Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03873402 | A Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Participants With Advanced Kidney Cancer | PHASE3 | ACTIVE NOT_RECRUITING | 437 | — | — | Jun 21, 2019 | Mar 11, 2027 | Jan 21, 2026 | 78 | United States, Argentina +12 |
| NCT03141177 | A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma | PHASE3 | ACTIVE NOT_RECRUITING | 701 | — | — | Jul 23, 2017 | Jan 16, 2026 | Jun 6, 2025 | 135 | United States, Argentina +16 |
| NCT05148546 | Neoadjuvant Study With Combination Immuno-oncology for Primary Clear Cell Renal Cell Cancer | PHASE2 | ACTIVE NOT_RECRUITING | 69 | — | — | Apr 28, 2022 | Apr 1, 2029 | Sep 30, 2025 | 2 | Netherlands, United Kingdom |
| NCT03029780 | An Investigational Immuno-Therapy Safety and Efficacy Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Renal Cell Carcinoma | PHASE2 | COMPLETED | 104 | — | — | Feb 16, 2017 | Jun 15, 2021 | Jun 29, 2022 | 11 | United States, Australia +1 |
| NCT01354431 | BMS-936558 (MDX-1106) In Subjects With Advanced/Metastatic Clear-Cell Renal Cell Carcinoma (RCC) | PHASE2 | COMPLETED | 168 | — | — | May 31, 2011 | Apr 15, 2021 | May 12, 2022 | 41 | United States, Canada +2 |
| NCT04540705 | A Study to Compare Bempegaldesleukin (BEMPEG: NKTR-214) Combined With Nivolumab and Tyrosine Kinase Inhibitor (TKI) to Nivolumab and TKI Alone in Participants With Previously Untreated Kidney Cancer That is Advanced or Has Spread | PHASE1 | COMPLETED | 30 | — | — | Sep 11, 2020 | Jan 18, 2024 | Feb 28, 2024 | 39 | United States, Argentina +6 |
| NCT01472081 | Nivolumab (BMS-936558; MDX-1106) in Combination With Sunitinib, Pazopanib, or Ipilimumab in Subjects With Metastatic Renal Cell Carcinoma (RCC) (CheckMate 016) | PHASE1 | COMPLETED | 194 | — | — | Feb 9, 2012 | Jun 3, 2021 | Dec 2, 2021 | 14 | United States, Canada |
| NCT01358721 | Phase I Biomarker Study (BMS-936558) | PHASE1 | COMPLETED | 119 | — | — | Sep 23, 2011 | May 22, 2019 | Oct 28, 2021 | 14 | United States, France +1 |
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 sum on study
Pathologic response rate is defined as the proportion of patients demonstrating a complete pathologic or partial pathologic response, according to central revision (pathology of NKI)
The percentage of participants who experienced at least 1 adverse event in the MedDRA Anaphylactic Reaction broad scope SMQ with onset on the day of or within 2 days after any study therapy infusion during the combination period (Part 1).
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.
The objective of the study was to investigate the pharmacodynamic immunomodulatory activity of anti-PD-1 antibody in activated and memory T cells with metastatic clear-cell Renal Cell Carcinoma (RCC)
Objective is to investigate the pharmacodynamic immunomodulatory activity of serum chemokines (CXCL9, CXCL10)
Objective is to investigate the pharmacodynamic immunomodulatory activity of serum chemokines (CXCL9, CXCL10)
The objective of the study was to investigate the pharmacodynamic immunomodulatory activity of anti-PD-1 antibody on circulating CD4 infiltrations in tumors in participants with metastatic clear-cell Renal Cell Carcinoma (RCC).
The objective of the study was to investigate the pharmacodynamic immunomodulatory activity of anti-PD-1 antibody on circulating CD8 infiltrations in tumors in participants with metastatic clear-cell Renal Cell Carcinoma (RCC).
