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Association details:
Evidence:
Evidence Level:
Sensitive: A2 - Guideline
New
Source:
Title:

BLADDER CANCER: ESMO CLINICAL PRACTICE GUIDELINE FOR DIAGNOSIS, TREATMENT AND FOLLOW-UP†

Excerpt:
Adjuvant nivolumab for 1-year versus placebo showed improved DFS 0.70 (95% CI 0.54-0.89; median follow-up of 20.9 months). There were also positive results in the 26% of patients who were PD-L1-positive [DFS 0.53 (95% CI 0.34-0.84)]. OS (a secondary endpoint) has not yet been presented.65 17.9% grade 3 or more treatment-related adverse events occurred in the nivolumab arm. These results are promising, especially in the biomarker-positive population. Due to the inconsistency across trials and uncertainty of the relationship between DFS and OS with immunotherapy, OS results are awaited before this treatment can be recommended
DOI:
https://doi.org/10.1016/j.annonc.2021.11.012
Evidence Level:
Sensitive: C1 - Off-label
  (Approved for Non Small Cell Lung Cancer)
New
Title:

Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) with Chemotherapy as Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer at High Risk of Recurrence in Patients with Tumor Cell PD-L1 Expression ≥1%

Excerpt:
Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has approved Opdivo (nivolumab) in combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adult patients with tumor cell PD-L1 expression ≥1%....The EC’s decision is based on results from the Phase 3 CheckMate -816 trial, in which three cycles of Opdivo with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS) and pathologic complete response (pCR) compared to chemotherapy alone when administered before surgery.
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Tailored ImmunoTherapy Approach With Nivolumab in Subjects With Metastatic or Advanced Renal Cell Carcinoma

Excerpt:
...NCCN-FACT FKSI-19 (Version 2)`To monitor immunogenicity of nivolumab and nivolumab/ipilimumab "boosts" with regard to prediction of response as well as immune related adverse events, including: frequency, differentiation and activation of blood-circulating CD4+ and CD8+ T cells (CD27, CD28, CD45RA, CD45RO, CD57, CD95, CD69, CD25, IFN-γ, TNF- α, IL-4, IL 17, IL-10, CD107a) frequency of blood-circulating dendritic cells (HLA-DR, slan, CD1c, CD11c, CD123, CD141, CD303), myeloid-derived suppressor cells (HLA-DR, CD11b, CD14, CD15, CD33), and regulatory T cells (FoxP3, CD25, CD45RA, CD127) expression of molecules involved in immune checkpoint modulation (ICOS, PD-1, PD-L1, CTLA-4) on blood-circulating dendritic cells and T cells To determine the presence of autoantibodies in the serum of RCC patients To explore the expression of PD-L1 and PD-L2 in tumor tissues of mRCC patients and correlation with efficacy parameters...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Combining Radiosurgery and Nivolumab in the Treatment of Brain Metastases

Excerpt:
...Maximum response rate of distant non-irradiated disease`Progression-free survival`Correlation between tumor PD-L1 expression and clinical outcomes`Patient quality of life`Neurocognitive function, as measured by the HVLT-R`Neurocognitive function, as measured by TMT`Neurocognitive function, as measured by COWA`Acute and late toxicity of SRS + Nivolumab`Imaging indicators of response...
Trial ID:
More C2 evidence
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Study of Nivolumab (BMS-936558) vs. Everolimus in Pre-Treated Advanced or Metastatic Clear-cell Renal Cell Carcinoma (CheckMate 025)

Excerpt:
...Investigator-assessed Objective Response Rate (ORR)`Investigator-assessed Duration of Objective Response`Investigator-assessed Time to Objective Response`Investigator-assessed Time of Progression-free Survival (PFS)`Overall Survival (OS) by Programmed Death-Ligand 1 (PD-L1) Expression Level`Number of Participants With Serious Adverse Events, Death, Discontinuation Due to Adverse Events`Percentage of Participants With Disease-related Symptom Progression (DRSP)`Number of Participants Meeting Marked Laboratory Abnormality Criteria in Specific Liver and Thyroid Tests`Number of Participants With Abnormal Hematology and Serum Chemistry Laboratory Parameters by Worse CTC Grade - SI Units...
Trial ID:
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Phase II Study of Nivolumab and Salvage Nivolumab/Ipilimumab in Treatment-Naive Patients With Advanced Clear Cell Renal Cell Carcinoma (HCRN GU16-260-Cohort A)

Published date:
04/20/2022
Excerpt:
Eligible patients with treatment-naive ccRCC received nivolumab until progressive disease (PD), toxicity, or completing 96 treatment weeks (part A). Patients with PD before or stable disease at 48 weeks could receive salvage nivolumab/ipilimumab (part B)....The ORR was 26.9%, 50.0%, and 75.0% for patients with the tumor PD-L1 expression of 0, 1-20, or > 20%, respectively (trend test P value = .002). The median duration of response was 27.6 (19.3 to not reached) months, with 26 of 42 responders including 17 of 20 with favorable-risk disease remaining progression-free.
DOI:
10.1200/JCO.21.02938
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

MP18-11: Predictive efficacy of serum soluble PD-L1 on patients with metastatic renal cell carcinoma treated with nivolumab.

Published date:
05/15/2020
Excerpt:
Progression-free survival was significantly longer in patients with a low sPD-L1 level (not reached vs. 2.3 months, p = 0.03). Overall survival was not significantly different regardless of the sPD-L1 level (both not reached, p = 0.33). The objective response rate in patients with high and low levels were 0.0% and 27.2%, respectively...sPD-L1 might be a strong predictive factor of the efficacy of nivolumab monotherapy.
Evidence Level:
Sensitive: C3 – Early Trials
New
Title:

Proliferative potential and response to nivolumab in clear cell renal cell carcinoma patients

Excerpt:
Cell proliferation has value in predicting response to nivolumab in clear cell mRCC patients, especially when combined with PD-L1 expression.
DOI:
https://doi.org/10.1080/2162402X.2020.1773200