1. 5 W o me n of C hil d be ari n g P ot e nti al A w o ma n of c hil d beari n g p ote ntial ( W O C B P) is defi ne d as a n y fe m ale w h o has e x perie nce d me narc h e a n d w h o h as n ot u n der g o ne s ur gical sterilizati o n ( h ysterect o m y or bilateral o o p h orect o m y) a n d is n ot p ost me n o pa usal. Me n o pa use is defi n e d as 1 2 m o nt hs of a me n orr h ea i n a w o ma n o ver a ge 4 5 years i n t he a bse nce of ot her bi ol o gical or p h ysi ol o gical ca uses. I n a d diti o n, fe males u n der t he a ge of 5 5 years m ust ha ve a ser u m f ollicle sti m ulati n g h or m o ne ( F S H) le vel > 4 0 mI U/ m L t o c o nfir m me n o pa use. Fe males treate d wit h h or m o ne re place me nt t hera p y ( H R T) are li kel y t o ha v e artificiall y s u p presse d F S H le vels a n d ma y re q uire a was h o ut peri o d i n or der t o o btai n a p h ysi ol o gic F S H le vel. T he d urati o n of t he was h o ut peri o d is a f u n cti o n of t he t y pe of H R T use d. T he d urati o n of t he was h o ut p eri o d bel o w are s u g geste d g ui deli nes a n d t h e i n vesti gat ors s h o ul d use t heir j u d g me nt i n c hec ki n g ser u m F S H le vels. If t h e ser u m F S H le v el is > 4 0 mI U/ ml at a n y ti me d uri n g t he w as h o ut peri o d, t he w o ma n ca n b e c o nsi der e d p ost me n o pa usal: 1 w ee k mi ni m u m f or va gi n al h or m o nal pr o d ucts (ri n gs, crea ms, gels) Pr ot oc ol: Versi o n 8. 0. Se pte m ber 1 9 , 2 0 1 8 Pa ge | 2 5 4 w ee k mi ni m u m f or tra ns der m al pr o d u cts 8 w ee k mi ni m u m f or oral pr o d ucts P os t me n o pa usal w o me n ma y c o nti n ue H R T after F S H testi n g is c o m plete d a n d p ost me n o pa usal stat us is c o nfir me d. Ot her pare nt eral pr o d u cts ma y re q uir e was h o ut peri o ds as l o n g as 6 m o nt hs. 5. 2 Tri al Tre at me nts T he treat me nt t o be us e d i n t his trial is o utli ne d bel o w i n Ta ble 2 Ta ble 2 Trial Treat me nt Dr u g D ose P ote nc y D ose Fre q ue nc y R o ute of A d mi nistrati o n Re gi me n Treat me nt Peri o d Use I n d u cti o n I m m u n ot hera p y I pili m u ma b 3 m g/ k g Q 3 W I V i nf usi o n Da y 1 x 4 c ycl es I n v esti gati o n al Ni v ol u ma b 1 m g/ k g Q 3 W I V i nf usi o n Da y 1 x 4 c ycl es I n v esti gati o n al A d. p 5 3 -D C 1-5 x 1 0 6 via ble p 5 3 + D C Q 2 W I D i njecti o n x3 per st u d y cale n dar I n v esti gati o n al Mai nte na nce I m m u n ot hera p y Ni v ol u ma b 4 8 0 m g Q4W I V i nf usi o n Da y 1 x u ntil disease pr o gressi o n ( P D) I n v esti gati o n al A d. p 5 3 -D C 1-5 x 1 0 6 via ble p 5 3 + D C Q 4 W I D i njecti o n x3 per st u d y cale n dar Trial treat me nt s h o ul d be gi n wit hi n 2 - 3 wee ks of t he le u k o p her esis. 5.