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1
Females of childbearing potential who are sexually active with a non sterilized male partner must use at least 1 highly effective method of contraception from the time of screening and must agree to continue using such precautions for 180 days after the last dose of durvalumab + tremelimumab combination therapy or 90 days after the last dose of durvalumab monotherapy; non-sterilized male partners of a female patient must use male condom plus spermicide throughout this period; cessation of birth control after this point should be discussed with a responsible physician; not engaging in sexual activity for the total duration of the drug treatment and the drug washout period is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control; female patients should also refrain from breastfeeding throughout this period
2
Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy or 180 days after the last dose of durvalumab + tremelimumab combination therapy, whichever is later
3
Women of childbearing potential (?12 months of non-therapy-induced amenorrhea or surgically sterile) must have had a negative serum pregnancy test within the past 21 days and must use a birth control method in addition to barrier methods (condoms).
4
Although they will not be considered formal eligibility (exclusion) criteria, physicians should recognize that the following may seriously increase the risk to the patient entering this protocol:\r\n* Psychiatric illness which would prevent the patient from giving informed consent\r\n* Medical condition such as uncontrolled infection (including human immunodeficiency virus [HIV]), uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient\r\n* Patients with a “currently active” second malignancy other than non-melanoma skin cancers; patients are not considered to have a “currently active” malignancy if they have completed therapy and are free of disease for >= 3 years; there is an exception for patients with a history of well differentiated thyroid cancer that has progressed to anaplastic thyroid cancer\r\n* Patients who cannot swallow oral formulations of the agent(s)\r\n* Women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study ; appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives or double barrier method (diaphragm plus condom)\r\n* Efatutazone is metabolized by cytochrome P450, family 3, subfamily A, polypeptide 4/5 (CYP3A4/5), and inhibits CYP2C8, 2C9, 2C19, and 3A4, and is a substrate of P-glycoprotein (PgP) and breast cancer resistance protein (BCRP)
5
Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control throughout protocol treatment
6
The patient must agree to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agree to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug
7
Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use two methods of birth control- a medically accepted barrier method of contraceptive method (e.g., male or female condom) and a second effective method of birth control-during protocol therapy and for at least 4 months after the last dose of XL184; abstinence is an acceptable method of birth control
8
Men who are sterile OR agree to use at least two forms of a reliable and highly effective method of birth control and to not donate sperm and for at least 180 days following last dose of TRC105 or sorafenib.
9
Female participants of childbearing potential must adhere to using a medically accepted method of birth control up to 28 days prior to screening and agree to continue its use during the study or be surgically sterilized (e.g., hysterectomy or tubal ligation) and males must agree to use barrier methods of birth control while on study; WOCBP must agree to use effective contraception during treatment and for at least 5 months following the last dose of study treatment
10
Women of reproductive potential must be non-pregnant and non-nursing and must agree to employ an effective barrier method of birth control throughout the study and for up to 6 months following treatment
11
Females who are pregnant or lactating, fertile males, or females of child-bearing potential who are not willing to comply with an effective double method of birth control are NOT eligible for participation
12
Patients who are pregnant or breast-feeding are not eligible; nursing mothers must agree not to breastfeed during therapy; females of childbearing potential must practice an effective method of birth control while participating in this study and for those who have achieved menarche, must have a negative pregnancy test prior to study entry
13
Sexually active male or female must be surgically sterile post-menopausal, or must agree to use a physician-approved method of birth control during the study through a minimum of 120 days after the last study drug administration.
14
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods; if barrier contraceptives are being used, these must be continued throughout the trial by both sexes; hormonal contraceptives are not acceptable as a method of contraception; (women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to starting treatment)
15
Due to unknown effects of this therapy on a fetus, pregnant women are excluded from this research. The male partner should use a condom. Females of child-bearing potential must be willing to utilize one of the more effective birth control methods during the study unless female has had a hysterectomy or tubal ligation
16
Female patients with negative pregnancy test at Screening and use of acceptable method of birth control for study duration, unless surgically sterile or postmenopausal for at least 1 year prior to Screening.
17
Female patients who are not surgically sterile or postmenopausal (for at least 1 year) must practice at least one of the following methods of birth control throughout the duration of study participation and for at least 3 months after study treatment:
18
Non-vasectomized male patients must comply with at least one of the following methods of birth control throughout the duration of study participation and for at least 3 months after study treatment:
19
Women who are pregnant or nursing. Female patients of childbearing potential must have a negative pregnancy test and must adhere to using a medically acceptable method of birth control prior to screening and agree to continue its use during the study and for 30 days after the last dose of study drug, or be surgically sterilized (e.g., hysterectomy or tubal ligation). Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause. Males must agree to use barrier methods of birth control while on study and for 90 days post last dose of study drug.
20
Adults of reproductive potential not employing two forms of birth control: \r\n* Males having partners who are female with child-bearing potential must agree that they and/or their partners will use at least two effective contraceptive methods (including one barrier method) when engaging in reproductive sexual activity throughout the study from the time of informed consent, and will avoid conceiving for 28 days after the last dose of CC-115
21
Fertile men must agree to use an effective method of birth control during the study and for up to 6 months after the last dose of study drug.
22
Women of reproductive potential must be non-pregnant and non-nursing and must agree to employ an effective barrier method of birth control throughout the study and for up to 6 months following treatment
23
Fertile men must agree to use an effective method of birth control during the study and for up to 3 months after the last dose of study drug
24
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods; if barrier contraceptives are being used, these must be continued throughout the trial by both sexes; hormonal contraceptives are not acceptable as a sole method of contraception; (women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of everolimus)
25
Pregnancy or lactation or unwillingness to use adequate method of birth control.
26
Inclusion\n\n          1. Has provided written informed consent\n\n          2. Has advanced solid tumors (excluding breast cancer)\n\n          3. Has normal renal function, mild, moderate, or severe renal impairment and is not on\n             dialysis\n\n          4. ECOG performance status of ?2\n\n          5. Is able to take medications orally\n\n          6. Has adequate organ function\n\n          7. Women of childbearing potential must have a negative pregnancy test and must agree to\n             adequate birth control if conception is possible. Males must agree to adequate birth\n             control.\n\n        Exclusion\n\n          1. Certain serious illnesses or medical condition(s)\n\n          2. Has had certain other recent treatment e.g. major surgery, anticancer therapy,\n             extended field radiation, received investigational agent, within the specified time\n             frames prior to study drug administration\n\n          3. Has received TAS-102\n\n          4. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any\n             prior therapies\n\n          5. Is a pregnant or lactating female
27
Sexually active subjects (men and women) must agree to use medically accepted barrier methods of contraception (e.g., male or female condom) during the course of the study and for 4 months after the last dose of study drug(s), even if oral contraceptives are also used; all subjects of reproductive potential must agree to use both a barrier method and a second method of birth control during the course of the study and for 4 months after the last dose of study drug(s)
28
Male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration
29
Sexually active fertile men must use effective birth control if their partners are WOCBP
30
Men and women of childbearing potential must be willing to practice an effective method of birth control during treatment and at least 4 months after treatment is finished
31
Females of child-bearing potential and sexually-active males must consent to follow acceptable birth control methods to avoid contraception while on treatment
32
Women who are pregnant or nursing a child may not take part in this study; subjects of childbearing ability must agree, with the study doctor, on a method of birth control to use throughout the study; subjects who think they have gotten pregnant during the study must notify the study doctor immediately; pregnant women will be taken out of the study
33
TREATMENT: Pregnant women are excluded from this research; the male partner should use a condom; females of child-bearing potential must be willing to utilize one of the more effective birth control methods during the study unless female has had a hysterectomy or tubal ligation
34
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods; if barrier contraceptives are being used, these must be continued throughout the trial by both sexes; hormonal contraceptives are not acceptable as a sole method of contraception; (Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of RAD001)
35
Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 3 months after the study is concluded; the male partner should use a condom
36
Sexually active subjects (men and women) must agree to use medically accepted barrier methods of contraception (eg, male or female condom) during the study and for 4 months after the last dose of study drug(s), even if oral contraceptives are also used. All subjects of reproductive potential must agree to use both a barrier method and a second method of birth control or practice abstinence during the study and for 4 months after the last dose of study drug(s)
37
Women of childbearing potential who are sexually active and are not willing to use a highly effective method of birth control during the study period
38
Males who are sexually active and not willing to use a condom, and have a partner who is capable of becoming pregnant, if neither has had surgery to become sterilized, and/or who are not willing to use double barrier or whose partner is not using a highly effective method of birth control
39
Female patients who are pregnant or breastfeeding, or male or female patients of reproductive potential who are not willing to employ effective birth control.
40
Male subjects must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control (condoms with spermicide) for the duration of the study.
41
Male and female subjects of childbearing potential must agree to use an effective means of birth control to avoid pregnancy throughout the transplant procedure, while on immunosuppression, and if the subject experiences any chronic GvHD
42
Sexually active females of childbearing potential and males with partners of child bearing potential must agree to use birth control
43
Women of childbearing potential are willing to agree to use 1 of the study-defined effective methods of birth control from the time of study entry to 6 months after the last day of treatment
44
Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the T cell infusion
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INCLUSION - TREATMENT: Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded; the male partner should use a condom
46
Agree to use barrier methods of birth control during the docetaxel portion of the protocol and for at least one month after last docetaxel administration
47
11. Females of childbearing potential must be willing to use an acceptable method of birth control (i.e., intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
48
Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use two effective methods of birth control, including a medically accepted barrier or contraceptive method (e.g., male or female condom) for the duration of the study; abstinence is an acceptable method of birth control
49
Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug. Must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug.
50
Patients of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study and for 6 months after the last drug administration
51
If fertile, willing to use effective birth control methods during the study
52
Highly effective forms of birth control include:
53
Highly effective forms of birth control include:
54
If a female patient, must be surgically sterile, post-menopausal, or must agree to use physician-approved method of birth control during the study and for a minimum of 30 days after the last study drug administration, or if a male patient with a female partner, must agree to use physician-approved method of birth control during the study and for a minimum of 30 days after the last study drug administration
55
INCLUSION - INFUSION: Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded; the male partner should use a condom
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Patient on reliable birth control: combined oral contraceptive pill (OCP), long acting reversible contraceptive program (LARCP), bilateral tubal ligation (BLT) and Depo Provera shot/birth control shot
57
Patient not on reliable birth control
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Male patients with female partners of childbearing potential, and female patients of childbearing potential must agree to use effective birth control. Effective birth control and cessation of lactation must be complied at least 2 weeks prior to first study drug administration, during the trial participation, and for 3 months after the last dose of study drug
59
TREATMENT INCLUSION: Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded; the male partner should use a condom
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Willingness to use 2 methods of birth control during the study and for 12 months after the last dose of ZW25
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Sexually active women of childbearing potential enrolled in the study must agree to use two forms of accepted methods of contraception during the course of the study and for 3 months after their last dose of study drug. Effective birth control includes:
62
Female subjects must not be pregnant; willing to use 2 methods of birth control/abstinence if applicable through 120 days after the last dose of study drug
63
Patients of reproductive potential must use an acceptable form of birth control or abstain from sexual activity
64
Female of childbearing potential, unless birth control used on study and 12 wks post-treatment.
65
Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the T cell infusion; male partner should use a condom
66
Fertile men or women unwilling to use effective forms of birth control or abstinence for one year after transplantation
67
Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the ATL infusion; male partner should use a condom
68
Women of child bearing potential (WOCBP) must be willing to use medically acceptable methods of birth control during the study treatment and for one month after discontinuing study treatment
69
PHASE I: Sexually active male subjects must use an effective method of contraception (barrier method of birth control or abstinence) from the time of consent until at least 180 days following discontinuation of protocol therapy
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PHASE IB: Sexually active male subjects must use an effective method of contraception (barrier method of birth control or abstinence) from the time of consent until at least 180 days following discontinuation of protocol therapy
71
Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. Contraception must be continued for at least 2 months following the last dose of poly-ICLC. Women of childbearing potential must have a negative pregnancy test. While animal reproductive studies have been negative, the simulated viral infection and anti-proliferative activity of this experimental drug may theoretically affect the developing fetus or nursing infant.
72
Patients of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for four months after receiving the preparative regimen
73
ELIGIBILITY CRITERIA AT TIME OF TREATMENT: Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded; the male partner should use a condom
74
Patients of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control while being treated on this study
75
Women of childbearing potential are willing to agree to use 1 of the study defined effective methods of birth control from the time of study entry to 6 months after the last day of treatment
76
Pregnant women are excluded from this research; the male partner should use a condom; females of child-bearing potential must be willing to utilize one of the more effective birth control methods during the study unless female has had a hysterectomy or tubal ligation
77
Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for four months after treatment
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Subjects who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 1 week after last study drug administration
79
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods; women of child bearing potential (WOCBP) or male study participants of reproductive potential must agree to use double barrier birth control method of contraception during the course of the study treatment period and for 3 months after completing study treatment; WOCBP are defined as sexually mature women who have not undergone a hysterectomy or who are not postmenopausal (no menses) for at least 12 consecutive months; WOCBP must have a negative urine or serum pregnancy test within 7 days prior to administration of treatment
80
Patients in their reproductive age group should use an effective method of birth control; patients who are breast-feeding, or have a positive pregnancy test will be excluded from the study
81
Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded; the male partner should use a condom
82
All patients of childbearing potential must be willing to consent to using effective contraception, ie, intrauterine device, birth control pills, depo-provera, and condoms while on treatment and for 3 months after their participation in the study ends.
83
Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for up to four months after treatment
84
INCLUSION - TREATMENT: Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the cytotoxic T-lymphocyte (CTL) infusion; male partner should use a condom
85
Inability or refusal to practice effective contraception during therapy; men and women of childbearing potential must use an effective method of birth control or abstinence during treatment and for 4 months after completion of the treatment
86
Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for up to four months after treatment
87
Willing to practice birth control during treatment and for four months after receiving the treatment
88
Patients of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while they are being treated on this study
89
Women of child-bearing age and all men must use birth control of any type until at least 12 months after the last dose of therapy
90
Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months after completion of treatment
91
Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 8 weeks after treatment discontinuation
92
Subjects must agree to use a medically acceptable method of birth control (e.g., spermicide in conjunction with a barrier such as a condom) or sexual abstinence for the duration of the study, including 30 days after the last dose of study drug. Sperm donation is prohibited during the study and for 30 days after the last dose of study drug. Female partners must use hormonal or barrier contraception unless postmenopausal or abstinent
93
TREATMENT WITH SJCAR19: For females of child bearing age:\r\n* Not lactating with intent to breastfeed\r\n* Not pregnant with negative serum pregnancy test within 7 days prior to enrollment\r\n* If sexually active, agreement to use birth control until 6 months after T-cell infusion; male partners should use a condom
94
Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for up to four months after treatment.
95
Female patients who are pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study) or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy or 180 days after the last dose of durvalumab + tremelimumab combination therapy.
96
The effects of enasidenib on the developing human fetus are unknown. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) during the entire study treatment period and through 6 months after the last dose of treatment
97
Females of childbearing potential who are sexually active with a nonsterilized male partner agree to use 2 methods of effective contraception from screening, and agree to continue using such precautions for 90 days after the final dose of study drug; cessation of birth control after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control.
98
Male patients must agree to use adequate birth control during the study and up to 30 days after the last avelumab dose
99
Female subjects who are pregnant or breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control from screening to 180 days after the last dose of durvalumab + tremelimumab combination therapy or 90 days after the last dose of durvalumab monotherapy, whichever is the longer time period.
100
Patient is a female of childbearing potential (FCBP)* with a negative serum or urine pregnancy test prior to initiation of therapy and agrees to practice appropriate methods of birth control, or the patient is male and agrees to practice appropriate methods of birth control
101
Subjects of childbearing potential must be willing to practice an approved highly effective method of birth control starting at the time of informed consent and for 1 year after the completion of the lymphodepletion regimen. Approved methods of birth control are as follows: hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation or hysterectomy; subject/partner status post vasectomy; Implantable or injectable contraceptives; and condoms plus spermicide.
102
Patients of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for four months after receiving the preparative regimen
103
Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials; men must agree to not donate sperm during and after the study; for females, these restrictions apply for 1 month after the last dose of study drug; for males, these restrictions apply for 3 months after the last dose of study drug
104
Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug. Must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug
105
Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration. Female subjects must be surgically sterile, at least 2 years menopausal, or using an acceptable method of birth control. If of childbearing potential, the subject must have a documented negative pregnancy test within 24 hours before surgery.
