18 and older, any sex, with Renal Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression Free Survival (PFS)Primary· From randomization date to date of first documented tumor progression or death, whichever occurs first (Up to 31 months)
PFS is defined as the time from date of randomization to the first documented tumor progression date or death due to any cause, whichever occurs first based on BICR assessment using RECIST v1.1. Participants who die without a reported progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment on or prior to initiation of subsequent anti-cancer therapy. Progressive disease (PD); 20% increase in the sum of diameters of target lesions, taking as reference the smallest
Group
Value
95% CI
Treatment A
16.59
12.45 – 24.94
Treatment C
8.31
6.97 – 9.69
Overall Survival (OS)Secondary· From randomization date to death date (Up to 31 months)
Overall Survival is defined as the time between the date of randomization and the date of death due to any cause. For participants that are alive, their survival time will be censored at the date of last contact date (or "last known alive date").
Group
Value
95% CI
Treatment A
NA
NA – NA
Treatment C
NA
22.6 – NA
Objective Response Rate (ORR)Secondary· Up to 31 Months
Objective Response Rate (ORR) is defined as the percentage of randomized participants who achieve a best response of confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments (using RECIST v1.1 criteria) divided by the number of all randomized participants.
Complete response (CR): Disappearance of all target lesions. Partial response (PR): 30% decrease in the sum of diameters of target lesions.
Group
Value
95% CI
Treatment A
55.7
50.1 – 61.2
Treatment B
44.0
30.0 – 58.7
Treatment C
27.1
22.4 – 32.3
Number of Participants Experiencing Adverse Events (AEs)Secondary· From first dose to 100 days following last dose (Up to 32 Months)
Number of participants experiencing various types of any grade adverse events (AEs) during the specified time frame.
Group
Value
95% CI
Treatment A
319
Treatment B
50
Treatment C
317
Number of Participants Experiencing Serious Adverse Events (SAEs)Secondary· From first to dose to 100 days following last dose (Up to 32 months)
Number of participants experiencing various types of any grade serious adverse events (SAEs) during the specified time frame.
Group
Value
95% CI
Treatment A
160
Treatment B
28
Treatment C
144
Number of Participants Experiencing Adverse Events (AEs) Leading to DiscontinuationSecondary· From first dose to 30 days following last dose (Up to 30 months)
Number of participants experiencing various types of any grade adverse events (AEs) leading to discontinuation during the specified time frame.
Group
Value
95% CI
Treatment A
63
Treatment B
15
Treatment C
54
Number of DeathsSecondary· From first dose to (up to 31 months) following first dose
Number of deaths due to any cause during the specified time frame.
Group
Value
95% CI
Treatment A
67
Treatment B
14
Treatment C
99
Number of Participants With Laboratory AbnormalitiesSecondary· From first dose to 30 days following last dose (Up to 30 Months)
Number of participants experiencing laboratory abnormalities in hematology, serum chemistry and electrolytes with grade 3 or higher during the specified time frame.
Hemoglobin: Any grade
Group
Value
95% CI
Treatment A
235
Treatment B
35
Treatment C
256
Hemoglobin: Grade 3-4
Group
Value
95% CI
Treatment A
9
Treatment B
5
Treatment C
15
Platelet Count: Any grade
Group
Value
95% CI
Treatment A
137
Treatment B
27
Treatment C
216
Platelet Count: Grade 3-4
Group
Value
95% CI
Treatment A
1
Treatment B
0
Treatment C
30
Leukocytes: Any grade
Group
Value
95% CI
Treatment A
121
Treatment B
26
Treatment C
207
Leukocytes: Grade 3-4
Group
Value
95% CI
Treatment A
1
Treatment B
0
Treatment C
16
Lymphocytes: Any grade
Group
Value
95% CI
Treatment A
107
Treatment B
22
Treatment C
118
Lymphocytes: Grade 3-4
Group
Value
95% CI
Treatment A
16
Treatment B
4
Treatment C
24
Number of Participants With Laboratory Values Grade Shifting From BaselineSecondary· From first dose to 30 days following last dose (Up to 30 Months)
Number of participants experiencing worsening shift from baseline in any grade and grade 3-4 of laboratory values during the specified time frame.
Hemoglobin: Any grade
Group
Value
95% CI
Treatment A
117
Treatment B
23
Treatment C
190
Hemoglobin: Grade 3-4
Group
Value
95% CI
Treatment A
8
Treatment B
5
Treatment C
15
Platelet Count: Any grade
Group
Value
95% CI
Treatment A
129
Treatment B
24
Treatment C
216
Platelet Count: Grade 3-4
Group
Value
95% CI
Treatment A
2
Treatment B
0
Treatment C
30
Leukocytes: Any grade
Group
Value
95% CI
Treatment A
116
Treatment B
26
Treatment C
206
Leukocytes: Grade 3-4
Group
Value
95% CI
Treatment A
1
Treatment B
0
Treatment C
16
Lymphocytes: Any grade
Group
Value
95% CI
Treatment A
95
Treatment B
20
Treatment C
102
Lymphocytes: Grade 3-4
Group
Value
95% CI
Treatment A
15
Treatment B
4
Treatment C
23
Adverse events — posted to ClinicalTrials.gov
Time frame: All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Treatment A
Serious: 160/320 (50%)
Deaths: 67/320
Treatment B
Serious: 28/50 (56%)
Deaths: 14/50
Treatment C
Serious: 144/320 (45%)
Deaths: 99/320
Serious adverse events (259 terms)
Reaction
System
Treatment A
Treatment B
Treatment C
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
Diarrhoea
Gastrointestinal disorders
—
—
—
Anaemia
Blood and lymphatic system disorders
—
—
—
Pneumonia
Infections and infestations
—
—
—
Pleural effusion
Respiratory, thoracic and mediastinal disorders
—
—
—
Pneumonitis
Respiratory, thoracic and mediastinal disorders
—
—
—
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
—
—
—
Respiratory failure
Respiratory, thoracic and mediastinal disorders
—
—
—
Urinary tract infection
Infections and infestations
—
—
—
Hyponatraemia
Metabolism and nutrition disorders
—
—
—
Adrenal insufficiency
Endocrine disorders
—
—
—
Pain
General disorders
—
—
—
Acute kidney injury
Renal and urinary disorders
—
—
—
Vomiting
Gastrointestinal disorders
—
—
—
Pyrexia
General disorders
—
—
—
Abdominal pain
Gastrointestinal disorders
—
—
—
Sepsis
Infections and infestations
—
—
—
Hypercalcaemia
Metabolism and nutrition disorders
—
—
—
Back pain
Musculoskeletal and connective tissue disorders
—
—
—
Neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The purpose of this study is to determine whether Nivolumab Combined with Cabozantinib is safe and effective compared to Sunitinib in previously untreated advanced or metastatic renal cell carcinoma
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem
· Phase 2, PHASE3
· not yet recruiting
NCT07444619 — A Phase I Study of Pazopanib in Combination With Trabectedin, Ipilimumab and Nivolumab (TraPIN) in Pediatric and Young A
· Phase 1
· not yet recruiting
NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer
· Phase 3
· not yet recruiting
NCT07420439 — Treatment in Patients With Advanced Non-Small Cell Lung Carcinoma and Interstitial Lung Disease
· Phase 2
· not yet recruiting
NCT07510334 — VSV-IFNβ-NIS With Ipilimumab and Nivolumab for the Treatment of Advanced or Metastatic Clear Cell Renal Cell Carcinoma
· Phase 2
· not yet recruiting
NCT07195682 — A First-in-Human Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)
· Phase 1
· recruiting
NCT07285044 — The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Tr
· Phase 2
· recruiting
NCT07227402 — A Clinical Study of Belzutifan and Zanzalintinib in People With Recurrent Kidney Cancer Following Adjuvant Therapy (MK-6
· Phase 3
· recruiting
NCT07123090 — A Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma
· Phase 2
· recruiting
Other Bristol-Myers Squibb trials
Trials by the same sponsor.
NCT07441408 — Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis
· Phase 3
· not yet recruiting
NCT07459543 — A Study To Assess the Safety, and Tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) In Untreated, Unre
· Phase 4
· not yet recruiting
NCT07285798 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder
· Phase 3
· not yet recruiting
NCT07284745 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism
· Phase 3
· not yet recruiting
NCT07492680 — A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic S
· Phase 2
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bristol-Myers Squibb
Last refreshed: 6 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03141177.