Program. NSGO-CTU Biannual Investigator Meeting 30 November

Transcription

1 Nordic Society of Gynaecological Oncology Clinical Trial Unit Program NSGO-CTU Biannual Investigator Meeting 30 November Bella Sky Hotel, Center Blvd. 5, 2300 København S This meeting is partly sponsored by several pharma companies

2 Friday 30 November Registration Welcome Mansoor Raza Mirza, NSGO-CTU Future plans and status report of NSGO-CTU activities, Mansoor Raza Mirza, NSGO Surgical trials Scientific rational, evidence for and study designs will be presented followed by a panel discussion to discuss potential impact Chair: Johanna Mäenpää, Tampere, Finland Overview of Surgical trials: - AGO-OVAR OP.4/DESKTOP III - LION - AGO OVAR OP.7/AGO OVAR 19/TRUST Johanna Mäenpää, Tampere, Finland AGO OVAR OP.7/AGO OVAR 19/TRUST A multicenter prospective randomized study of primary radical vs. interval debulking surgery for advanced ovarian cancer Berit Jul Mosgaard, Copenhagen, Denmark Panel discussion Ulla Puistola, Oulu, Finland Päivi Lindvall Kannisto, Lund, Sweden Ingvild Vistad, Kristianssand, Norway Yun Wang, Oslo, Norway First line trials - Scientific rational, evidence for and study designs will be presented followed by a panel discussion to discuss potential impact of outcome Chair: Elisabeth Åvall Lundqvist, Linköping, Sweden Overview of First line trials: - ENGOT Ov-15/AGO-OVAR 17/GINECO OV118/BOOST - ENGOT OV-23/EWOC-1 - AGO-OVAR12 - OVAR16 - PRIMA - ENGOT-ov25/PAOLA-1 - ENGOT-ov39/IMagyn050 - ENGOT-ov44/First - DUO-O - ENGOT-ov45/NCRI/ATHENA Elisabeth Åvall Lundqvist, Linköping, Sweden

3 COFFEE ENGOT-ov44/First - An adaptive Randomized Phase 3 Comparison of Standard Platinum Based Treatment Versus Platinum and TSR-042 followed by Niraparib and TSR-042 maintenance Therapy in Patients with pithelial Stage III or IV Cancer of the Ovary, Fallopian Tube, or Peritoneum Bent Fiane, Stavanger, Norway DUO-O - Phase III Randomised, Double Blind, Placebo Controlled, Multicentre Study of durvalumab in combination with chemotherapy and bevacizumab followed by maintenance durvalumab, bevacizumab and olaparib in newly diagnosed advanced ovarian cancer patients Jørn Herrstedt, Roskilde, Denmark ENGOT-ov45/NCRI/ATHENA - A Multicenter, Randomized, Double-Blind, Placebo- Controlled Phase 3 Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment following Response to Front-Line Platinum- Based Chemotherapy Elisabeth Hjerpe, Stockholm, Sweden Panel discussion Henna Karkkainen, Kuopio, Finland Marit Sundset, Trondheim, Norway Relapsed disease - Scientific rational, evidence for and study designs will be presented followed by a panel discussion to discuss potential impact of outcome Chair: Annika Auranen, Tampere, Finland Overview of trials where platinum is an option: - INOVATYON - NOVA - ENGOT-OV24-NSGO/AVANOVA - ENGOT-ov38/OReO - ENGOT-ov34/2.29 Annika Auranen, Tampere, Finland NOVA - A phase 3 randomized double-blind trial of maintenance with Niraparib versus placebo in patients with platinum sensitive ovarian cancer Olesya Solheim, Oslo, Norway ENGOT-OV24-NSGO/AVANOVA - Niraparib and/or Niraparib-Bevacizumab Combination Against Bevacizumab Alone in HRD Platinum Sensitive Ovarian Cancer Maria Dimoula, Göteborg, Sweden ENGOT-ov38/OReO - A Phase IIIb, Randomised, Double-blind, Placebo-controlled,

4 Multicentre Study of Olaparib Maintenance Retreatment in Patients with Epithelial Ovarian Cancer Previously Treated With a PARPi and Responding to Repeat Platinum Chemotherapy Anja Ør Knudsen, Odense, Denmark ENGOT-ov34/2.29 Atezolizumab in combination with Bevacizumab and Chemotherapy versus Chemo-Bevacizumab standard in recurrent ovarian cancer a randomized Phase III trial Gabriel Lindahl, Linköping, Denmark Panel discussion Synnöve Staff, Tampere, Finland Hanna Dahlstrand, Uppsala, Norway Relapsed disease - Scientific rational, evidence for and study designs will be presented followed by a panel discussion to discuss potential impact of outcome Chair: Line Bjørge, Bergen, Norway Overview of trials where platinum is NOT an option: - Javalin - NSGO-OV-UMB1/ENGOT-OV30 - ENGOT-OV42-NSGO / AVANOVA-Immune1 - NiCCC Line Bjørge, Bergen, Norway NSGO-OV-UMB1/ENGOT-OV30 - A multicenter, phase 2, open-label non-randomized study to obtain preliminary evidence of efficacy of several novel combinations in relapsed ovarian cancer. This information regards Cohorte A, MEDI9447 and Duvalumab Jon Røikjær Henriksen, Vejle, Denmark ENGOT-OV42-NSGO / AVANOVA-Immune1 A randomized trial of atezolizumab, niraparib and bevacizumab combination versus standard of care for patients with recurrent ovarian cancer. Johanna Mäenpää, Tampere, Finland NICCC - A Randomised Phase II Study Of Nintedanib (BIBF1120) Compared To Chemotherapy in Patients With Recurrent Clear Cell Carcinoma Of The Ovary Or Endometrium Bente Lund, Aalborg, Denmark Panel discussion Kristina Aglund, Umeå, Sweden Annika Riska, Helsinki, Finland