106
Female subjects who are pregnant or breastfeeding or male or female subjects of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of study medications.
107
Willing to practice birth control during treatment and for four months after receiving the treatment
108
Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug. Must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug
109
Male patients whose sexual partners are WOCBP not using effective birth control
110
Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials; men must agree to not donate sperm during and after the study; for sexually active women of childbearing potential, these restrictions apply for 5 months after the last dose of study drug; for sexually active men, these restrictions apply for 7 months after the last dose of study drug
111
Males and females of reproductive potential who are not using and effective method of birth control and females who are pregnant or breastfeeding or have a positive (urine or serum) pregnancy test prior to study entry
112
Females of childbearing potential must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 4 weeks after treatment discontinuation. Subject's partner must also use barrier protection while subject is on study until 4 weeks after treatment discontinuation.
113
Subjects of both genders of child-bearing potential who are not willing to practice birth control from the time of consent through 6 months after the completion of KTE-C19
114
Women of Childbearing Potential (WOCBP) practicing at least one protocol specified method of birth control, starting at Study Day 1 through at least 90 days after the last dose of study drug.
115
Women of childbearing potential (WCBP) must agree to use highly effective methods of birth control throughout the duration of the study until 6 months following the last dose of study drug.
116
Female subjects of childbearing potential must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) for the duration of study treatment and 3 months after completion
117
Sexually active patients (men and women) must agree to use medically accepted barrier methods of contraception (e.g. male or female condom) during the course of the study and for 4 months after the last dose of study drug(s), even if oral contraceptives are also used. All sexually active subjects of reproductive potential must agree to use both a barrier method and a second method of birth control during the course of the study and for 4 months after the last dose of study drug(s).
118
Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug. Must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug
119
Patients who are breastfeeding, pregnant or refuse to use an effective form of birth control are excluded; abstinence is considered an effective form of birth control
120
Women of child-bearing potential must agree to utilize a form of birth control or agree to undergo sexual abstinence during radiation therapy
121
Not willing to use an effective method of birth control
122
Male subjects who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and for up to 90 days after the last dose of GC4419 are excluded.
123
Women of childbearing potential must use an acceptable form of birth control for 28 days prior to beginning study treatment, through the duration of study treatment, and for 3 months after discontinuing study treatment
124
Women of childbearing capacity are required to have a negative serum pregnancy test before treatment and must agree to maintain highly effective contraception by practicing abstinence or by using at least two methods of birth control from the date of consent through the end of the study; if abstinence is not practiced, one of the two methods of birth control should be an oral contraceptive (e.g., oral contraceptive and a spermicide)
125
Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation; subjects should use adequate birth control for at least 3 months after the last administration of immune checkpoint inhibitors
126
Male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration
127
Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for four months after treatment
128
Patients of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study
129
Fertile men must agree to use an effective method of birth control during the study and for up to 6 months after the last dose of study drug.
130
Pregnant and breastfeeding women are excluded; women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and up to 12 weeks after the study are excluded; this applies to any woman who has not experienced menarche and who has not undergone successful surgical sterilization or is not postmenopausal (defined as amenorrhea for at least 12 consecutive months); male subjects must also agree to use effective contraception for the same period as above
131
Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug. Must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug.
132
Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 180 days after the last dose of durvalumab + tremelimumab combination therapy or 90 days after the last dose of durvalumab monotherapy
133
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods as defined above. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes. Hormonal contraceptives are not acceptable as a sole method of contraception.
134
Patients who have partners of childbearing potential (e.g. female that has not been surgically sterilized or who are not amenorrheic for >= 12 months) must be willing to use a method of birth control in addition to adequate barrier protection as determined to be acceptable by the investigator during the study and for 13 weeks after last study drug administration. Please note that the efficacy of hormonal contraception may be decreased if administered with olaparib.
135
Sexually active females of childbearing potential and males with partners of child-bearing potential must agree to use adequate birth control during study treatment
136
Male patients whose sexual partners are WOCBP not using effective birth control
137
Or, if of childbearing potential: Agree not to try to become pregnant during the study and for 28 days after the final study drug administration; and have a negative urine or serum pregnancy test at screening; and, if heterosexually active, agree to consistently use 2 forms of highly effective birth control (at least one of which must be a barrier method) starting at screening and throughout the study and for 28 days after the final study drug administration.
138
Male subject who is of childbearing potential and their female spouse/partner who is of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control (at least one of which must be a barrier method) starting at screening and continue throughout the study, and for 90 days after the final study drug administration.
139
Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
140
All sexually active subjects of reproductive potential must agree to use both a medically accepted barrier method (e.g., male or female condom) and a second method of birth control during the course of the study and for 4 months after the last dose of study drug(s);
141
Women of childbearing potential must have a negative pregnancy test at study entry; all sexually active patients will be educated regarding the teratogenic potential of the chemotherapy they receive, as well as the infectious risks of intercourse; contraceptive methods will be discussed and sexually active patients must agree to use an effective birth control method for the duration of the study; a medically acceptable method of contraception appropriate to the patient’s underlying disease, risk factors and lifestyle will be offered in consultation with gynecology or adolescent medicine and will commence on study entry; in general, most postmenarchal female patients may qualify to receive depot medroxyprogesterone acetate (DMPA) 150 mg intramuscularly (IM) or 104 mg/0.65 mL for subcutaneous (SC) injection; injection needs to be repeated every 3 months while on study; prior to IM injection, ensure that platelet count is > 30,000 x 10^9/L; patients ineligible or refusing injectable contraceptives will be offered other medically acceptable contraceptives if appropriate, such as oral contraceptives or birth control patch, or barrier methods
142
Female patients who are pregnant or of reproductive potential not willing to use an effective method of birth control during study treatment and for at least 12 months thereafter; serum or urine pregnancy test must be performed within 7 days of enrollment
143
Male patients of reproductive potential who are not willing to employ effective birth control from screening to 180 days after the last dose of durvalumab + tremelimumab combination therapy or 90 days after the last dose of durvalumab monotherapy, whichever is the longer time period.
144
Willing to follow strict birth control measures
145
if male (and whether or not surgically or medically sterile), agree to use during the study and for at least one month after the last dose of study drug a double barrier method of birth control (in addition to any other birth control method practiced by his partner) while engaging in sexual intercourse with a partner who is pregnant, possibly pregnant or able to become pregnant.
146
Subjects of reproductive potential who are not willing to employ effective birth control from screening to 1 year after last dose of vaccine
147
Male and female subjects who agree to use both a highly effective method of birth control (e.g., implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], complete abstinence , or sterilized partner) and a barrier method (e.g., condoms, vaginal ring, sponge, etc) during the period of therapy; female patients of reproductive potential who are not surgically sterile must practice adequate birth control for a minimum of twelve months post-treatment; male patients who are not surgically sterile must practice adequate birth control for a minimum of three months post-treatment
148
Patients of childbearing potential must agree to use adequate birth control during and for 3 months after participation in this study
149
Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for up to four months after treatment
150
Female subjects who are pregnant, breast-feeding or female patients of reproductive potential who are not employing an effective method of birth control from starting dose of study medications (cycle 1 day 1), including dosing interruptions through 90 days after receipt of the last dose of durvalumab; refrain from egg cell donation while taking durvalumab and for at least 90 days after the last dose of durvalumab
151
Male subjects who are not employing an effective method of birth control from starting dose of study medications (cycle 1 day 1), including dosing interruptions through 6 months after receipt of study treatment; male subjects should agree to refrain from sperm donation while taking study treatment and for at least 6 months after the last dose of nab-paclitaxel and at least 90 days after the last dose of durvalumab; should a female partner of a male patient become pregnant or suspect she is pregnant while participating in the study, he should inform his treating physician and the female partner should call her physician immediately
152
Subjects of reproductive potential who do not use effective methods of birth control
153
Female subjects who are pregnant/breast-feeding or who are of reproductive potential and not employing acceptable methods of birth control
154
Women of child bearing age must have pregnancy test at time of enrollment, agree to use of adequate contraception (birth control hormone or barrier method) for the duration of the study and for six months after discontinuation of systemic agents
155
Non-pregnant, non-breast-feeding women may be enrolled if they are willing to use 2 methods of birth control or are considered highly unlikely to conceive; highly unlikely to conceive is defined as 1) surgically sterilized, or 2) postmenopausal (a woman who is >= 45 years of age and has not had menses for greater than 1 year will be considered postmenopausal), or 3) not heterosexually active for the duration of the study; the two birth control methods can be either two barrier methods or a barrier method plus a hormonal method to prevent pregnancy; subjects should start using birth control from study day 1 throughout the study period up to 120 days after the last dose of study therapy
156
Men and women of childbearing potential must practice birth control; women of child bearing potential must have a urine pregnancy test within 7 days of study entry; in accordance with topotecan hydrochloride (topotecan) administration guidelines, women must practice birth control for at least 1 month following chemotherapy infusion; men must practice birth control for at least four months following termination of chemotherapy infusion
157
Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
158
Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing two highly effective methods of birth control
159
Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
160
Patients of both genders must be willing to practice birth control during and for four months after receiving chemotherapy
161
Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 180 days after the last dose of durvalumab + tremelimumab combination therapy or 90 days after the last dose of durvalumab monotherapy, whichever is the longer time period
162
Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 180 days after the last dose of durvalumab + tremelimumab combination therapy or 90 days after the last dose of durvalumab monotherapy, whichever is the longer time period
163
Willing to use appropriate birth control for patients of child-bearing potential;
164
Sexually active male and female patients should use effective birth control (abstinence; hormonal or barrier method) for the duration of the study and at least 2 months from last dose.
165
Men and women of childbearing potential must be willing to exercise an effective form of birth control (abstinence/contraception) while on study and for 3 months after therapy completed
166
Pregnant or breastfeeding women will not be entered into this study due to risks of fetal and teratogenic adverse events as seen in animal studies. Pregnancy tests must be obtained in females who are post-menarchal and of child bearing potential (e.g. female that has not been amenorrheic for at least 12 consecutive months or surgically sterilized). Males or females of reproductive potential will not participate unless they have agreed to use effective contraception for the entire period in which they are receiving protocol therapy and for at least one month after treatment ends. Effective contraception is defined as intrauterine device (IUD), hormonal (birth control pill, injections, implants, patch), tubal ligation and partner’s vasectomy. Abstinence is an acceptable method of birth control
167
All sexually active subjects of reproductive potential are required to use or start using a reliable method of birth control at least 2 weeks prior to study enrollment, throughout the study, and for at least 3 months following completion of study therapy.
168
Not pregnant, and if of childbearing potential, agrees to use adequate birth control (hormonal or barrier method of birth control or abstinence) prior to study entry and during the study and agrees not to donate sperm or ova, for the duration of the study and 12 months post implantation of the investigational device (refer to Section 7.3 Permissible and Prohibited Medications/Treatments)
169
A Woman of Childbearing Potential (WOCBP) practicing at least one protocol specified method of birth control starting at Study Day 1 through at least 180 days after the last dose of study drug.
170
All participants who are able to have children must practice effective birth control while on study. Acceptable forms of birth control for female patients include: hormonal birth control, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence, for the length of the study. If the participant is a female and becomes pregnant or suspects pregnancy, she must immediately notify her doctor. If the participant becomes pregnant during this study, she will be taken off this study. Men who are able to have children must use effective birth control while on the study. If the male participant fathers a child or suspects that he has fathered a child while on the study, he must immediately notify his doctor.
171
Sexually active fertile men not using effective birth control if their partners are of child bearing potential
172
Male patients and must be willing to practice birth control from the time of enrollment on this study and for four months following the final CAR T cell infusion; pre-menopausal patients (female patients who have had a menstrual period within the last year) must be willing to practice birth control from the time of enrollment and for one year following the final CAR T cell infusion
173
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods; if barrier contraceptives are being used, these must be continued throughout the trial and for 8 weeks after stopping study drug, by both sexes; hormonal contraceptives are not acceptable as a sole method of contraception; (women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of EVE)
174
Subjects must agree to use a medically acceptable method of birth control (e.g., spermicide in conjunction with a barrier such as a condom) or sexual abstinence for the duration of the study, including 30 days after the last dose of study drug; sperm donation is prohibited during the study and for 30 days after the last dose of study drug; female partners must use hormonal or barrier contraception unless postmenopausal or abstinent
175
Subjects who are pregnant, breast-feeding or of reproductive potential who are not employing an effective method of birth control or are not willing to employ effective birth control from screening to 180 days after the last dose of durvalumab + tremelimumab combination therapy or 90 days after the last dose of durvalumab monotherapy, whichever is the longer time period.
176
Subjects of childbearing potential must agree to use hormonal or barrier birth control with spermicidal gel to avoid pregnancy during the study
177
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-1425) and continuing contraception use for at least 90 days after the last dose of study drug. Men/women should not donate sperm or ova during this time frame.
178
And, if heterosexually active, agree to consistently use 2 forms of highly effective birth control* (at least one of which must be a barrier method) starting at Screening and throughout the study period and for 6 months after the final study drug administration.
179
Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception* consisting of 2 forms of birth control (at least one of which must be a barrier method) starting at Screening and continue throughout the study period, and for 6 months after the final study drug administration
180
Male subject must not donate sperm starting at Screening and throughout the study period and, for 6 months after the final study drug administration Note: *Highly effective forms of birth control include:
181
Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
182
Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 180 days after the last dose of azacitidine, durvalumab (MEDI4736) and/or tremelimumab therapy; lactating females must agree not to breast feed throughout this period
183
Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 180 days after the last dose of durvalumab + tremelimumab combination therapy or 90 days after the last dose of durvalumab monotherapy, whichever is the longer time period
184
Women of childbearing potential (WoCBP)* must agree to use acceptable non-hormonal contraceptive methods of birth control from the day of the screening pregnancy test and up to 3 months after the last intake of ODM-201.
185
Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control
186
Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study and until 12 months following the last study treatment.
187
Females and males of childbearing potential must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 12 weeks (for males) and 5 months (for females) after treatment discontinuation
188
Sexually active females of childbearing potential and males with partners of child-bearing potential must agree to use adequate birth control during study treatment
189
Women of childbearing potential and men who are sexually active with a female partner of childbearing potential must be surgically sterilized, practicing abstinence, or agree to use 2 birth control methods before study entry, for the duration of study participation, and for 20 weeks after the final dose of study drug; cessation of birth control after this point should be discussed with a responsible physician. Women of childbearing potential are defined as those who are not surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause). Two methods of contraception which are considered accurate per protocol must be combined. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control
190
Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
191
Sexually active fertile men not using effective birth control if their partners are WOCBP
192
Women of child-bearing potential (WOCBP) and men who are able to father a child, unwilling to be abstinent or use highly effective methods of birth control that result in a low failure rate of less than 1% per year when used consistently and correctly prior to study entry, for the duration of study participation and for at least 4 weeks after treatment has ended
193
Female subjects who are pregnant, breast-feeding, or of reproductive potential who are not employing an effective method of birth control from screening to 180 days after the last dose of durvalumab + tremelimumab + olaparib combination therapy or 90 days after the last dose of durvalumab and olaparib therapy, whichever is the longer time period
194
Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug; must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug
195
Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation; men should use adequate birth control for at least three months after the last administration of lenvatinib
196
Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials; men must agree to not donate sperm during and after the study; for females, these restrictions apply for 1 month after the last dose of study drug; for males, these restrictions apply for 3 months after the last dose of study drug
197
Female patients who are pregnant or breast-feeding, or male or female patients of reproductive potential who are not employing an effective method of birth control
198
Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
199
Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use two methods of birth control- a medically accepted barrier method of contraceptive method (e.g., male or female condom) and a second effective method of birth control- during protocol therapy and for at least 4 months after the last dose of cabozantinib; abstinence is an acceptable method of birth control
200
Male and female patients of reproductive potential must agree to follow accepted birth control measures throughout the study period and for 30 days after the last dose of either study drug for females and 3 months after the last dose of study drug for males
201
Women of child-bearing potential (WOCBP) must be willing to use acceptable means of birth control
202
Men who could potentially father a child must also use birth control
203
Patients of both genders must be willing to practice birth control from the time of enrollment on this study up to four months after treatment; patients must be willing to undergo testing for HPV-16 prior to becoming pregnant after this period
204
Women of childbearing potential (WOCBP) must have a negative pregnancy test (urine or serum) within 7 days prior to starting the study drug. Both males and females must agree to use effective birth control during the study (prior to the first dose and for 6 months after the last dose) if conception is possible during this interval.
