Male and female patients able to have children must agree to use 2 highly effective methods of contraception throughout the study and for at least 90 days after last dose of chemotherapy or at least 30 days after last dose of avelumab, whichever is longer
Both male and female subjects must be willing to use highly effective contraception (that is, methods with a failure rate of less than 1% per year) throughout the study and for at least 30 days after last avelumab treatment administration if the risk of conception exists\r\n* (NOTE: Women of childbearing potential and men must agree to use highly effective contraception, as stipulated in national or local guidelines; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, the treating physician should be informed immediately)
Highly effective contraception (i.e., methods with a failure rate of less than 1 % per year) for both male and female subjects if the risk of conception exists (Note: The effects of the trial treatment on the developing human fetus are unknown; thus, women of childbearing potential and men must agree to use highly effective contraception, defined in Protocol Appendix 9.3, or as stipulated in national or local guidelines. Highly effective contraception must be used for the duration of trial treatment, and at least for 60 days after stopping trial treatment or 6 months after stopping chemotherapy [or per label]. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this trial, the treating physician should be informed immediately).
Patient (male or female) ?18 years of age willing to agree to not father a child/become pregnant and comply with effective contraception criteria.
Effective contraception during the study period and for 5 months after the last study treatment administration (male and female patient)
Male participants must have had a successful vasectomy (confirmed azoospermia) or they and their female partners must meet the criteria above (ie, not of childbearing potential or practicing highly effective contraception and use a condom throughout the study period and for 90 days after study drug discontinuation)
do not agree to use a highly effective method of contraception for the entire study period and for 28 days after study drug discontinuation, ie:
Pregnant or breastfeeding; males and females of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after last dose of investigational product
Vasectomy (A vasectomy is a highly effective contraception method provided the absence of sperm has been confirmed. If not, an additional highly effective method of contraception should be used.)
Agreement to use highly effective contraceptive methods as stated in protocol
Highly effective contraception for both male and female subjects if the risk of conception exists. Highly effective contraception must be used 30 days prior to first trial administration, for the duration of trial treatment, and at least for 4 months after stopping trial treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this trial, the treating physician should be informed immediately.
Women who are unwilling, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of randomization and for at least 30 days after the last dose of study drug. Men who are unwilling, if not surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of randomization and for at least 90 days after the last dose of study drug.
Highly effective contraception for both male and female subjects if the risk of conception exists. Highly effective contraception must be used 30 days prior to first trial administration, for the duration of trial treatment, and at least for 4 months after stopping trial treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this trial, the treating physician should be informed immediately.
Male and female patients able to have children must agree to use 2 highly effective methods of contraception throughout the study and for at least 60 days after last dose
Do not agree to use a highly effective method of contraception for the entire study period and for 6 months after study drug discontinuation, ie:
Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria above (ie, not of childbearing potential or practicing highly effective contraception throughout the study period or for 3 months after study drug discontinuation). No sperm donation is allowed during the study period or for 3 months after study drug discontinuation.
Highly effective contraception for both male and female subjects throughout the study and for at least 120 days after last avelumab treatment administration if the risk of conception exists
Highly effective contraception for male subjects with childbearing potential throughout the study and for at least 60 days after last avelumab treatment administration if the risk of conception exists
Highly effective contraception for both male and female subjects if the risk of conception exists; Note: women of childbearing potential and men able to father a child must agree to use 2 highly effective contraception, defined as methods with a failure rate of less than 1% per year; highly effective contraception is required at least 28 days prior, throughout and for at least 60 days after avelumab treatment
Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria above (ie, not of childbearing potential or practicing highly effective contraception throughout the study period or for 6 months after study drug discontinuation)
Fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 105 days after the last dose of investigational product.
