Men and non-pregnant, non-breast-feeding women may be enrolled if they are willing to use  methods of birth control or are considered highly unlikely to conceive; highly unlikely to conceive is defined as ) surgically sterilized, or ) postmenopausal (a woman who is >=  years of age and has not had menses for greater than  years will be considered postmenopausal), or ) not heterosexually active for the duration of the study; the two birth control methods can be barrier method or a barrier method plus a hormonal method to prevent pregnancy; patients should start using birth control from study visit  throughout the study period up to  days after the last dose of study therapy; the following are considered adequate barrier methods of contraception: diaphragm, condom (by the partner), copper intrauterine device, sponge, or spermicide; appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents)
Patient of child-bearing potential is willing to employ adequate contraception; appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives, or double barrier method (diaphragm plus condom)
Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for at least  days following last dose of ABT-\r\n* Women of childbearing potential (WOCBP) includes any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea >=  consecutive months; or women on hormone replacement therapy [HRT] with documented serum follicle stimulating hormone [FSH] level >  mIU/mL)\r\n** Prior to study enrollment, WOCBP must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy\r\n** The following birth control methods are allowed during the study:\r\n*** Barrier methods:\r\n**** Intra-uterine device (IUD)\r\n**** Diaphragm with spermicide\r\n**** Cervical cap with spermicide\r\n**** Condom with spermicide\r\n*** Hormonal method:\r\n**** Hormonal contraceptives (such as the birth control pill)\r\n*** Abstinence (no heterosexual activity)\r\n* Non-vasectomized males must agree to use adequate contraception for at least  days after the last dose of ABT-\r\n** The following birth control methods are allowed during the study:\r\n*** Partner is not WOCBP or is taking hormonal contraceptives\r\n*** Barrier methods:\r\n**** Intra-uterine device (IUD)\r\n**** Diaphragm with spermicide\r\n**** Cervical cap with spermicide\r\n**** Condom with spermicide\r\n*** Abstinence (no heterosexual activity)\r\n** Males must also abstain from sperm donations for at least  days after the last dose of ABT-
Male patients with partners of childbearing potential who are unwilling to use condoms in combination with a second effective method of contraception (defined as hormonal contraception, intrauterine device, condom with spermicide, etc.) during the trial and for  months after the last administration of BI .
Highly effective methods of contraception:\r\n* Barrier methods\r\n** Male condom with spermicide\r\n** Copper T intrauterine device\r\n** Levonorgestrel-releasing intrauterine system (eg, Mirena) (also considered a hormonal method)\r\n* Hormonal methods\r\n** Implants\r\n** Hormone shot or injection\r\n** Combined pill\r\n** Minipill\r\n** Patch
Double barrier methods of contraception such as condom plus diaphragm or cervical/vault cap with spermicide
Verify the pregnancy status of females of reproductive potential within  days prior to initiating vismodegib; for women of childbearing potential, a negative pregnancy test within  days prior to commencement of dosing is required; women of reproductive potential are required to use two forms of acceptable contraception (including one acceptable barrier method with spermicide) during therapy and for  months after completing therapy; acceptable forms of primary contraception include the following: combination hormonal contraceptives, subcutaneous hormonal implant, hormonal patch, hormonal contraceptives (levonorgestre-releasing intrauterine system, medroxyprogesterone acetate depot), tubal sterilization, vasectomy, and intrauterine device (IUD); acceptable forms of barrier contraception include the following: any male condom (with spermicide) or diaphragm (with spermicide)
Pregnant or lactating women; patients who are unable or are unwilling to adhere to the required contraceptive methods are excluded from the study\r\n* Women of reproductive potential are required to use two forms of acceptable contraception (including one acceptable barrier method with spermicide) during therapy and for  months after completing therapy; acceptable forms of primary contraception include the following: combination hormonal contraceptives, subcutaneous hormonal implant, hormonal patch, hormonal contraceptives (levonorgestrel-releasing intrauterine system, medroxyprogesterone acetate depot), tubal sterilization, vasectomy and intrauterine device (IUD); acceptable forms of barrier contraception include the following: any male condom (with spermicide) or diaphragm (with spermicide)\r\n* Women should not breastfeed a baby while on this study, or for  months after completing therapy\r\n* Male patients must use condoms at all times, even after a vasectomy, during sexual intercourse with female partners of reproductive potential during treatment with vismodegib and for  months after the last dose to avoid exposing a pregnant partner and unborn fetus to vismodegib
Sexually active women, unless surgically sterile (at least  months prior to study drug administration) or postmenopausal for at least  consecutive months, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile [at least  months prior to study drug administration] sexual partner) for at least  weeks prior to study drug administration, during study and up to  days or till next chemotherapy cycle; cessation of birth control after this point should be discussed with a responsible physician; investigator will discuss with patient on the above points and the patient agreement will be documented in the source document; the investigator should ensure that the patient is using an effective method of avoiding pregnancy as per protocol; in case of male patients: either patient partners or patients themselves must use an effective method of avoiding pregnancy for at least  weeks prior to study drug administration, during study and up to  days or till next chemotherapy cycle
Females of childbearing potential and males must be willing to abstain from heterosexual activity* or to use effective methods of contraception from the time of informed consent until  days after treatment discontinuation; acceptable contraception methods can be comprised of an intrauterine device (IUD), vasectomy of a female subjects male partner, contraceptive rod implanted into the skin, or use of two of the following: diaphragm with spermicide (cannot be used in conjunction with cervical cap/spermicide), cervical cap with spermicide (nulliparous women only), contraceptive sponge (nulliparous women only), male condom or female condom (cannot be used together), hormonal contraceptive\r\n* Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
FCBP and male patients whose sexual partner(s) are FCBP must agree to abstain from heterosexual activity or use a double barrier method of contraception (e.g., condom and occlusive cap with spermicide) or highly effective contraception (intrauterine device or system, established hormonal contraceptive methods on a stable dose from the time of the last menstrual cycle, or vasectomized partner with confirmed azoospermia) from the time of study entry to  month after the last day of treatment
Female subjects must be surgically sterile, postmenopausal (minimum  year without menses), or agree to use one or more of the following forms of contraception from the time of signing the informed consent form through day +: hormonal (i.e., oral, transdermal, implant, or injection); double barrier (i.e., condom, diaphragm with spermicide); intrauterine device (IUD); vasectomized partner (six months minimum); or abstinence; male subjects must also agree to use one or more of the above forms of birth control for either themselves or their partner, as appropriate, from the time of signing the informed consent form through day +
DONOR: female and male donors must agree to use one or more forms of birth control for either themselves or their partner, as appropriate, from the time of signing the informed consent form through day +: hormonal (i.e., oral, transdermal, implant, or injection); double barrier (i.e., condom, diaphragm with spermicide); intrauterine device (IUD); vasectomized partner (six months minimum); or abstinence