205
Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug; must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug
206
For women of child bearing potential, documented negative pregnancy test within two weeks of study entry and agreement to acceptable birth control throughout the trial starting with the screening visit through 120 days after the last dose of study medication\r\n* Abstinence is an acceptable method of birth control
207
Male subjects with a female partner(s) of child-bearing potential must agree to use acceptable birth control throughout the trial starting with the screening visit through 120 days after the last dose of study medication
208
Women of reproductive potential must be non-pregnant and non-nursing and must agree to employ an effective barrier method of birth control throughout the study and for up to 6 months following treatment
209
Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for up to four months after treatment
210
Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
211
Subjects whose partners are women of childbearing potential (WOCBP) must use an adequate method of birth control while on study drug and at least for 3 weeks after discontinuation of study drug.
212
Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
213
Subjects of reproductive potential must agree to use acceptable birth control methods
214
Patients must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry, for the duration of chemoradiation (treatment) and for 3 months after discontinuing treatment; women of childbearing potential must have a negative serum or urine pregnancy test within 3 days prior to starting treatment
215
Women of childbearing potential (WOCBP) must practice 2 effective methods of birth control during the course of the study; male patients who are partners of WOCBP should also practice an effective method of contraception: postmenopausal women must be amenorrheic for >= 12 months to be considered of non-childbearing potential; women and men must continue birth control for the duration of the trial and >= 3 months after the last dose of study drug; all WOCBP MUST have a negative pregnancy test prior to first receiving study medication(s)
216
Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for up to four months after cells are no longer detected in the blood
217
Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug; must also agree not to donate sperm during the study and for 3 months following the last dose of study drug
218
Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 4 weeks after treatment discontinuation
219
Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the 1st dose, if more than 7 days prior, a urine pregnancy test must be performed before the 1st dose. The female subject must be willing to use highly effective methods of birth control during the period of therapy and for 6 months following the last study IP administration. Highly effective methods of birth control include sexual abstinence, hormonal birth control, or intrauterine device (women), vasectomy or a condom with spermicide (men) in combination with barrier methods.
220
Male subjects who are willing to use highly effective methods of birth control during the period of therapy and for 6 months following the last IP administration.
221
All study subjects must be willing to ensure that corresponding sexual partners practice these same methods of highly effective birth control for the same duration.
222
Women and men of reproductive potential who are unwilling or unable to use an effective means of birth control during the study and for 3 months after receiving study drug
223
Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy or 180 days after the last dose of durvalumab + tremelimumab combination therapy
224
Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials; men must agree to not donate sperm during and after the study; for females, these restrictions apply for 12 months after last dose of obinutuzumab, or 1 month after the last dose of ibrutinib, whichever is later; for males, these restrictions apply for 12 months after the last dose of obinutuzumab or 3 months after the last dose of ibrutinib, whichever is later
225
Male patients whose sexual partners are WOCBP not using effective birth control
226
Sexually active females of childbearing potential and males with partners of child-bearing potential must agree to use adequate birth control during study treatment
227
Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug; must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug
228
Either a female or male of reproductive capacity wishing to participate in this study must be using, or agree to use, one or more types of birth control during the entire study and for 3 months after completing the study. Birth control methods may include condoms, diaphragms, birth control pills, spermicidal gels or foams, anti-gonadotropin injections, intrauterine devices (IUD), surgical sterilization, or subcutaneous implants. Another choice is for a subject's sexual partner to use one of these birth control methods. Women of reproductive capacity will be required to undergo a urine pregnancy test before completion of the post-screening informed consent process.
229
Subjects who are pregnant, breast feeding or sexually active and unwilling to use effective birth control while on treatment with TKI
230
Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
231
Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 180 days after the last dose of durvalumab + tremelimumab combination therapy or 90 days after the last dose of durvalumab monotherapy, whichever is the longer time period
232
Male patients and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration
233
Using corticosteroids or estrogen-based oral birth control
234
Pre-menopausal patients must have a negative pregnancy test and agree to use birth control methods while participating in the study; women of childbearing age and their male counterparts should use a barrier method of contraception during and for 3 months following protocol therapy
235
Patients who are pregnant, breast-feeding, or unwilling to practice an effective method of birth control
236
Females of child bearing potential and sexually active males must agree to use adequate birth control during study treatment
237
Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for four months after receiving the preparative regimen
238
commit to continued abstinence from heterosexual intercourse (excluding periodic abstinence or the withdrawal method) or begin two acceptable methods of birth control with a Pearl-Index ? 1%. without interruption from 4 weeks before starting study drug, throughout study drug therapy and for 12 months after end of study drug therapy, even if she has amenorrhoea. Apart from abstinence, acceptable methods of birth control are:
239
Women of childbearing potential (WOCBP) who are pregnant or lactating or unwilling to use 2 forms of effective birth control
240
Men who are fertile and sexually active unwilling to use 2 forms of effective birth control if their partners are WOCBP
241
Subjects of reproductive potential must agree to use acceptable birth control methods
242
Women of childbearing potential and men who are sexually active with a woman of childbearing potential must be practicing a highly effective method of birth control during and after the study (12 months for women and 3 months for men), consistent with local regulations regarding the use of birth control methods for subjects participating in this clinical study; men must agree to not donate sperm during and for up to 3 months after their conclusion of therapy on study
243
Women of childbearing potential and men must agree to use adequate contraception (simultaneous use of 2 methods of birth control) prior to study entry, for the duration of study participation and for 90 days following completion of therapy.
244
Subjects of reproductive potential must agree to use acceptable birth control methods
245
Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for up to four months after treatment
246
Female subjects who are pregnant, breast-feeding or male or female subjects of reproductive potential who are not employing an effective method of birth control
247
Subjects of reproductive potential must agree to use acceptable birth control methods
248
No pregnant or breastfeeding women; men or women of child bearing potential must agree to use an acceptable method of birth control (hormonal or barrier method of birth control; abstinence) to avoid pregnancy for at least 90 days after last study treatment (radiation or fresolimumab); all women of child bearing potential (last menstrual period within the previous 12 months and not surgically sterile) will be tested for pregnancy at pre-entry
249
Subjects of reproductive potential must agree to use acceptable birth control methods
250
Women of child-bearing potential must have negative serum pregnancy test and use accepted highly effective methods of birth control throughout the study and for 90 days after dosing and must agree to use effective contraception.
251
Fertile male subjects must agree to use a medically acceptable contraceptive method (allowed methods of birth control include vasectomy or condom with spermicide) during the trial and for a period of at least 6 months following the last administration of trial drugs
252
Female and male patients of reproductive potential must agree to use effective birth control from screening to 180 days after the last dose of durvalumab + tremelimumab combination therapy or 180 days after the last dose of durvalumab monotherapy, whichever is the longer time period; should a female patient become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
253
Women who are breast feeding, or have a positive pregnancy test (reproductive age should use effective birth control during study if randomized to SBRT treatment arm)
254
Men and women of reproductive potential must agree to follow accepted birth control methods for the duration of the study; female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study; male subject agrees to use an acceptable method for contraception for the duration of the study
255
Effective birth control should be utilized as indicated
256
Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential OR agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug; must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug
257
WOCBP and males with partners of child-bearing potential must agree to use adequate birth control throughout their participation and for 5 months following the last study treatment
258
Women of childbearing potential must have a negative pregnancy test and must agree to use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration
259
Patients of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence during study treatment and 12 months after the last dose of alisertib
260
Women of childbearing potential must have a negative pregnancy test at study entry; all sexually active patients will be educated regarding the teratogenic potential of the chemotherapy they receive, as well as the infectious risks of intercourse; contraceptive methods will be discussed and sexually active patients must agree to use an effective birth control method for the duration of the study; a medically acceptable method of contraception appropriate to the patient’s underlying disease, risk factors and lifestyle will be offered in consultation with gynecology or adolescent medicine and will commence on study entry; in general, most postmenarchal female patients may qualify to receive depot medroxyprogesterone acetate (DMPA) 150 mg intramuscularly (IM) or 104 mg/0.65 mL for subcutaneous (SC) injection; injection needs to be repeated every 3 months while on study; prior to IM injection, ensure that platelet count is > 30,000 x 10^9/L; patients ineligible or refusing injectable contraceptives will be offered other medically acceptable contraceptives if appropriate, such as oral contraceptives or birth control patch, or barrier methods
261
Female patients who are pregnant or breast-feeding or of reproductive potential not willing to use an effective method of birth control during study treatment and for at least 12 months thereafter
262
Women of child-bearing potential must be willing to practice an effective method of birth control while on treatment
263
Patients of both genders must practice birth control for four months after receiving the preparative regimen (lymphodepletion) and continue to practice birth control throughout the study; patients must have a documented negative pregnancy test (urine or serum) for women who have menstruated in the past 12 months and without sterilization surgery
264
Men and women of childbearing potential must be willing to practice an effective method of birth control during treatment and for at least 4 months following treatment on study
265
Women of childbearing potential and men who are sexually active must affirm they are practicing a highly effective method of barrier birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials; men must agree to not donate sperm during or after the study; these restrictions apply throughout the treatment period and for three months after the last dose of enzalutamide
266
Not pregnant or lactating; sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 3 months after the study is concluded; the male partner should use a condom
267
ELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Patients must not be pregnant or lactating; sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 3 months after the study is concluded; the male partner should use a condom
268
Use of an effective means of contraception (men and women) is mandated in subjects of child-bearing potential; female subjects will be advised that they not become pregnant for at least one month after completing participation in the study; avoiding sexual activity is the only certain method to prevent pregnancy; however, if subjects choose to be sexually active, they should use an appropriate “double barrier” method of birth control (such as female use of a diaphragm, intrauterine device [IUD], or contraceptive sponge, in addition to male use of a condom) or the use of prescribed “birth control” pills, injections, or implants
269
Men who are sexually active with WOCBP must use acceptable birth control methods; acceptable birth control methods include: oral or injectable hormonal birth control, intrauterine devices (IUDS), and double barrier methods (for example a condom in combination with spermicide); men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product; women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) as well as azoospermic men do not require contraception
270
Males must agree to use a medically acceptable form of birth control in order to be in this study and for 3 months after infusion
271
AT THE TIME OF INFUSION: Sexually active subjects must be willing to utilize one of the more effective birth control methods for 6 months after the T cell infusion; the male partner should use a condom
272
Men who are sterile (including vasectomy confirmed by post vasectomy semen analysis) or agree to use at least two forms of a reliable and highly effective method of birth control and to not donate sperm and for at least 180 days following last dose of TRC105, bevacizumab, paclitaxel, and/or carboplatin
273
Men who are able to father a child must agree to use an acceptable method of birth control while receiving radiation, and for 3 months after radiation
274
Men and women of child-bearing potential must agree to use effective birth control or abstinence during and for a period of 4 months after the last vaccination therapy
275
TREATMENT: Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded; the male partner should use a condom
276
Patients of childbearing potential must agree to use an effective birth control method
277
Women of childbearing potential and men must agree to use a medically accepted form of birth control during the treatment and for 2 months following completion of study treatment
278
Sexually active patients (men and women) must agree to use medically accepted barrier methods of contraception (e.g., male or female condom) during the course of the study and for 4 months after the last dose of study drug(s), even if oral contraceptives are also used; all subjects of reproductive potential must agree to use both a barrier method and a second method of birth control during the course of the study and for 4 months after the last dose of study drug(s)
279
TREATMENT: Pregnant women are excluded from this research; the male partner should use a condom; females of child-bearing potential must be willing to utilize one of the more effective birth control methods during the study unless female has had a hysterectomy or tubal ligation
280
Women who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control; double barrier contraceptives must be used through the trial by both sexes; oral, implantable, or injectable contraceptives are not considered effective for this study
281
Females of childbearing potential who are sexually active with a nonsterilized male partner must use 2 methods of effective contraception from screening, and must agree to continue using such precautions for 90 days after the final dose of investigational product; cessation of birth control after this point should be discussed with a responsible physician; periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control\r\n* Females of childbearing potential are defined as those who are not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause)\r\n* Subjects must use 2 acceptable methods of effective contraception
282
Women who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
283
Women of childbearing potential and men who are sexually active must affirm they are practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials; men must agree to not donate sperm during or after the study; for females, these restrictions apply for 1 month after the last dose of study drug; for males, these restrictions apply for 3 months after the last dose of the study drug
284
Pregnant and breastfeeding women are excluded; women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and up to 12 weeks after the study are excluded; this applies to any woman who has not experienced menarche and who has not undergone successful surgical sterilization or is not postmenopausal (defined as amenorrhea for at least 12 consecutive months); male subjects must also agree to use effective contraception for the same period as above
285
Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for up to four months after treatment
286
Women who are able to become pregnant and men who can father a child must use birth control while on study and for at least 8 weeks after your last dose of study drug(s); acceptable birth control includes a condom or a diaphragm with spermicidal jelly; and birth control methods that are taken by mouth, injected, or implanted; if you are already using birth control, you must check with the study staff to make sure that it is considered one of the acceptable forms to use in this study
287
Women of childbearing potential and men who are not practicing an acceptable form of birth control (i.e. diaphragm, cervical cap, condom, surgical sterility or birth control pills. Women whose partner has or men who have undergone a vasectomy must use a second form of birth control).
288
Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for up to four months after treatment
289
Women of childbearing potential must have a negative pregnancy test (urine or serum) and must not be lactating at the time of informed consent\r\n* Women and men must use adequate birth control while taking part in this study (such as a condom or diaphragm with contraceptive cream/jelly, birth control pills, Norplant, abstinence [no sexual intercourse] or surgical sterilization)
290
Sexually active subjects (men and women) must agree to use medically accepted barrier methods of contraception (e.g., male or female condom) during the course of the study and for 4 months after the last dose of study drug(s), even if oral contraceptives are also used; all subjects of reproductive potential must agree to use both a barrier method and a second method of birth control during the course of the study and for 4 months after the last dose of study drug(s)
291
Patients of childbearing potential must have a negative serum pregnancy test within 14 days of treatment; patients must agree to use a reliable barrier method of birth control during and for 3 months following the last dose of study drug
292
Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for up to four months after treatment
293
Sexually active fertile men not using effective birth control if their partners are women of child-bearing potential (WOCBP)
294
Patients of both genders must practice birth control for four months after receiving the preparative regimen (lymphodepletion) and continue to practice birth control throughout the study; patients must have a documented negative pregnancy test (urine or serum) for women who have menstruation in the past 12 months and without sterilization surgery (Turnstile II)
295
Pregnant and nursing women should be excluded from the protocol; if the patient is sexually active, the patient must agree to use a medically acceptable form of birth control while receiving treatment and for a period of 4 months following the last vaccination therapy; it is not known whether the treatment used in this study could affect the sperm and could potentially harm a child that may be fathered while on this study
296
Be non-fertile or not pregnant or lactating & agree to use birth control during the study through the end of last treatment visit
297
Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded; the male partner should use a condom
298
No patients who are pregnant or lactating will be allowed; patients of childbearing potential must practice an effective method of birth control while participating on this study
299
Women of childbearing potential and men must agree to use a medically accepted form of birth control for the duration of study participation and for 2 months following completion of study treatment
300
Males and females must agree to use effective birth control methods during the course of vaccination (from the first vaccine to two weeks after the last vaccine)
301
Female subjects of child-bearing potential must be using a medically accepted method of birth control before beginning study-drug treatment and agree to continue its use for 30 days after stopping study medication.
302
Women of child-bearing potential must be willing to practice an effective method of birth control while on treatment
303
Patients of both genders must practice birth control for four months after receiving the preparative regimen (lymphodepletion) and continue to practice birth control throughout the study; patients must have a documented negative pregnancy test (urine or serum) for women who have menstruation in the past 12 months and without sterilization surgery (Turnstile II)
304
Patients who do not agree to practice appropriate birth control methods while on therapy.
