Trial · NCT03055013
Nivolumab in Treating Patients With Localized Kidney Cancer Undergoing Nephrectomy
NCT03055013, Phase 3, Active not recruiting, National Cancer Institute (NCI); results first posted 2024-04-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Nivolumab in Treating Patients With Localized Kidney Cancer Undergoing Nephrectomy. Trials, record NCT03055013. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03055013
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nivolumab in Treating Patients With Localized Kidney Cancer Undergoing Nephrectomy
- NCT number
- NCT03055013
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 819 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Metastatic Renal Cell Carcinoma, Sarcomatoid Renal Cell Carcinoma, Stage II Renal Cell Cancer AJCC v7, Stage III Renal Cell Cancer AJCC v7, Unclassified Renal Cell Carcinoma
- Interventions
- Nephrectomy, Nivolumab, Patient Observation, Quality-of-Life Assessment, Questionnaire Administration
- First posted
- 2017-02-16
- Last updated
- 2026-08-28
- Results first posted
- 2024-04-25
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recurrence-free Survival (RFS) Rate at 5 Years | Assessed at 20 weeks, 40 weeks, then every 3 months for patients <2 years from randomization, then every 6 months for 3 years | RFS is defined as time from randomization to disease recurrence or death from any cause. Patients who did not undergo nephrectomy or were not disease-free following nephrectomy were considered as having an event at day 1. Patients that are alive without an event were censored at the date of last disease evaluation. RFS rate at 5 years was the proportion of patients who are recurrence-free and alive at 5 years based on Kaplan-Meier estimates. |
| Secondary | Recurrence-free Survival (RFS) Rate at 3 Years Among Patients With Clear Cell Histology | Assessed at 20 weeks, 40 weeks, then every 3 months for patients <2 years from randomization, then every 6 months for 1 year | RFS is defined as time from randomization to disease recurrence or death from any cause. Patients who did not undergo nephrectomy or were not disease-free following nephrectomy were considered as having an event at day 1. Patients that are alive without an event were censored at the date of last disease evaluation. RFS rate at 3 years was the proportion of patients who are recurrence-free and alive at 3 years based on Kaplan-Meier estimates. |
| Secondary | Overall Survival Rate at 5 Years | Assessed at 20 weeks, 40 weeks, then every 3 months for patients <2 years from randomization, then every 6 months for 3 years | Overall survival is defined as time from randomization to death from any cause. Overall survival rate at 5 years was the proportion of patients who are alive at 5 years based on Kaplan-Meier estimates. |
| Other | Association Between the Primary Tumor's Expression of PD-L1 With Outcome | Assessed at 20 weeks, 40 weeks, then every 3 months for patients <2 years from randomization, then every 6 months for 3 years, then annually for 5 years | Association between the primary tumor's expression of PD-L1 with outcome |
| Other | Association Between the Expression of PD-L1 on Tumor Tissue at Nephrectomy as Well as Recurrence and Outcome | Assessed at 20 weeks, 40 weeks, then every 3 months for patients <2 years from randomization, then every 6 months for 3 years, then annually for 5 years | Association between the expression of PD-L1 on tumor tissue at nephrectomy as well as recurrence and outcome |
| Other | To Archive Images for Potential Central Confirmation of Recurrence and for Future Correlative Work | Assessed at 20 weeks, 40 weeks, then every 3 months for patients <2 years from randomization, then every 6 months for 3 years, then annually for 5 years | To archive images for potential central confirmation of recurrence and for future correlative work |
| Other | To Collect Tumor and Biologic Specimens for Future Correlative Studies | Assessed at baseline, nephrectomy, 9 months and recurrence | To collect tumor and biologic specimens for future correlative studies |
