Trial · NCT01472081
Nivolumab (BMS-936558; MDX-1106) in Combination With Sunitinib, Pazopanib, or Ipilimumab in Subjects With Metastatic Renal Cell Carcinoma (RCC) (CheckMate 016)
NCT01472081, Phase 1, Completed, Bristol-Myers Squibb; results first posted 2019-08-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Nivolumab (BMS-936558; MDX-1106) in Combination With Sunitinib, Pazopanib, or Ipilimumab in Subjects With Metastatic Renal Cell Carcinoma (RCC) (CheckMate 016). Trials, record NCT01472081. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01472081
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nivolumab (BMS-936558; MDX-1106) in Combination With Sunitinib, Pazopanib, or Ipilimumab in Subjects With Metastatic Renal Cell Carcinoma (RCC) (CheckMate 016)
- NCT number
- NCT01472081
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 194 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Renal Cell Carcinoma, Clear-cell Metastatic Renal Cell Carcinoma
- Interventions
- Nivolumab, Pazopanib, Sunitinib, Ipilimumab
- First posted
- 2011-11-16
- Last updated
- 2021-12-02
- Results first posted
- 2019-08-02
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation | From date of first dose to date of last dose plus 100 days (assessed up to March 2016, approximately 49 months) | Safety assessments by treatment arm and dose level were based on incidence of AEs, and the incidence of serious adverse events (SAEs). AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. |
| Secondary | Best Overall Response Rate (BOR) | From date of first dose to date of disease progression or subsequent anti-cancer therapy, whichever occurred first (assessed up to March 2016, approximately 49 months) | BOR was defined as the best response designation over the study as a whole, recorded between the date of first dose of study medication and the date of objectively documented progression per RECIST 1.1 criteria or the date of subsequent anti-cancer therapy, whichever occurred first. CR = Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD = At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. SD = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
| Secondary | Objective Response Rate (ORR) | From date of first dose to interim analysis (Assessed up to March 2016, approximately 49 months) | ORR was defined as the proportion of participants who achieved a BOR of either complete response (CR) or partial response (PR) in the population of interest. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Duration of Response (DOR) | From date of first dose to date of disease progression or death, whichever occurred first (assessed up to March 2016, approximately 49 months) | DOR was computed for participants with BOR of CR or PR only, and defined as the time between the date of first documented objective response and the date of the first subsequent disease progression or death. Participants who remained alive and had not progressed were censored on the last tumor assessment date (prior to subsequent cancer therapy). |
| Secondary | Rate of Progression-free Survival (PFS) at Week 24 | 24 weeks | Rate of PFS at week 24 was defined as the proportion of participants remaining progression free or surviving at 24 weeks, calculated by the product-limit method (Kaplan-Meier estimate) which took into account censored data. Participants who did not have any on-study tumor assessment and did not die were censored on the date of first dose of study medication. |
| Secondary | Progression-free Survival (PFS) | From date of first dose to date of disease progression or death, whichever occurred first (assessed up to March 2016, approximately 49 months) | PFS was defined as the time from the date of first dose of study medication to the date of first disease progression or death. Participants who did not have any on-study tumor assessment and did not die were censored on the date of first dose of study medication. |
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 | Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation | From date of first dose to date of last dose plus 100 days (assessed up to March 2016, approximately 49 months) | All treated participants | participants | NUMBER |
| SECONDARY | Best Overall Response Rate (BOR) | From date of first dose to date of disease progression or subsequent anti-cancer therapy, whichever occurred first (assessed up to March 2016, approximately 49 months) | All treated participants | percentage of participants | NUMBER |
| SECONDARY | Objective Response Rate (ORR) | From date of first dose to interim analysis (Assessed up to March 2016, approximately 49 months) | All treated participants | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | From date of first dose to date of disease progression or death, whichever occurred first (assessed up to March 2016, approximately 49 months) | All treated participants | weeks | MEDIAN |
| SECONDARY | Rate of Progression-free Survival (PFS) at Week 24 | 24 weeks | All treated participants | Percentage of participants with PFS | NUMBER |
| SECONDARY | Progression-free Survival (PFS) | From date of first dose to date of disease progression or death, whichever occurred first (assessed up to March 2016, approximately 49 months) | All treated participants | months | MEDIAN |
Source ClinicalTrials.gov
Results by group114
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation | Arm S: SUN + NIV2 | All-causality SAEs (any grade) | 3 | participants | |
| Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation | Arm S: SUN + NIV5 | All-causality SAEs (any grade) | 16 | participants | |
| Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation | Arm P: PAZ + NIV2 | All-causality SAEs (any grade) | 13 | participants | |
| Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation | Arm I-1: IPI1 + NIV3 | All-causality SAEs (any grade) | 29 | participants | |
| Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation | Arm I-3: IPI3 + NIV1 | All-causality SAEs (any grade) | 30 | participants | |
| Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation | Arm IN-3: IPI3 + NIV3 | All-causality SAEs (any grade) | 4 | participants | |
| Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation | Arm S: SUN + NIV2 | All-causality SAEs (grade 3-4) | 1 | participants | |
| Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation | Arm S: SUN + NIV5 | All-causality SAEs (grade 3-4) | 14 | participants | |
| Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation | Arm P: PAZ + NIV2 | All-causality SAEs (grade 3-4) | 10 | participants | |
| Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation | Arm I-1: IPI1 + NIV3 | All-causality SAEs (grade 3-4) | 20 | participants |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm S: SUN + NIV2 | 7 | |
| Overall Study | STARTED | Arm S: SUN + NIV5 | 26 | |
| Overall Study | STARTED | Arm P: PAZ + NIV2 | 20 | |
| Overall Study | STARTED | Arm I-1: IPI1 + NIV3 | 47 | |
| Overall Study | STARTED | Arm I-3: IPI3 + NIV1 | 47 | |
| Overall Study | STARTED | Arm IN-3: IPI3 + NIV3 | 6 | |
| Overall Study | COMPLETED | Arm S: SUN + NIV2 | 0 | |
| Overall Study | COMPLETED | Arm S: SUN + NIV5 | 0 | |
| Overall Study | COMPLETED | Arm P: PAZ + NIV2 | 0 | |
| Overall Study | COMPLETED | Arm I-1: IPI1 + NIV3 | 1 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events1,870
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 | Anaemia | Blood and lymphatic system disorders | SUNITINIB+NIVOLUMAB | 8 | 33 | |
| other | Anaemia | Blood and lymphatic system disorders | PAZOPANIB+NIVOLUMAB | 3 | 20 | |
| other | Anaemia | Blood and lymphatic system disorders | NIVO 3+IPI 1 (MG/KG) | 7 | 47 | |
| other | Anaemia | Blood and lymphatic system disorders | NIVO 1+IPI 3 (MG/KG) | 10 | 47 | |
| other | Anaemia | Blood and lymphatic system disorders | NIVO 3+IPI 3 (MG/KG) | 1 | 6 | |
| other | Leukopenia | Blood and lymphatic system disorders | SUNITINIB+NIVOLUMAB | 3 | 33 | |
| other | Leukopenia | Blood and lymphatic system disorders | PAZOPANIB+NIVOLUMAB | 0 | 20 | |
| other | Leukopenia | Blood and lymphatic system disorders | NIVO 3+IPI 1 (MG/KG) | 0 | 47 | |
| other | Leukopenia | Blood and lymphatic system disorders | NIVO 1+IPI 3 (MG/KG) | 0 | 47 | |
| other | Leukopenia | Blood and lymphatic system disorders | NIVO 3+IPI 3 (MG/KG) | 0 | 6 |
1 to 10 of 1,870Source ClinicalTrials.gov
See all 1,870 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SUNITINIB+NIVOLUMAB | ||
| Total, all-cause mortality | PAZOPANIB+NIVOLUMAB | ||
| Total, all-cause mortality | NIVO 3+IPI 1 (MG/KG) | ||
| Total, all-cause mortality | NIVO 1+IPI 3 (MG/KG) | ||
| Total, all-cause mortality | NIVO 3+IPI 3 (MG/KG) | ||
| Total, other adverse events | SUNITINIB+NIVOLUMAB | 33 | 33 |
| Total, other adverse events | PAZOPANIB+NIVOLUMAB | 20 | 20 |
| Total, other adverse events | NIVO 3+IPI 1 (MG/KG) | 47 | 47 |
| Total, other adverse events | NIVO 1+IPI 3 (MG/KG) | 46 | 47 |
| Total, other adverse events | NIVO 3+IPI 3 (MG/KG) | 6 | 6 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 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 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/NCT01472081
GET https://conductscience.org/api/trials/v1/NCT01472081/results?page=2