![]() In patients with ALT ≥3 times upper limit of normal (ULN) (Grades 2–4, n=116), ALT resolved to Grades 0–1 in 94%. Fifty-nine percent of the patients with increased ALT received systemic corticosteroids. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased alanine aminotransferase (ALT) (20%) and increased aspartate aminotransferase (AST) (13%) were seen at a higher frequency compared to KEYTRUDA alone. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed. Consider monitoring more frequently as compared to when the drugs are administered as single agents. Monitor liver enzymes before initiation of and periodically throughout treatment. KEYTRUDA in combination with axitinib can cause hepatic toxicity.Metastatic or Unresectable, Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) KEYTRUDA, as a single agent, is indicated for adjuvant treatment following resection and platinum-based chemotherapy for adult patients with stage IB (T2a ≥4 cm), II, or IIIA non–small cell lung cancer (NSCLC). Patients with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors express programmed death ligand 1 (PD-L1) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. stage III where patients are not candidates for surgical resection or definitive chemoradiation, or.KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with non–small cell lung cancer (NSCLC) expressing programmed death ligand 1 (PD-L1) as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations, and is: KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein‑bound, is indicated for the first‑line treatment of patients with metastatic squamous non–small cell lung cancer (NSCLC). This defined as, at least 5 instillations of induction BCG and an overall of at least 7 instillations of BCG within 9 months.įor patients to be unresponsive to BCG, they must have persistent high risk NMIBC at 6 months (±4 weeks) after adequate BCG or recurrent high risk NMIBC within 9 months of the last BCG instillation despite having received adequate BCG.įurthermore, an eligible patient’s most recent cystoscopy must have High Grade Ta or any Grade T1 without CIS.KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. This trial targets patients with High Risk Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG) Therapy.Įligible patients must have first received an adequate course of BCG therapy. The MK-3475-057 study is a Phase II Clinical Trial for Bladder Cancer. ![]() Bladder Cancer – MK3475-057 Study (Clinical Trial):
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