SERVICE DE GYNÉCOLOGIE-ONCOLOGIE PROTOCOLES EN RECRUTEMENT

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1 SERVICE DE GYNÉCOLOGIE-ONCOLOGIE PROTOCOLES EN RECRUTEMENT OVAIRES PROTOCOLES PTES PHASE DESCRIPTION OV25 DP/GSO/GSO/FG 6 II PRÉVENTION A Randmized Phase II Duble-Blind Placeb-Cntrlled Trials f Acetylsalicylic Acid (ASA) in Chempreventin f Ovarian Cancer with BRCA 1 and 2 Mutatins (STICs and STONEs) Previusly dcumented germline BRCA1/2 pathgenic mutatin r likely pathgenic variant based n the ACMG 2015 guidelines. Risk-reducing surgery (bilateral salping-phrectmy r bilateral salpingectmy inclusive f fimbria) scheduled fr within 6 mnths t 2 years after the date f randmizatin as standard f care. Surgery shuld nt be delayed t allw subjects t participate in the trial. Subjects with a previus unilateral salpingectmy/phrectmy fr ther reasns will be eligible. 1 LIGNE 2 LIGNES A Phase 1b Study t Evaluate the Safety, Tlerability and Pharmackinetics f Mirvetuximab Sravtansine (IMGN853) in Cmbinatin with Bevacizumab, Carbplatin, Pegylated GY014Lipsmal Dxrubicin, Pembrlizumab, r Bevacizumab + Carbplatin, in Adults with Flate Receptr Alpha Psitive Advanced Epithelial Ovarian Cancer, Primary Peritneal Cancer, r Fallpian Tube Cancer FORWARD2 DP/NG/ET/AV 2 Ib Advanced EOC Primary peritneal cancer Fallpian tube cancer Patients must have cnfirmatin f FRα + Patients must have at least ne lesin that meets the definitin f measurable disease accrding t RECIST 1.1. Patients must have received 1 but nt mre than 2 prir systemic treatment regimens; prir systemic treatment regimens may include VEGF inhibitrs (including BEV), and must include at least ne platinum-based chemtherapy. Adjuvant ±Neadjuvant will be cnsidered as ne regimen Maintenance therapy will be cnsidered t be part f the preceding regimen Patients wh have received IMGN853 are excluded. Patients must have ptentially platinum sensitive disease. Platinum sensitive disease is disease that respnded t platinum therapy and did nt prgress within 6 mnths f cmpleting the treatment. Time frm prir therapy: Systemic anti-neplastic therapy: five half-lives r fur weeks, whichever is shrter Raditherapy: wide-field raditherapy (e.g. > 30% f marrwbearing bnes) cmpleted at least fur weeks, r fcal radiatin

2 LIGHT DP/GL/ET/AV ARIEL4 DP/ST/ET/AV cmpleted at least tw weeks, prir t starting study treatment. 2 LIGNES (sensible 1ière ligne) 9 II 2 III Nn-Randmized, Open-Label Phase II Study t Assess Olaparib Tablets as a Treatment fr Subjects with Different HRD Tumr Status and with Platinum-Sensitive, Relapsed, High-Grade Serus r High-Grade Endmetriid Ovarian, Fallpian Tube, r Primary Peritneal Cancer That Have Received at Least 1 Prir Line f Chemtherapy HGSerus/HGEndmetriid At least 1 lesin (RECIST v1.1) that can be accurately assessed at baseline by CT/MRI and is suitable fr repeated assessment; At least 1 prir platinum-based line f chemtherapy fr varian cancer. Nte: There is n limit n the number f lines f chemtherapy Partially-platinum-sensitive (defined as prgressin 6 t 12 mnths after the end f the last platinum-based chemtherapy) r platinum-sensitive (defined as prgressin > 12 mnths after the end f the last platinumbased chemtherapy) A Phase 3 Multicenter, Randmized Study f Rucaparib versus Chemtherapy in Patients with Relapsed, BRCA-Mutant, High-Grade Epithelial Ovarian, Fallpian Tube, r Primary Peritneal Cancer Have a histlgically cnfirmed diagnsis f high-grade serus r Grade 2 r Grade 3 endmetriid epithelial varian, fallpian tube, r primary peritneal cancer If mixed histlgy, > 50% f the primary tumr must be cnfirmed t be high-grade serus r endmetriid upn review by lcal pathlgy Patients with a histlgy f ther than serus r endmetriid are als eligible if they are knwn t harbr a deleterius germline r smatic BRCA1/2 mutatin Received min 1 platin sensible Pas de taxl Hebd, sensible au 1er platin. Received 2 prir chemtherapy regimens and have relapsed r prgressive disease as cnfirmed by radilgic assessment Had dcumented treatment-free interval f 6 mnths fllwing the first chemtherapy regimen received Hrmnal agents (eg, tamxifen, letrzle, etc), anti-angigenic agents (eg, bevacizumab, pazpanib, cediranib, etc), and ther nn-chemtherapy agents will nt be cunted as a chemtherapy regimen fr the purpse f determining patient eligibility Agents administered in the maintenance setting will nt be cunted as a separate regimen Have either a deleterius BRCA1/2 mutatin as cnfirmed by the central labratry. Nte: patients knwn t harbr a deleterius germline r smatic BRCA1/2 mutatin based n lcal assessment may be enrlled withut central tissue analysis prvided there is cnfirmatin that tumr tissue is available t be prvided t the central labratry. MAINTENANCE COL MAINTENANCE

