Approval Probability
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Also known as Nivolumab, Nivolumab Injection [Opdivo], Opdivo, nivolumab, Nivolumab and rHuPH20, nivolumab 480mg, Nivolumab 480mg and relatlimab 160mg, Nivolumab and relatlimab
Neoadjuvant nivolumab · 8 trials · 2 indications
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 ...
BMS-936558, also known as nivolumab and marketed as Opdivo, is an investigational oncology drug being studied for advanced or metastatic melanoma, non-squamous cell non-small cell lung cancer, localized oesogastric adenocarcinoma, follicular lymphoma, cancer, and gastric cancer. It is developed by Bristol-Myers Squibb Company (BMY) and is currently in Phase 1 clinical development.
BMS-936558 is a monoclonal antibody (target class -mab) that targets the programmed cell death protein 1 (PD-1) receptor. By binding to PD-1, it is designed to enhance the immune system's ability to fight cancer cells. This mechanism is being evaluated across multiple oncology indications.
BMS-936558 is developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker BMY. The drug is also known as nivolumab and is marketed under the brand name Opdivo.
BMS-936558 is currently in Phase 1 clinical development. It has received FDA breakthrough therapy designation and priority review status. The drug is investigational and not yet approved, with ongoing clinical trials evaluating its safety and efficacy in various cancer types.
BMS-936558 has been studied in multiple clinical trials, including NCT02741570, a Phase 3 trial in head and neck cancer, and NCT02823574, a Phase 2 trial in the same condition. Other trials include NCT03355560 and NCT03894891, both Phase 2 studies in head and neck cancer. Across 14 trials, total enrollment is 6,828 patients.
Yes, BMS-936558 is the same as Opdivo. The drug is also known as nivolumab, nivolumab injection, and nivolumab 10 mg/ml. It is being developed by Bristol-Myers Squibb and is currently in Phase 1 trials for multiple oncology indications.