Enrollment in the Celgene THALOMID REMS Program:\r\n* If enrolled in Arm III of this study, patient must be registered at the Celgene THALOMID REMS Program\r\n* If enrolled in Arm III of this study, patient must be willing to practice birth control as outlined in the THALOMID REMS Program from the beginning of the study until at least  weeks following discontinuation of thalidomide therapy; two reliable forms of contraception must be used simultaneously unless continuous abstinence from heterosexual sexual contact is chosen; contraceptive methods must include at least one highly effective method (e.g. oral contraceptive pills, injections, hormonal patches, intrauterine device [IUD], or implants), AND one additional effective barrier method (e.g. latex condom, diaphragm, cervical cap); if hormonal or IUD contraception is medically contraindicated, another highly effective method or two barrier methods must be used at the same time\r\n* Pregnancy surveillance:\r\n** Patient must have a negative in office pregnancy test sensitive to within  mIU/mL (serum or urine) within  hours of beginning thalidomide even if continuous abstinence is the preferred method of birth control\r\n** A pregnancy test must be performed weekly during the first  weeks of therapy and repeated monthly for patients with regular menses or every  weeks for patients with irregular menses\r\n** Negative pregnancy tests are valid for only  days\r\n** If irregular bleeding or skipped menses, pregnancy test should be performed and pregnancy counseling given\r\n** If pregnancy occurs during treatment, thalidomide must be immediately discontinued; any suspected lethal exposure must be reported immediately to Celgene Customer Care Center at ---, and the patient referred to an obstetrician (OB)/gynecologist (GYN) experienced in reproductive toxicity for further evaluation and counseling
Acceptable birth control methods:\r\n* Total sexual abstinence i.e., refrain from any form of sexual intercourse in line with the patients usual and/or preferred lifestyle. Abstinence must be for the total duration of the study treatment and for at least  month (for female patients) or  months (for male patients) after the last dose of study treatment. Periodic abstinence (e.g., calendar ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Vasectomized sexual partner PLUS male condom. With participant assurance that partner received post-vasectomy confirmation of azoospermia\r\n* Tubal occlusion PLUS male condom\r\n* Intrauterine device PLUS male condom. Provided coils are copper-banded\r\n* Etonogestrel implants (e.g., Implanon, Norplant) PLUS male condom\r\n* Normal and low dose combined oral pills PLUS male condom\r\n* Hormonal shot or injection (e.g., Depo-Provera) PLUS male condom\r\n* Intrauterine system device (e.g., levonorgestrel-releasing intrauterine system -Mirena) PLUS male condom\r\n* Norelgestromin/ethinyl estradiol transdermal system PLUS male condom\r\n* Intravaginal device (e.g., ethinyl estradiol and etonogestrel) PLUS male condom\r\n* Cerazette (desogestrel) PLUS male condom. Cerazette is currently the only highly efficacious progesterone based pill
Females of childbearing potential and males must be willing to abstain from heterosexual activity or to use  forms of highly effective methods of contraception from the time of informed consent until  days after treatment discontinuation. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method.\r\n* Acceptable non-hormonal birth control methods:\r\n** Total sexual abstinence ie, refrain from any form of sexual intercourse in line with the patients usual and/or preferred lifestyle. Abstinence must be for the total duration of the study treatment and for at least  month (for female patients) or  months (for male patients) after the last dose of study treatment. Periodic abstinence (eg, calendar ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.\r\n** Vasectomized sexual partner PLUS male condom. With participant assurance that partner received post-vasectomy confirmation of azoospermia.\r\n** Tubal occlusion PLUS male condom.\r\n** Intrauterine Device PLUS male condom. Provided coils are copper-banded.\r\n* Acceptable hormonal methods:\r\n** Etonogestrel implants (eg, Implanon, Norplant) PLUS male condom.\r\n** Normal and low dose combined oral pills PLUS male condom.\r\n** Hormonal shot or injection (eg, Depo-Provera) PLUS male condom.\r\n** Intrauterine system device (eg, levonorgestrel-releasing intrauterine system - Mirena) PLUS male condom.
Women of childbearing potential (WoCBP) must have a negative serum pregnancy test within  days prior to the first dose of study treatment and agree to use highly effective contraception, during the study and for  days following the last dose of osimertinib\r\n* Women of childbearing potential (WoCBP): women between menarche and menopause who have not been permanently or surgically sterilized and are capable of procreation\r\n* Women NOT of childbearing potential: women who are permanently or surgically sterilized or postmenopausal\r\n** Permanent sterilization includes hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy but excludes bilateral tubal occlusion; tubal occlusion is considered a highly effective method of birth control but does not absolutely exclude possibility of pregnancy; (the term occlusion refers to both occluding and ligating techniques that do not physically remove the oviducts)\r\n* Women who have undergone tubal occlusion should be managed on trials as if they are of WoCBP (e.g. undergo pregnancy testing etc., as required by the study protocol)\r\n* Women will be considered postmenopausal if they are amenorrhoeic for  months without an alternative medical cause; the following age-specific requirements apply:\r\n** Women under  years old will be considered postmenopausal if they have been amenorrhoeic for  months or more following cessation of exogenous hormonal treatments and with luteinizing hormone and follicle-stimulating hormone levels in the postmenopausal range\r\n** Women over  years of age will be considered postmenopausal if they have been amenorrhoeic for  months or more following cessation of all exogenous hormonal treatments\r\n* Acceptable contraception methods are:\r\n** Total sexual abstinence (abstinence must be for the total duration of the trial and the\r\nfollow-up period)\r\n** Vasectomized sexual partner plus male condom (with participant assurance that partner received post-vasectomy confirmation of azoospermia)\r\n** Tubal occlusion plus male condom\r\n** Intra-uterine device  provided coils are copper-banded, plus male condom\r\n** Intra-uterine system (IUS) levonorgestrel IUS (e.g., Mirena), plus male condom\r\n** Medroxyprogesterone injections (Depo-Provera) plus male condom\r\n** Etonogestrel implants (e.g., Implanon, Norplan) plus male condom\r\n** Normal and low dose combined oral contraceptive pills, plus male condom\r\n** Norelgestromin / ethinylestradiol transdermal system plus male condom\r\n** Intravaginal device (e.g., ethinylestradiol and etonogestrel) plus male condom\r\n** Cerazette (desogestrel) plus male condom (Cerazette is currently the only highly efficacious progesterone based pill)\r\n* Unacceptable Contraception Methods\r\nThe following methods are considered not to be highly effective and are therefore not\r\nacceptable contraceptive methods:\r\n** Triphasic combined oral contraceptives\r\n** All progesterone only pills except, Cerazette\r\n** All barrier methods, if intended to be used alone\r\n** Non-copper containing intra-uterine devices\r\n** Fertility awareness methods\r\n** Coitus interruptus
Non-sterilized males who are sexually active with a female partner of childbearing potential must use adequate contraception for the duration of the study and  month after the last dose of study medication. Adequate contraception methods include: birth control pills (eg combined oral contraceptive pill), barrier protection (eg condom plus spermicide, cervical/vault cap or intrauterine device), and abstinence. Patients should not father a child for  months after completion of the study medication. Patients should refrain from donating sperm from the start of dosing until  months after discontinuing the study medication. If male patients wish to father children they should be advised to arrange for freezing of sperm samples prior to the start of the study medication
Female subjects of childbearing potential must be willing to use an adequate method of contraception. Contraception, for the course of the study through  days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject. Acceptable methods of contraception are as follows:\r\n* Single method (one of the following is acceptable): intrauterine device (IUD), vasectomy of a female subjects male partner, contraceptive rod implanted into the skin.\r\n* Combination method (requires use of two of the following): diaphragm with spermicide (cannot be used in conjunction with cervical cap/spermicide), cervical cap with spermicide (nulliparous women only), contraceptive sponge (nulliparous women only), male condom or female condom (cannot be used together), hormonal contraceptive: oral contraceptive pill (estrogen/ progestin pill or progestin- only pill), contraceptive skin patch, vaginal contraceptive ring, or subcutaneous contraceptive injection. Abstinence is acceptable if this is the usual lifestyle and preferred contraception method for the subject.
