Trial · NCT03117309
Study of Front Line Therapy With Nivolumab and Salvage Nivolumab + Ipilimumab in Patients With Advanced Renal Cell Carcinoma
NCT03117309, Phase 2, Completed, Michael B. Atkins, MD; results first posted 2025-07-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Front Line Therapy With Nivolumab and Salvage Nivolumab + Ipilimumab in Patients With Advanced Renal Cell Carcinoma. Trials, record NCT03117309. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03117309
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Front Line Therapy With Nivolumab and Salvage Nivolumab + Ipilimumab in Patients With Advanced Renal Cell Carcinoma
- NCT number
- NCT03117309
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 164 participants, actual
- Lead sponsor
- Michael B. Atkins, MD
- Conditions
- Advanced Renal Cell Carcinoma
- Interventions
- Nivolumab 240 mg, Ipilimumab 1mg/kg, Nivolumab 3mg/kg, Nivolumab 360mg
- First posted
- 2017-04-17
- Last updated
- 2025-07-10
- Results first posted
- 2025-07-10
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 1-year Progression Free Survival (PFS) Rate for ccRCC Patients | 1 year | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. 1-year Progression-Free Survival (PFS) Rate refers to the percentage of patients who have not experienced disease progression or death from any cause within one year of starting treatment. The 1-year PFS rate of nivolumab in treatment-naïve patients with clear cell renal cell carcinoma (ccRCC) was assessed according to tumor PD-L1 expression levels. |
| Secondary | Objective Response Rate for ccRCC Patients Treated With Nivolumab Monotherapy | Up to 39 Months | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. ORR = CR +PR Evaluate ORR for nivolumab in patients with treatment naïve clear cell renal cell carcinoma (ccRCC) based on PD-L1 expression. |
| Secondary | Objective Response Rate (ORR) for ccRCC Patients Treated With Nivolumab and Ipilimumab | Up to 39 Months | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. ORR = CR +PR. Evaluate ORR in combined nivolumab and ipilimumab therapy at the time of nivolumab failure for ccRCC patients based on PD-L1 expression. |
| Secondary | Clinical Activity for nccRCC Patients | Up to 39 Months | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Clinical Activity = CR +PR+SD. Evaluate the clinical activity of nivolumab in patients with treatment naive nccRCC. |
| Secondary | 1-year Progression Free Survival (PFS) Rate for nccRCC Patients | 1 year | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. 1-year Progression-Free Survival (PFS) Rate refers to the percentage of patients who have not experienced disease progression or death from any cause within one year of starting treatment. |
| Secondary | Number of Participants With Adverse Events | Up to 28 months | Adverse events will be assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 1-year Progression Free Survival (PFS) Rate for ccRCC Patients | 1 year | In accordance with the Statistical Analysis Plan, the analysis population for the endpoint progression-free survival for ccRCC patients was defined as all patients treated with nivolumab and has PD-L1 expression. | Percentage of participants | NUMBER |
| SECONDARY | Objective Response Rate for ccRCC Patients Treated With Nivolumab Monotherapy | Up to 39 Months | In accordance with the Statistical Analysis Plan, the analysis population for the endpoint progression-free survival for ccRCC patients was defined as all patients treated with nivolumab and has PD-L1 expression. | Percentage of participants | NUMBER |
| SECONDARY | Objective Response Rate (ORR) for ccRCC Patients Treated With Nivolumab and Ipilimumab | Up to 39 Months | In accordance with the Statistical Analysis Plan, the analysis population for the endpoint progression-free survival for Part B (treated with Nivolumab and Ipilimumab) ccRCC patients was defined as all patients who entered Part B and had PD-L1 expression. | Percentage of participants | NUMBER |
| SECONDARY | Clinical Activity for nccRCC Patients | Up to 39 Months | Percentage of participants | NUMBER | |
| SECONDARY | 1-year Progression Free Survival (PFS) Rate for nccRCC Patients | 1 year | Percentage of participants | NUMBER | |
| SECONDARY | Number of Participants With Adverse Events | Up to 28 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 1-year Progression Free Survival (PFS) Rate for ccRCC Patients | Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC | PD-L1 0% | 34.6 | 95% Confidence Interval 24.3 to 45.1 | Percentage of participants |
| 1-year Progression Free Survival (PFS) Rate for ccRCC Patients | Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC | PD-L1 1-5% | 53.8 | 95% Confidence Interval 24.8 to 76.0 | Percentage of participants |
| 1-year Progression Free Survival (PFS) Rate for ccRCC Patients | Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC | PD-L1 5-20% | 33.3 | 95% Confidence Interval 0.9 to 77.4 | Percentage of participants |
| 1-year Progression Free Survival (PFS) Rate for ccRCC Patients | Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC | PD-L1 > 20% | 75 | 95% Confidence Interval 31.5 to 93.1 | Percentage of participants |
| Objective Response Rate for ccRCC Patients Treated With Nivolumab Monotherapy | Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC | PD-L1 0% | 26.9 | 95% Confidence Interval 17.5 to 38.2 | Percentage of participants |
| Objective Response Rate for ccRCC Patients Treated With Nivolumab Monotherapy | Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC | PD-L1 1-5% | 53.8 | 95% Confidence Interval 25.1 to 80.8 | Percentage of participants |
| Objective Response Rate for ccRCC Patients Treated With Nivolumab Monotherapy | Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC | PD-L1 5-20% | 33.3 | 95% Confidence Interval 0.8 to 90.6 | Percentage of participants |
| Objective Response Rate for ccRCC Patients Treated With Nivolumab Monotherapy | Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC | PD-L1 > 20% | 75 | 95% Confidence Interval 34.9 to 96.8 | Percentage of participants |
| Objective Response Rate (ORR) for ccRCC Patients Treated With Nivolumab and Ipilimumab | Cohort A Part B: Nivolumab and Ipilimumab in Clear Cell RCC | PD-L1 0% | 7.7 | 95% Confidence Interval 0.9 to 25.1 | Percentage of participants |
| Objective Response Rate (ORR) for ccRCC Patients Treated With Nivolumab and Ipilimumab | Cohort A Part B: Nivolumab and Ipilimumab in Clear Cell RCC | PD-L1 1-5% | 66.7 | 95% Confidence Interval 9.4 to 99.2 | Percentage of participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A: Nivolumab and Salvage Nivolumab/Ipilimumab in Clear Cell RCC | 128 | |
| Overall Study | STARTED | Cohort B: Nivolumab and Salvage Nivolumab/Ipilimumab in Non-clear Cell RCC | 36 | |
| Overall Study | COMPLETED | Cohort A: Nivolumab and Salvage Nivolumab/Ipilimumab in Clear Cell RCC | 128 | |
| Overall Study | COMPLETED | Cohort B: Nivolumab and Salvage Nivolumab/Ipilimumab in Non-clear Cell RCC | 35 | |
| Overall Study | NOT COMPLETED | Cohort A: Nivolumab and Salvage Nivolumab/Ipilimumab in Clear Cell RCC | 0 | |
| Overall Study | NOT COMPLETED | Cohort B: Nivolumab and Salvage Nivolumab/Ipilimumab in Non-clear Cell RCC | 1 |
Source ClinicalTrials.gov
Adverse events1,352
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 INFECTION | Infections and infestations | Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC | 1 | 128 | 1 |
| other | ABDOMINAL INFECTION | Infections and infestations | Cohort A Part B: Nivolumab/Ipilimumab in Clear Cell RCC | 0 | 40 | 0 |
| other | ABDOMINAL INFECTION | Infections and infestations | Cohort B Part A: Nivolumab Monotherapy in Non-clear Cell RCC | 0 | 35 | 0 |
| other | ABDOMINAL INFECTION | Infections and infestations | Cohort B Part B: Nivolumab/Ipilimumab in Non-clear Cell RCC | 0 | 17 | 0 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC | 19 | 128 | 23 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Cohort A Part B: Nivolumab/Ipilimumab in Clear Cell RCC | 5 | 40 | 5 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Cohort B Part A: Nivolumab Monotherapy in Non-clear Cell RCC | 6 | 35 | 8 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Cohort B Part B: Nivolumab/Ipilimumab in Non-clear Cell RCC | 4 | 17 | 7 |
| other | ACUTE KIDNEY INJURY | Renal and urinary disorders | Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC | 2 | 128 | 2 |
| other | ACUTE KIDNEY INJURY | Renal and urinary disorders | Cohort A Part B: Nivolumab/Ipilimumab in Clear Cell RCC | 2 | 40 | 2 |
1 to 10 of 1,352Source ClinicalTrials.gov
See all 1,352 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC | 38 | 128 |
| Total, all-cause mortality | Cohort A Part B: Nivolumab/Ipilimumab in Clear Cell RCC | 28 | 40 |
| Total, all-cause mortality | Cohort B Part A: Nivolumab Monotherapy in Non-clear Cell RCC | 11 | 35 |
| Total, all-cause mortality | Cohort B Part B: Nivolumab/Ipilimumab in Non-clear Cell RCC | 15 | 17 |
| Total, other adverse events | Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC | 127 | 128 |
| Total, other adverse events | Cohort A Part B: Nivolumab/Ipilimumab in Clear Cell RCC | 38 | 40 |
| Total, other adverse events | Cohort B Part A: Nivolumab Monotherapy in Non-clear Cell RCC | 34 | 35 |
| Total, other adverse events | Cohort B Part B: Nivolumab/Ipilimumab in Non-clear Cell RCC | 17 | 17 |
| Total, serious adverse events | Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC | 41 | 128 |
| Total, serious adverse events | Cohort A Part B: Nivolumab/Ipilimumab in Clear Cell RCC | 19 | 40 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Cohort A: Nivolumab and Salvage Nivolumab/Ipilimumab in Clear Cell RCC vs Cohort B: Nivolumab and Salvage Nivolumab/Ipilimumab in Non-clear Cell RCC: Number of Participants With Adverse Events |
Source 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/NCT03117309
GET https://conductscience.org/api/trials/v1/NCT03117309/events?page=2