3 Regenern (empwer) R2810-ONC-1676 VS/ST/CT/FG AIM2CERV 1 CX.5 VS/ST/ET/FG GARNET VS/ST/ET/AV 11 III 34 III 5 III 1 LIGNE An Open Label, Randmized, Phase 3 Clinical Trial f REGN2810 vs Therapy f Investigatr's Chice Chemtherapy in Recurrent r metastatic Platinum- Refractry Cervical Carcinma Recurrent, persistent, and/r metastatic cervical cancer, fr which there is nt a curativeintent ptin (surgery r radiatin therapy with r withut chemtherapy). Acceptable histlgies are squamus carcinma, adencarcinma, and adensquamus carcinma. Sarcmas and neurendcrine carcinmas are nt eligible histlgies. Tumr prgressin r recurrence within 6 mnths f last dse f platinum therapy that was used t treat metastatic, persistent r recurrent cervical cancer Patients must meet at least ne f the fllwing criteria regarding prir bevacizumab therapy: Received prir bevacizumab-cntaining therapy, which was discntinued due t prgressin f disease Received prir bevacizumab-cntaining therapy, which was discntinued due t txicity Was deemed unsuitable fr prir bevacizumab therapy fr ne f the fllwing reasns: Unacceptable risk f fistula frmatin, prly cntrlled hypertensin, lw risk disease accrding t the Mre Criteria Refused prir bevacizumab therapy. Did nt have access t bevacizumab therapy due t lgistical reasns Patients must meet at least ne f the fllwing criteria regarding prir paclitaxel therapy: Received prir paclitaxel-cntaining therapy, which was discntinued due t prgressin f disease Received prir paclitaxel-cntaining therapy, which was discntinued due t txicity Was deemed unsuitable fr prir paclitaxel therapy fr ne f the fllwing reasns: Neurpathy allergy t paclitaxel r its cmpnents Refused prir paclitaxel therapy Cancer du cl précce et à faible risque Cmparer hystérectmie radicale u simple cmbinés à la dissectin des ganglins pelviens ENDOMÈTRE 1 ière LIGNE, 2 ième LIGNE A Phase 1 Dse Escalatin and Chrt Expansin Study f TSR-042, an anti-pd-1 Mnclnal Antibdy, in Patients with Advanced Slid Tumrs Part 2B: Histlgically r cytlgically prven recurrent r advanced slid tumr with measurable lesin(s) per RECIST v.1.1 and meets ne f the fllwing disease types: Chrt A1 (MSI-H endmetrial cancer) Chrt A2 (MSS endmetrial cancer) Patients must have prgressed n r after platinum dublet therapy 2 lines fr recurrent/advanced ( Stage IIIB) disease. Prir Tx with hrmne therapies is acceptable and des nt cunt twards the number f anti-cancer therapies nted in the criterin abve fr this chrt. All endmetrial cancer histlgies are allwed except endmetrial sarcma (including carcinsarcma). Pt must submit 2 scans demnstrating increase in tumr measurement that meet criteria fr PD based n RECIST v.1.1 Presence f at least 1 measurable lesin n baseline scan will be cnfirmed by central radilgy review. MSI (MSI-H vs MSS) shuld be knwn via lcal r central lab testing befre patients receive the first dse f TSR-042.