Male participants and their female partners, who are sexually active and of childbearing potential, must agree to the use of two highly effective forms of contraception in combination (see below for acceptable methods), and not to donate sperm, throughout the period of taking study treatment and for  months after last dose of study drug(s) to prevent pregnancy in a partner; acceptable methods of contraception to be used in this study include:\r\n* Condom with spermicide and one of the following:\r\n** Oral contraceptive or hormonal therapy (e.g. hormone implants)\r\n** Placement of an intra-uterine device\r\n* Acceptable non-hormonal birth control methods include:\r\n** Total sexual abstinence; abstinence must be for the total duration of the study and the drug washout period\r\n** Vasectomized sexual partner plus male condom; with participant assurance that partner received post-vasectomy confirmation of azoospermia\r\n** Tubal occlusion plus male condom with spermicide\r\n** Intrauterine device (IUD) plus male condom+spermicide; provided coils are copper-banded\r\n* Acceptable hormonal methods:\r\n** Etonogestrel implants (eg, Implanon, Norplan) + male condom with spermicide\r\n** Normal and low dose combined oral pills + male condom with spermicide\r\n** Norelgestromin/ethinyl estradiol (EE) transdermal system + male condom with spermicide\r\n** Intravaginal device + male condom with spermicide (eg, EE and etonogestrel)\r\n** Cerazette (desogestrel) + male condom with spermicide; cerazette is currently the only highly efficacious progesterone based pill
WOCBP must be willing to use either two adequate barrier methods or a barrier method plus a hormonal method of contraception to prevent pregnancy, or to abstain from heterosexual activity (complete abstinence) throughout the study, starting with visit  through  months after the last dose of study therapy; approved contraceptive methods include, for example; intrauterine device, diaphragm with spermicide, cervical cap with spermicide, male condoms, female condoms with spermicide, or oral contraceptives; spermicides alone are not an acceptable method of contraception; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
Females of childbearing potential must be willing to abstain from heterosexual activity or to use  forms of effective methods of contraception from the time of informed consent until  weeks ( months) after treatment discontinuation; the two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method or an intrauterine device that meets < % failure rate for protection from pregnancy in the product label
Women of childbearing potential (WOCBP) must use method(s) of contraception for  days +  half-lives ( days) of the study drugs. For a teratogenic study drug and/or when there is insufficient information to assess teratogenicity (preclinical studies have not been done), a highly effective method(s) of contraception (failure rate of less than % per year) is required. Highly effective birth control in this study is defined as a double barrier method. Examples include a condom (with spermicide) in combination with a diaphragm, cervical cap, or intrauterine device (IUD). The individual methods of contraception should be determined in consultation with the investigator.
Female and male subjects of reproductive potential must agree to avoid becoming pregnant or impregnating a partner, respectively, while receiving study drug and for  days after the last dose of study drug by complying with one of the following:\r\n* Practice abstinence from heterosexual activity; OR\r\n* Use (or have their partner use) acceptable contraception during heterosexual activity\r\nAcceptable methods of contraception are:\r\n* Single method (one of the following is acceptable):\r\n** Intrauterine device (IUD)\r\n** Vasectomy of a female subjects male partner\r\n** Contraceptive rod implanted into the skin\r\n* Combination method (requires use of two of the following):\r\n** Diaphragm with spermicide (cannot be used in conjunction with cervical cap/spermicide)\r\n** Cervical cap with spermicide (nulliparous women only)\r\n** Contraceptive sponge (nulliparous women only)\r\n** Male condom or female condom (cannot be used together)\r\n** Hormonal contraceptive: oral contraceptive pill (estrogen/progestin pill or progestin-only pill), contraceptive skin patch, vaginal contraceptive ring, or subcutaneous contraceptive injection\r\n* Abstinence (relative to heterosexual activity) can be used as the sole method of contraception if it is consistently employed as the subjects preferred and usual lifestyle and if considered acceptable by local regulatory agencies and Electronic Research Collection (ERC)s/Institutional Review Board (IRB)s; periodic abstinence (e.g., calendar, ovulation, sympto-thermal, post-ovulation methods, etc.) and withdrawal are not acceptable methods of contraception\r\n* If a contraceptive method listed above is restricted by local regulations/guidelines, then it does not qualify as an acceptable method of contraception for subjects participating at sites in this country/region\r\n* Subjects should be informed that taking the study medication may involve unknown risks to the fetus (unborn baby) if pregnancy were to occur during the study; in order to participate in the study subjects of childbearing potential must adhere to the contraception requirement (described above) from the day of study medication initiation (or  days prior to the initiation of study medication for oral contraception) throughout the study period up to  days after the last dose of trial therapy; if there is any question that a subject of childbearing potential will not reliably comply with the requirements for contraception, that subject should not be entered into the study
Females of childbearing potential and males must be willing to abstain from heterosexual activity or to use  forms of effective methods of contraception from the time of informed consent until  days after treatment discontinuation; the two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method
Requirement to use contraception prior to, during and after the completion of the study; women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of the study and  months after completion of anetumab ravtansine or pembrolizumab administration; acceptable methods of contraception are:\r\n* Single method ( of the following is acceptable):\r\n** Intrauterine device (IUD)\r\n** Vasectomy of a female patients male partner\r\n** Contraceptive rod implanted into the skin\r\n* Combination method (requires use of  of the following):\r\n** Diaphragm with spermicide (cannot be used in conjunction with cervical cap/spermicide)\r\n** Cervical cap with spermicide (nulliparous women only)\r\n** Contraceptive sponge (nulliparous women only)\r\n** Male condom or female condom (cannot be used together)\r\n** Hormonal contraceptive: oral contraceptive pill (estrogen/progestin pill or progestin-only pill), contraceptive skin patch, vaginal contraceptive ring, or subcutaneous contraceptive injection\r\n* Abstinence (relative to heterosexual activity) can be used as the sole method of contraception if it is consistently employed as the patients preferred and usual lifestyle and if considered acceptable by local regulatory agencies and Institutional Review Boards (IRBs); periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods, etc.) and withdrawal are not acceptable methods of contraception\r\n* If there is any question that a patient will not reliably comply with the requirements for contraception, that patient should not be entered into the study; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
Subject of childbearing potential is willing to use effective methods of birth control include: ) use of hormonal birth control methods: pills, shots/injections, implants (placed under the skin by a health care provider), or patches (placed on the skin); ) intrauterine devices (IUDs); ) using  barrier methods (each partner must use  barrier method) with a spermicide; males must use the male condom (latex or other synthetic material) with spermicide; females must choose either a diaphragm with spermicide, or cervical cap with spermicide, or a sponge (spermicide is already in the contraceptive sponge); female patients of childbearing potential must have a negative urine pregnancy test no more than  days prior to starting study drug; ) for male participant, they must agree and commit to use a barrier method of contraception while on treatment and for  months after the last dose of investigational product
Non-sterilized males who are sexually active with a female partner of childbearing potential must use adequate contraception for the duration of the study and  days after the last dose of study medication; adequate contraception methods include: birth control pills (e.g. combined oral contraceptive pill), barrier protection (e.g. condom plus spermicide, cervical/vault cap or intrauterine device), and abstinence
Male or female patients of reproductive potential who are not employing an effective method of birth control; adequate contraception methods include: birth control pills (e.g. combined oral contraceptive pill), barrier protection (e.g. condom plus spermicide cervical/vault cap or intrauterine device), and abstinence
Female patients enrolled in the study, who are not free from menses for >  years, post hysterectomy/oophorectomy, or surgically sterilized, must be willing to use either  adequate barrier methods or a barrier method plus a hormonal method of contraception to prevent pregnancy or to abstain from heterosexual activity throughout the study, starting with visit  through  days after the last dose of study therapy; approved contraceptive methods include for example; intra uterine device, diaphragm with spermicide, cervical cap with spermicide, male condoms, female condoms with spermicide, or oral contraceptives; spermicides alone are not an acceptable method of contraception
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of childbearing potential who are unwilling to employ adequate contraception within the projected duration of the study, starting with the screening visit through  days after the last dose of study medication; adequate contraception is defined as  methods of birth control (e.g., hormonal contraceptives, intrauterine device, diaphragm with spermicide, cervical cap with spermicide, male condoms, or female condom with spermicide) or prior surgical sterilization, or abstinence from heterosexual activity
Pregnant females; breastfeeding females; and males and females of childbearing potential not willing to use two highly effective methods of birth control, one being barrier method. Intrauterine Devices (IUD) and birth control pills are not barrier methods, but are highly effective especially when combined with a barrier method (e.g. latex condom or a diaphragm or cervical cap) while taking investigational product (SY-) and continuing contraception use for at least  days after the last dose of study drug. Men/women should not donate sperm or ova during this time frame.