Contraception should be continued using two highly effective methods for a period of 90 days
Highly effective contraception for both male and female subjects if the risk of conception exists; (Note: women of childbearing potential and men must agree to use highly effective contraception, defined as 2 barrier methods, or 1 barrier method with a spermicide, an intrauterine device or use of oral female contraceptive; effective contraception must be used 30 days prior to first study drug administration, for the duration of trial participation, and at least for 30 days after last avelumab treatment administration if the risk of conception exists; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this trial, the treating physician should be informed immediately)\r\n* Pregnancy test: negative serum or urine pregnancy test at screening for women of childbearing potential
Highly effective contraception for both male and female subjects if the risk of conception exists; (Note: the effects of the trial drug on the developing human fetus are unknown; thus, women of childbearing potential and men able to father a child must agree to use 2 highly effective contraception, defined as methods with a failure rate of less than 1 % per year; highly effective contraception is required at least 28 days prior, throughout and for at least 60 days after avelumab treatment
Must agree to the use of effective contraception while on study treatment, unless they are highly unlikely to conceive (defined as [1] surgically sterilized, or [2] postmenopausal [i.e., a woman who is > 50 years old or who has not had menses for >= 1 year], or [3] not heterosexually active for the duration of the study)
A female of childbearing potential unwilling to use highly effective method of contraception during treatment and for an additional 48 hours (Period 1) or 72 hours (Period 2), respectively, after the last dose of blinatumomab.
Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must use highly effective methods of contraception during the study and 8 weeks after; highly effective contraception methods include combination of any two of those listed in the protocol
Female subjects of childbearing potential or male subjects who are unwilling to use 2 highly effective methods of contraception during study treatment and through 3 months after the last dose of study treatment
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 1 months after pasireotide s.c. last dose and 3 months after pasireotide LAR last dose Highly effective contraception methods include:
Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must use highly effective methods of contraception during the study and 8 weeks after; highly effective contraception methods include combination of any two of the following:
Both male and female patients must be willing to consent to using highly effective contraception prior to study entry, while on treatment and at least 3 months thereafter.
Do not agree to use a highly effective method of contraception for the entire study period and for 6 months after study drug discontinuation, ie:
Males who have not had a successful vasectomy (confirmed azoospermia) or if they and their female partners do not meet the criteria above (ie, not of childbearing potential or practicing highly effective contraception throughout the study period or for 28 days after study drug discontinuation). No sperm donation is allowed during the study period or for 28 days after study drug discontinuation.
Highly effective contraception
Consent to use one highly effective method of contraception
WOCBP or males with a WOCB partners not willing to use highly effective and medically accepted methods of contraception for 90 days after last study drug administration.
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the study and for 30 days after the final dose of imatinib. Male patients must use highly effective contraception during the study and for 30 days after the final dose of imatinib. Highly effective contraception is defined as either:
Male subject's using contraception should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Males are eligible to participate if they as detailed below: Agree to use a male condom and female partner to use an additional highly effective contraceptive method with a failure rate of <1% per year when having sexual intercourse with a WOCBP who is not currently pregnant.