5 LUNCH ENDOMETRIAL CANCER Endometrial Cancer - Scientific rational, evidence for and study designs will be presented followed by a panel discussion to discuss potential impact of outcome Chair: Mansoor Raza Mirza, Copenhagen, Denmark COFFEE ENGOT-EN2-DGCG A phase III Trial of postoperative chemotherapy or no further treatment for patients with node-negative stage I-II intermediate or high risk endometrial cancer Caroline Lundgren, Stockholm, Sweden ENGOT-EN1/FANDANGO A Randomized Phase II Trial of First-line Combination Chemotherapy With Nintedanib / Placebo for Patients With Advanced or Recurrent Endometrial Cancer Christine Vestergård Madsen, Vejle, Denmark ENGOT-EN3-NSGO/PALEO A randomized, double-blind, placebo-controlled, phase II trial of Palbociclib in combination with Letrozole versus Placebo in combination with Letrozole for patients with Estrogen Receptor Positive advanced or recurrent Endometrial cancer Gitte-Bettina Nyvang, Odense, Denmark ENGOT-EN6-NSGO/TSR A Phase 3 Randomized Open-Label Study of TSR-042, an anti-pd-1 Monoclonal Antibody, Versus Investigator s Choice Chemotherapy in Advanced/Recurrent Endometrial Cancer (TBD) Panel discussion Marjut Rintala, Turku, Finland Kathrine Woie, Bergen, Norway CERVICAL CANCER Cervical Cancer - Scientific rational, evidence for and study designs will be presented followed by a panel discussion to discuss potential impact of outcome Chair: Trine Jakobi Nøttrup, Copenhagen, Denmark Overview of Cervical Cancer trials: - ENGOT-Cx4 GINECO-CE106/Senticol III - ENGOT-CX7-NSGO/MaRuC - ENGOT-Cx10/GEICO 68-C/BEAT cc - ENGOT-cx6-NSGO/Tisotumab Trine Jakobi Nøttrup, Copenhagen, Denmark

6 Update of minimal invasive surgery trials (LACC, SENTICOL) Ane Gerda Zahl Eriksson, Oslo, Norway ENGOT-CX7-NSGO/MaRuC A randomized double-blind placebo-controlled phase II trial of Rucaparib maintenance therapy for patients with locally advanced cervical cancer Kristina Hellman, Stockholm, Sweden ENGOT-Cx10/GEICO 68-C/BEAT cc - A Randomized Phase III Trial of Platinum Chemotherapy plus Paclitaxel with Bevacizumab and Atezolizumab versus Platinum Chemotherapy plus Paclitaxel and Bevacizumab in Metastatic (stage IVB), Persistent or Recurrent Carcinoma of the Cervix Maarit Anttila, Kuopio, Finland ENGOT-cx6-NSGO/Tisotumab - A Single arm, Multicenter, Phase 2b Trial Investigating the Efficacy of Tisotumab Vedotin (HuMax -TF-ADC) Therapy in Previously treated Patients with Recurrent or Metastatic Cervical Cancer Susanne Malander, Lund, Sweden Panel discussion Sinikka Oksa, Pori, Finland Anne Beate Vereide, Tromsoe, Norway Vulvar CANCER Vulvar Cancer - Scientific rational, evidence for and study designs will be presented followed by a panel discussion to discuss potential impact of outcome Chair: Kristina Lindemann, Oslo, Norway End of meeting Mansoor Mirza, NSGO GROINSS-V - GRONINGEN INTERNATIONAL STUDY ON SENTINEL NODES IN VULVAR CANCER III - A PROSPECTIVE PHASE II TREATMENT TRIAL Kristina Lindemann, Oslo, Norway Panel discussion Ulla Peen, Herlev, Denmark Päivi Vuolo-Merilä, Oulu, Finland Bengt Tholander, Uppsala, Sweden NSGO-CTU will reimburse travel expenses maximum 200 Euros each for one investigator and one research nurse from an NSGO site + one single room at Hotel Bella Sky from November 2018, if these expenses are not covered by the hospital. Any expenses over 200 Euros + hotel single room cannot be reimbursed by NSGO-CTU.