Females of childbearing potential and males must be willing to abstain from heterosexual activity or to use  forms of effective methods of contraception from the time of informed consent until  days after treatment discontinuation; the two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method
LYMPHODEPLETION: Females and males of childbearing potential must be willing to abstain from heterosexual activity or to use  forms of effective methods of contraception from the time of informed consent until  months after treatment discontinuation; the two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method; female participants will inform their male partners that they must use the methods of birth control required by the protocol
iC-CAR CELL INFUSION: Females and males of childbearing potential must be willing to abstain from heterosexual activity or to use  forms of effective methods of contraception from the time of informed consent until  months after treatment discontinuation; the two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method; female participants will inform their male partners that they must use the methods of birth control required by the protocol
WOCBP must be willing to use either two adequate barrier methods or a barrier method plus a hormonal method of contraception to prevent pregnancy, or to abstain from heterosexual activity (complete abstinence) throughout the study, starting with visit  through  days after the last dose of study therapy; approved contraceptive methods include for example; intrauterine device, diaphragm with spermicide, cervical cap with spermicide, male condoms, female condoms with spermicide, or oral contraceptives; spermicides alone are not an acceptable method of contraception; non-pregnant, non-breast-feeding women may be enrolled if they are considered highly unlikely to conceive; highly unlikely to conceive is defined as ) surgically sterilized, or ) postmenopausal (a woman who is >=  years of age and has not had menses for greater than  years will be considered postmenopausal), or ) amenorrheic for <  years without a hysterectomy and oophorectomy and with a documented follicle stimulating hormone (FSH) value in the postmenopausal range, or ) not heterosexually active for the duration of the study, or ) heterosexually active and willing to use  methods of birth control (which is also required for the female partners of male patients)\r\n* Male patients must agree to use an adequate method of contraception, or to abstain from heterosexual activity (complete abstinence), starting with the first dose of study drug through  days after the last dose of study therapy
Females of childbearing potential and male subjects with female partners of childbearing potential must agree to avoid pregnancy by using an adequate method of contraception ( barrier method or  barrier method with a spermicide or intrauterine device for  weeks prior to screening, during and  weeks after the last dose of trial medication; adequate methods of contraception are provided as examples; other acceptable and effective methods of birth control are also permitted (e.g., abstinence)
Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following: a) agree to practice effective barrier contraception during the entire study treatment period and through  days after the last dose of study drug, OR b) latex or non-latex condom with or without a spermicidal agent, diaphragm with spermicide; cervical cap with a spermicide; sponge with a spermicide
Be willing to use an adequate method of contraception for the course of the study through  days after the last dose of study medication (male and female subjects of childbearing potential; acceptable methods of contraception are as follows: A) single method (one of the following is acceptable): a) intrauterine device (IUD); b) vasectomy of a female subjects male partner; c) contraceptive rod implanted into the skin B) combination method (requires use of two of the following): a) diaphragm with spermicide (cannot be used in conjunction with cervical cap/spermicide); c) cervical cap with spermicide (nulliparous women only); d) contraceptive sponge (nulliparous women only); e) male condom or female condom (cannot be used together); f) hormonal contraceptive: oral contraceptive pill (estrogen/progestin pill or progestin-only pill), contraceptive skin patch, vaginal contraceptive ring, or subcutaneous contraceptive injection; abstinence (relative to heterosexual activity) can be used as the sole method of contraception if it is consistently employed as the subjects preferred and usual lifestyle and if considered acceptable by local regulatory agencies and Ethical Review Committees (ERCs)/Institutional Review Boards (IRBs); periodic abstinence (e.g., calendar, ovulation, sympto-thermal, post-ovulation methods, etc.) and withdrawal are not acceptable methods of contraception; if a contraceptive method listed above is restricted by local regulations/guidelines, then it does not qualify as an acceptable method of contraception for subjects participating at sites in this country/region
Be willing to use an adequate method of contraception for the course of the study through  days after the last dose of study medication (male and female subjects of childbearing potential; Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject; acceptable methods of contraception are as follows: single method (one of the following is acceptable): intrauterine device (IUD), vasectomy of a female subjects male partner, contraceptive rod implanted into the skin; combination method (requires use of two of the following): diaphragm with spermicide (cannot be used in conjunction with cervical cap/spermicide), cervical cap with spermicide (nulliparous women only), contraceptive sponge (nulliparous women only), male condom or female condom (cannot be used together), hormonal contraceptive: oral contraceptive pill (estrogen/progestin pill or progestin-only pill), contraceptive skin patch, vaginal contraceptive ring, or subcutaneous contraceptive injection; abstinence is acceptable if this is the usual lifestyle and preferred contraception method for the subject
Patients of childbearing potential (women who are postmenopausal for <  year, not surgically sterilized, or not abstinent), have a negative urine pregnancy test, and agree to the consistent and correct use of one of the following acceptable methods of birth control: male partner who is sterile before the female subjects entry into the study and is the sole sexual partner for that female subject; intrauterine device, oral contraception, or barrier methods, including diaphragm or condom with a spermicide
Female patients enrolled in the study, who are not free from menses for >  years, post hysterectomy/oophorectomy, or surgically sterilized, must be willing to use either  highly effective barrier methods or a barrier method plus a hormonal method of contraception to prevent pregnancy or to abstain from heterosexual activity throughout the study, starting with visit  and at least  months from the last dose of nivolumab; approved contraceptive methods include for example; intra uterine device, diaphragm with spermicide, cervical cap with spermicide, male condoms, female condoms with spermicide, or oral contraceptives; spermicides alone are not an acceptable method of contraception\r\n* Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) as well as azoospermic men do not require contraception
Female subjects who are pregnant/breast-feeding or who are of reproductive potential and not employing acceptable methods of birth control; acceptable methods of contraception include true abstinence in line with the preferred and usual lifestyle choice of the patient, tubal ligation, vasectomized partner, barrier methods (e.g., cap plus spermicide, sponge plus spermicide, diaphragm plus spermicide, or male condom plus a spermicide), intrauterine device methods (e.g., Copper T or Levonorgestrel-releasing intrauterine system), or hormonal methods (e.g., any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent) and that is administered via the oral, subcutaneous, transdermal, intrauterine, or intramuscular route as an implant, hormone shot or injection, combined pill, minipill or patch; all methods of contraception should be used in combination with the use of a condom by their male sexual partner for intercourse
WOCBP must be willing to use either two adequate barrier methods or a barrier method plus a hormonal method of contraception to prevent pregnancy or to abstain from heterosexual activity throughout the study, starting with visit  through  days after the last dose of study therapy; approved contraceptive methods include for example; intrauterine device, diaphragm with spermicide, cervical cap with spermicide, male condoms, female condoms with spermicide, or oral contraceptives; spermicides alone are not an acceptable method of contraception; male patients must agree to use an adequate method of contraception starting with the first dose of study drug through  days after the last dose of study therapy
Women of childbearing potential (WOCBP) should be willing to use  methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study; WOCBP are those who have not been surgically sterilized or have not been free from menses for >  year; the two birth control methods can be composed of: two barrier methods or a barrier method plus a hormonal method to prevent pregnancy; subjects should start using birth control from the screening visit and continue throughout study mandated treatment and for  days after the final dose of study drug; the following are considered adequate barrier methods of contraception: diaphragm, condom (by the partner), copper intrauterine device, sponge, or spermicide; appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents)
