CERVICAL/VULVAR CANCER CLINICAL TRIALS

Transcription

1 CERVICAL/VULVAR CANCER CLINICAL TRIALS ALL-COMERS Primary Treatment Locally Advanced Recurrent Cervical GTFB ( ) TISSUE BANK ALL GYN TISSUE ETCTN (Phase II) ( ) LAO-MD017/#10010 Phase II Study of Atezolizumab (MPDL3280A) in Combination with Bevacizumab I Patients with Recurrent, Persistent or Metastatic Cervical Cancer 1-2 prior therapies Multi- Specific COMERS NRG-GY006 ( ) Phase II RT and Cisplatin Alone or in Combination with Intravenous Triapine in Women with Newly Diagnosed Bulky Stage IB2, Stage II, IIIB, or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal Cancer =88/188 UCH Enrollment=0 =11/22 UCH Enrollment=1 Local PI: Corr Vulvar T3 Study ( ) Merck Pembrolizumab No known mutation

2 ENDOMETRIAL CANCER CLINICAL TRIALS Newly Dx, Stg I-IV STAGE III-IV REC/PERSIS Xenetic ( ) Phase II Sodium Cridanimod + Progestin therapy for patients who have failed progestin monotherapy or are PrR negative = 0/72 0 T3 Study ( ) Pharmamar NEWLY-DX UTERINE LEIOMYOSARCOMA ADVANCED, PERSISTENT, OR RECURRENT UTERINE CARCINOSARCOMA Lurbinectidin No Known mutation Patients must have received one prior line of chemo

3 OVARIAN CANCER CLINICAL TRIALS FRONT-LINE THERAPIES FRONT-LINE MAINTENANCE STG III, IV PHASE 3 GOG 3015/Roche YO39523 ( ) Carbo/Taxol/Bev/Atezolizumab ECOG 0-2 Allows for primary cytoreductive surgery or interval debulking surgery = / Tesaro ( ) Phase 2 Open-label Study to Evaluate the Safety and Efficacy of Niraparib Combined with Bevacizumab as Maintenance Treatment in Patients with Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Following Front-Line Platinum-Based Chemotherapy with Bevacizumab FIGO Stage IIIB-IV Must have complete respsonse to first-line platinumbased treatment Must have received a minimum of 3 cycles of bevacizumab (2 for patients who have undergone interval debulking) = /90 Local CRC: TBD ALL-COMERS COMPLETE RESPONSE TO FRONT-LINE Non Therapeutic GTFB ( ) TISSUE BANK ALL GYN TISSUE GOG 225 ( ) Diet and Physical Activity = 1111/ Guntupalli Local CRC: Becky Kissane Gyn tools/ study flow sheet

4 RECURRENT OVARIAN CANCER CLINICAL TRIALS Platinum-Sensitive Disease ETCTN (Phase II) ( ) LAO-MN026/#8329 PH 1/2 of ABT-888 and Topotecan in patients with Relapsed Ovarian or Primary Peritoneal After Prior Platinum ABT-888 and Topotecan < than 3 lines prior treatment No Prior use of Parp inhibitor of Topotecan =72/102 2 Morphotek ( ) PH 2 double blind placebo controlled study of Farletuzumab in Combination with Carboplatin plus Paclitaxel or Carboplatin plus Pegylated Liposomal Doxorubicin Patients must have low CA125 (<3x s ULN) and measurable disease Only one prior treatment =178/210 2 IIT ( ) PH 1 of SBRT for Patients with Limited Locoregional Recurrences of Ovarian and Uterine Serous Carcinoma Initial oligorecurrence defined as first recurrence after initial standard of care surgery and chemotherapy with 3 or less sites of disease or Subsequent oligorecurrence limited to 3 or less sites of disease or Oligoprogressive disease defined as 3 or less sites of active disease in the setting of otherwise controlled additional systemic disease. Systemic Therapy No limit of on prior lines of systemic therapy =3/18 3 NanoPac ( ) PH 2 IP NanoPac plus 6 cycles of IV Carboplatin/Paclitaxel for Platinum Sensitive Recurrent Pts Undergoing Second Cytoreductive Surgery Intraperitoneal NanoPac during cytoreductive surgery 6 cycles carbo/paclitaxel = 0/61 0 Our site participating in Phase II portion Local PI: Christine Fisher Local CRC: Chelsea Schaefer

5 RECURRENT OVARIAN CANCER CLINICAL TRIALS Platinum-Resistant Disease ETCTN (Phase II) ( ) LAO-MN026/#8329 PH 1/2 of ABT-888 and Topotecan in patients with Relapsed Ovarian or Primary Peritoneal After Prior Platinum ABT-888 and Topotecan < than 3 lines prior treatment No Prior use of Parp inhibitor of Topotecan =71/102 1 Our site participating in Phase II portion NRG GY005 ( ) PH 2/3 Combo Olaparib/Cediranib compared to Olaparib or Cediranib alone or SOC for recurrent Platinum-Resistant or Refractory Ovarian Phase II - Randomized - Olap. & Cediranib vs Olap. vs Cediranib vs standard non- platinum chemo No more than 2 prior treatments /Bev for upfront treatment = 213/650 4 Guntupalli Temp. closed for interim analysis 6/16/17 Local CRC: Leah Clemente OncoMed ( ) Phase 1b Study of OMP-305B83 plus Weekly Paclitaxel in Subjects with Platinum Resistant Ovarian, Primary Peritoneal or Fallopian Tube Cancer Must have received prior bevacizumab and/or >2 prior therapies = 16/30 4 Local PI: Brad Corr NRG GY009 ( ) Randomized Phase II/III of PLD and Atezolizumab vs plus PLD/Bev/Atezo vs PLD/Bev for Platinum Resistant Ovarian 1-2 prior regimens (including primary tx) Measureable or evaluable disease = 22/488 0 Guntupalli Local CRC: Leah Clemente Nucana ( ) Phase II Open-Label Study of NUC-1031 in Patients with Platinum-Resistant Ovarian Cancer At least 3 prior chemotherapy containing regimens = 0/64 0 IIT ( ) PH 1 of SBRT for Patients with Limited Locoregional Recurrences of Ovarian and Uterine Serous Carcinoma Initial oligorecurrence defined as first recurrence after initial standard of care surgery and chemotherapy with 3 or less sites of disease or Subsequent oligorecurrence limited to 3 or less sites of disease or Oligoprogressive disease defined as 3 or less sites of active disease in the setting of otherwise controlled additional systemic disease. Systemic Therapy No limit of on prior lines of systemic therapy =3/18 3 Local PI: Christine Fisher Local CRC: Chelsea Schaefer