor Immune Response and Stability of T Cell Activation | Up to 1 year from study entry | Levels of protocol-specified marker analytes and tumor expression before and after treatment and changes due to treatment will be described using descriptive statistics. |
| Other | Pharmacokinetics (PK) Parameters of Axitinib | Up to 12 weeks from study entry | PKs will be evaluated at day 1 of cycles 1, 2, and 3. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) | Up to 1 year from study entry | The data was analyzed with revised intention-to-treat approach. The following patients were excluded: Three (3) Arm B patients (as of Amendment 2A, the arm permanently closed to accrual and patients were randomly assigned to Arms A and C), One (1) Arm A patient who is ineligible for the study. 11 total patients were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | Up to 1 year from study entry | The data was analyzed with revised intention-to-treat approach. The following patients were excluded: Three (3) Arm B patients (as of Amendment 2A, the arm permanently closed to accrual and patients were randomly assigned to Arms A and C), One (1) Arm A patient who is ineligible for the study. 11 total patients were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Overall Response Rate (ORR) | Up to 1 year from study entry | The data was analyzed with revised intention-to-treat approach. The following patients were excluded: Three (3) Arm B patients (as of Amendment 2A, the arm permanently closed to accrual and patients were randomly assigned to Arms A and C), One (1) Arm A patient who is ineligible for the study. 11 total patients were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients Experiencing Adverse Events (AEs) | Up to 2 years from study entry | The data was analyzed with revised intention-to-treat approach. The following patients were excluded: Three (3) Arm B patients (as of Amendment 2A, the arm permanently closed to accrual and patients were randomly assigned to Arms A and C), One (1) Arm A patient who is ineligible for the study. 11 total patients were analyzed. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Translocation Morphology Renal Cell Carcinoma Clinical Behavior | Up to 2 years from study entry | |||
| OTHER_PRE_SPECIFIED | Type of Antitumor Immune Response and Stability of T Cell Activation | Up to 1 year from study entry | |||
| OTHER_PRE_SPECIFIED | Pharmacokinetics (PK) Parameters of Axitinib | Up to 12 weeks from study entry |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) | Arm A (Axitinib, Nivolumab) | 33 | 70% Confidence Interval 18.32 to 60.64 | percentage of participants | |
| Progression Free Survival (PFS) | Arm C (Nivolumab) | 0 | 70% Confidence Interval NA to NA | percentage of participants | |
| Overall Survival (OS) | Arm A (Axitinib, Nivolumab) | 100 | 70% Confidence Interval NA to NA | percentage of participants | |
| Overall Survival (OS) | Arm C (Nivolumab) | 80 | 70% Confidence Interval 63.45 to 100 | percentage of participants | |
| Overall Response Rate (ORR) | Arm A (Axitinib, Nivolumab) | 33 | 70% Confidence Interval 11.50 to 62.18 | percentage of participants | |
| Overall Response Rate (ORR) | Arm C (Nivolumab) | 0 | 70% Confidence Interval 0 to 31.54 | percentage of participants | |
| Percentage of Patients Experiencing Adverse Events (AEs) | Arm A (Axitinib, Nivolumab) | 50 | 70% Confidence Interval 30.52 to 69.48 | percentage of participants | |
| Percentage of Patients Experiencing Adverse Events (AEs) | Arm C (Nivolumab) | 80 | 70% Confidence Interval 46.87 to 97.39 | percentage of participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (Axitinib, Nivolumab) | 7 | |
| Overall Study | STARTED | Arm B (Axitinib) | 3 | |
| Overall Study | STARTED | Arm C (Nivolumab) | 5 | |
| Overall Study | COMPLETED | Arm A (Axitinib, Nivolumab) | 1 | |
| Overall Study | COMPLETED | Arm B (Axitinib) | 0 | |
| Overall Study | COMPLETED | Arm C (Nivolumab) | 0 | |
| Overall Study | NOT COMPLETED | Arm A (Axitinib, Nivolumab) | 6 | |
| Overall Study | NOT COMPLETED | Arm B (Axitinib) | 3 | |
| Overall Study | NOT COMPLETED | Arm C (Nivolumab) | 5 |
Source ClinicalTrials.gov
Adverse events150
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Arm A (Axitinib, Nivolumab) | 1 | 6 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Arm B (Axitinib) | 0 | 2 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Arm C (Nivolumab) | 0 | 5 | 0 |
| other | Alanine aminotransferase increased | Investigations | Arm A (Axitinib, Nivolumab) | 1 | 6 | 2 |
| other | Alanine aminotransferase increased | Investigations | Arm B (Axitinib) | 0 | 2 | 0 |
| other | Alanine aminotransferase increased | Investigations | Arm C (Nivolumab) | 0 | 5 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Arm A (Axitinib, Nivolumab) | 1 | 6 | 4 |
| other | Anemia | Blood and lymphatic system disorders | Arm B (Axitinib) | 0 | 2 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Arm C (Nivolumab) | 0 | 5 | 0 |
| other | Anorexia | Metabolism and nutrition disorders | Arm A (Axitinib, Nivolumab) | 1 | 6 | 1 |
1 to 10 of 150Source ClinicalTrials.gov
See all 150 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A (Axitinib, Nivolumab) | 1 | 6 |
| Total, all-cause mortality | Arm B (Axitinib) | 2 | 2 |
| Total, all-cause mortality | Arm C (Nivolumab) | 4 | 5 |
| Total, other adverse events | Arm A (Axitinib, Nivolumab) | 2 | 6 |
| Total, other adverse events | Arm B (Axitinib) | 0 | 2 |
| Total, other adverse events | Arm C (Nivolumab) | 1 | 5 |
| Total, serious adverse events | Arm A (Axitinib, Nivolumab) | 4 | 6 |
| Total, serious adverse events | Arm B (Axitinib) | 2 | 2 |
| Total, serious adverse events | Arm C (Nivolumab) | 5 | 5 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA180886 | COG NCTN Network Group Operations Center | Hawkins, Douglas S. | COG RESEARCH FOUNDATION, LLC | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
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/NCT03595124
GET https://conductscience.org/api/trials/v1/NCT03595124/events?page=2