Effective methods of contraception:\r\n* Barrier methods\r\n** Cap plus spermicide\r\n** Sponge plus spermicide\r\n** Diaphragm plus spermicide\r\n* Intrauterine device methods\r\n** Copper T\r\n** Levonorgestrel-releasing intrauterine system (e.g., Mirena); this is also considered a hormonal method\r\n* Hormonal methods\r\n** Any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents) such as\r\n*** Implants\r\n*** Hormone shot or injection\r\n*** Combined pill\r\n*** Minipill\r\n*** Patch
Willingness to use effective contraceptive methods during the study; female patients may participate if patient is either not of childbearing potential (defined as postmenopausal for >  year or surgically sterile) or is practicing two forms of contraception; sexually active male participants must agree to use a physical barrier method (male latex rubber condom with or without spermicide)
Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (beta-hCG) pregnancy test result within  days prior to the first dose of study drugs and must agree to use an effective contraception method during the study and for  days following the last dose of study drug; females of non-childbearing potential are those who are postmenopausal greater than  year or who have had a bilateral tubal ligation or hysterectomy; appropriate methods of birth control include the following: any  of the following methods used together: birth control implants, injections, or pills (except for progesterone only pills), intrauterine device (IUD), vasectomy, tubal ligation, barrier method (female or male condom with spermicide, cervical cap with spermicide, diaphragm with spermicide); male condom with spermicide and diaphragm; male condom with spermicide and cervical cap; unacceptable methods of birth control include using no birth control, withdrawal, rhythm method, vaginal sponge, any barrier method that does not use spermicide, progesterone only pills, and using male and female condoms at the same time
Subjects of childbearing potential should be willing to use effective methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through at least  months after the last dose of study drug; subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for >  year; effective methods of birth control include: \r\n* Use of hormonal birth control methods: pills, shots/injections, implants (placed under the skin by a health care provider), or patches (placed on the skin)\r\n* Intrauterine devices (IUDs)\r\n* Using  barrier methods (each partner must use  barrier method) with a spermicide; males must use the male condom (latex or other synthetic material) with spermicide; females must choose either a diaphragm with spermicide, or cervical cap with spermicide, or a sponge (spermicide is already in the contraceptive sponge)
Subjects who choose complete abstinence are not required to use a second method of contraception, but female subjects must continue to have pregnancy tests; acceptable alternate methods of highly effective contraception must be discussed in the event that the subject chooses to forego complete abstinence; LESS EFFECTIVE METHODS OF CONTRACEPTION:\r\n* Diaphragm with spermicide\r\n* Cervical cap with spermicide\r\n* Vaginal sponge\r\n* Male condom without spermicide\r\n** A male and female condom must not be used together\r\n* Progestin only pills by WOCBP subject or male subjects WOCBP partner\r\n* Female condom\r\n** A male and female condom must not be used together
Female patients enrolled in the study, who are not free from menses for >  years, post hysterectomy/oophorectomy, or surgically sterilized, must be willing to use either  adequate barrier methods or a barrier method plus a hormonal method of contraception to prevent pregnancy, or to abstain from heterosexual activity throughout the study, starting with the first dose of study drug at visit  through  days after the last dose of study drug; approved contraceptive methods include for example: intra- uterine device, diaphragm with spermicide, cervical cap with spermicide, male condoms, or female condom with spermicide; spermicides alone are not an acceptable method of contraception; male patients must agree to use an adequate method of contraception starting with the first dose of study drug through  days after the last dose of study drug
Women of child-bearing potential defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means and males who have not been sterilized by vasectomy or other means with partners who are women of child-bearing potential (WOCBP), UNLESS the women are using two birth control methods; the two methods can be a double barrier method or a barrier method plus a hormonal method; adequate barrier methods of contraception include:\r\n* Diaphragm, condom (by the partner/patient where appropriate), intrauterine device (copper or hormonal), sponge or spermicide; hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent; reliable contraception should be maintained throughout the study and for  months after study drug discontinuation
Do not have a vasectomized partner with confirmed azoospermia. For sites outside of the European Union (EU), it is permissible that if a highly effective method of contraception is not appropriate or acceptable to the participant, or the participant has changed oral hormonal contraceptive product/dose within  weeks prior to study drug administration, then the participant must agree to use a medically acceptable method of contraception, ie, double barrier methods of contraception such as condoms plus diaphragm or cervical/vault cap with spermicide.
Females of childbearing potential must be willing to abstain from heterosexual activity or to use  forms of effective methods of contraception from the time of informed consent until  months after treatment discontinuation; the two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method or an intrauterine device that meets < % failure rate for protection from pregnancy in the product label
Patient of childbearing potential is using either  adequate barrier methods or a barrier method plus a hormonal method of contraception to prevent pregnancy or to abstain from heterosexual activity throughout the study, starting with visit  through  days after the last dose of study therapy; approved contraceptive methods include  of the following barrier methods or one barrier method combined with a hormonal contraceptive: a. intra uterine device, diaphragm with spermicide, cervical cap with spermicide, male condoms, or female condom with spermicide; spermicides or condoms alone are not an acceptable method of contraception; b. male patients must agree to use an adequate method of contraception starting with the first dose of study drug through  days after the last dose of study therapy
Pregnant or breastfeeding women or women of child-bearing potential who are not willing to use two highly effective methods of contraception (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence)
LESS EFFECTIVE METHODS OF CONTRACEPTION\r\n* Diaphragm with spermicide\r\n* Cervical cap with spermicide\r\n* Vaginal sponge\r\n* Male Condom without spermicide\r\n* Progestin only pills by WOCBP subject or male subjects WOCBP partner\r\n* Female Condom\r\n** A male and female condom must not be used together
Patient agrees to use acceptable form of contraception during the study and for up to  days after last study drug dose if female partner is of childbearing potential\r\n* Acceptable forms of contraception:\r\n** Latex condom (always used with spermicide)\r\n** Diaphragm (always used with spermicide)\r\n** Cervical cap (always used with spermicide)\r\n* Acceptable forms of secondary contraception, when used along with a barrier method:\r\n** Hormonal contraception methods, including pills, patches, rings, or injections except progestin-only containing pills (i.e. Mini-pill)\r\n** Tubal ligation\r\n** Partners vasectomy\r\n** Intrauterine device (non-progesterone T)\r\n** Vaginal sponge (containing spermicide)\r\n* Other acceptable forms:\r\n** % commitment to abstinence\r\n* Unacceptable forms of contraception for women of childbearing potential:\r\n** Oral contraception containing progestins only\r\n** Intrauterine device (IUD) progesterone T\r\n** Female condom\r\n** Natural family planning (rhythm method) or breastfeeding\r\n** Fertility awareness\r\n** Withdrawal\r\n** Cervical shield
Men and non-pregnant, non-breast-feeding women may be enrolled if they are willing to use  methods of birth control or are considered highly unlikely to conceive; highly unlikely to conceive is defined as ) surgically sterilized, or ) postmenopausal (a woman who is >=  years of age and has not had menses for greater than  years will be considered postmenopausal), or ) not heterosexually active for the duration of the study; the two birth control methods can be barrier method or a barrier method plus a hormonal method to prevent pregnancy; patients should start using birth control from study visit  throughout the study period up to  days after the last dose of study therapy; the following are considered adequate barrier methods of contraception: diaphragm, condom (by the partner), copper intrauterine device, sponge, or spermicide; appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents); patients should continue contraceptive measures for  months from the last dose of all study medications
