--- a +++ b/clusters/9knumclustersv2/clust_1314.txt @@ -0,0 +1,40 @@ +Patients must not have received immunization with an attenuated live vaccine (e.g., intranasal influenza, measles, mumps, and rubella [MMR], oral polio, varicella, zoster, yellow fever, and Bacillus CalmetteGuerin [BCG] vaccines) within seven days prior to registration nor have plans to receive such vaccination while on protocol treatment +Patients must not have received live vaccines within days prior to registration; examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, shingles, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine; seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed +Patients must not have received live vaccines within days prior to registration; examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, shingles, yellow fever, rabies, Bacillus CalmetteGuerin (BCG), and typhoid (oral) vaccine; seasonal influenza vaccines for injection are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist) are not allowed +Live vaccine within days prior to day of protocol therapy (e.g. measles, mumps, rubella, varicella, yellow fever, rabies, Bacillus CalmetteGuerin [BCG], oral polio vaccine, and oral typhoid) +Receipt of live attenuated vaccines (including, but not limited to: intranasal influenza vaccine [FluMist], measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacillus Calmette-Guerin [BCG], and typhoid vaccine) within days before the first dose of study treatment +Patients who received a live vaccine within days of planned start of study therapy are not eligible; examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, bacillus Calmette-Guerin (BCG), and typhoid vaccine\r\n* NOTE: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed +Received a live vaccine within days prior to the first dose of trial treatment. Examples of live vaccines include, but are not limited to: measles, mumps, rubella, chicken pox, yellow fever, rabies, BCG, and typhoid (oral) vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. Flu-Mist) are live attenuated vaccines and are not allowed. +Received a live vaccine within days prior to the first study treatment; examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine; seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. FluMist) are live attenuated vaccines and are not allowed +Patients who have received the last vaccination of a live vaccine =< days prior to enrollment are ineligible; examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella, yellow fever, rabies, bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine; seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. Flu-Mist) are live attenuated vaccines, and must meet timeline for live vaccine +EXCLUSION CRITERIA FOR STRATUM C: Patients who have received the last vaccination of a live vaccine =< days prior to enrollment are ineligible; examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella, yellow fever, rabies, BCG, and typhoid (oral) vaccine; seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. Flu-Mist) are live attenuated vaccines, and must meet timeline for live vaccine +Received a live vaccine within days prior to the first dose of MK-; examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine; seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. FluMist) are live attenuated vaccines and are not allowed +Received a live vaccine within days prior to the first dose of MK-; examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine; seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. FluMist) are live attenuated viruses and are not allowed +Patients must not have received live vaccines within days prior to trial registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, shingles, yellow fever, rabies, bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed. +Has received a live vaccine within days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus CalmetteGuerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist) are live attenuated vaccines and are not allowed +Patients who have received a live vaccine within days of the start date of the planned study therapy; examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine; note: seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed +Patients must not have received live vaccines within days prior to registration; examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, shingles, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine; seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed +Has received a live vaccine within days prior to the first dose of the trial drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette - Gurin (BCG), and typhoid vaccine. +Live vaccines within days prior to the first dose of trial treatment and while participating in the trial; examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, Bacille Calmette-Guerin (BCG), and typhoid vaccine +Treatment with a live, attenuated vaccine within weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during treatment with avelumab or within months after the last dose of avelumab\r\n* Attenuated live vaccines include but are not limited to:\r\n** Tuberculosis (Bacillus Calmette-Guerin [BCG])\r\n** Oral polio vaccine\r\n** Measles, mumps, rubella, alone or as part of measles/mumps/rubella vaccine (MMR)\r\n** Rotavirus\r\n** Yellow fever\r\n** Typhoid\r\n** Rabies vaccine should be utilized as recommended by an infectious disease specialist\r\n** Nasal flu vaccine +The participant has received a live vaccine within days prior to the first dose of trial treatment and while participating in the trial; examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, Bacillus CalmetteGuerin (BCG), and typhoid vaccine; the use of the inactivated seasonal influenza vaccine (Fluzone) is allowed +Patients are prohibited from receiving the following therapies during the screening and treatment phases of this trial:\r\n* Antineoplastic systemic chemotherapy or biological therapy\r\n* Immunotherapy not specified in this protocol\r\n* Chemotherapy not specified in this protocol\r\n* Investigational agents other than anetumab ravtansine and MK- (pembrolizumab)\r\n* Radiation therapy \r\n** Note: Radiation therapy to