4 TAK-C31004 DP/NG/SDS/AV 5 II Chrt B: SqCC f anus, penis, cervix, vagina, r vulva wh have prgressed n r after at least 1 prir systemic Tx fr recurrent r advanced disease. Chrt C - Patients with serus r clear cell varian, fallpian tube, r primary peritneal cancer wh have recurrent disease and were previusly treated with chemtherapy fr recurrent r advanced disease and wh are currently cnsidered platinum-resistant r refractry. Chrt D - Patients with breast cancer that is human epidermal grwth factr receptr 2 (HER2)-negative, estrgen receptr-negative, and prgesterne receptrnegative (TNBC) wh have prgressed n r after at least 1 prir regimen fr recurrent r advanced disease r wh relapsed/prgressed while n r within 1 mnth frm cmpletin f adjuvant chemtherapy. Chrt E - Patients with NSCLC wh prgressed after at least 1 prir platinum-based systemic chemtherapy regimen fr recurrent r advanced disease. Chemtherapy regimen in the adjuvant r neadjuvant setting fllwing surgery and/r radiatin is acceptable if recurrent r advanced disease develps within 6 mnths frm cmpletin f therapy Patients with a knwn epidermal grwth factr receptr (EGFR) mutatin must have received a chemtherapy regimen and an EGFR tyrsine kinase inhibitr (TKI) (e.g., erltinib, gefitinib, afatinib, r experimental) Patients with a knwn anaplastic lymphma kinase (ALK) translcatin must have received a chemtherapy regimen and an ALK inhibitr (e.g., criztinib, ceritinib, r experimental) Chrt F Patients with recurrent r advanced MSI-H slid tumrs r POLE-mut slid tumrs, except endmetrial cancers, that have prgressed fllwing up t 2 prir lines f systemic therapy fr recurrent r advanced ( Stage IIIB) disease and wh have n alternative treatment ptins. A Phase 2, Randmized Study f MLN0128 (a Dual TORC1/2 Inhibitr), MLN0128+MLN1117 (a PI3Kα Inhibitr), Weekly Paclitaxel, r the Cmbinatin f Weekly Paclitaxel and MLN0128 in Wmen With Advanced, Recurrent, r Persistent Endmetrial Cancer Histlgic r cytlgic diagnsis f endmetrial carcinma Endmetriid Serus Mixed adencarcinma Clear-cell carcinma Carcinsarcma). Evidence that the endmetrial cancer is advanced, recurrent, r persistent and has relapsed r is refractry t curative therapy r established treatments. At least 1 prir platinum-based regimen, nt mre than 2 prir. Prir treatment may include chemtherapy, chemtherapy/radiatin therapy, and/r cnslidatin/maintenance therapy. Chemtherapy administered in cnjunctin with primary radiatin as a radi-sensitized therapy will be cnsidered a systemic chemtherapy regimen. LUNCHBOX BC/NG/ET/AV 5 III A Randmized Phase III Trial f Cisplatin and Tumr Vlume Directed Irradiatin Fllwed by Carbplatin and Paclitaxel Vs. Sandwich Therapy f Carbplatin and Paclitaxel Fllwed by Tumr Vlume Directed Irradiatin Then Further Carbplatin and Paclitaxel fr Optimally Debulked Advanced Endmetrial Carcinma All patients with Surgical Stage III r IVA endmetrial carcinma per FIGO 2009 staging criteria, including clear cell and serus papillary and undifferentiated carcinmas Surgical Stage III disease includes thse patients with psitive adnexa, parametrial invlvement, tumr invading the sersa, psitive pelvic and/r para-artic ndes, r vaginal invlvement Surgical Stage IVA includes patients with bladder r bwel mucsal invlvement, but n spread utside the pelvis

5 Patients with FIGO 2009 surgical Stage I r II endmetrial clear cell r serus carcinma and with psitive peritneal cytlgy Surgery must have included a hysterectmy and bilateral salpingphrectmy. Pelvic lymph nde sampling and para-artic lymph nde sampling are ptinal. KEYNOTE-775 DP/GL/GSO/AV 0 III MK3475 Prtcl 775 A Multicenter, Open-label, Randmized, Phase 3 Trial t Cmpare the Efficacy and Safety f Lenvatinib in Cmbinatin with Pembrlizumab Versus Treatment f Physician s Chice in Participants with Advanced Endmetrial Cancer Histlgically cnfirmed diagnsis f endmetrial carcinma. Dcumented evidence f advanced, recurrent r metastatic EC. Radigraphic evidence f disease prgressin after 1 prir systemic, platinum -based chemtherapy regimen fr recurrent, metastatic r primary unresectable disease. Participants wh prgress <1 year after cmpletin f prir adjuvant r neadjuvant platinum-based chemtherapy are eligible withut further systemic treatment. Participants wh prgress 1 year after cmpletin f prir adjuvant r neadjuvant platinum-based chemtherapy must receive 1 additinal cyttxic systemic treatment prir t enrllment in this study.