| Other | To Characterize the Pharmacokinetics of Nivolumab and Explore Exposure Response Relationships With Respect to Safety and Efficacy | Assessed at 20 weeks, 40 weeks, then every 3 months for patients <2 years from randomization, then every 6 months for 3 years, then annually for 5 years | To characterize the pharmacokinetics of nivolumab and explore exposure response relationships with respect to safety and efficacy |
| Other | To Characterize the Immunogenicity of Nivolumab | Assessed at 20 weeks, 40 weeks, then every 3 months for patients <2 years from randomization, then every 6 months for 3 years, then annually for 5 years | To characterize the immunogenicity of nivolumab |
| Other | To Evaluate Differences in Change From Baseline in Patient-reported Symptoms and Toxicities Among Patients Randomized to Treatment With Nivolumab Compared to Surgery Alone | Assessed at baseline, pre-nephrectomy, 8 weeks post-nephrectomy, 20 weeks, 40 weeks, 54 weeks, recurrence and 2 years post randomization | To evaluate differences in change from baseline in patient-reported symptoms and toxicities among patients randomized to treatment with nivolumab compared to surgery alone |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Recurrence-free Survival (RFS) Rate at 5 Years | Assessed at 20 weeks, 40 weeks, then every 3 months for patients <2 years from randomization, then every 6 months for 3 years | All randomized RCC patients were included in this analysis. | proportion of participants | NUMBER |
| SECONDARY | Recurrence-free Survival (RFS) Rate at 3 Years Among Patients With Clear Cell Histology | Assessed at 20 weeks, 40 weeks, then every 3 months for patients <2 years from randomization, then every 6 months for 1 year | All randomized RCC patients who had clear cell histology according to surgery or biopsy were included in this analysis. | proportion of participants | NUMBER |
| SECONDARY | Overall Survival Rate at 5 Years | Assessed at 20 weeks, 40 weeks, then every 3 months for patients <2 years from randomization, then every 6 months for 3 years | All randomized patients were included in this analysis. | proportion of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Association Between the Primary Tumor's Expression of PD-L1 With Outcome | Assessed at 20 weeks, 40 weeks, then every 3 months for patients <2 years from randomization, then every 6 months for 3 years, then annually for 5 years | |||
| OTHER_PRE_SPECIFIED | Association Between the Expression of PD-L1 on Tumor Tissue at Nephrectomy as Well as Recurrence and Outcome | Assessed at 20 weeks, 40 weeks, then every 3 months for patients <2 years from randomization, then every 6 months for 3 years, then annually for 5 years | |||
| OTHER_PRE_SPECIFIED | To Archive Images for Potential Central Confirmation of Recurrence and for Future Correlative Work | Assessed at 20 weeks, 40 weeks, then every 3 months for patients <2 years from randomization, then every 6 months for 3 years, then annually for 5 years | |||
| OTHER_PRE_SPECIFIED | To Collect Tumor and Biologic Specimens for Future Correlative Studies | Assessed at baseline, nephrectomy, 9 months and recurrence | |||
| OTHER_PRE_SPECIFIED | To Characterize the Pharmacokinetics of Nivolumab and Explore Exposure Response Relationships With Respect to Safety and Efficacy | Assessed at 20 weeks, 40 weeks, then every 3 months for patients <2 years from randomization, then every 6 months for 3 years, then annually for 5 years | |||
| OTHER_PRE_SPECIFIED | To Characterize the Immunogenicity of Nivolumab | Assessed at 20 weeks, 40 weeks, then every 3 months for patients <2 years from randomization, then every 6 months for 3 years, then annually for 5 years | |||
| OTHER_PRE_SPECIFIED | To Evaluate Differences in Change From Baseline in Patient-reported Symptoms and Toxicities Among Patients Randomized to Treatment With Nivolumab Compared to Surgery Alone | Assessed at baseline, pre-nephrectomy, 8 weeks post-nephrectomy, 20 weeks, 40 weeks, 54 weeks, recurrence and 2 years post randomization |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Recurrence-free Survival (RFS) Rate at 5 Years | Arm A (Nephrectomy + Nivolumab) | 0.63 | 95% Confidence Interval 0.577 to 0.688 | proportion of participants | |