Patients who are unwilling or unable to use 2 highly effective methods of contraception as outlined in this protocol
Women who are pregnant or breastfeeding, or male or female patients of reproductive potential who are not employing two highly effective and acceptable forms of contraception throughout their participation in the study and for 90 days after last dose of study drug
For fertile patient (female able to become pregnant or male able to father a child), refusal to use effective contraception during the period of the trial and for 6 months after the last dose of rucaparib
Negative pregnancy test done =< 72 hours prior to registration for women of childbearing potential only; Note: all female subjects will be considered to be of child-bearing potential unless they are postmenopausal (at least 12 months consecutive amenorrhea, in the appropriate age group and without other known or suspected cause), or have been sterilized surgically (i.e., bilateral tubal ligation >= 1 menstrual cycle prior to randomization, or have undergone a hysterectomy and/or bilateral oophorectomy)\r\n* All female subjects will be considered to be of child-bearing potential unless they are postmenopausal (at least 12 months consecutive amenorrhea, in the appropriate age group and without other known or suspected cause), or have been sterilized surgically (i.e., bilateral tubal ligation >= 1 menstrual cycle prior to randomization, or have undergone a hysterectomy and/or bilateral oophorectomy); female subjects of child-bearing potential must agree to use highly effective contraception during the study treatment and for 3 months after the final dose of study treatment; female subjects exempt from this requirement are subjects who practice total abstinence; if currently abstinent, the subject must agree to use a double barrier method of contraception (i.e., condom and occlusive cap [diaphragm or cervical/vault caps]) with spermicide or until they are established on highly effective contraception for at least one menstrual cycle if they become sexually active during the study treatment and for 3 months after the final dose of study treatment\r\n* Highly effective contraception includes:\r\n** Placement of intrauterine device or system\r\n** Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault cap) with spermicide\r\n** Vasectomized partner with confirmed azoospermia\r\n* Male subjects and their female partner who are of child-bearing potential (as defined above), and are not practicing total abstinence, must agree to use highly effective contraception during study treatment and for 3 months after the final dose of study treatment; if currently abstinent, the subject must agree to use a double barrier method of contraception if they become sexually active, or until they are established on highly effective contraception as described above
Women of childbearing potential must use highly effective methods of contraception throughout the study and for 4 months after study drug discontinuation
Subjects with reproductive potential must be willing to use, in combination with his/her partner, 2 highly effective methods of effective contraception or practice sexual abstinence throughout the study and continue for 5 months after the study duration; subjects who are surgically sterile (e.g. history of bilateral tubal ligation, hysterectomy) or whose sexual partner is sterile (e.g. history of vasectomy) are not required to use additional contraceptive measures
Highly effective contraception for both male and female subjects if the risk of conception exists
Patient who does not apply highly effective contraception during the study and through the duration as defined below after the final dose of study treatment
Use of highly effective contraception (as defined by protocol) and until 5 months after the last dose of atezolizumab and for 3 months after the last dose of alectinib or for 2 weeks after the last dose of erlotinib, whichever is longer; Males must also refrain from sperm donatation during this same time period. Participants must not be pregnant or breastfeeding.
? 18 years of age 7. Life expectancy of ? 6 months per the investigator 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 9. ECG without evidence of clinically significant arrhythmia or ischemia 10. If female of childbearing potential (FCBP), willing to undergo pregnancy testing and agrees to use at least one highly effective or two effective contraceptive methods during the dosing period and for three months after last CMB305 injection 11. If male and sexually active with a FCBP, must agree to use highly effective contraception such as latex condom during the dosing period and for three months after last CMB305 injection
If female of childbearing potential (FCBP), willing to undergo pregnancy testing and agrees to use at least one highly effective or two effective contraceptive methods during the dosing period and for three months after last LV305 injection. If enrolled on the arm that includes pembrolizumab, agrees to use highly effective contraceptive methods during the dosing period and for 120 days after last injection of study drug.
If male and sexually active with a FCBP, must agree to use highly effective contraception such as latex condom during the dosing period and for three months after last LV305 injection. If enrolled on the arm that includes pembrolizumab, agrees to use highly effective contraceptive methods during the dosing period and for 120 days after last injection of study drug.
Use of highly effective method of contraception as defined by the protocol
If male and sexually active with a FCBP, must agree to use highly effective contraception such as latex condom or is sterile (e.g. following a surgical procedure) during the dosing period and for three months after last study treatment, or if receiving pembrolizumab, four months after last treatment
Highly effective contraception for both male and female subjects, if the risk of conception exists
For female and male patients who are fertile, agree to use a highly effective form of contraception, as defined by the study protocol.
