Common use of Contraception Clause in Contracts

Contraception. Study therapy may have adverse effects on a fetus in utero. It is not known if pembrolizumab has transient adverse effects on the composition of sperm. Female patients of reproductive potential must agree to use (or have their partner use) acceptable contraception during heterosexual activity to avoid becoming pregnant or impregnating a partner, respectively, while receiving study drug and for 120 days after the last dose of study drug. See Appendix B for acceptable methods of contraception. For this trial, male partners of female patients of child bearing potential will be considered to be of non-reproductive potential if they have azoospermia (whether due to having had a vasectomy or due to an underlying medical condition). Female patients will be considered of non-reproductive potential if they are either: • postmenopausal (defined as at least 12 months with no menses without an alternative medical cause; in women < 45 years of age a high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.); or • have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion, at least 6 weeks prior to screening; or • has a congenital or acquired condition that prevents childbearing.