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    Association details:
    Biomarker:PD-L1 expression
    Cancer:Bladder Cancer
    Drug:Opdivo (nivolumab) (PD1 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    ASCO-GU 2021
    Title:

    First results from the phase 3 CheckMate 274 trial of adjuvant nivolumab vs placebo in patients who underwent radical surgery for high-risk muscle-invasive urothelial carcinoma (MIUC).

    Published date:
    02/08/2021
    Excerpt:
    ...multicenter trial of NIVO vs PBO in pts with high-risk MIUC (bladder, ureter, or renal pelvis)...In total, 353 pts were randomized to NIVO (PD-L1 ≥ 1%, n = 140) and 356 pts to PBO (PD-L1 ≥ 1%, n = 142). The primary endpoint of DFS was met in ITT pts (median follow-up, 20.9 mo for NIVO; 19.5 mo for PBO) and in pts with PD-L1 ≥ 1%. DFS and NUTRFS were improved with NIVO vs PBO in both populations...NIVO demonstrated a statistically significant and clinically meaningful improvement in DFS vs PBO for MIUC after radical surgery, both in ITT pts and pts with PD-L1 ≥ 1%.
    DOI:
    10.1200/JCO.2021.39.6_suppl.391
    Trial ID:
    CheckMate 274
    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
    Source:
    clinicaltrials.gov
    Title:

    Cisplatin, Nab-paclitaxel, Nivolumab With Radiotherapy After Resection of Non-Metastatic Muscle Invasive Bladder Cancer

    Excerpt:
    ...Median Disease Free Survival by PD-L1 expression.`...
    Trial ID:
    CNN-BC
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Go to data
    Source:
    clinicaltrials.gov
    Title:

    An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer

    Excerpt:
    ...Disease Free Survival (DFS)`Disease Free Survival (DFS) in PD-L1 Expression ≥ 1% Population...
    Trial ID:
    CheckMate 274
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Nivolumab and RT in Treating Patients With Localized/Locally Advanced Urothelial Bladder Cancer Ineligible for Chemo

    Excerpt:
    ...Overall Response Rate (ORR)`Metastasis-free Survival (MFS)`Overall Survival (OS)`Quality of Life (QOL) and Bladder Functioning Questionnaires Assessment`PD-1 and PDL-1 Expression Analysis Using Immunohistochemistry (IHC)`Th1/Th2 Cytokine Ratio Analysis...
    Trial ID:
    NUTRA
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of Nivolumab in Participants With Metastatic or Unresectable Bladder Cancer

    Excerpt:
    ...BIRC= blinded independent review committee PD-L1 expression level= membranous staining in greater than or equal to 5% and greater than or equal to 1% tumor cells. ...
    Trial ID:
    CheckMate 275
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Int J Radiat Oncol Biol Phys
    Title:

    Phase II trial of Concurrent Nivolumab and Radiation therapy in Elderly or Chemotherapy ineligible Muscle Invasive Bladder Cancer

    Published date:
    11/18/2023
    Excerpt:
    In conclusion, concurrent nivolumab and radiation therapy is tolerable but demonstrated limited efficacy in an elderly population with multiple comorbidities. Immune correlates demonstrated that patients with baseline PD-L1 combined prognostic score (CPS) ≥5% had numerically longer PFS.
    DOI:
    https://doi.org/10.1016/j.ijrobp.2023.11.024