Pregnancy Prevention Patients of childbearing or child fathering potential must use a highly effective method of contraception throughout the study while taking the drug and for 21 days after stopping treatment
Male participants must have had a successful vasectomy (confirmed azoospermia) or they and their female partners must meet the criteria above (ie, not of childbearing potential or practicing highly effective contraception throughout the study period and for 6 months after discontinuation of chemotherapy and for 5 weeks after Test Article (amatuximab or placebo) discontinuation (whichever is later). No sperm donation is allowed during the study period and for 90 days after Test Article discontinuation.
Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing a highly effective form of contraception. During the study treatment and for 8 weeks after stopping the treatment. Highly effective contraception methods include combination of any two of the following:
Use of highly effective contraception as defined by the study protocol
Male subjects must have had a successful vasectomy (confirmed azoospermia) or they and their female partners must meet the criteria above (i.e., not of childbearing potential or practicing highly effective contraception throughout the study period and for 30 days after study drug discontinuation). No sperm donation is allowed during the study period and for 30 days after study drug discontinuation.
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.
Effective contraception for both male and female subjects if the risk of conception exists
Agreement to use highly effective contraceptive methods per protocol
Female and male participants who are fertile must agree to use a highly effective form of contraception with their sexual partners throughout study participation.
Patients must agree to use highly effective contraception (details outlined in the consent form) during treatment and for a period of 90 days after ending treatment with palbociclib
Use of highly effective contraception
Is a non-sterile male or female willing to use of one of the protocol-defined highly effective contraception methods:
Female patients of childbearing potential (a female not free from menses > 2 years or not surgically sterilized) must be willing to use highly effective contraception to prevent pregnancy or agree to abstain from heterosexual activity throughout the study; highly effective contraception, defined as male condom with spermicide, diaphragm with spermicide, intra-uterine device; highly effective contraception must be used by both sexes during the study and must be continued for 5 months after the last dose of denosumab
Male subjects must have had a successful vasectomy (confirmed azoospermia) or they and their female partners must meet the criteria above (i.e., not of childbearing potential or practicing highly effective contraception throughout the study period and for 30 days after study drug discontinuation). No sperm donation is allowed during the study period and for 30 days after study drug discontinuation.
Women of child-bearing potential unless they are using highly effective methods of contraception during the dosing and for at least 36 hours after last dose. Highly effective contraception as defined in the protocol.
Pregnant and nursing women, or women planning to become pregnant within 6 months after the end of treatment, are excluded from this study; a negative pregnancy test will be required of women of child-bearing age within 72 hours of study enrollment; subjects (male or female) who are not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment are excluded
Effective contraception for both male and female subjects if risk of conception exists.
For both male and female patients, effective methods of contraception must be used throughout the study and for 3 months following the last dose of study treatment
Male subjects must be surgically sterile or must agree to use highly effective physician-approved contraception from Screening to 90 days following the last study drug administration
Male and female patients of childbearing potential and at risk for pregnancy must agree to use two (2) highly effective methods of contraception throughout the study and for 60 days after the last dose of assigned study treatment.
Male subjects able to father children and female patients of childbearing potential and at risk for pregnancy must agree to use two highly effective methods of contraception throughout the study and for 90 days after the last dose of assigned treatment.
Vasectomy (A vasectomy is a highly effective contraception method provided the absence of sperm has been confirmed. If not, an additional highly effective method of contraception should be used).
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 45 days after stopping study medication. Highly effective contraception methods include:
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception throughout the study and for 3 months after study drug discontinuation; highly effective methods of contraception are further defined
Effective contraception during the study period and for 3 months after the last study treatment administration (male and female patient)
Males who have had a successful vasectomy (confirmed azoospermia) or they and their female partners meet the criteria above (that is, not of childbearing potential or practicing highly effective contraception throughout the study period or for 120 days after study drug discontinuation). No sperm donation is allowed during the study period or for 120 days after study drug discontinuation.
Patient who does not apply highly effective contraception during the study from screening until 90 days after discontinuing study treatment Protocol No. PQR309-003 Protocol Amendment 3, 23 September 2015 PIQUR Therapeutics AG - Confidential Page 16 of 108 (see section 11.3).