Female participants enrolled in the study, who are not free from menses for >  years, post hysterectomy/oophorectomy, or surgically sterilized, must be willing to use either  adequate barrier methods or a barrier method plus a hormonal method of contraception to prevent pregnancy or to abstain from sexual activity throughout the study, starting with visit  through  days after the last dose of study therapy; approved contraceptive methods include for example; intra uterine device, diaphragm with spermicide, cervical cap with spermicide, male condoms, or female condom with spermicide; spermicides alone are not an acceptable method of contraception
Female patients enrolled in the study, who are not free from menses for >  years, post hysterectomy/oophorectomy, or surgically sterilized, must be willing to use either  adequate barrier methods or a barrier method plus a hormonal method of contraception to prevent pregnancy or to abstain from sexual activity throughout the study, starting with visit  through  weeks after the last dose of study therapy; approved contraceptive methods include for example; intrauterine device, diaphragm with spermicide, cervical cap with spermicide, male condoms, or female condom with spermicide; spermicides alone are not an acceptable method of contraception
Participant agrees to use acceptable form of contraception during the study and for up to  months after last study drug dose\r\n* Acceptable forms of contraception:\r\n** Latex condom (always used with spermicide)\r\n** Diaphragm (always used with spermicide)\r\n** Cervical cap (always used with spermicide)\r\n* Acceptable forms of secondary contraception, when used along with a barrier method:\r\n** Hormonal contraception methods, including pills, patches, rings, or injections except progestin-only containing pills (i.e. Mini-pill)\r\n** Tubal ligation\r\n** Partners vasectomy\r\n** Intrauterine device (non-progesterone T)\r\n** Vaginal sponge (containing spermicide)\r\n* Other acceptable forms:\r\n** % commitment to abstinence\r\n* Unacceptable forms of contraception for women of childbearing potential:\r\n** Oral contraception containing progestins only\r\n** Intrauterine device (IUD) progesterone T\r\n** Female condom\r\n** Natural family planning (rhythm method) or breastfeeding\r\n** Fertility awareness\r\n** Withdrawal\r\n** Cervical shield
Acceptable methods of contraception:\r\n* Barrier methods:\r\n** Male condom plus spermicide\r\n** Copper T intrauterine device\r\n** Levonogestral-releasing intrauterine system\r\n* Hormonal methods\r\n** Implants\r\n** Hormonal shot or injection\r\n** Combined pill\r\n** Mini pill\r\n** Patch
Are using oral hormonal contraceptives and who do not agree to add a barrier method. (NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal [amenorrheic for at least  consecutive months, in the appropriate age group, and without other known or suspected cause] or have been sterilized surgically [i.e. bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least  month before dosing]). For sites outside of the European Union (EU), it is permissible that if a highly effective method of contraception is not appropriate or acceptable to the subject, then the subject must agree to use a medically acceptable method of contraception, i.e. double barrier methods of contraception such as condom plus diaphragm or cervical/vault cap with spermicide.
Female subjects of childbearing potential (FPCP) must have a negative urine or serum pregnancy test. NOTE: FPCP is defined as premenopausal and not surgically sterilized. FPCP must agree to use maximally effective birth control or to abstain from heterosexual activity throughout the study, starting at the first dose of chemotherapy through  months after the infusion of cells and/or for  months after there is no evidence of persistence/gene modified cells in the blood, whichever is longer. Effective contraceptive methods include intra-uterine device, oral and/or injectable hormonal contraception, or  adequate barrier methods (e.g. diaphragm with spermicide, cervical cap with spermicide, or female condom with spermicide). Spermicides alone are not an adequate method of contraception. Or Male subjects must be surgically sterile or agrees to use a double barrier contraception method or abstain from heterosexual activity with a female of childbearing potential upon enrolment starting at the first dose of chemotherapy through and for  months thereafter or longer (if indicated in the country specific monograph/label for cyclophosphamide.
Female participants, who are not free from menses for > years, post hysterectomy / oophorectomy, or surgically sterilized, must be willing to use either  adequate barrier methods or a barrier method plus a hormonal method of contraception to prevent pregnancy or to abstain from sexual activity throughout the study, from screening through  months after the last dose of study treatment (including nivolumab single agent). Approved contraceptive methods include, for example: intrauterine device, diaphragm with spermicide, cervical cap with spermicide, male condom with spermicide, or female condom with spermicide. Spermicides alone are not an acceptable method of contraception.
Female patients of child-bearing potential must have a negative serum or urine pregnancy test within  days prior to planned first dose of treatment, and agree to use dual method of contraception through  days after study drug treatment. Approved methods of contraception include an IUD with spermicide, a female condom with spermicide, a diaphragm with spermicide, a cervical cap with spermicide, use of a condom with spermicide by sexual partner or a sterile sexual partner. Women of childbearing potential are defined to include any female who:
Patient agrees to use an acceptable form of contraception during the study and for up to  days after the last dose of Reolysin if patient or female partner is post-menarche; acceptable methods include ) a double barrier method, such as condom and spermicide; ) hormonal contraception methods, including pills, patches, rings, or injections except progestin-only containing pills (i.e., mini-pill); ) intrauterine device (non-progesterone T); ) surgical methods such as a bilateral tubal ligation or a vasectomy; ) abstinence
Women of childbearing potential (WOCBP) must use method(s) of contraception for  days plus (+)  half-lives ( days) of the study drugs; for a teratogenic study drug and/or when there is insufficient information to assess teratogenicity (preclinical studies have not been done), a highly effective method(s) of contraception (failure rate of less than % per year) is required; highly effective birth control in this study is defined as a double barrier method; examples include a condom (with spermicide) in combination with a diaphragm, cervical cap, or intrauterine device (IUD); the individual methods of contraception should be determined in consultation with the investigator
Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through  days after the last dose of trial treatment\r\n* NOTE: pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with MK-\r\n* Men and nonpregnant, non-breast-feeding women may be enrolled if they are willing to use  methods of birth control or are considered highly unlikely to conceive; highly unlikely to conceive is defined as () surgically sterilized, or () postmenopausal (a woman who is >=  years of age and has not had menses for greater than  year will be considered postmenopausal), or () not heterosexually active for the duration of the study; the  birth control methods can be barrier method or a barrier method plus a hormonal method to prevent pregnancy; subjects should start using birth control from the screening visit throughout the study period up to  days after the last dose of study therapy\r\n* The following are considered adequate barrier methods of contraception: diaphragm, condom (by the partner), copper intrauterine device, sponge, or spermicide; appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents)\r\n* Patients should be informed that taking the study medication may involve unknown risks to the fetus (unborn baby) if pregnancy were to occur during the study; in order to participate in the study, they must adhere to the contraception requirement (described above) for the duration of the study and during the follow-up period described above; if there is any question that a subject will not reliably comply with the requirements for contraception, that subject should not be entered into the study\r\n* Pregnancy: if a patient inadvertently becomes pregnant while on treatment with MK-, the patient will immediately be removed from the study; the site will contact the patient at least monthly and document the patients status until the pregnancy has been completed or terminated; the outcome of the pregnancy will be reported without delay and within  hours if the outcome is a serious adverse experience (e.g., death, abortion, congenital anomaly, or other disabling or life-threatening complication to the mother or newborn); the study investigator will make every effort to obtain permission to follow the outcome of the pregnancy and report the condition of the fetus or newborn; if a male patient impregnates his female partner the study personnel at the site must be informed immediately and the pregnancy reported and followed\r\n* Subjects who are breast-feeding are not eligible for enrollment
Participants of child-bearing or child-fathering potential must be willing to use a medically effective form of birth control, which includes abstinence, while taking vandetanib and for  months after the last dose; female patients must be  year post-menopausal, surgically sterile, or using an acceptable method of contraception (an acceptable method of contraception is defined as a barrier method in conjunction with a spermicide) for the duration of the study (from the time they sign the informed consent form [ICF]) and for  months after the last dose of vandetanib to prevent pregnancy; in addition, oral contraceptives, approved contraceptive implant, long-term injectable contraception, intrauterine device, or tubal ligation are allowed; oral contraception alone is not acceptable; additional barrier methods in conjunction with spermicide must be used
Subject is practicing an acceptable method of contraception; female subjects (or female partners of male subject) must either be of non-childbearing potential (hysterectomy, bilateral oophorectomy, bilateral tubal ligation or post-menopausal >  year), or of childbearing potential and use one of the following highly effective methods of contraception (i.e. Pearl index < .%) from  weeks prior to administration of study medication, throughout the study, and  days after completion or premature discontinuation from the study: complete abstinence from intercourse; intrauterine device (IUD); two forms of barrier contraception (diaphragm plus spermicide, and for males condom plus spermicide); male partner is sterile prior to entry into the study and is the only partner of the female; systemic contraceptives (combined or progesterone only)
Female patients enrolled in the study, who are not free from menses for >  years, post hysterectomy/oophorectomy, or surgically sterilized, must be willing to use either  adequate barrier methods or a barrier method plus a hormonal method of contraception to prevent pregnancy or to abstain from heterosexual activity throughout the study, starting with visit  through  days after the last dose of study therapy; approved contraceptive methods include for example; intra uterine device, diaphragm with spermicide, cervical cap with spermicide, male condoms, female condoms with spermicide, or oral contraceptives; spermicides alone are not an acceptable method of contraception
Other study-specific criteria:\r\n* Men of child-bearing potential must not donate sperm while on this study and for  days after their last study treatment;\r\n** NOTE: Acceptable forms of birth control are listed below:\r\n*** One barrier method (cervical cap with spermicide plus male condom; diaphragm with spermicide plus male condom) PLUS\r\n*** Hormonal method (oral contraceptives, implants, or injections) or an intrauterine device (e.g., Copper-T)
Pregnant women or women who are breastfeeding or of childbearing potential and not using a highly effective method of birth control for at least one month prior to enrollment; if the risk of contraception exists, male and female subjects must use highly effective contraception throughout the study and for at least  days after last avelumab treatment\r\n* Highly effective contraception includes either  barrier methods (diaphragm, condom by the partner, copper intrauterine device, sponge, or spermicide), or  barrier method and  hormonal method (any oral, subcutaneous, intrauterine, or intramuscular registered and marketed contraceptive agent that contains an estrogen and/or a progesterone agent)
barrier methods (eg, condom, diaphragm) used in combination with hormonal methods associated with inhibition of ovulation
Subject is practicing an acceptable method of contraception (documented in chart). Female subjects (or female partners of male subject) must either be of non-childbearing potential (hysterectomy, bilateral oophorectomy, bilateral tubal ligation or post-menopausal >  year), or of childbearing potential and use one of the following highly effective methods of contraception (i.e. Pearl index < .%) from  weeks prior to administration of study medication, throughout the study, and  days after completion or premature discontinuation from the study: - Complete abstinence from intercourse; - Intrauterine device (IUD); - Two forms of barrier contraception (diaphragm plus spermicide, and for males condom plus spermicide); - Male partner is sterile prior to entry into the study and is the only partner of the female; - Systemic contraceptives (combined or progesterone only).
For women and men of childbearing potential, a medically acceptable method of highly effective contraception (oral hormonal contraceptive, condom plus spermicide, or hormone implants) must be used throughout the study period and for  days after their final vaccine administration. (A barrier method of contraception must be employed by all subjects [male and female], regardless of other methods.)
Patients must not be pregnant/breast feeding and must agree to practice adequate contraception (acceptable forms of birth control include condom with spermicide and/or diaphragm with spermicide, and non-barrier contraception such as tubal ligation, vasectomy, oral contraceptives, implanted levonorgestrel, vaginal hormonal contraceptive ring)
Females of childbearing potential must have a negative urine or beta-human chorionic gonadotropin serum pregnancy test within  weeks prior to Cycle , Day . A urine pregnancy test should be repeated prior to chemotherapy if not conducted within  hours of start of treatment. Female subjects of childbearing potential must agree to be abstinent or to use a highly effective method of contraception (e.g., condom + spermicide, condom + diaphragm with spermicide, intrauterine device (IUD), or have a vasectomized partner) having started for at least one menstrual cycle prior to starting study drug and throughout the entire study period and for  days (longer if appropriate) after the last dose of study drug. Perimenopausal women must be amenorrheic for at least  months to be considered of nonchildbearing potential. Male subjects who are not abstinent or who have undergone a successful vasectomy, who are partners of women of childbearing potential must use, or their partners must use, a highly effective method of contraception (e.g., condom + spermicide, condom + diaphragm with spermicide, IUD) starting for at least one menstrual cycle prior to starting study drug and throughout the entire study period and for  days (longer if appropriate) after the last dose of study drug. Subjects with partners using hormonal contraceptives must also be using an additional approved method of contraception (as described previously).
Female patients of childbearing potential must be willing to use birth control; the  birth control methods can be either  barrier methods or a barrier method plus a hormonal method to prevent pregnancy, used throughout the study starting with visit ; the following are considered adequate barrier methods of contraception: diaphragm, condom (by the partner) or sponge; other methods of contraception such as copper intrauterine device or spermicide may be used; appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents)
Female patients of childbearing potential (WOCBP) must be willing to use birth control; the  birth control methods can be either two barrier methods or a barrier method plus a hormonal method to prevent pregnancy, used throughout the study starting with visit ; the following are considered adequate barrier methods of contraception: diaphragm, condom (by the partner) or sponge; other methods of contraception such as copper intrauterine device or spermicide may be used; appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents)
Women of childbearing potential and men must be surgically sterilized, practicing abstinence, or agree to use  birth control methods prior to study entry and for the duration of study participation including up to  days after the last dose of MK-; the  methods of birth control can be either  barrier methods or a barrier method plus a hormonal method to prevent pregnancy; the following are considered adequate barrier methods of contraception: diaphragm or sponge, and condom; other methods of contraception such as copper intrauterine device or spermicide may be used; appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents); should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Use of highly effective contraception (females) or male condom plus spermicide (males).
Female subjects must have a negative urine or serum pregnancy test within  hours prior to taking study medication if of childbearing potential as defined in this protocol. Women of childbearing potential (WOCBP) must be willing to use  medically acceptable method of contraceptive from Day  through  days after the last dose of trial treatment. The  medically acceptable birth control methods can be either  barrier methods or a barrier method plus a hormonal method to prevent pregnancy. The following are considered adequate barrier methods of contraception: diaphragm, condom (by the partner), cooper intrauterine device, sponge, or spermicide as per local regulations or guidelines. Appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents).