| Recurrence-free Survival (RFS) Rate at 5 Years | Arm B (Nephrectomy Only) | 0.605 | 95% Confidence Interval 0.545 to 0.671 | proportion of participants | |
| Recurrence-free Survival (RFS) Rate at 3 Years Among Patients With Clear Cell Histology | Arm A (Nephrectomy + Nivolumab) | 0.663 | 95% Confidence Interval 0.606 to 0.725 | proportion of participants | |
| Recurrence-free Survival (RFS) Rate at 3 Years Among Patients With Clear Cell Histology | Arm B (Nephrectomy Only) | 0.675 | 95% Confidence Interval 0.623 to 0.732 | proportion of participants | |
| Overall Survival Rate at 5 Years | Arm A (Nephrectomy + Nivolumab) | 0.73 | 95% Confidence Interval 0.611 to 0.873 | proportion of participants | |
| Overall Survival Rate at 5 Years | Arm B (Nephrectomy Only) | 0.811 | 95% Confidence Interval 0.728 to 0.904 | proportion of participants |
Source ClinicalTrials.gov
Participant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (Nephrectomy + Nivolumab) | 404 | |
| Overall Study | STARTED | Arm B (Nephrectomy Only) | 415 | |
| Overall Study | RCC Patients | Arm A (Nephrectomy + Nivolumab) | 381 | |
| Overall Study | RCC Patients | Arm B (Nephrectomy Only) | 399 | |
| Overall Study | Patients Who Received Treatment and Were Assessed for Adverse Events | Arm A (Nephrectomy + Nivolumab) | 357 | |
| Overall Study | Patients Who Received Treatment and Were Assessed for Adverse Events | Arm B (Nephrectomy Only) | 377 | |
| Overall Study | COMPLETED | Arm A (Nephrectomy + Nivolumab) | 197 | |
| Overall Study | COMPLETED | Arm B (Nephrectomy Only) | 387 | |
| Overall Study | NOT COMPLETED | Arm A (Nephrectomy + Nivolumab) | 207 | |
| Overall Study | NOT COMPLETED | Arm B (Nephrectomy Only) | 28 |
Source ClinicalTrials.gov
Adverse events264
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 | Anemia | Blood and lymphatic system disorders | Arm A (Nephrectomy + Nivolumab) | 30 | 357 | |
| other | Anemia | Blood and lymphatic system disorders | Arm B (Nephrectomy Only) | 21 | 377 | |
| other | Fatigue | General disorders | Arm A (Nephrectomy + Nivolumab) | 138 | 357 | |
| other | Fatigue | General disorders | Arm B (Nephrectomy Only) | 28 | 377 | |
| other | Pain | General disorders | Arm A (Nephrectomy + Nivolumab) | 16 | 357 | |
| other | Pain | General disorders | Arm B (Nephrectomy Only) | 21 | 377 | |
| other | Dry skin | Skin and subcutaneous tissue disorders | Arm A (Nephrectomy + Nivolumab) | 18 | 357 | |
| other | Dry skin | Skin and subcutaneous tissue disorders | Arm B (Nephrectomy Only) | 0 | 377 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | Arm A (Nephrectomy + Nivolumab) | 89 | 357 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | Arm B (Nephrectomy Only) | 2 | 377 |
1 to 10 of 264Source ClinicalTrials.gov
See all 264 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A (Nephrectomy + Nivolumab) | 48 | 404 |
| Total, all-cause mortality | Arm B (Nephrectomy Only) | 40 | 415 |
| Total, other adverse events | Arm A (Nephrectomy + Nivolumab) | 278 | 357 |
| Total, other adverse events | Arm B (Nephrectomy Only) | 114 | 377 |
| Total, serious adverse events | Arm A (Nephrectomy + Nivolumab) | 113 | 357 |
| Total, serious adverse events | Arm B (Nephrectomy Only) | 46 | 377 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|---|---|---|---|
| U10CA180820 | ECOG-ACRIN Network Group Operations Center | ODwyer, Peter J; SCHNALL, MITCHELL D. | ECOG-ACRIN MEDICAL RESEARCH FOUNDATION | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A (Nephrectomy + Nivolumab) vs Arm B (Nephrectomy Only): deaths from any cause | Trial comparisons |
| Arm A (Nephrectomy + Nivolumab) vs Arm B (Nephrectomy Only): serious adverse events | Trial comparisons |
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/NCT03055013
GET https://conductscience.org/api/trials/v1/NCT03055013/events?page=2