| Arm | Type | Description |
|---|---|---|
| Nivolumab + ipilimumab | EXPERIMENTAL | - |
| Nivolumab + ipilimumab placebo | EXPERIMENTAL | - |
| Doublet | EXPERIMENTAL | Nivolumab and Cabozantinib |
| Monotherapy | ACTIVE_COMPARATOR | Sunitinib |
| Triplet | EXPERIMENTAL | Nivolumab, Ipilimumab, Cabozantinib \*Enrollment to the triplet arm was discontinued by protocol amendment |
| A: Neoadjuvant nivolumab | EXPERIMENTAL | Neoadjuvant 2 cycles of nivolumab 360mg every 3 weeks |
| B: Neoadjuvant nivolumab + ipilimumab | EXPERIMENTAL | Neoadjuvant 2 cycles of nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks |
| C: Neoadjuvant nivolumab + relatlimab | EXPERIMENTAL | Neoadjuvant 2 cycles of nivolumab 360mg + relatlimab 360mg every 3 weeks |
| Co-Administration | EXPERIMENTAL | Nivolumab and Ipilimumab Co-Administration |
| Sequential Administration | EXPERIMENTAL | Nivolumab and Ipilimumab Sequential Administration |
| Arm 1: nivolumab - 0.3 mg/kg | EXPERIMENTAL | - |
| Arm 2: nivolumab - 2.0 mg/kg | EXPERIMENTAL | - |
| Arm 3: nivolumab - 10.0 mg/kg | EXPERIMENTAL | - |
| Part 1A (Part 1): Nivolumab + Axitinib | EXPERIMENTAL | - |
| Part 1B (Part 1): Nivolumab + Cabozantinib | EXPERIMENTAL | - |
| Arm S: Nivolumab + Sunitinib | EXPERIMENTAL | Nivolumab 0.3, 2.0 (starting dose), 5.0 mg/kg solution intravenously every 21 days until Progressive disease (PD), toxicity or discontinue for other reasons Sunitinib 50 mg capsule by mouth on Days 1-28 of 42 day cycle until Progressive disease (PD), toxicity or discontinue for other reasons |
| Arm P: Nivolumab + Pazopanib | EXPERIMENTAL | Nivolumab 0.3, 2.0 (starting dose), 5.0 mg/kg solution intravenously every 21 days until Progressive disease (PD), toxicity or discontinue for other reasons Pazopanib 800 mg tablet by mouth daily until Progressive disease (PD), toxicity or discontinue for other reasons |
| Arm I-1: Nivolumab + Ipilimumab | EXPERIMENTAL | Nivolumab 3 mg/kg solution intravenously (IV) every 21 days during Induction phase and every 14 days during Maintenance phase until Progressive disease (PD), toxicity or discontinue for other reasons Ipilimumab 1mg/kg solution intravenously (IV) every 21 days during Induction phase (Ipilimumab will not be administered during Maintenance phase) until Progressive disease (PD), toxicity or discontinue for other reasons |
| Arm I-3: Nivolumab + Ipilimumab | EXPERIMENTAL | Nivolumab 1mg/kg solution intravenously (IV) every 21 days during Induction phase and 3mg/kg solution intravenously (IV) every 14 days during Maintenance phase Ipilimumab 3mg/kg solution intravenously (IV) every 21 days during Induction phase. Ipilimumab will not be administered during Maintenance phase |
| Arm IN-3: Nivolumab+Ipilimumab | EXPERIMENTAL | Nivolumab 3mg/kg solution intravenously (IV) every 21 days during Induction phase and 3mg/kg solution intravenously (IV) every 14 days during Maintenance phase Ipilimumab 3mg/kg solution intravenously (IV) every 21 days during Induction phase. Ipilimumab will not be administered during Maintenance phase |
| Arm 1: BMS-936558 | EXPERIMENTAL | - |
| Arm 2: BMS-936558 | EXPERIMENTAL | - |
| Arm 3: BMS-936558 | EXPERIMENTAL | - |
| Arm 4: BMS-936558 | EXPERIMENTAL | (treatment naive) |
| Name | Type | Description |
|---|---|---|
| Nivolumab | BIOLOGICAL | Specified dose on specified days |
| Ipilimumab | BIOLOGICAL | Specified dose on specified days |
| Ipilimumab placebo | OTHER | Specified dose on specified days |
| Cabozantinib | DRUG | Specified dose on specified days |
| Sunitinib | DRUG | Specified dose on specified days. |
| Neoadjuvant nivolumab | DRUG | Patients will receive 2 cycles of nivolumab 360mg (arm A and C) or 3mg/kg (arm B) every 3 weeks followed by a nephrectomy. |
| Neoadjuvant ipilimumab | DRUG | Patients will receive 2 cycles of ipilimumab 1mg/kg every 3 weeks followed by a nephrectomy. |
| Neoadjuvant relatlimab | DRUG | Patients will receive 2 cycles of relatlimab 360mg every 3 weeks followed by a nephrectomy. |
| Opdivo | BIOLOGICAL | Specified dose on specified days |
| Yervoy | BIOLOGICAL | Specified dose on specified days |
| Axitinib | DRUG | Specified dose on specified days |
| Pazopanib | BIOLOGICAL | - |
| BMS-936558 (Anti-PD-1) | DRUG | Solution, Intravenous infusion, 0.3 mg/kg, Every 3 weeks, Indefinitely depending on response |
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Histological confirmation of renal carcinoma with clear cell component including participants who may have sarcomatoid features. * Advanced (not amenable to ...