305
Men and women of reproductive potential must agree to follow accepted birth control methods for the duration of the study; female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study; male subject agrees to use an acceptable method for contraception for the duration of the study
306
In agreement to use an effective barrier method of birth control to avoid pregnancy during the study and for a minimum of 30 days after study treatment, for all male and female patients who are fertile
307
Pregnant or breast-feeding female (women of childbearing potential [WOCBP], defined as not post-menopausal for 12 months or without previous surgical sterilization, must have a negative urine pregnancy test within 30 days of the first administration of domperidone and must either commit to continued abstinence from heterosexual intercourse or use an effective method of birth control during the course of the study)
308
Female and male patients (and when relevant their partners) must be willing to practice birth control (including abstinence) during and for two months after treatment, if of childbearing potential during sexual contact with a female of childbearing potential
309
Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded; the male partner should use a condom
310
Patients who are pregnant, breast feeding, or if sexually active and unwilling to use effective birth control for the duration of this study will be excluded
311
Females must not be pregnant or breast feeding, and must use accepted birth control methods; males must use accepted birth control methods
312
Pregnant and/or breastfeeding women are excluded; women of child-bearing potential who are unwilling or unable to use and acceptable method of birth control to avoid pregnancy for the entire study period and up to 12 weeks after the study are excluded; male subjects must also agree to use effective contraception for the same period as above
313
Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for four months after treatment
314
Women of child bearing potential must agree to use birth control for the duration of the study
315
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods; barrier contraceptives must be used throughout the trial by both sexes; hormonal contraceptives are not acceptable as a sole method of contraception; (women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of everolimus and sorafenib)
316
Women of child-bearing potential must be willing to practice an effective method of birth control while on treatment
317
Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug; must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug; abstinence is an acceptable method of birth control
318
Patients of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study
319
Eligibility criteria specific to the abemaciclib arm:\r\n* Participants must be willing and able to provide written informed consent/assent for the abemaciclib arm of the INSIGhT trial\r\n* Women of child bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from date of initial dose and for 3 months following the last dose of abemaciclib
320
Eligibility criteria specific to the neratinib arm:\r\n* Participants must be willing and able to provide written informed consent/assent for the neratinib arm of the INSIGhT trial\r\n* Women of child bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from date of initial dose and for 28 days following the last dose of neratinib; men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) during intercourse with women of childbearing potential from date of initial dose and for 3 months following the last dose of neratinib
321
Throughout study, male subject and a female partner who is of childbearing potential must use two acceptable methods of birth control (one of which must include a condom barrier method of contraception) starting at screening and continuing throughout the study period and for three months after the final study drug administration. Two acceptable methods of birth control thus include the following:
322
Women of child-bearing potential who are sexually active with a non-sterilized male partner, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective contraception from screening throughout study treatment, and must agree to continue using such precautions for 6 months after the final dose of investigational product; cessation of birth control after this point should be discussed with a responsible physician. Highly effective methods include the following:
323
Female subjects of childbearing potential and male subjects with partners of childbearing potential should ensure use of a highly effective method of birth control as defined in study protocol
324
ELIGIBILITY CRITERIA FOR REGISTRATION: women of child-bearing potential must agree to use an effective method of birth control on trial; an effective method of birth control includes surgical sterilization of woman or her partner, abstinence, or two barrier methods (e.g. condom plus diaphragm); or hormonal methods of birth control (oral contraceptives or intrauterine device)
325
Females of childbearing age must be on an acceptable form of birth control per institutional standards
326
Women of childbearing potential must agree to practice effective birth control throughout their participation in the treatment phase of the study
327
Subjects in their reproductive age group should use an effective method of birth control; subjects who are breast-feeding, or have a positive pregnancy test will be excluded from the study
328
Patients who are pregnant or breast-feeding are not eligible; nursing mothers must agree not to breastfeed during therapy; females of childbearing potential must practice an effective method of birth control while participating in this study and for those who have achieved menarche, must have a negative pregnancy test prior to study entry
329
Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded; the male partner should use a condom
330
Agree to use adequate birth control, if of childbearing potential
331
Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months after completion of treatment
332
Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the cytotoxic T lymphocyte (CTL) infusion; male partner should use a condom
333
Women of child-bearing potential and sexually active males must use an accepted and effective method of birth control
334
Women who are pregnant (confirmed by a serum pregnancy test in females of reproductive potential) or breast-feeding; women of child-bearing potential and sexually active males must be advised to take precautions to prevent pregnancy during treatment (unless the subject or subject’s partner(s) is sterile (i.e. women who have had a hysterectomy or have been post-menopausal for at least twelve consecutive months) or remain abstinent, men and women of reproductive potential must agree to use TWO of the following forms of birth control every time they have sex throughout the study and for up to 3 months following discontinuation of study drug: condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicidal, intrauterine device (IUD), or surgical sterilization while participating in this study; hormonal birth control methods are not permitted
335
Women of child-bearing potential must use birth control (oral contraceptive, barrier, abstinence or any other acceptable method) for the duration of the study
336
if heterosexually active, agree to consistently use 1 form of highly effective birth control starting at Screening and throughout the study period and for 6 months after the final study drug administration.
337
Male subject has not had a vasectomy or is not sterile as defined below, subject's female partner(s) is utilizing 1 form of highly effective birth control*starting at Screening and continue throughout study treatment and for 6 months after the subject receives final study drug administration
338
Female subjects agree not to be pregnant or lactating from beginning of the study screening until 4 months after receiving the last treatment; Male and female subjects and their sexual partners are willing and able to employ a highly effective method of birth control/contraception.
339
Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) during treatment
340
Female patients who are pregnant or breastfeeding or female patients of reproductive potential who are not willing to employ effective birth control from screening to 180 days after the last dose of durvalumab + tremelimumab combination therapy or 90 days after the last dose of durvalumab monotherapy, whichever is the longer time period
341
Subjects of childbearing potential must agree to utilize effective contraceptive methods of birth control during study participation and for 30 days following the last treatment with IMP (Investigational Medicinal Product)
342
Female participants / women of childbearing potential (WOCBP) must adhere to using a medically accepted method of birth control up to 28 days prior to screening and agree to continue its use during the study or be surgically sterilized (e.g., hysterectomy or tubal ligation) and males must agree to use barrier methods of birth control while on study. WOCBP must agree to use effective contraception during treatment and for at least 5 months following the last dose of study treatment.
343
Either a female or male of reproductive capacity wishing to participate in this study must be using, or agree to use, one or more types of birth control during the entire study and for 3 months after completing the study. Birth control methods may include condoms, diaphragms, birth control pills, spermicidal gels or foams, anti-gonadotropin injections, intrauterine devices (IUD), surgical sterilization, or subcutaneous implants. Another choice is for a subject's sexual partner to use one of these birth control methods. Women of reproductive capacity will be required to undergo a urine pregnancy test before completion of the post-screening informed consent process.
344
Women must not be able to become pregnant (e.g. post-menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study. Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating. Both male and female patients of reproductive potential must agree to use a reliable method of birth control during the study.
345
Women of child-bearing potential will practice a highly effective method of birth control during and for 3 months after the chemotherapy/ custirsen last dose. Men of reproductive potential who are not surgically sterile must agree to abstain from sexual activity or use medically accepted and highly effective method of contraception during and for 6 months after the chemotherapy/custirsen last dose.
346
Woman with child bearing potential must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking lenalidomide
347
Subjects are required to agree to practice effective birth control (i.e. abstinence, intrauterine device for female subjects) during the study period.
348
Willingness of male and female subjects who are not surgically sterile or postmenopausal to use medically acceptable methods of birth control from the first dose of study drug to 30 days after the last dose of duvelisib and for 12 months after last dose of ofatumumab. Sexually active men, and women using oral contraceptive pills, should also use barrier contraception
349
218 Males and females of reproductive potential who are unwilling to practice highly effective method(s) of birth control while on study through 110 days (females) and 170 days (males) after receiving the last dose of study drug. Highly effective methods of birth control include sexual abstinence (males, females); vasectomy; bilateral tubal ligation/occlusion; or a condom with spermicide (males) in combination with hormonal birth control or intrauterine device (IUD) (females).
350
Sexually abstinent or correct and consistent use of one of the following methods of birth control in addition to a male partner using a condom from Screening to 3 months after the last dose of study drug:
351
vasectomy in male partner. Male patients must agree to sexual abstinence or to consistently and correctly use a condom in combination with one of the above methods of birth control from Screening to 3 months after the last dose of study drug.
352
ORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Female of childbearing potential (less than 12 months post-menopausal) or male with a partner of childbearing potential either agrees to be abstinent or uses a medically acceptable form of birth control during the study and for a period of 1 year after if on Arm 1
353
HPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: Female of childbearing potential (less than 12 months post-menopausal) or male with a partner of childbearing potential either agrees to be abstinent or uses a medically acceptable form of birth control during the study and for a period of 1 year after if on Arm 1
354
All patients must practice a highly effective method of birth control
355
Women of childbearing potential must use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry until 6 months after the infusion of IMA202 product
356
All participants who are able to have children must practice effective birth control while on study. Acceptable forms of birth control for female patients include: hormonal birth control, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence, for the length of the study. If the participant is a female and becomes pregnant or suspects pregnancy, she must immediately notify her doctor. If the participant becomes pregnant during this study, she will be taken off this study. Men who are able to have children must use effective birth control while on the study. If the male participant fathers a child or suspects that he has fathered a child while on the study, he must immediately notify his doctor
357
Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug; must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug
358
Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 180 days after receipt of the last dose of study drugs
359
RENAL & BLADDER: Sexually active subjects (men and women) must agree to use medically accepted barrier methods of contraception (eg, male or female condom) during the course of the study and for 4 months after the last dose of study drug(s), even if oral contraceptives are also used; all subjects of reproductive potential must agree to use both a barrier method and a second method of birth control during the course of the study and for 4 months after the last dose of study drug(s)
360
Sexually active subjects (men and women) must agree to use medically accepted barrier methods of contraception (eg, male or female condom) during the course of the study and for 4 months after the last dose of study drug(s), even if oral contraceptives are also used; all subjects of reproductive potential must agree to use both a barrier method and a second method of birth control during the course of the study and for 4 months after the last dose of study drug(s)
361
Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for up to four months after receiving the treatment
362
Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy or 180 days after the last dose of durvalumab + tremelimumab combination therapy
363
Men must be willing and able to use an acceptable method of birth control such as latex condom during the dosing period and for at least 3 months after completion of the study agent administration (T cell infusion and/or LV305 or CMB305) if their sexual partners are WOCBP.
364
Men must be willing and able to use an acceptable method of birth control, during and for at least 3 months after completion of the study, if their sexual partners are WOCBP
365
Female subjects who are pregnant, breast-feeding or female patients of reproductive potential who are not employing an effective method of birth control from starting dose of durvalumab (cycle 1 day 1), including dosing interruptions through 90 days after receipt of the last dose of durvalumab; refrain from egg cell donation while taking durvalumab and for at least 90 days after the last dose of durvalumab
366
Men (including men with vasectomies) must agree to use adequate contraception (a condom and another effective method of birth control) prior to registration, for the duration of study participation, and for at least 3 months thereafter; men must also agree not to donate sperm for the duration of study participation, and for at least 3 months thereafter
367
Men and women of reproductive potential who are unwilling to practice acceptable methods of effective birth control while on study through 5 weeks (women) or 3 months (men) after receiving the last dose of AMG 232; acceptable methods of effective birth control include sexual abstinence (men, women); vasectomy; or a condom with spermicide (men) in combination with barrier methods, hormonal birth control or IUD (women)
368
Patients who are pregnant, breastfeeding or plan to become pregnant; sexually active patients and their partners must be willing to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, during the study participation, and for four months after the last dose of T-VEC
369
Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing effective methods of birth control for at least 6 months after completion of the last dose of MEDI4736 and AC chemotherapy
370
Women of child-bearing potential must agree to use an effective method of birth control during treatment and for 3 months after receiving their last dose of study drug; fertile men must also agree to use an acceptable method of birth control while on study drug and for at least 3 months after last dose
371
Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control
372
Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
373
Female subjects who are pregnant, breast-feeding or male or female subjects of reproductive potential who are not employing an effective method of birth control
374
Male patients must agree to use adequate birth control during the study and up to 6 months after discontinuation of study drug treatment
375
Pregnant women are excluded from this study; breastfeeding should be discontinued; women of child-bearing potential must agree to use adequate birth control throughout the study duration
376
Female and male patients (and when relevant their partners) must be willing to practice birth control (including abstinence) during and for two months after treatment if female of childbearing potential or male having sexual contact with a female of childbearing potential
377
Males and females must agree, in the consent form, to use effective birth control methods during the course of vaccination
378
Male and female patients who do not agree to practice approved methods of birth control for the duration of the study are ineligible
379
Pregnant and/or lactating women will be excluded; premenopausal patients will undergo pregnancy testing when indicated; women will practice effective birth control while receiving protocol treatment
380
If of child-bearing potential, patient agrees to use adequate birth control measures during study participation
381
Sexually active women of childbearing age and men should be willing to use two acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at screening and continuing through 3 months after the final study drugs administration; men must agree to avoid sperm donation while on study and 3 months after the final study drugs administration
382
Women who are pregnant or breast feeding, or women/men able to conceive and unwilling to practice an effective method of birth control (one of which must include a condom as a barrier method of contraception) starting at screening and continuing through 3 months after the final study drugs administration
383
Patients (men and women) of childbearing potential must agree to use double barrier method of birth control beginning at the signing of the informed consent form (ICF) until at least 3 months after the last dose of study drug
384
Sexually active fertile men not using effective birth control if their partners are WOCBP
385
All subjects, including those who are surgically sterilized, must be willing to use an effective method of contraception (barrier method of birth control or abstinence) from the time informed consent is signed until 6 months after completion of protocol therapy
386
Patients who are pregnant or breast-feeding are not eligible for this study; negative pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective birth control method
387
Adequate birth control
388
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods; if barrier contraceptives are being used, these must be continued throughout the trial by both sexes; hormonal contraceptives are not acceptable as a sole method of contraception; (women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of EVEROLIMUS)
389
Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for four months after receiving the preparative regimen
390
Adequate birth control in sexually active women of childbearing potential
391
Any women who are pregnant or breast feeding, or women/men able to conceive and unwilling to practice an effective method of birth control
392
Female and male patients (and when relevant their partners) must be willing to practice birth control (including abstinence) during and for two months after treatment, if of childbearing potential
393
Pregnancy or nursing or unwilling to take adequate birth control during therapy; NOTE: breastfeeding should be discontinued
394
Females of childbearing potential who are sexually active with a non-sterilized male partner must use highly effective contraception from screening, and must agree to continue using such precautions for at least 90 days after the final dose of investigational product; cessation of birth control after this point should be discussed with a responsible physician; periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control
395
Must agree to use effective birth control (such as a condom) or abstinence during and for a period of 6 months after the last vaccination therapy
396
Patients of both genders must be willing to practice birth control during and for four months after receiving chemotherapy
397
Patients must not be pregnant, lactating, or unwilling to use birth control
398
Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for up to four months after receiving the treatment
399
Non pregnant and non-nursing; treatment under this protocol would expose a fetus to significant risks; women of childbearing potential should have a negative pregnancy test prior to study entry; women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial; appropriate methods of birth control include oral contraceptives, implantable hormonal contraceptives (Norplant), or double barrier method (diaphragm plus condom)
400
Female and male subjects must agree to use a medically acceptable method of birth control prior to screening and agree to continue its use throughout the study; females of childbearing potential should be counseled in the appropriate use of birth control while on this study
401
Patients of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for four months after receiving the preparative regimen
402
Women of childbearing potential and fertile men who are not practicing or who are\n             unwilling to practice birth control while enrolled in the study until at least 12\n             weeks after the last milatuzumab infusion
403
Females of childbearing potential and males not using adequate birth control.
404
Patients must be able to rinse and expectorate study medication rather than swallow it; female patients must be willing to practice birth control (including abstinence) during and for two months after treatment, if of childbearing potential
405
Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study
406
Women of childbearing potential must have a negative pregnancy test prior to first receiving investigational product; sexually active women of childbearing potential (WOCBP) must use an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized; all WOCBP should be instructed to contact the investigator immediately if they suspect they might be pregnant (e.g., missed or late menstrual period) at any time during study participation
407
Pregnant and lactating women are excluded from this study; women of reproductive potential that are not using or are unwilling to use effective birth control methods throughout the trial are excluded
408
Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the CTL infusion; male partner should use a condom
409
Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 3 months after the study is concluded; the male partner should use a condom
410
Men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control
411
Female patients of childbearing potential must use maximally effective birth control during the period of therapy, must be willing to use contraception for 1 month following the last study drug infusion and must have a negative urine or serum pregnancy test upon entry into this study. Otherwise, female patients must be postmenopausal (no menstrual period for a minimum of 12 months) or surgically sterile. 'Maximally effective birth control' means that the patient, if sexually active, should be using a combination of two methods of birth control that are approved and recognized to be effective by Regulatory Agencies
412
Women of child-bearing potential (WOCP) and sexually active men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry, during treatment and for three months after completing treatment
413
The participant, if male, is sterile or agrees to use a reliable method of birth control.
414
The participant, if female, is surgically sterile, is postmenopausal, or agrees to use a highly effective method of birth control.
415
Must use acceptable form of birth control throughout the study. After the final dose of study drug, an acceptable form of birth control must be used for 23 weeks for women of childbearing potential (WOCBP) and 31 weeks for men who are sexually active with WOCBP
416
Subject and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting a Screening and continuing throughout the study period and for 3 months after final study drug administration • Two acceptable forms of birth control include:
417
Females of child-bearing potential and males who use adequate birth control through 120 days post dose.
418
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods; two acceptable forms of contraceptives must be continued throughout the trial by either sex; hormonal contraceptives are not acceptable as a sole method of contraception (women of childbearing potential must have a negative serum pregnancy test within 7 days prior to day 1 of study drug)
419
Males who cannot comply with birth control use to avoid fathering a child
420
Women of childbearing potential must commit to either abstain continuously from sexual intercourse or to use 2 methods of reliable birth control simultaneously as deemed appropriate by the Investigator. Contraception must begin 4 weeks prior to dosing and must continue for 3 months after the last dose of daratumumab
421
Female subject who is pregnant, breastfeeding, or if of child bearing potential is unwilling to practice birth control until 3 years following surgery.
422
Pregnancy or nursing or unwilling to take adequate birth control during therapy
423
Sexually active subjects (men and women) must agree to use medically accepted barrier methods of contraception (e.g., male or female condom) at the time of the serum pregnancy test (women of childbearing potential only); during the course of the study and for 4 months after the last dose of study drug(s), even if oral contraceptives are also used; all subjects of reproductive potential must agree to use both a barrier method and a second method of birth control during the course of the study and for 4 months after the last dose of study drug(s)
424
Men and women with reproductive potential: Must agree to use a reliable method of birth control during the study and for 3 months following the last dose of study drug(s) or country requirements, whichever is longer.
425
Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.
426
Patients of childbearing potential must agree to use an approved method of birth control
427
Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control
428
Male or female patients. Women of childbearing potential must agree to use highly effective methods of birth control during the trial and for at least 1 year after the last dose of BI 836826 and 1 month after the last dose of ibrutinib.
429
If female of childbearing potential (FCBP), willing to undergo pregnancy testing and agrees to use two methods of birth control or is considered highly unlikely to conceive during the dosing period and for three months after last study treatment, or if receiving pembrolizumab, four months after last treatment
430
Subjects who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protections as determined acceptable by the principal investigator during the study and for 1 week after the last dose of abiraterone acetate
431
Both male and female patients of childbearing potential enrolled in this trial must use adequate birth control measures during the course of the trial and for at least one month after discontinuing study drug.
432
Males, and female patients who are biologically capable of having children, must agree to use a medically acceptable method of birth control.
433
Or, if of childbearing potential, Agree not to try to become pregnant during the study and for 180 days after the final study drug administration; And have a negative urine pregnancy test at Day 1; And, if heterosexually active, agree to consistently use two forms of highly effective birth control (at least one of which must be a barrier method) starting at Screening and throughout the study period and for 180 days after the final study drug administration.
434
Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of two forms of birth control (at least one of which must be a barrier method) starting at Screening and continue throughout the study period, and for 120 days after the final study drug administration.
435
Women of child bearing potential (WCBP), defined as a sexually mature woman not surgically sterilized or not post-menopausal for at least 24 consecutive months if ?55 years or 12 months if >55 years, must have a negative serum pregnancy test within four weeks prior to the first dose of study drug and must agree to use adequate methods of birth control throughout the study. Adequate methods of contraception are outlined in the protocol.
436
Female patients of child bearing potential and non-vasectomized male patients agree to practice appropriate methods of birth control
437
Female participants must be either surgically sterile (via hysterectomy or bilateral tubal ligation), post-menopausal, or agree to use a medically effective means of birth control (hormonal or barrier method of birth control; abstinence) prior to study entry and throughout their participation in the treatment phase of this study; female participants of child bearing potential must also have a negative serum pregnancy test within 2 weeks prior to registration
438
Women who are pregnant or breast feeding. Adults of reproductive potential not employing two forms of birth control as per Pregnancy Prevention Risk Management Plan.
439
Pregnant and/or breastfeeding or female patients of reproductive potential who are not employing an effective method of birth control
440
Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control from screening to 90 days after the last dose of tremelimumab monotherapy
441
All subjects, including those who are surgically sterilized, must be willing to use an effective method of contraception (barrier method of birth control or abstinence) from the time informed consent is signed until 6 months after completion of protocol therapy.
442
Fertile male patients willing to use at least one medically acceptable form of birth control for the duration of the study and for 2 weeks after treatment stops.
443
A woman must agree to use an effective method of birth control and agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 3 months after receiving the last dose of study drug
444
Agree to use a reliable medically approved method of birth control.
445
Female subjects and their male partners must agree must agree to use a highly reliable method of birth control
446
Patients (men and women) of child bearing potential should use an effective (for them) method of birth control throughout their participation in this study
447
Women of childbearing potential must agree to use a medically acceptable form of birth control (medically accepted methods: birth control pills, condoms and spermicidal lubricants, intrauterine device, and diaphragm) during their participation in the study
448
Patients of childbearing potential must have a negative blood pregnancy test within 14 days of treatment; patients must agree to use a reliable barrier method of birth control during and for 3 months following the last dose of study drug
449
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods; two acceptable forms of contraceptives must be continued throughout the trial by either sex and for 4 months (120 days) following last dose of either drug; hormonal contraceptives are not acceptable as a sole method of contraception; (women of childbearing potential must have a negative serum pregnancy test within 7 days prior to day 1 of study drug)
450
Non-child bearing potential or able to follow birth control requirements
451
Women of childbearing potential must agree to use a medically acceptable form of birth control (medically accepted methods: birth control pills, condoms and spermicidal lubricants, intrauterine device, and diaphragm) during their participation in the study
452
Sexually active fertile men not using effective birth control if their partners are WOCBP
453
Women of childl-bearing potential must have a negative pregnancy test within 7 days prior to starting the study drug. Beth males and females must agree to adequate birth control if conception is possible during the study and for 6 months after the last dose
454
Patients with childbearing potential must agree to use appropriate forms of birth control
455
Sexually active women and men of childbearing potential must agree to use an effective method of birth control during the course of the study and for up to 3 months following the last dose of the study drug, in a manner such that risk of pregnancy is minimized; surgical sterilization, intrauterine device, birth control pills, or barrier method (e.g. condom and/or diaphragm with spermicidal agents) are acceptable forms of birth control; women of childbearing potential must have a negative pregnancy test (serum) within 7 days prior to treatment; a pregnancy test is not required for registration; women who have not menstruated for more than 2 years will be considered postmenopausal, thus not of childbearing potential
456
Men and women of child bearing potential must agree to use adequate birth control throughout their participation in the study and for 30 days following the last study treatment.
457
Women of child-bearing potential must have a negative pregnancy test within 7 days of initiation of dosing and must agree to use an acceptable method of birth control while on study drug and for 3 months after the last dose; women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for >=1 year; men who are able to father a child must also agree to use an acceptable method of birth control while on study drug, and for 3 months after the last dose
458
Female subject is either post-menopausal or surgically sterilized; females of childbearing potential must have a negative serum pregnancy test within 48 hours prior to prescribing bendamustine and must commit to continued abstinence from heterosexual intercourse or use TWO acceptable methods of birth control (at least one barrier method) AT THE SAME TIME during the study and for 6 months after the last study drug; sexually active males must use a medically acceptable form of birth control for the duration of the study and for 6 months after last dose of drug
459
Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 3 months after the study is concluded; the male partner should use condom
460
All men and women of childbearing potential who are participating in the study must agree to use effective forms of birth control throughout the duration of their treatment
461
Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded; the male partner should use a condom
462
Subjects must agree to consistently use 2 forms of highly effective contraception/birth control between signing of the informed consent and 60 days after the last study drug administration.
463
Females of childbearing potential must agree to use highly effective forms of birth control throughout the course of the study and at least up to 90 days after last dose of study drug. Males must have undergone sterilization- vasectomy, or utilize a barrier method
464
Men and women of reproductive potential who are unwilling to practice acceptable methods of effective birth control while on study through 5 weeks (women) or 3 months (men) after receiving the last dose of AMG 232; acceptable methods of effective birth control include sexual abstinence (men, women); vasectomy; or a condom with spermicide (men) in combination with barrier methods, hormonal birth control or intrauterine device (IUD) (women)
465
Subjects of both genders of child-bearing potential who are not willing to practice birth control from the time of consent through 6 months after the completion of KTE-C19
466
Male patients must be willing and able to use an acceptable method of birth control, during and for at least 3 months after completion of the study, if their sexual partners are WOCBP.
467
Female subjects who are pregnant, breast-feeding or female patients of reproductive potential who are not employing an effective method of birth control from starting dose of durvalumab (cycle 1 day 1), including dosing interruptions through 90 days after receipt of the last dose of durvalumab are not eligible; female subjects should agree to refrain from egg cell donation while taking durvalumab and for at least 90 days after the last dose of durvalumab
468
Male subjects who are not employing an effective method of birth control from starting dose of durvalumab (cycle 1 day 1), including dosing interruptions through 90 days after receipt of the last dose of durvalumab are not eligible; male subjects should agree to refrain from sperm donation while taking durvalumab and for at least 90 days after the last dose of durvalumab; should a female partner of a male patient become pregnant or suspect she is pregnant while participating in the study, he should inform his treating physician and the female partner should call her physician immediately
469
Women of childbearing potential must agree to use highly effective methods of birth control.
470
Women of childbearing potential (WOCBP) must practice 2 effective methods of birth control during the course of the study; male patients who are partners of WOCBP should also practice an effective method of contraception; effective methods of birth control include diaphragm or condoms with spermicidal foam or jelly, birth control pills (BCPs), injections or patches, intra-uterine devices (IUDs) and surgical sterilization; postmenopausal women must be amenorrheic for >= 12 months to be considered of non-childbearing potential, women and men must continue birth control for the duration of the trial and >= 3 months after the last dose of study drug, All WOCBP MUST have a negative pregnancy test prior to beginning ibrutinib on study
471
Subjects who are pregnant, breast-feeding or of reproductive potential who are not employing an effective method of birth control
472
Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trial; men must agree to not donate sperm during and after the study\r\n* For females, these restrictions apply for 1 month after the last dose of study drug; for males, these restrictions apply for 4 months after the last dose of study drug
473
Women of child-bearing potential are expected to use an effective method of birth control to prevent exposing a fetus to potentially dangerous agent with unknown risk
474
Female is not breastfeeding, is postmenopausal or surgically sterile; demonstrates non-pregnant state, and agrees to use 2 acceptable methods of birth control throughout the trial, until 120 days after the last dose of treatment
475
If fertile male or female of child-bearing potential, agree to consistently use a highly effective method of birth control (including birth control pills, barrier device, or intrauterine device) from the time of consent through 4 months following the last dose of study drug
476
Female patients who are pregnant or breastfeeding, or male or female patients of reproductive potential who are not employing an effective method of birth control
477
Contraception in patients with preserved reproductive capacity; patients will be considered to be of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation/salpingectomy, or postmenopausal for at least two years; women of childbearing potential who are sexually active and not using a highly effective method of birth control during the trial and for at least three months (in case of monotherapy with BIBF 1120) after the end of active therapy are not allowed to participate in the trial; a highly effective method of birth control is defined as one which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomized partner
478
Male and female patients of reproductive potential must agree follow accepted birth control measures
479
Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study; females of childbearing potential: must either completely abstain from heterosexual sexual conduct or must use 2 methods of reliable contraception, 1 highly effective (intrauterine device, birth control pills, hormonal patches, injections, vaginal rings, or implants) and at least 1 additional method (condom, diaphragm, cervical cap) of birth control; reliable contraceptive methods must be started at least 4 weeks before lenalidomide; males who are sexually active must be practicing complete abstinence or agree to a condom during sexual contact with a pregnant female or female of child bearing potential; men must agree to not donate sperm during and after the study; for females, these restrictions apply at least 4 weeks before study treatment, during the period of therapy and for 1 month after the last dose of study drug; for males, these restrictions apply during the period of therapy and for 3 months after the last dose of study drug
480
Or, if of childbearing potential: must have a negative urine pregnancy test at Screening and on Day 1 before the first dose of study drug is administered, and must use 2 acceptable methods of birth control* if sexually active from Screening through 3 months after the last dose of study drug.
481
Sexually active male subject and his female partner who is of childbearing potential must use 2 acceptable methods of birth control from Screening through 3 months after the last dose of study drug. * Two acceptable methods of birth control are as follows:
482
Sexually active subjects (men and women) must agree to use medically accepted barrier methods of contraception (eg, male or female condom) during the course of the study and for 4 months after the last dose of study drug(s), even if oral contraceptives are also used; all subjects of reproductive potential must agree to use both a barrier method and a second method of birth control during the course of the study and for 4 months after the last dose of study drug(s)
483
Inclusion Criteria:\n\n        Patients must meet the following criteria to be eligible for study participation:\n\n          1. Patients with recurrent squamous carcinoma of the Head and Neck, who in the opinion of\n             their treating physician, cannot be satisfactorily treated with surgery, radiation, or\n             platinum chemotherapy. Diagnosis must be confirmed by biopsy and histopathology.\n\n          2. Patient must have received prior systemic platinum-based chemotherapy for treatment of\n             their head and neck cancer, unless in the opinion of the medical oncologist, the use\n             of platinum-based chemotherapy is contraindicated or not recommended, e.g., renal\n             impairment, allergy to platinum compounds, age, liver disease, myelosuppression,\n             neuropathy, hearing loss, etc.\n\n          3. Patients must have life expectancy > 6 months based on investigator judgment.\n\n          4. Male or female patients at least 18 years old. Female patients must not be pregnant or\n             breast feeding and must be practicing a medically acceptable form of birth control, be\n             sterile, or post-menopausal. Females of childbearing potential (FCBP) is defined as\n             premenopausal women capable of becoming pregnant. This includes women who are\n             post-menopausal for at least 12 months after the last menses. FCBP must agree to use a\n             medically acceptable form of birth control during the study and for at least 6 months\n             after discontinuation of Erbitux® or study medication. Females must agree not to\n             breast feed during the study and for at least two months after discontinuation of\n             Erbitux® or study medication. Male patients should be using a double barrier\n             protection method that is a medically acceptable form of birth control during the\n             study or be sterile.\n\n          5. Patients must have an ECOG score of 0 - 2.\n\n          6. Patient must understand the investigational nature of this study and sign an\n             Independent Ethics Committee/Institutional Review Board approved written informed\n             consent form prior to receiving any study related procedure.\n\n        Exclusion Criteria:\n\n        Patients with any of the following will be excluded from participation in the study:\n\n          1. Patients with a history of significant Erbitux infusion reactions (? Grade 3).\n\n          2. Patients on chemotherapy or Erbitux® therapy or radiation therapy within 4 weeks of\n             enrollment.\n\n          3. Tumor invading a major blood vessel (such as the carotid artery) unless the vessel has\n             been embolized, stented or surgically ligated to prevent hemorrhage.\n\n          4. Tumor is not clearly shown on a CT scan or clinically measurable.\n\n          5. Location and extension of the tumor precludes an effective PIT.\n\n          6. Patients with impaired hepatic function (ALP (hepatic), AST and/or ALT >3 times the\n             upper normal limits, or total serum bilirubin > 2 mg/dL.\n\n          7. Patients with impairment of renal function (serum creatinine >2 mg/dL).\n\n          8. Unwilling or unable to follow protocol requirements.\n\n          9. Any condition which in the Investigator's opinion deems the patient an unsuitable\n             candidate to receive study drug.\n\n         10. Uncontrolled intercurrent illness including, but not limited to, ongoing or active\n             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac\n             arrhythmia, or psychiatric illness/social situations that would limit compliance with\n             study requirements.\n\n         11. Patient requires examinations or treatments within 4 weeks after study drug\n             administration where they would be exposed to significant light, e.g., eye\n             examinations, surgical procedures, endoscopy, etc.
484
Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test and must be willing to use acceptable methods of birth control during the study and for 90 days after the last dose of study treatment; acceptable methods of birth control include condoms with birth control foam, birth control pills, implantable or injectable birth control, birth control patch, intrauterine device (IUD), or diaphragm with spermicidal gel; male patients must use an effective barrier method of contraception (i.e. , condoms with birth control foam or diaphragm with spermicidal gel) during the study and for 90 days following the last dose of study treatment if sexually active with a female of childbearing potential; contraception must be in place at least 2 weeks prior to initiating study treatment; a female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
485
Willing to employ adequate and appropriate birth control if applicable\r\n* NOTE: This study is for patients aged 60 and older and most female patients will have entered menopause by this time; however patients should not become pregnant while on this study; pre-menopausal women need to use birth control while on this study and women should not breastfeed a baby while on this study; any man treated on this study will also need to use contraception if his partner is a premenopausal female; patients should check with their health care provider about what kind of birth control methods to use and how long to use them
486
Women of child-bearing potential and men must agree to adequate contraception (hormonal or barrier method of birth control; abstinence) during and up to 30 days after discontinuing treatment
487
Willingness to use acceptable birth control. Subjects with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. Female subjects of child-bearing potential must have a negative pregnancy test.
488
Patients of childbearing potential must have a negative serum pregnancy test within 14 days of treatment; patients must agree to use a reliable method of birth control during and for 6 months following the last dose of study drug
489
Women of child-bearing potential must have a negative pregnancy test within 7 days of initiation of dosing and must agree to use an acceptable method of birth control while on study drug and for 3 months after the last dose; women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for >= 1 year; men of child-bearing potential must also agree to use an acceptable method of birth control while on study drug, and for 3 months after the last dose
490
Note: Women with potential to have children must be willing to practice acceptable methods of birth control during the study
491
All patients of childbearing potential must be willing to consent to using effective contraception, i.e., intrauterine device (IUD), birth control pills, Depo-Provera, and condoms while on treatment and for 3 months after their participation in the study ends
492
Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study
493
Women of reproductive potential must be non-pregnant and non-nursing and must agree to employ an effective barrier method of birth control throughout the study and for up to 6 months following treatment
494
Willingness to use effective means of birth control throughout the duration of clinical study and for at least 3 months after completion of study drug
495
Patient agrees to use adequate contraception (barrier method of birth control) prior to study entry, during therapy and up to 3 months after last dose of ipilimumab
496
AT THE TIME OF INFUSION: Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded; the male partner should use a condom
497
Male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration; patients are also required to use a condom if having sex with a pregnant woman
498
Men must be willing and able to use an acceptable method of birth control, for at least 3 months after completion of the study, if their sexual partners are WOCBP
499
Participants who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator (PI) during the treatment period and for 1 week after last dose of AA
500
Female patients of childbearing age must have a negative serum HCG test unless prior hysterectomy or menopause (defined as age ? 55 and twelve consecutive months without menstrual activity). Female patients should not become pregnant or breast-feed while on this study. Sexually active male and female patients should use effective birth control
501
Patients who are breastfeeding, pregnant or refuse to use an effective form of birth control are excluded; abstinence is considered an effective form of birth control
502
Participants must use effective birth control throughout study until at least 30 days after study treatment or 1 year after rituximab treatment, whichever is later; female participants must not be pregnant or breast-feeding
503
Willingness of male and female subjects who are not surgically sterile or postmenopausal to use medically acceptable methods of birth control from the first dose of study drug to 30 days after the last dose of duvelisib and for 12 months after last dose of ofatumumab. Sexually active men, and women using oral contraceptive pills, should also use barrier contraception
504
Male subject and his female partner who is of childbearing potential must use two acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at Screening and continuing throughout the study period and for 3 months after final study drug administration.
505
Two acceptable forms of birth control include:
506
Females of childbearing potential who are sexually active with a nonsterilized male partner must use 2 methods of effective contraception from screening, and must agree to continue using such precautions for 6 months after the final dose of investigational product; cessation of birth control after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Females of childbearing potential are defined as those who are not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause). Nonsterilized males who are sexually active with a female partner of childbearing potential must use 2 acceptable methods of effective contraception from Day 1 and for 6 months after receipt of the final dose of investigational product.
507
Subjects of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study
508
Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator during the treatment period and for 1 week after last dose of abiraterone acetate
509
must use two forms of birth control* (at least one of which must be a barrier method) starting at Screening and throughout the study period and for 180 days after the final study drug administration. *Acceptable forms of birth control include:
510
Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of two forms of birth control* (one of which must be a barrier method) starting at Screening and continue throughout the study period and for 120 days after the final study drug administration.
511
Women and men of childbearing potential must be willing to use an effective method of contraception (e.g. hormonal or barrier method of birth control; abstinence) from the time consent is signed until 4 weeks after protocol therapy discontinuation.
512
Sexually active fertile men not using effective birth control if their partners are women of childbearing potential (WOCBP)
513
Willingness to use birth control while on study
514
Females of childbearing potential and males able to father a child must be willing to practice acceptable methods of birth control to prevent pregnancy
515
Participants who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator during the treatment period and for 1 week after last dose of enzalutamide
516
Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 1 week after last dose of abiraterone acetate
517
Women who are pregnant or breast-feeding and women or men not practicing effective birth control
518
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using barrier birth control methods, are not eligible for participation
519
Willingness to discontinue sex hormonal therapy, e.g. birth control pills, prior to registration and while on study
520
Women of child-bearing potential must have a negative pregnancy test within 14 days of initiation of dosing and must agree to use an acceptable method of birth control while on study drug and for 3 months after the last dose. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ?1 year. Men of child-bearing potential must also agree to use an acceptable method of birth control while on study drug, and for 3 months after the last dose.
521
Women of childbearing potential and sexually active males must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to enrollment and for the duration of study participation; protections against pregnancy must be continued for at least 8 months after the last dose of study drug
522
Pregnant women are excluded; we recommend that women of child-bearing potential use an acceptable method of birth control to avoid pregnancy for 6 months following stereotactic radiosurgery and that male subjects use effective contraception for the same period
523
Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator during the study and for 1 week after last dose of abiraterone acetate
524
Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) beginning 14 days prior to first dose of pazopanib, through the dosing period, and for at least 28 days after the last dose of pazopanib
525
Females of childbearing potential and males should agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation
526
Male patients whose sexual partners are WOCBP not using effective birth control
527
Pregnancy or breastfeeding in women and women of childbearing potential not using an acceptable method of birth control.
528
Women of child-bearing potential must be willing to practice an effective method of birth control while on treatment
529
Subjects of childbearing potential requires acceptable form of birth control
530
Sexually active fertile men not using effective birth control if their partners are WOCBP
531
Women of child-bearing potential must agree to use an effective method of birth control during treatment and for six months after receiving their last dose of study drug
532
Sexually active participants (men and women) must agree to use medically accepted barrier methods of contraception (e.g., male or female condom) during the course of the study and for 4 months after the last dose of study drug(s), even if oral contraceptives are also used; all participants of reproductive potential must agree to use both a barrier method and a second method of birth control
533
Inability or refusal to practice effective contraception during therapy or the presence of pregnancy or active breastfeeding (men and women of childbearing potential must use an effective method of birth control or abstinence during treatment and for 4 months after completion of treatment)
534
Female patients of childbearing potential are not eligible unless they commit to complete abstinence or have been on 2 methods of birth control, including 1 highly effective method and 1 additional method at the same time (unless committing to complete abstinence of heterosexual intercourse) at least 28 days (4 weeks) prior to study enrollment; sexually active females must also agree to remain on 2 methods of birth control, during treatment (including during dose interruptions), and continuing for at least 28 days after the completion of protocol therapy; examples of methods of contraception are as follows:\r\n* Highly effective methods (must use at least 1):\r\n** Intrauterine device (IUD)\r\n** Hormonal (prescription birth control pills, injections, implants)\r\n** Tubal ligation\r\n** Partner’s vasectomy\r\n* Additional effective methods:\r\n** Male condom\r\n** Diaphragm\r\n** Cervical cap\r\nThe two methods of birth control requirement applies to all sexually active females unless they have undergone a hysterectomy or bilateral oophorectomy
535
Pregnant women and women of child-bearing potential who are not using an effective method of birth control
536
Non-pregnant and non-nursing; women and men of reproductive potential should agree to use an effective means of birth control
537
Females who are pregnant or breast-feeding during the study period will be excluded; adults of reproductive potential not employing an effective method of birth control will be excluded; sexually active women of child bearing potential, whose partner is male, must use medically accepted birth control; sexually active men, whose partner is a female of childbearing potential, must use a medically accepted birth control
538
Women of childbearing potential must agree to use adequate birth control measures and agree to not donate eggs for the purpose of assisted reproduction during the study and for 3 months after receiving the last dose of study agent, and must have a negative pregnancy test at screening
539
Men must agree to use a double-barrier method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study agent
540
Females of child-bearing potential and sexually-active males must consent to follow acceptable birth control methods to avoid contraception while on treatment
541
Subjects of reproductive potential agree to use birth control throughout their participation in this study, and for three months following study termination.
542
Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for up to four months after receiving the treatment
543
Sexually active subjects must agree to use medically accepted methods of birth control during the course of the study and for 3 months following discontinuation of study treatments (excluding women who are not of child bearing potential and men who have been sterilized)
544
Women of child-bearing potential eligible as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods etc.); hysterectomy or menopause must be clinically documented
545
Men and women of child-bearing potential must be willing to practice an effective method of birth control during treatment and at least 4 months after treatment is finished
546
Men and women with reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment
547
Female subjects of child-bearing potential and male subjects with partners of child-bearing potential must agree to use an effective means of birth control while on study therapy and for a minimum of 4 months following last plerixafor dose and 6 months following last bevacizumab dose\r\n* Effective birth control includes:\r\n** Birth control pills, depot progesterone, or an intrauterine device plus one barrier method\r\n** or 2 barrier methods\r\n* Effective barrier methods are male and female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm)\r\n* Hormonal contraceptive methods are not sufficient, as information about any interaction of plerixafor with hormonal contraceptives is not known\r\n* Men or women of child-bearing potential (WOCP) who are unwilling or unable to use an acceptable method to avoid pregnancy (noted above) for the entire study period and for up to 2 weeks after the last dose of study drug are excluded from this study
548
Pregnant or breast feeding women, or women of child-bearing potential (and/or their partners) who are unwilling to utilize an approved method of birth control during the study and for 1 month afterward
549
Patients of childbearing potential (females who have not been postmenopausal for at least 12 consecutive months or who have not undergone previous surgical sterilization or males who have not been surgically sterilized) must be willing to practice birth control during the study
550
Women of childbearing potential and men with reproductive potential must be willing to continue practicing acceptable methods of birth control during the study NOTE: Oral contraceptives are not reliable due to potential drug-drug interaction with GSK2118436
551
Patients of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study
552
Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (HCG) within 72 hours prior to study entry and must be willing to practice effective birth control to prevent pregnancy while receiving treatment and for three months after treatment is discontinued; all males of child fathering potential must also be willing to practice effective birth control
553
Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control .
554
Non-pregnant and non-nursing; women and men of reproductive potential should agree to use an effective means of birth control
555
Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 180 days after the last dose of durvalumab (MEDI4736) + tremelimumab combination therapy or 90 days after the last dose of durvalumab (MEDI4736) monotherapy, whichever is the longer time period
556
Patients who are pregnant or breastfeeding or patients of reproductive potential who are not willing to employ effective birth control from screening to 180 days after the last dose of durvalumab + tremelimumab combination therapy or 90 days after the last dose of durvalumab monotherapy, whichever is the longer time period
557
Women of childbearing potential (WOCP) must have a negative pregnancy test result prior to enrollment. WOCP and men whose partners are WOCP must agree to use a highly effective method of birth control during the study and for 6 months following the last dose of study drug. A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year).
558
consistent and correct use of 1 of the following highly effective methods of birth control for one month prior to the start of the study agent and 6 months after the last dose:
559
Patients (men and women) of childbearing potential must use effective method of birth control throughout their participation in this study
560
Patients must not be pregnant; all premenopausal patients will undergo pregnancy testing; men will agree to not father a child while on protocol treatment; men and women will practice effective birth control while receiving protocol treatment
561
Non-pregnant and non-nursing; women of child bearing potential and men must agree to use an appropriate method of birth control throughout their participation in this study; appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives (Norplant), or double barrier methods (diaphragm plus condom)
562
Women of childbearing potential and men must agree to use a medically accepted form of birth control for the duration of study participation and for 4 months following completion of study treatment
563
Pregnant and lactating women will be excluded; all premenopausal patients will undergo pregnancy testing; men will agree to not father a child while on protocol treatment; men and women will practice effective birth control while receiving protocol treatment
564
Women who are pregnant or breast-feeding and women or men not practicing effective birth control
565
The effects of dendritic cell vaccines on the developing human fetus are unknown; for this reason men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation
566
Patients of both gender must practice a barrier method of birth control while participating in this trial
567
Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for four months after treatment
568
Study participant must use birth control measure prior to study entry (during screening), during study participation, and for 12 weeks after bevacizumab is discontinued
569
Sexually active fertile men not using effective birth control if their partners are WOCBP
570
Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the CTL infusion; the male partner should use a condom
571
Females who are pregnant or need to breast feed during the study period will be excluded; patients found to be pregnant will be excluded; male and female enrolled patients will be advised to practice an effective method of birth control
572
Or, if of childbearing potential: Agree not to try to become pregnant during the study and for 28 days after the final study drug administration; And have a negative serum pregnancy test at Screening; And, if heterosexually active, agree to consistently use 2 forms of highly effective birth control (at least 1 of which must be a highly effective method and one must be a barrier method) starting at Screening and throughout the study period and for 28 days after the final study drug administration.
573
Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control (1 of which must be a barrier method) starting at Screening and continue throughout the study period and for 90 days after the final study drug administration.
574
For males and females of child-bearing potential, willingness to use adequate birth control through 90 days after the last dose of epacadostat or atezolizumab.
575
Women of childbearing potential who are not using an acceptable method of birth control (e.g., pill, patch, IUD, ring, condom, sponge, foam).
576
Women of child-bearing potential must have a negative pregnancy test within 7 days of initiation of dosing and must agree to use an acceptable method of birth control. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ?1 year. Fertile men must also agree to use an acceptable method of birth control while on study drug and up to 3 months after the last dose of study drug.
577
Subjects and spouse/partner who are of childbearing potential must be using high effective contraception consisting of 2 forms of birth control (at least 1 of which much be barrier method) starting at Screening and continuing through the entire study (for at least 3 months after the last dose of ALXN1007 if study treatment is stopped early or subject withdraws consent).
578
Subjects who are pregnant, breast feeding or sexually active and unwilling to use effective birth control for the duration of the study.
579
Women of childbearing potential must agree to practice effective birth control throughout their participation in the treatment phase of the study
580
Women of childbearing potential and men who are sexually active must affirm they are practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials; men must agree to not donate sperm during or after the study; for females, these restrictions apply for 1 month after the last dose of study drug; for males, these restrictions apply for 3 months after the last dose of the study drug
581
Woman of potential childbearing age agrees to a medically effective birth control method,
582
Men and women of child bearing potential must agree to use adequate birth control throughout their participation in the study and for 60 days following the last study treatment.
583
Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
584
Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 180 days after the last dose of durvalumab + tremelimumab combination therapy or 90 days after the last dose of durvalumab monotherapy, whichever is the longer time period
585
And if heterosexually active, agrees to consistently use 1 form of highly effective birth control* starting at screening and throughout the study period and for 28 days after the final study drug administration.
586
Highly effective forms of birth control include:
587
Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials; men must agree to not donate sperm during and after the study; for women, these restrictions apply for 1 month after the last dose of study drug; for men, these restrictions apply for 3 months after the last dose of study drug
588
Throughout the study, male patients and their female partners of childbearing potential must use 2 acceptable methods of birth control (1 of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration. Two acceptable methods of birth control thus include the following:
589
Women of child-bearing potential must have a negative pregnancy test within 7 days prior to initiation of dosing and must agree to use an acceptable method of birth control from the time of the negative pregnancy test up to 3 months after the last dose of study drug, Fertile men must also agree to use an acceptable method of birth control while on study drug and up to 3 months after the last dose of study drug.
590
Females must be post-menopausal for more than 2 years or surgically sterile or practicing acceptable forms of birth control.
591
And, if heterosexually active, agree to consistently use 2 forms of highly effective birth control
592
Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control
593
For female subjects of childbearing potential, the subject presents with a negative serum pregnancy test at screening and agrees to employ 2 forms of adequate birth control measures, including at least 1 barrier method (eg, diaphragm with spermicidal jelly or foam, or [for male partner] condom) throughout the course of the study and for at least 90 days after the last administration of BAX69. Other acceptable contraceptive measures include birth control pills/patches or intrauterine devices
594
Throughout study, male subject and a female partner who is of childbearing potential must use 2 acceptable methods of birth control (1 of which must include a condom barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration. Two acceptable methods of birth control thus include the following:
595
The patient is pregnant or unwilling to practice appropriate birth control
596
Adequate birth control in fertile patients
597
All subjects of childbearing potential must agree to use acceptable methods of birth control (men and women)
598
Adequate birth control when appropriate
599
In agreement to use an effective barrier method of birth control to avoid pregnancy during the study and for a minimum of 30 days after study treatment, for all male and female patients who are fertile
600
Female subjects of childbearing potential and male subjects with partners of childbearing potential should ensure use of a highly effective method of birth control as defined by the investigator, for example, those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly during the study and for a period of 3 months following the last dose of any drug administered during the study.
601
Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for up to four months after treatment
602
Fertile male subjects willing to use at least one medically acceptable form of birth control for the duration of the study and for 2 weeks after treatment stops
603
Non-menopausal or non-sterile female subjects of childbearing potential must have a negative serum beta-HCG and use a medically acceptable form of birth control
604
Any risk of pregnancy - ALL female patients must have an effective means of birth control or be infertile due to hysterectomy, fallopian tube surgery, or menopause
605
Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for up to four months after treatment
606
Not pregnant, not lactating, and agree to use effective birth control
607
FCBP must agree to use a highly-effective form of birth control while taking the study drug and for 1 month after the last dose of study drug; highly-effective forms of birth control include implants, injectables, birth control pills with 2 hormones, some intrauterine devices (IUDs), or having a sterilized partner; the type of birth control used must be discussed with and approved by the attending physician prior to initiation of study drug
608
Female subjects of childbearing potential must have negative pregnancy test within 7 days prior to first dose of study drug; practicing an acceptable form of birth control for greater than 2 months prior to screening and commits to use for the duration of the study and for 3 months following the last dose of study treatment.
609
Male subjects must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control for the duration of the study until at least 3 months after the last dose of study treatment in such a manner that the risk of pregnancy for a partner is minimized.
610
Pregnant and breastfeeding women are excluded; as well as women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control (hormonal or barrier method of birth control; abstinence) to avoid pregnancy for the duration of the study
611
Female patients (and when relevant their male partners) must be willing to practice birth control (including abstinence) during and for two months after treatment, if of childbearing potential
612
Women who are pregnant or lactating, as well as women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the duration of the study
613
Female subjects of childbearing age must have a negative urine HCG test unless prior hysterectomy or menopause (defined as age above 55 and twelve months without menstrual activity). Female subjects should not become pregnant or breast-feed while on this study. Sexually active male and female subjects should use effective birth control.
614
Pregnant or breastfeeding women and adults of reproductive potential not employing an effective method of birth control are excluded from this study
615
Sexually active subjects and their partners must agree to use medically accepted barrier methods of contraception (eg, male or female condom) during the course of the study and for 4 months after the last dose of study drug(s), even if oral contraceptives are also used; all subjects of reproductive potential must agree to use both a barrier method and a second method of birth control during the course of the study
616
TREATMENT: Patients must be willing to practice birth control during and for four months following treatment
617
Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for up to four months after treatment
618
RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study and for 3 months after the last dose of panobinostat
619
NON-PROGRESSED DIPG (STRATUM 2): Patients of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study and for 3 months after the last dose of panobinostat
620
Women of child-bearing potential must agree to use adequate contraception (barrier method of birth control; abstinence); women must not breast feed while on study
621
For patients of childbearing potential, agreement to use two effective forms of contraception (e.g., surgical sterilization, a reliable barrier method, birth control pills, or contraceptive hormone implants) and to continue its use for the duration of the study and for 30 days after the last LY3023414 dose
622
Women of reproductive potential must be non-pregnant and non-nursing and must agree to employ an effective barrier method of birth control throughout the study and for up to 6 months following treatment
623
Sexually active subjects (men and women) must agree to use medically accepted barrier methods of contraception (e.g., male or female condom) during the course of the study and for 23 or 31 weeks for women or men respectively, after the last dose of study drugs, even if oral contraceptives are also used; all subjects of reproductive potential must agree to use both a barrier method and a second method of birth control during the course of the study and for 23 or 31 weeks for women and men respectively after the last dose of study drugs
624
Fertile men must agree to use an effective method of birth control during the study and for up to 6 months after the last dose of study drug.
625
Male patients whose sexual partners are WOCBP not using effective birth control
626
The patient, if female and of child bearing potential, must be postmenopausal or surgically sterile, or on one of the following methods of birth control for a minimum of 2 months prior to entry into this study and throughout the duration of the study: intrauterine device (IUD), oral contraceptives, or Depo-Provera; this criteria can be waved at the discretion of the investigator if the patient’s intracranial tumor is considered life threatening and the 2 month wait required is not in the best interest of the patient; in this case, the patient must be on a reliable form of birth control as stated above
627
Men and women of reproductive potential must agree to follow accepted birth control methods for the duration of the study. Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Male subject agrees to use an acceptable method for contraception for the duration of the study.
628
Female patients of childbearing potential must have a negative pregnancy test at screening and must agree to use a highly effective birth control method from the time of the first dose of study drug through 45 days after last dose of study drug.
629
Willing to use physician approved birth control method
630
Patients who are known or thought to be sexually active must use effective birth control.**
631
Effective birth control includes absolute abstinence, or double barrier birth control methods, i.e. condom and one of the following: combined oral contraceptive, diaphragm, depot contraceptive injection.
632
Women of child-bearing potential must agree to use an effective method of birth control during treatment and for three months after receiving their last dose of study drug. Fertile men must also agree to use an acceptable method of birth control while on study drug and for at least 3 months after last dose.
633
Women of child-bearing potential must either commit to continued abstinence from heterosexual intercourse or begin one acceptable method of birth control (IUD, tubal ligation, or partner's vasectomy) while on crenolanib and for 3 months following the last dose of crenolanib. Hormonal contraception alone is not an acceptable method of birth control for the purpose of this trial.
634
A woman must be either: Not of childbearing potential: postmenopausal (more than [>] 45 years of age with amenorrhea for at least 12 months; If, of childbearing potential must be practicing a highly effective method of birth control
635
Male subject and a female spouse/partner who is of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control (one of which must be a barrier method) starting at screening and continue throughout the study period and for 120 days after the final study drug administration.
636
if heterosexually active must use two forms of birth control
637
Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at Screening and continue throughout the study period and for 90 days after the final study drug administration.
638
Women of childbearing potential and male participants must agree to practice adequate means of birth control throughout their participation in the study and for 6 months after their last treatment
639
Inclusion\n\n          1. Has provided written informed consent\n\n          2. Has advanced solid tumors (excluding breast cancer)\n\n          3. Has normal hepatic function, mild, moderate, or severe hepatic impairment\n\n          4. ECOG performance status of ?2\n\n          5. Is able to take medications orally\n\n          6. Has adequate organ function\n\n          7. Women of childbearing potential must have a negative pregnancy test and must agree to\n             adequate birth control if conception is possible. Males must agree to adequate birth\n             control.\n\n        Exclusion\n\n          1. Certain serious illnesses or medical condition(s)\n\n          2. Has had certain other recent treatment e.g. major surgery, anticancer therapy,\n             extended field radiation, received investigational agent, shunt in the liver within\n             the specified time frames prior to study drug administration\n\n          3. Has received TAS-102\n\n          4. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any\n             prior therapies\n\n          5. Is a pregnant or lactating female
640
Patients of both genders must be willing to practice birth control from the time of enrollment on this study up to 4 months after treatment; patients must be willing to undergo testing for HPV-16 prior to becoming pregnant
641
If fertile male or female of child-bearing potential, agree to consistently use a highly effective method of birth control (including birth control pills, barrier device, or intrauterine device, abstinence or other methods prescribed by a licensed healthcare provider) from the time of consent through 70 days following the last dose of study drug
642
Male and female subjects must agree to use a highly reliable method of birth control for the duration of the study.
643
Women of childbearing potential as well as fertile men and their partners must use an effective method of birth control
644
Pregnancy or breastfeeding; women of childbearing potential (WOCBP) must practice acceptable methods of birth control to prevent pregnancy; 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; in addition, men enrolled on this study must be informed of the risks to any sexual partner of childbearing potential and should practice an effective method of birth control
645
Female subjects of childbearing potential and males must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) for the duration of study treatment
646
Pregnant or lactating females are excluded. Women of childbearing age, and their sexual partners, must use an effective contraception program. Males who are having sexual relations with women capable of child bearing must use the barrier birth control while on the study and for 3- months after the last dose of the study drug.
647
Willing to practice methods of birth control (both males who have partners of childbearing potential and females of childbearing potential) from screening through 3 months after taking the final dose of RTA 408;
648
Adequate birth control methods for the duration of the study
649
If fertile male or female of child-bearing potential, agree to consistently use a highly effective method of birth control (including birth control pills, barrier device, or intrauterine device) from the time of consent through 3 months following the last dose of study drug
650
Women with child-bearing potential must be willing to practice acceptable methods of birth control during the study
651
Unwillingness to practice birth control
652
Woman with child bearing potential must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME
653
Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.
654
Not pregnant or breast feeding; women of childbearing potential and sexually active men must agree to use an accepted and effective method of birth control
655
Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection during the study and for 1 week after the last dose of abiraterone acetate
656
Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 1 week after last study drug administration
657
Highly effective methods of birth control for females & males
658
Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal, barrier method of birth control or abstinence) from the time the consent is signed, during the duration of study participation and 4 months after discontinuation of protocol therapy
659
Male patients whose sexual partners are WOCBP not using effective birth control
660
Sexually active subjects (men and women) must agree to use medically accepted barrier methods of contraception (eg, male or female condom) during the course of the study and for 4 months after the last dose of study drug(s), even if oral contraceptives are also used; all subjects of reproductive potential must agree to use both a barrier method and a second method of birth control; women of childbearing potential must have a negative pregnancy test at screening
661
Male and female patients must agree to use a highly reliable method of birth control.
662
Women of childbearing potential or men with partners of childbearing potential who are not protected or who are unwilling to use an effective contraceptive method of birth control during the course of the study and for a period of 6 months following the last dose.
663
Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for up to four months after receiving treatment
664
Patients of both genders must be willing to practice birth control from the time of enrollment on the study and for four months after treatment
665
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods; adequate contraception must be used throughout the trial and for 8 weeks after the last dose of study drug by both sexes
666
Patients of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study
667
Women of childbearing potential and male participants must agree to use a medically effective means of birth control, such as condom/diaphragm and spermicidal foam, intrauterine device (IUD), or prescription birth control pills, throughout their participation in the treatment phase of the study
668
Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 1 week after last dose of abiraterone acetate
669
Sexually active women of childbearing potential must use an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized; prior to study enrollment, women of childbearing potential (WOCBP) must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy; in addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control; all WOCBP MUST have a negative pregnancy test prior to first receiving investigational product; if the pregnancy test is positive, the patient must not receive investigational product and must not be enrolled in the study; in addition, all WOCBP should be instructed to contact the Investigator immediately if they suspect they might be pregnant (e.g., missed or late menstrual period) at any time during study participation
670
Sexually active fertile men not using effective birth control if their partners are WOCBP
671
Pregnant and/or lactating women will be excluded; all premenopausal patients will undergo pregnancy testing; men will agree to not father a child while on protocol treatment; men and women will practice effective birth control while receiving protocol treatment
672
Women who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control; double barrier contraceptives must be used through the trial by both sexes; oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study
673
Women of childbearing potential not using a highly effective method of birth control during the trial until one year after the last dose.
674
Women of childbearing potential with a positive serum pregnancy test performed within 7 days prior to the start of treatment; women and men of childbearing potential that do not agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation; men who do not agree to use adequate birth control for at least three months after the last administration of sorafenib
675
Men and woman of reproductive potential, unwilling to practice a highly effective method of birth control for the duration of the study and continuing for 2 weeks (for women) and 12 weeks (for men) after receiving the last dose of study drug.
676
Women with reproductive potential must be willing to practice acceptable methods of birth control during the study and for up to 4 weeks after the last dose of study medication.
677
Men with reproductive potential must be willing to practice acceptable methods of birth control during the study and for up to 16 weeks after the last dose of study medication.
678
Patients who are potentially fertile and sexually active must be willing to utilize effective birth control
679
Pregnant or lactating females are excluded. Women of childbearing age, and their sexual partners, must use an effective contraception program. Males who are having sexual relations with women capable of child bearing must use birth control while on the study and for 3-months after the last dose of the study drug.
680
Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 4 weeks after treatment discontinuation.
681
Current use of hormone-containing forms of birth control such as implants (i.e. Norplants, or injectables ( i.e. depo-provera)
682
Inability or refusal to practice effective contraception during therapy or the presence of pregnancy or active breastfeeding (men and women of childbearing potential must use an effective method of birth control or abstinence during treatment and for four months after completion of treatment)
683
Subjects of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while they are being treated on this study (cohort 1)
684
Subjects of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while they are being treated on this study
685
Adequate birth control
686
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods; if barrier contraceptives are being used, these must be continued throughout the trial by both sexes; hormonal contraceptives are not acceptable as a sole method of contraception (women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of EVEROLIMUS)
687
There is no available information, as yet, regarding human fetal or teratogenic toxicities; pregnancy tests with a negative result must be obtained in girls who are postmenarchal within 10 days before start of treatment; women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation; men and women should use adequate birth control for at least three months after the last administration of study treatment
688
Men capable of producing offspring and not surgically sterile must practice abstinence or use a barrier method of birth control.
689
Women with potential to have children must be willing to practice acceptable methods of birth control during the study;
690
Use of acceptable birth control
691
Sexually active women of childbearing potential must use effective birth control during the trial and for at least two months following the trial, and sexually active men must be willing to avoid fathering a new child while receiving therapy
692
Female patients of childbearing age not on effective birth control
693
Females and males must be willing to use an approved form of birth control while on this study and for 2 weeks after completion.
694
Patients of reproductive age must agree to use a medically accepted form of birth control while on the study.
695
Childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (IUD, birth control pills, or barrier device) during and for 3 months after completion of trial therapy.
696
Women and men agree to use protocol specific birth control measures
697
Any of the following:\r\n* Pregnant persons\r\n* Nursing persons\r\n* Persons of childbearing potential who are unwilling to employ adequate contraception; Note: persons of childbearing potential and persons able to father a child who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials; subjects must agree to not donate sperm during and after the study; for persons of childbearing potential, these restrictions apply for 1 month after the last dose of study drug; for persons able to father a child, these restrictions apply for 3 months after the last dose of study drug
698
If female patient with reproductive capacity: on effective means of barrier birth control during the entire duration of the treatment
699
Pregnant women are ineligible, as treatment involves unforeseeable risks to the embryo or fetus; female patients with reproductive capacity are required to use effective means of birth control during the entire duration of the treatment
700
Patients of reproductive potential who are not employing an effective method of birth control; male patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy, whichever is the longer time period
701
Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials; men must agree to not donate sperm during and after the study; for females, these restrictions apply for 3 months after the last dose of ibrutinib and 6 month after the last dose of nivolumab; for males, these restrictions apply for 3 month after the last dose of study drugs
702
Patients must be willing to practice birth control during and for four months following treatment
703
A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control e.g., either condom with spermicidals or partner with occlusive cap with spermicidals and all men must also not donate sperm during the study and for 3 months after receiving the last dose of study drug
704
If heterosexually active must use two forms of birth control* (at least one of which must be a barrier method) starting at screening and throughout the study period and for 28 days after the final study drug administration.
705
Male subject and his female spouse/partner who is of childbearing potential must be using highly effective contraception consisting of two forms of birth control* (one of which must be a barrier method) starting at screening and continue throughout the study period and for 90 days after the final study drug administration.
706
Women of childbearing potential and men who are sexually active with a woman of childbearing potential must be practicing a highly effective method of birth control during and after the study (12 months for women and 3 months for men), consistent with local regulations regarding the use of birth control methods for subjects participating in this clinical study
707
Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for up to four months after treatment
708
Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for up to four months after treatment
709
Women and men of reproductive potential must agree to use an effective means of birth control during the study and for 3 months after receiving study drug
710
Pregnant or breast feeding; women and men of reproductive potential must agree to use an effective means of birth control during the study and for 3 months after receiving study drug
711
Females or males whose partners are women of childbearing potential must agree to use a reliable method of birth control prior to drug initiation and for the duration of their study participation
712
Women of child-bearing potential must agree to utilize a form of birth control or agree to undergo sexual abstinence during radiation therapy
713
Pregnant women or women who are breast feeding or of child bearing potential not using a highly effective method of birth control for at least one month prior to enrollment\r\n* Patients will be considered to be of childbearing potential unless surgical sterilized by hysterectomy or bilateral tubal ligation/salpingectomy, or post-menopausal for at least two years; women of childbearing potential who are sexually active and not using a highly effective method of birth control before the trial for at least one month, during the trial, and for at least three months after the end of active therapy are not allowed to participate in the trial; a highly effective method of birth control is defined as one which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, intrauterine devices (IUDs), sexual abstinence or vasectomized partner
714
Sexually active males not committing to birth control during the course of the study (except if their partner is not of childbearing potential)
715
A male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration
716
Female patients who are pregnant or lactating, or are of childbearing potential (FCBP, defined as all women physiologically capable of becoming pregnant) and not practicing an effective method of contraception/birth control\r\n* FCBP must have a current negative serum pregnancy test prior to transplant per institutional practice
717
Male and female subjects of reproductive potential who agree to use both a highly effective method of birth control and a barrier method during the period of therapy and for 90 days after the last dose of drug.
718
Women of childbearing potential are will to agree to use 1 of the study defined effective methods of birth control from the time of study entry to 60 days after the final study drug administration
719
Male patients must use highly effective contraception methods consisting of 2 forms of birth control (at least 1 of which must be a barrier method) starting at screening and continuing throughout the study period and for 60 days after the final study drug administration.
720
Female patients of childbearing potential must have a negative serum pregnancy test at screening, and must agree to use a highly effective birth control method from the time of the first dose of study drug through 45 days after the last dose of study drug.
721
Women of childbearing potential and their male partners must agree to use TWO effective forms of birth control (abstinence is not an allowed method) prior to study entry and for the duration of study participation, and for two months following the last dose of study medications; effective birth control methods are: copper IUD [intrauterine device], diaphragm/cervical cap/shield, spermicide, contraceptive sponge, condoms; women of childbearing potential must have a negative pregnancy test within seven days before starting study medications; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
722
Subject and female partner who is of childbearing potential must continue to use 2 forms of birth control, of which 1 must be highly effective and 1 must be a barrier method throughout the study and for 3 months after final enzalutamide administration.
723
Female patients of childbearing potential must have a negative pregnancy test before the first dose of talazoparib and must agree to use a highly effective birth control method from the time of the first dose of talazoparib through 45 days after the last dose.
724
Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug; must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug
725
Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials; men must agree to not donate sperm during and after the study; for females, these restrictions apply for 1 month after the last dose of study drug; for males, these restrictions apply for 3 months after the last dose of study drug
726
Women who are not practicing an effective form of birth control (condoms, diaphragm, birth control pill, intrauterine device [IUD]) or currently pregnant
727
Pregnant or lactating women, childbearing age women who are not on birth control; negative pregnancy test for women of childbearing potential, as defined by intact uterus and ovaries, and a history of menses within the last 12 months; pregnancy test to be performed no greater than 14 days prior to consent in study; in cases of women with elevated b-HCG, these candidates will be eligible to participate so long as the level of b-HCG is not consistent with pregnancy; women of childbearing potential need to be on or use contraception, or be abstinent during the study period; their male partners must also use contraception (condom) or maintain abstinence; birth controls specifications: women who are able to become pregnant must use birth control during the study and for 30 days after the last anamorelin dose; acceptable forms of birth control include barrier methods (such as condom or diaphragm) with spermicide
728
Male 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; (1) female patients must have a negative pregnancy test at screening; (2) female patients of childbearing potential must agree to use an acceptable method of birth control (excluding hormonal birth control methods) for 72 hours prior to admission and to continue its use during the study and for at least 30 days after the final dose; (3) male patients must agree to use an acceptable form of birth control from study day 1 through at least 30 days after the final dose
729
Either post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control during study treatment and for 3 months afterwards
730
Male and female patients who are fertile who do not agree to use an effective barrier methods of birth control (i.e. abstinence) to avoid pregnancy while receiving study treatment
731
For women of childbearing potential: unwillingness to use an effective method of birth control (e.g., abstinence, oral contraceptive) while in this study
732
Pregnant or able to become pregnant and unwilling to use two forms of birth control during the study period
733
Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control
734
Patients must agree to use an effective birth control method
735
For sexually active females, patient agrees to use acceptable method of birth control
736
If a woman of childbearing potential, must have a negative serum pregnancy test upon entry into this study and must be willing to use highly effective birth control upon enrollment, during the treatment period and for 6 months following the last dose of investigational drug or cytarabine, whichever is later. A woman is considered of childbearing potential following menarche and until becoming postmenopausal (no menstrual period for a minimum of 12 months);
737
If male, must be surgically sterile or willing to use highly effective birth control upon enrollment, during the treatment period, and for 6 months following the last dose of investigational drug or cytarabine, whichever is later.
738
Sexually active subjects (men and women) must agree to use medically accepted barrier methods of contraception (e.g., male or female condom) during the course of the study; all subjects of reproductive potential must agree to use both a barrier method and a second method of birth control during the course of the study
739
Acceptable birth control.
740
Participant must be willing to use two effective forms of birth control during protocol therapy; men and women must continue using two effective forms of birth control for 6 months following treatment
741
Male and female subjects of child-bearing potential must agree to use medically acceptable methods of birth control throughout the study and for thirty (30) days after the last dose of study medication.
742
Men who could father a child must agree to use at least one form of birth control during or continued abstinence from heterosexual intercourse if receiving topical treatment during the study, and for 2 weeks after stopping topical treatment
743
Negative pregnancy test for women of childbearing potential, as defined by intact uterus and ovaries, and a history of menses within the last 12 months; pregnancy test to be performed no greater than 14 days prior to consent in study; in cases of women with elevated beta human chorionic gonadotropin (b-HCG), these candidates will be eligible to participate so long as the level of b-HCG is not consistent with pregnancy; women of childbearing potential need to be on or use contraception, or be abstinent during the study period; their male partners must also use contraception (condom) or maintain abstinence; birth controls specifications; women who are able to become pregnant must use birth control during the study and for 30 days after the last ginseng/placebo dose; acceptable forms of birth control include barrier methods (such as condom or diaphragm) with spermicide
744
Females of childbearing potential must use a highly effective method of birth control for at least 28 days before starting study, during participation and at least 112 days following last dose of sotatercept
745
Agree to utilize medically accepted methods of birth control during study participation and for 90 days following the last treatment with study drug if a female subject is of childbearing potential or if a male subject has an opposite sex partner of child bearing potential.
746
Women of reproductive capability will be enrolled, but each woman needs to discuss with the study team the method of birth control used and if the method is a reliable and effective method for her; if a woman becomes pregnant during the course of active study participation, she must agree prior to enrolling in the study that she will report the pregnancy to the study team; with a confirmed pregnancy, the subject will no longer receive the assigned treatment, but will continue to be followed per protocol
747
If female of reproductive age, or male partner of female of reproductive age, unwilling to use two medically reliable forms of birth control while on vismodegib
748
Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection during the study and for 1 week after the last dose of ranolazine
749
Sexually active female patients of reproductive potential are not eligible unless they agree to use an effective contraceptive method during study and for 2 months after stopping the study drug; abstinence is an acceptable method of birth control
750
Women of childbearing potential (FCBP) must have a negative urine pregnancy test within 7 days prior to randomization enrollment; female participants enrolled in the treatment arm are advised to not become pregnant during study participation; all women of childbearing potential must agree to either commit to continued abstinence from heterosexual intercourse or to use a reliable birth control method during heterosexual intercourse (oral contraceptive pills, intrauterine device, Nexplanon, DepoProvera, or bilateral tubal ligation, etc., or another acceptable method as determined by the investigator) during the entire period of the trial (5 years or more), and must not intend to become pregnant during study participation and for 3 months after treatment is discontinued if the participant is enrolled in the treatment arm; female participants, if engaging in heterosexual intercourse, must be willing to comply with an acceptable birth control regimen as determined by the investigator
751
If currently menstruating, subjects must use a reliable method of birth control
752
Premenopausal women taking non hormonal intra-uterine device (IUD) birth control method will be eligible, if they have been on the same IUD for at least 3 months prior to enrollment and plan to continue using the same method throughout the study
753
Women of childbearing potential (WOCBP) must practice 2 effective methods of birth control during the course of the study; male patients who are partners of WOCBP should also practice an effective method of contraception; effective methods of birth control include diaphragm or condoms with spermicidal foam or jelly, birth control pills (BCPs), injections or patches, intra-uterine devices (IUDs) and surgical sterilization
754
Women and men must continue birth control for the duration of the trial and >= 3 months after the last dose of study drug
755
Female patients of childbearing potential must agree to use an acceptable method of birth control from the signing of informed consent form and to continue its use during the study and for at least 90 days after the final dose
756
Male patients must agree to use an acceptable form of birth control from study day 1 through at least 90 days after the final dose
757
Breast surgeons may recommend that this patient population should not take any oral contraceptives or hormone eluting intrauterine devices (IUDs); sexually active heterosexual women must agree to use an effective form of birth control for the duration of study participation; women who are NOT having 1) a hysterectomy, 2) fallopian tubes removed and/or 3) ovaries removed at the time of their breast surgery will also be required to use an effective form of birth control for 56 days following the last dose of study medication\r\n* The following women are not considered able to bear children and therefore are eligible to participate without the use of concurrent birth control:\r\n** Female with hysterectomy with intact functioning ovaries\r\n** Female with fallopian tubes cut, tied, sealed, or removed\r\n** Female with sterilization implant (e.g. Adiana, Essure) place > 3 months prior to beginning study drug\r\n* One of the following methods of birth control must be used by sexually active women of childbearing potential for the duration of study participation and for 56 days following the last dose of study medication:\r\n** Combined oral contraceptive pill in continuous use for > 90 days prior to study entry\r\n** Vaginal ring (e.g.NuvaRing) in continuous use for > 90 days prior to study entry\r\n** Skin patch (e.g. Ortho Evra) in continuous use for > 90 days prior to study entry\r\n** Injection (e.g. Depo-Proveera, Noristerat) in continuous use prior to study entry\r\n** IUD\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\r\n** Male partner who has had a vasectomy\r\n* Women who indicate that they are abstinent from heterosexual encounters for the duration of study participation and for the 56 days following the last dose of study medication will not be required to use birth control
758
If female, agreement to use birth control (any form) to avoid pregnancy during study procedures
759
If female, must be either post-menopausal (one year or greater without menses), surgically sterile, or, for female subjects of child-bearing potential who are capable of conception must be: practicing two effective methods of birth control
760
If male, must be surgically sterile or willing to practice two effective methods of birth control
761
Sexually active females of childbearing potential and males with partners of child-bearing potential must agree to use adequate birth control during study treatment
762
Willing to use adequate contraception (barrier method, abstinence, subject has had a vasectomy or partner is using effective birth control or is postmenopausal) for the duration of study participation
763
Participants will be required to use a medically-approved method of birth control or abstinence if their sexual partner is of child-bearing potential
764
CONTROL GROUP
765
Participants of reproductive potential agree to remain abstinent, or use a medically accepted method of birth control
766
Women of childbearing potential must agree to use a medically acceptable form of birth control (medically accepted methods: birth control pills, condoms and spermicidal lubricants, intrauterine device, and diaphragm) during their participation in the study
767
Women who are pregnant or breast feeding. Adults of reproductive potential not willing to employ two forms of birth control.
768
Male and female subjects must agree to use a highly reliable method of birth control (expected failure rate less than 5% per year) from the screening visit through 28 days after the last dose of study drug. Women of childbearing potential must have a negative pregnancy test at screening.
769
Male patients must be willing to practice birth control (including abstinence) during and for 4 months after treatment. Female patients must be willing to practice birth control (including abstinence) during treatment and for 4 months after gene modified cells are no longer detected in body.
770
Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy or 180 days after the last dose of durvalumab + tremelimumab combination therapy
771
Are pregnant, breastfeeding, or unwilling to practice an acceptable form of birth control during the study.
772
Female or male participant who is not of reproductive potential, or, if of reproductive potential, agrees to true abstinence or to use (or have their partner use) 2 acceptable methods of birth control from the time of consent through 90 days after the last dose of study drug
773
Fertile subjects must use adequate contraception (abstinence, barrier methods, or birth control pills) prior to study entry and for the duration of study participation
774
All patients of childbearing age must use an acceptable form of birth control
775
Agree to use an acceptable form of birth control for a period of 7 days after the Cu-64-TP3805 injection
776
Not currently on estrogen medication for birth control, menopause, or other reason
777
Women of child-bearing potential must be willing to practice an effective method of birth control while on study
778
All patients of childbearing and child-creating age must be using an acceptable form of birth control
779
Willingness to use birth control while on study
780
CONTROL GROUP
781
All patients of childbearing and child-creating age must be using an acceptable form of birth control
782
Birth weight below five pounds, premature birth prior to 36 weeks of gestation, or ischemic episode at birth
783
Patients who have partners of childbearing potential who are not willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 13 weeks after last study drug administration
784
For women of childbearing potential, agreement to use an effective form of contraception (patient and/or partner, e.g., surgical sterilization, a reliable barrier method, birth control pills, or contraceptive hormone implants) and to continue its use for the duration of the study treatment, and for a minimum of 6 months following trastuzumab and/or pertuzumab administration
785
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
786
Subjects who are of reproductive potential who refuse to use effective methods of birth control during the course of participation of the study and within 5 month for women and 7 months for men of the last dose of investigational agent are ineligible to participate in the study.
787
Subjects of both genders of child-bearing potential who are not willing to practice birth control from the time of consent through 6 months after the completion of KITE-718
788
Patients must not be pregnant; all premenopausal patients will undergo pregnancy testing; men will agree to not father a child while on protocol treatment; men and women will practice effective birth control while receiving protocol treatment
789
Female subjects who are pregnant, breast-feeding or female patients of reproductive potential who are not employing an effective method of birth control from starting vaccine, including dosing interruptions through 90 days after receipt of the last vaccine; refrain from egg cell donation while receiving vaccination and for at least 90 days after the last vaccine
790
Women of childbearing potential not practicing adequate forms of birth control
791
Female of child bearing potential (FCBP) and non-vasectomized male agree to practice appropriate methods of birth control
792
Adequate birth control
793
Pregnancy, lactation or inability to use medically acceptable birth control if of childbearing potential
794
Male participants: Agree to use a reliable method of birth control and to not donate sperm during the study and for at least 12 weeks following last dose of study drug or country requirements, whichever is longer.
795
Sexually active and not willing/able to use medically acceptable forms of contraception (hormonal or barrier method of birth control, abstinence) upon entering the study and for 60 days after injection of LUM015.
796
Female patients of childbearing potential and male patients with partners of childbearing potential must continue to use an effective method of birth control as well as their partners.
797
Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) starting the day entering the study, and for 60 days after injection of the imaging agent.
798
Female patients of child bearing potential and non-vasectomized male patients agree to practice appropriate methods of birth control
799
Males, and female patients who are biologically capable of having children, must agree to use a medically acceptable method of birth control.