Resolution or stabilization of clinically significant adverse events from prior therapy (completed at least days prior to first dose of talimogene laherparepvec [TVEC])
Woman of childbearing potential unwilling to use effective contraception during protocol treatment and for months after last dose of talimogene laherparepvec
Patients who have previously been treated with talimogene laherparepvec, any other oncolytic virus or pelvic radiation are ineligible
Subject who is unwilling to minimize exposure with his/her blood or other body fluids to individuals who are at higher risks for herpes simplex virus (HSV)- induced complications such as immunosuppressed individuals, individuals known to have HIV infection, pregnant women, or children under the age of year, during talimogene laherparepvec treatment and through days after the last dose of talimogene laherparepvec are ineligible
The study treatment must be excluded in the following patients:\r\n* Female subject is pregnant or breast-feeding, or planning to become pregnant during study treatment and through months after the last dose of talimogene laherparepvec\r\n* Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during study treatment and through months after the last dose of talimogene laherparepvec\r\n* Sexually active subjects and their partners unwilling to use male or female latex condom to avoid potential viral transmission during sexual contact while on treatment and within days after treatment with talimogene laherparepvec
Previous treatment with talimogene laherparepvec or any other oncolytic virus
Subject has known sensitivity to talimogene laherparepvec or any of its components to be administered during dosing
Subject who is unwilling to minimize exposure with his/her blood or other body fluids to individuals who are at higher risks for herpes simplex virus (HSV)- induced complications such as immunosuppressed individuals, individuals known to have HIV infection, pregnant women, or children under the age of year, during talimogene laherparepvec treatment and through days after the last dose of talimogene laherparepvec
Subject who is unwilling to minimize exposure with his/her blood or other body fluids to individuals who are at higher risks for human herpesvirus (HSV-) induced complications such as immunosuppressed individuals, individuals known to have HIV infection, pregnant women, or children under the age of year, during talimogene laherparepvec treatment and through days after the last dose of talimogene laherparepvec
Known previous history of sensitivity to talimogene laherparepvec or any of its components to be administered during dosing (e.g. sorbitol, myo-inositol)
Prior therapy with talimogene laherparepvec, tumor vaccine
Previous treatment with talimogene laherparepvec or any other oncolytic virus
FCBP who are unwilling to use acceptable method(s) of effective contraception during study treatment and through months after the last dose of talimogene laherparepvec
Subjects who are unwilling to minimize exposure with his/her blood or other body fluids to individuals who are at higher risks for HSV induced complications (immunosuppressed individuals, HIV positive individuals, pregnant women, or children under the age of year) during talimogene laherparepvec treatment and through days after the last dose of talimogene laherparepvec
Previous treatment with talimogene laherparepvec or other herpes virus based therapy; (prior therapy with checkpoint inhibitors and/or other immunotherapy is allowed)
Subject who is unwilling to minimize exposure with his/her blood or other body fluids to individuals who are at higher risks for human herpesvirus (HSV-) induced complications such as immunosuppressed individuals, individuals known to have HIV infection, pregnant women, or children under the age of year, during talimogene laherparepvec treatment and through days after the last dose of talimogene laherparepvec
Previous treatment with talimogene laherparepvec (T-VEC) or any other oncolytic virus
Patients who are unwilling to minimize exposure with his/her blood or other body fluids to individuals who are at higher risks for herpes simplex virus (HSV)- induced complications such as immunosuppressed individuals, individuals known to have HIV infection, pregnant women, or children under the age of year, during talimogene laherparepvec (T-VEC) treatment and through days after the last dose of talimogene laherparepvec (T-VEC)
Subject must not have been treated previously with talimogene laherparepvec or tumor vaccine.
Patients who are known sensitive to any of the products or components to be administered during treatment with talimogene laherparepvec
Phase b: Prior talimogene laherparepvec, ipilimumab, other CTLA- inhibitors, PD- inhibitors, or tumor vaccine
Phase : Prior talimogene laherparepvec, other oncolytic virus therapies, or tumor vaccines
Males with partners of childbearing potential, must agree for the duration of the treatment with talimogene laherparepvec and continuing for months after the last tumor injection of talimogene laherparepvec to either:\r\n* Abstain from sexual activity\r\n* Use highly effective barrier protection (latex condom)
Female subjects of childbearing potential should have a negative urine or serum pregnancy test within hours prior to enrollment; if urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\r\n* If a pregnancy occurs, the study doctor must be notified; the study doctor should notify the study sponsor as well as Amgen of the pregnancy, discuss any follow-up with the subject (and/or his partner), and ask for information on the pregnancy outcome; the patient should be asked if she wishes to consent to follow up through the Amgen pregnancy surveillance program\r\n* If the female partner is already pregnant when the male subject begins treatment with talimogene laherparepvec, he must refrain from any sort of sexual activity that could expose his partner or the unborn baby to talimogene laherparepvec through semen, or wear a latex condom during sexual activity while receiving treatment with talimogene laherparepvec and for at least months after the last talimogene laherparepvec administration
Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during study treatment and through months after the last dose of talimogene laherparepvec
Previous treatment with talimogene laherparepvec or any other oncolytic virus
Patients must not have received prior treatment with talimogene laherparepvec (T-VEC) or other oncolytic virus agents
Prior therapy with talimogene laherparepvec, pembrolizumab, other anti-PD-, any other antibody or drug specifically targeting T-cell co-stimulation or immune check point pathway.
Subject who is unwilling to minimize exposure with his/her blood or other body fluids to individuals who are at higher risks for HSV- induced complications (eg, immunosuppressed individuals, HIV-positive individuals, pregnant women, or children under the age of year) during talimogene laherparepvec treatment and through days after the last dose of talimogene laherparepvec
Prior treatment with talimogene laherparepvec or any other oncolytic virus.
No antiplatelet or anticoagulation medications allowed within days prior to talimogene laherparepvec injection except low-dose heparin needed to maintain venous catheter patency.
Subject who is unwilling to minimize exposure with his/her blood or other body fluids to individuals who are at higher risks for HSV- induced complications (immunosuppressed individuals, HIV-positive individuals, pregnant women, or children under the age of year) during talimogene laherparepvec treatment and through days after the last dose of talimogene laherparepvec.