Claims for Patent: 10,426,972

Summary for Patent: 10,426,972

Title:	Methods of treating melanoma
Abstract:	The present disclosure is directed to methods of treating malignant melanoma by irradiating sites to which melanoma cells have become locally advanced, surgically undesirable, or have metastasized. In various embodiments of the invention, patients are treated with radiation doses in amounts ranging from about 25 to 230 cGy, preferably about 100 cGy to about 200 cGy, at least twice a day. The treatment regimen can be performed in the absence of additional treatments for the metastatic melanoma (e.g., chemotherapy/targeted therapy/immunotherapy) or in combination with additional therapies for chemotherapy/targeted therapy/immunotherapy. Various additional embodiments relate to the administration of between 20 and 100 fractions of radiation, preferably between 20 and 56 fractions of radiation.
Inventor(s):	Anderson; Norman H. (Ocala, FL)
Assignee:	MALIGNANT MELANOMA, LLC (Ocala, FL)
Application Number:	15/864,178
Patent Claims:	1. A method for treating cutaneous malignant melanoma in a subject comprising irradiating cutaneous malignant melanoma on the skin of the subject with at least two fractions of radiation per day, said fractions of radiation being selected from about 100 centiGray (cGy) or about 135 centiGray (cGy) and said fractions being separated by a time interval of at least about 0.5 hour. 2. The method according to claim 1, said method comprising irradiating said cutaneous malignant melanoma on the skin of the subject with at least two fractions of radiation per day, said fractions of radiation being about 100 centiGray (cGy) and said fractions being separated by a time interval of at least about 0.5 hour. 3. The method according to claim 1, said method comprising irradiating cutaneous malignant melanoma on the skin of the subject with at least two fractions of radiation per day, said fractions of radiation being about 135 centiGray (cGy) and said fractions being separated by a time interval of at least about 0.5 hour. 4. The method according to claim 1, wherein the fractions of radiation are separated by a time interval ranging between about 1 hour and, maximally, about 23 hours. 5. The method according to claim 1, wherein the fractions of radiation are separated by a time interval ranging between about 1 hour and about 8 hours. 6. The method according to claim 1, wherein the fractions of radiation are separated by a time interval ranging between about 2 hours and about 8 hours. 7. The method according to claim 1, wherein the fractions of radiation are separated by a time interval ranging between about 1 hour and about 6 hours. 8. The method according to claim 1, said method comprising treating said subject with radiation and a therapy comprising surgery, chemotherapy, targeted immunotherapy, immunotherapy or a combination of said therapies. 9. The method according to claim 8, wherein said chemotherapy, targeted immunotherapy or immunotherapy is selected from treatment with vemurafenib, dabrafenib, trametinib, cobimetinib, temozolomide, dacarbazine, paclitaxel or combinations thereof. 10. The method according to claim 9, wherein said subject is treated with a total of between 20 and 100 fractions of radiation. 11. The method according to claim 10, wherein said subject is treated with a total of between 20 and 56 fractions of radiation. 12. The method according to claim 8, wherein said chemotherapy, targeted immunotherapy or immunotherapy is selected from treatment with pembrolizumab, ipilmumab, nivolumab, interferon alpha, interferon alpha 2b or combinations thereof. 13. The method according to claim 12, wherein said subject is treated with a total of between 20 and 100 fractions of radiation. 14. The method according to claim 13, wherein said subject is treated with a total of between 20 and 56 fractions of radiation. 15. The method according to claim 8, wherein said subject is treated with a total of between 20 and 100 fractions of radiation. 16. The method according to claim 15, wherein said subject is treated with a total of between 20 and 56 fractions of radiation. 17. The method according to claim 1, wherein said subject is treated with a total of between 20 and 100 fractions of radiation. 18. The method according to claim 17, wherein said subject is treated with a total of between 20 and 56 fractions of radiation. 19. The method according to claim 1, said method comprising irradiating said cutaneous malignant melanoma on the skin of the subject with at least two fractions of radiation per day, said fractions of radiation being about 100 centiGray (cGy) and said fractions being separated by a time interval of at least about 1 hour.

Details for Patent 10,426,972

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	KEYTRUDA	pembrolizumab	For Injection	125514	09/04/2014		2037-03-30
Merck Sharp & Dohme Corp.	KEYTRUDA	pembrolizumab	Injection	125514	01/15/2015		2037-03-30
Bristol-myers Squibb Company	OPDIVO	nivolumab	Injection	125554	12/22/2014		2037-03-30
Bristol-myers Squibb Company	OPDIVO	nivolumab	Injection	125554	10/04/2017		2037-03-30
Bristol-myers Squibb Company	OPDIVO	nivolumab	Injection	125554	08/27/2021		2037-03-30