Highly effective contraception as defined by the protocol Participants with Ovarian Cancer
Women and men of reproductive potential must agree to use highly effective contraception when sexually active. This applies for the period between signing of the informed consent and 30 days after the last administration of study drug. Highly effective contraception includes a hormonal contraception with implants or combined oral contraceptives, certain intrauterine devices, bilateral tubal ligation, hysterectomy, or vasectomy of the partner. In addition, the use of condoms for subjects or their partners is required.
Use of highly effective form of contraception
Patient who does not use highly effective contraception methods to avoid becoming pregnant or conceiving offspring.
All female subjects will be considered to be of child-bearing potential unless they are postmenopausal (at least 12 months consecutive amenorrhea, in the appropriate age group and without other known or suspected cause), or have been sterilized surgically (i.e., bilateral tubal ligation greater than or equal to 1 menstrual cycle prior to randomization, or have undergone a hysterectomy and/or bilateral oophorectomy). Female subjects of child-bearing potential must agree to use two forms of highly effective contraception from the last menstrual period prior to randomization (or use a double barrier method as described below until they are on two forms of highly effective contraception for at least one menstrual cycle), during the study treatment, and for 3 months after the final dose of study treatment. Female subjects exempt from this requirement are subjects who practice total abstinence. If currently abstinent, the subject must agree to use a double barrier method of contraception, i.e., condom and occlusive cap (diaphragm or cervical/vault caps) with spermicide or until they are on two forms of highly effective contraception for at least one menstrual cycle if they become sexually active during the study treatment and for 3 months after the final dose of study treatment. Highly effective contraception includes:
Male subjects and their female partner who are of child-bearing potential (as defined in Inclusion 10), and are not practicing total abstinence, must agree to use two forms of highly effective contraception from the last menstrual period of their female partner prior to randomization (or use a double barrier method as described above until they are on two forms of highly effective contraception for at least one menstrual cycle), during study treatment, and for 3 months (or 6 months if they received dacarbazine) after the final dose of study treatment. If currently abstinent, must agree to use a double barrier method of contraception if they become sexually active, or until they are on two forms of highly effective contraception as described above.
Concurrent oral contraceptive use / Women of childbearing potential not using highly effective means of contraception;
Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria above (i.e., not of childbearing potential or practicing highly effective contraception throughout the study period or for 28 days after study drug discontinuation). No sperm donation is allowed during the study period and for 28 days after study drug discontinuation.
Woman of reproductive potential must agree to use highly effective methods of birth control during the period of therapy and for 30 days after the last dose of the study drug; men who are sexually active must agree to use highly effective contraception during the period of therapy and for 3 months after the last dose
All subjects, except post-menopausal women, must be willing to utilize a highly effective method of contraception throughout the study
Females of childbearing potential should avoid becoming pregnant and use highly effective contraception while on treatment and for at least 1 month after finishing treatment.
Highly effective contraception for both male and female subjects if the risk of conception exists; (Note: women of childbearing potential and men able to father a child must agree to use 2 methods of highly effective contraception, defined as methods with a failure rate of less than 1 % per year; highly effective contraception is required at least 28 days prior, throughout and for at least and 5 months following the last dose of trabectedin)
Pregnant females; breastfeeding females; males and females of childbearing potential; males and females of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception for at least 28 days after last dose of investigational product; males and females of childbearing potential not using two (2) methods of highly effective contraception or not agreeing to continue two (2) methods of highly effective contraception for at least 28 days after last dose of investigational product.
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the study and for 14 days after the final dose of nilotinib. Highly effective contraception is defined as either:
Sexually active women and men of reproductive potential must agree to use highly effective contraception. This applies for the period between signing of the informed consent and 3 months after the last administration of study drug. These procedures should be documented in source documents. The investigator or a designated associate is requested to advise the patient on how to achieve highly effective birth control. Highly effective contraception includes: