RESULTS FROM CLINICAL TRIALS WITH KEYTRUDA
SEARCH FOR A CANCER
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Advanced
Cervical cancer
KEYTRUDA is a prescription medicine used to treat a kind of cancer called cervical cancer.
- KEYTRUDA may be used with chemotherapy and radiation therapy when your cervical cancer has spread to nearby tissue or organs or has affected your kidneys (Stage 3A to 4A cervical cancer based on FIGO 2014 classification).
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- your cervical cancer does not go away (persistent), has returned, or has spread (advanced cervical cancer), and
- your tumor tests positive for “PD⁠-⁠L1.”
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- has returned, or has spread (advanced cervical cancer), and
- you have received chemotherapy, and it did not work or is no longer working, and
- your tumor tests positive for “PD⁠-⁠L1.”
PD⁠-⁠L1 = programmed death ligand 1.
FIGO = International Federation of Gynecology and Obstetrics.
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Cutaneous squamous cell carcinoma (cSCC)
KEYTRUDA is a prescription medicine used to treat a kind of skin cancer called cutaneous squamous cell carcinoma (cSCC). KEYTRUDA may be used when your skin cancer has returned or spread, and cannot be cured by surgery or radiation.
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Advanced
Endometrial cancer
KEYTRUDA is a prescription medicine used to treat a kind of uterine cancer called advanced endometrial carcinoma.
- KEYTRUDA may be used with the chemotherapy medicines carboplatin and paclitaxel, and then KEYTRUDA may be used alone, in adults:
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- when your cancer has spread (advanced), or
- if your cancer has returned.
- KEYTRUDA may be used alone in adults:
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- if your cancer is shown by a laboratory test to be microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), and
- you have received anti-cancer treatment and it is no longer working, and
- your cancer cannot be cured by surgery or radiation.
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Advanced
Esophageal cancer
KEYTRUDA is a prescription medicine used to treat a kind of cancer called esophageal or certain gastroesophageal junction (GEJ) carcinomas that cannot be cured by surgery or a combination of chemotherapy and radiation therapy.
- KEYTRUDA may be used with platinum- and fluoropyrimidine-based chemotherapy medicines.
- KEYTRUDA may be used alone when:
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- you have received one or more types of treatment, and it did not work or it is no longer working, and
- your tumor is a type called “squamous,” and
- your tumor tests positive for “PD-L1.”
PD-L1 = programmed death ligand 1.
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Head and neck squamous cell cancer
KEYTRUDA is a prescription medicine used to treat a kind of cancer called head and neck squamous cell cancer (HNSCC).
- KEYTRUDA may be used with the chemotherapy medicines fluorouracil and a platinum as your first treatment when your head and neck cancer has spread or returned and cannot be removed by surgery.
- KEYTRUDA may be used alone as your first treatment when your head and neck cancer:
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- has spread or returned and cannot be removed by surgery, and
- your tumor tests positive for “PD-L1.”
- KEYTRUDA may be used alone when your head and neck cancer:
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- has spread or returned, and
- you have received chemotherapy that contains platinum and it did not work or is no longer working.
PD-L1 = programmed death ligand 1.
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Kidney cancer (RCC)
KEYTRUDA is a prescription medicine used to treat a kind of kidney cancer called renal cell carcinoma (RCC). KEYTRUDA may be used:
- In adults with the medicine axitinib as your first treatment when your kidney cancer has spread or cannot be removed by surgery (advanced RCC).
- alone if you are at intermediate-high or high risk of your kidney cancer (RCC) coming back after surgery to:
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- remove all or part of your kidney, or
- remove all or part of your kidney and also surgery to remove cancer that has spread to other parts of the body (metastatic lesions).
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Melanoma
KEYTRUDA is a prescription medicine used to treat a kind of skin cancer called melanoma. KEYTRUDA may be used:
- when your melanoma has spread or cannot be removed by surgery (advanced melanoma), or
- in adults and children 12 years of age and older with stage IIB, stage IIC, or stage III melanoma, to help prevent melanoma from coming back after it and lymph nodes that contain cancer have been removed by surgery.
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MSI⁠‐⁠H⁠/⁠dMMR colorectal cancer
KEYTRUDA is a prescription medicine used to treat a kind of cancer called colon or rectal cancer. KEYTRUDA may be used when your cancer:
- has spread or cannot be removed by surgery (advanced colon or rectal cancer), and
- has been shown by a laboratory test to be microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).
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Non⁠–⁠small cell lung cancer (NSCLC)
KEYTRUDA is a prescription medicine used to treat a kind of lung cancer called non–small cell lung cancer (NSCLC).
- KEYTRUDA may be used with the chemotherapy medicines pemetrexed and a platinum as your first treatment when your lung cancer has spread (advanced NSCLC) and is a type called “nonsquamous” and your tumor does not have an abnormal “EGFR” or “ALK” gene.
- KEYTRUDA may be used with the chemotherapy medicines carboplatin and either paclitaxel or paclitaxel protein-bound as your first treatment when your lung cancer has spread (advanced NSCLC), and is a type called “squamous.”
- KEYTRUDA may be used alone as your first treatment when your lung cancer has not spread outside your chest (stage III) and you cannot have surgery or chemotherapy with radiation, or your NSCLC has spread to other areas of your body (advanced NSCLC), and your tumor tests positive for “PD-L1” and does not have an abnormal “EGFR” or “ALK” gene.
- KEYTRUDA may also be used alone for advanced NSCLC if you have tried chemotherapy that contains platinum and it did not work or is no longer working and, your tumor tests positive for “PD-L1” and if your tumor has an abnormal “EGFR” or “ALK” gene, you have also received an “EGFR” or “ALK” inhibitor medicine that did not work or is no longer working.
- KEYTRUDA may be used in combination with chemotherapy that contains platinum and another chemotherapy medicine before surgery when you have early-stage NSCLC, which can be removed by surgery, and then continued alone after surgery to help prevent your lung cancer from coming back.
- KEYTRUDA may be used alone as a treatment in adults for your lung cancer to help prevent your lung cancer from coming back after your tumor(s) has been removed by surgery and you have received platinum-based chemotherapy, and you have stage IB and your tumor(s) is 4 cm or greater in size, stage II, or stage IIIA NSCLC.
PD-L1 = programmed death ligand 1; EGFR = epidermal growth factor receptor; ALK = anaplastic lymphoma kinase.
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Stomach cancer (HER2-negative gastric or GEJ)
KEYTRUDA is a prescription medicine used to treat a kind of stomach cancer called gastric or gastroesophageal junction (GEJ) adenocarcinoma:
- KEYTRUDA may be used in adults in combination with fluoropyrimidine and platinum chemotherapy as your first treatment when your stomach cancer:
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- is HER2-negative, and
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- has spread or cannot be removed by surgery (advanced gastric cancer).
HER2 = human epidermal growth factor receptor 2.
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Triple-negative breast cancer (TNBC)
KEYTRUDA is a prescription medicine used to treat a kind of cancer called triple-negative breast cancer (TNBC).
- KEYTRUDA may be used with chemotherapy medicines as treatment before surgery and then continued alone after surgery when you have early-stage breast cancer, and are at high risk of your breast cancer coming back.
- KEYTRUDA may be used with chemotherapy medicines when your breast cancer has returned and cannot be removed by surgery or has spread, and tests positive for “PD-L1.”
PD-L1 = programmed death ligand 1.
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Urothelial bladder cancer
KEYTRUDA is a prescription medicine used to treat a kind of bladder and urinary tract cancer called urothelial cancer.
- KEYTRUDA may be used with the medicine enfortumab vedotin in adults when your bladder or urinary tract cancer:
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- has spread or cannot be removed by surgery (advanced urothelial cancer).
- KEYTRUDA may be used alone when your bladder or urinary tract cancer:
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- has spread or cannot be removed by surgery (advanced urothelial cancer), and
- you are not able to receive chemotherapy that contains platinum (medicines called either cisplatin or carboplatin), or
- you have received chemotherapy that contains platinum, and it did not work or is no longer working.
- KEYTRUDA may be used alone when your cancer has not spread to nearby tissue in the bladder, but is at high-risk for spreading (high-risk, non-muscle invasive bladder cancer [NMIBC]) when:
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- your tumor is a type called “carcinoma in situ” (CIS), and
- you have tried treatment with Bacillus Calmette-Guerin (BCG) and it did not work, and
- you are not able to or have decided not to have surgery to remove your bladder.