a symptomatic solitary lesion or to the brain may be considered on an exceptional case by case basis after consultation with Cancer Therapy Evaluation Program (CTEP); the patient must have clear measurable disease outside the radiated field; administration of palliative radiation therapy will be considered clinical progression for the purposes of determining progression free survival (PFS)\r\n* Live vaccines within days prior to the first dose of trial treatment and while participating in the trial; examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacillus ChalmetteGuerin (BCG), and typhoid (oral) vaccine; seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed\r\n* Systemic glucocorticoids for any purpose other than to modulate symptoms from an event of suspected immunologic etiology; the use of physiologic doses of corticosteroids may be approved after consultation with the study principal investigator (PI) and CTEP +Have received any live vaccine therapies used for the prevention of infectious disease within days prior to enrollment and during treatment period; examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacille Calmette-Guerin (BCG), and typhoid (oral) vaccine; seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, Flu-Mist) are live attenuated vaccines, and are not allowed +Patients who have received any non-oncology live vaccine therapy used for prevention of infectious diseases within days of study treatment; examples include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine\r\n* Note: seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. Flu-Mist) are live-attenuated vaccines, and are not allowed within days of study treatment +Received a live vaccine within days prior to the first dose of pembrolizumab; examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine; seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. FluMist) are live attenuated vaccines and are not allowed +Received a live vaccine within days prior to the first dose of MK-; examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine; seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. FluMist) are live attenuated vaccines and are not allowed +Has received a live vaccine within days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. FluMist) are live attenuated vaccines and are not allowed +Attenuated vaccines within days prior to the first dose of trial treatment and while participating in the trial; examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, seasonal flu, hemagglutinin type (H) neuraminidase type (N) flu, rabies, bacillus Calmette-Guerin (BCG), and typhoid vaccine +Has received a live vaccine within days of planned start of study therapy; examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine\r\n* Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed +Live vaccines within days prior to the first dose of IL- and while participating in the trial; examples of live vaccines include, but are not limited to, measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine; seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu - Mist) are live attenuated vaccines, and are not allowed +Has received a live vaccine within days prior to the first dose of study drug; examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus CalmetteGuerin (BCG), and typhoid vaccine; seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist) are live attenuated vaccines and are not allowed +Patients must not have received live vaccines within days prior to registration; examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, shingles, yellow fever, rabies, bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine; seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed +Receipt of live vaccines within days before the first dose of trial treatment and while participating in the trial; examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, seasonal flu, HN flu, rabies, bacillus Calmette-Gurin (BCG), and typhoid vaccine +The participant has received a live vaccine within days prior to registration; examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine; the use of the inactivated seasonal influenza vaccine is allowed +Within days prior to the planned start of study treatment:\r\n* Has received a live vaccine; examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, Bacillus CalmetteGuerin (BCG), and typhoid vaccine; seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed\r\n* Has participated in a study of an investigational agent and received study therapy or used an investigational device +Receipt of a live vaccine within days of the start of treatment; examples are measles, mumps, rubella, varicella, yellow fever, rabies, Bacillus CalmetteGuerin (BCG), oral polio vaccine, and oral typhoid vaccine +Received a live vaccine within days prior to the first dose of trial treatment: Examples of live vaccines include, but are not limited to: measles, mumps, rubella, chicken pox, yellow fever, rabies, BCG, and typhoid (oral) vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. Flu-Mist) are live attenuated vaccines and are not allowed. +Patient has had live vaccines within days before the first dose of trial treatment and while participating in the trial; examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, seasonal flu, HN flu, rabies, bacille de Calmette et Gurin (BCG), and typhoid vaccine +Patients who have received any non-oncology vaccine therapy used for prevention of infectious diseases including seasonal vaccinations within days of study treatment; examples include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, seasonal flu, HN flu, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine +Has received a live vaccine within days of planned start of study medication. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Gurin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. FluMist) are live attenuated vaccines and are not allowed. +Has received a live vaccine within days before to the first dose of trial treatment; examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, seasonal flu (some), HN flu, rabies, Bacille Calmette-Guerin (BCG), and typhoid vaccine; seasonal flu vaccines that do not contain live virus are permitted