Agrees to use a medically effective method of contraception. Male subjects and women of child-bearing potential (WOCBP) must agree to use effective contraception, e.g., oral contraceptives, double barrier method (condom plus spermicide or diaphragm plus spermicide), or practice true abstinence from sexual intercourse during the study and for  months after the last dose. Women of child-bearing potential include female subjects who have experienced menarche and have not undergone surgical sterilization or are not postmenopausal (defined as amenorrhea ?  consecutive months without an alternative medical cause);
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-study visit through  days after the last dose of trial treatment; breastfeeding should be discontinued if the mother is treated with MK-\r\n* Men and non-pregnant, non-breast-feeding women may be enrolled if they are willing to use  methods of birth control or are considered highly unlikely to conceive; highly unlikely to conceive is defined as ) surgically sterilized, or ) postmenopausal (a woman who is >=  years of age and has not had menses for greater than  year will be considered postmenopausal), or ) not heterosexually active for the duration of the study; the two birth control methods can be barrier method or a barrier method plus a hormonal method to prevent pregnancy; patients should start using birth control from the time of the pre-study visit, through the course of the study and for  days after the last dose of study medication; the following are considered adequate barrier methods of contraception: diaphragm, condom (by the partner), copper intrauterine device, sponge, or spermicide; appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents)\r\n* Patients should be informed that taking the study medication may involve unknown risks to the fetus (unborn baby) if pregnancy were to occur during the study; in order to participate in the study they must adhere to the contraception requirement (described above) for the duration of the study and during the follow-up period; if there is any question that a patient will not reliably comply with the requirements for contraception, that patient should not be entered into the study\r\n* If a patient inadvertently becomes pregnant while on treatment with MK-, the patient will immediately be removed from the study; the site will contact the patient at least monthly and document the patients status until the pregnancy has been completed or terminated; the outcome of the pregnancy will be reported without delay and within  hours if the outcome is a serious adverse experience (e.g., death, abortion, congenital anomaly, or other disabling or life-threatening complication to the mother or newborn); the study investigator will make every effort to obtain permission to follow the outcome of the pregnancy and report the condition of the fetus or newborn; if a male patient impregnates his female partner the study personnel at the site must be informed immediately and the pregnancy reported and followed
For women and men of childbearing potential, a medically acceptable method of highly effective contraception (oral hormonal contraceptive, condom plus spermicide, or hormone implants) must be used throughout the study period and for  days after their final vaccine administration. A barrier method of contraception must be employed by all subjects (male and female), regardless of other methods.
If female, agreement to use birth control (any form of hormonal contraception such as Depo-Provera, daily oral contraception, transdermal patch, or Nuva-ring; intrauterine device; sterilization; or double barrier contraception, which is a combination of any two of the following methods: condoms, spermicide, diaphragm) to avoid pregnancy
For women and men of childbearing potential, a medically acceptable method of highly effective contraception (oral hormonal contraceptive, condom plus spermicide, or hormone implants) must be used throughout the study period and for  days after their final vaccine administration. (A barrier method of contraception must be employed by all subjects [male and female], regardless of other methods.)
Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault cap) with spermicide,
Female subjects of childbearing potential (Female subjects who are not surgically sterilized, not at least  year postmenopausal) must agree to use adequate contraception (e.g. intrauterine device (IUD), condom plus spermicide, diaphragm, or cervical cap plus spermicide) or medical contraception: during the study and for at least  month prior to drug administration and for  months after treatment. Females who are not currently sexually active must agree and consent to use one of the above-mentioned methods should they become sexually active while participating in the Study.
Males and females of child bearing potential must use acceptable methods of birth control which include oral contraceptives, spermicide with either a condom, diaphragm or cervical cap, use of an intrauterine device (IUD) or abstinence
Patient is practicing an acceptable method of contraception (documented in chart); female patients (or female partners of male patients) must either be non-childbearing potential (hysterectomy, bilateral oophorectomy, bilateral tubal ligation or post-menopausal >  year), or of childbearing potential and use  of the following highly effective methods of contraception (i.e., Pearl Index < .%) from  weeks prior to administration of study medication, throughout the study, and  days after completion or premature discontinuation from the study:\r\n* Complete abstinence from intercourse\r\n* Intrauterine device (IUD)\r\n* Two forms of barrier contraception (diaphragm plus spermicide, and for males condom plus spermicide)\r\n* Male partner is sterile prior to entry into the study and is the only partner of the female\r\n* Systemic contraceptives (combined or progesterone only)
Women of reproductive potential must agree to use two forms of acceptable contraception (including one acceptable barrier method with spermicide) during therapy and for  months after completing therapy; acceptable forms of primary contraception include the following: combination (levonorgestrel-releasing intrauterine system, medroxyprogesterone acetate depot), tubal sterilization, vasectomy and intrauterine device (IUD); acceptable forms of barrier contraception include the following: any male condom (with spermicide) or diaphragm (with spermicide)
Females of childbearing potential and males must be willing to abstain from heterosexual activity or to use  forms of effective methods of contraception from the time of informed consent until  days after treatment discontinuation; the two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method
Women of childbearing potential must use an effective, non-hormonal form of contraception from Screening throughout the Treatment Phase and until  days after the last dose of Study treatment  Acceptable methods include: copper intrauterine device or double barrier methods, including male/female condoms with spermicide and use of contraceptive sponge, cervical cap, or diaphragm
Male patients must use an effective, non-hormonal form of contraception from Screening throughout the Treatment Phase and until  days after last dose of Study treatment  Acceptable methods include male/female condoms with spermicide, or vasectomy with medical confirmation of surgical success.
Heterosexual women and men must agree to use TWO effective forms of birth control for the duration of study participation and for  days following the last dose of study medication\r\n* Men must agree not to donate sperm during the study and for three months after receiving the last dose of study drug\r\n* The following persons are not considered to be able to father or bear children and therefore are eligible to participate without the use of concurrent birth control:\r\n** Female with bilateral oophorectomy and/or hysterectomy\r\n** Female with fallopian tubes cut, tied, or sealed\r\n** Female with sterilization implant (e.g. Adiana, Essure) placed >  months prior to randomization\r\n** Female post-menopausal (>  year since last menses)\r\n** Male with vasectomy >  months prior to randomization\r\n* One of the following methods of birth control must be used by women of childbearing potential:\r\n** Combined oral contraceptive pill in continuous use for >  days prior to study entry\r\n** Vaginal ring (e.g. NuvaRing) in continuous use for >  days prior to study entry\r\n** Skin patch (e.g. Ortho Evra) in continuous use for >  days prior to study entry\r\n** Injection (e.g. Depo-Provera, Noristerat) in continuous use for >  days prior to study entry\r\n** Copper intrauterine device (IUD) (e.g. ParaGard)\r\n* Note: The following hormonal methods are NOT acceptable:\r\n** Low dose progesterone only oral contraceptive pill (mini pills e.g. Micronor, Nor-Q.D., Ovrette)  \r\n** Norplant subdermal implant\r\n** Mirena Hormonal Implanted Uterine Device (IUD) \r\n* In addition to the above method of contraception, one of the following methods of contraception will ALSO be used for the duration of study participation and for  days following the last dose of study medication: \r\n** Diaphragm, cervical cap, or cervical shield with spermicide\r\n** Contraceptive sponge (e.g. Today Sponge)\r\n** Condom (male or female type) plus spermicide
Currently using two forms of effective birth control (one of which is a barrier method) for the duration of the study for both males and females of childbearing potential. Effective methods of birth control include hormonal contraception (i.e., birth control pills, injected hormones, vaginal ring), intrauterine device, or barrier methods with spermicide (i.e., diaphragm with spermicide, condom with spermicide), or
Women of childbearing potential (WoCBP) may be included only if acceptable contraception is in place for two weeks before study entry, for the duration of the study and for  days after the last dose of AZD; WoCBP are defined as those who are not surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as  months with no menses without an alternative medical cause); acceptable methods of contraception include true abstinence in line with the preferred and usual lifestyle choice of the patient, tubal ligation, vasectomized partner, barrier methods (eg, cap plus spermicide, sponge plus spermicide, diaphragm plus spermicide, or male condom plus a spermicide), intrauterine device methods (eg, Copper T or Levonorgestrel-releasing intrauterine system), or hormonal methods (eg, any registered and marketed contraceptive agent that contains an oestrogen and/or a progestational agent and that is administered via the oral, subcutaneous, transdermal, intrauterine, or intramuscular route as an implant, hormone shot or injection, combined pill, minipill or patch); all methods of contraception (with the exception of total abstinence) should be used in combination with the use of a condom by their male sexual partner for intercourse; periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control; all WoCBP must have a negative pregnancy test within  days prior to study the initiation of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately