Disease group Breast OPEN TRIALS Trial Title Accrual Target IBCSG 48-14 POSITIVE IBCSG 50-14 OLYMPIA IBCSG 52-15 PALLAS SAKK 21/12 A study evaluating the pregnancy outcomes and safety of interrupting endocrine therapy for young women with endocrine responsive breast cancer who desire pregnancy (POSITIVE). A randomised, double-blind, parallel group, placebo-controlled multi-centre Phase III study to assess the efficacy and safety of olaparib vs placebo as adjuvant treatment in patients with high risk germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy. PALbociclib CoLlaborative Adjuvant Study: A randomized phase III trial of Palbociclib with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy alone for hormone receptor positive (HR+) / human epidermal growth factor receptor 2 (HER2)- negative early breast cancer. A stratified, multicenter Phase II trial of transdermal CR1447 (4-OH-testosterone) in endocrine responsive-her2 negative and triple negative-androgen receptor positive metastatic or locally advanced breast cancer. Current Accrual Estimated closure for accrual 500 15 (in CH) 30-Jun-2018 1320 6 (in CH) 31-Mar-2019 4600 37 (in CH) 31-Mar-2019 105 14 in stratum A 31-Mar-2018 5 in stratum B 19 total CPM ibcsg48_positive@fstrf.org ibcsg50_olympia@fstrf.org ibcsg50_olympia@fstrf.org karin.rothgiesser@sakk.ch SAKK 24/14 Anti-EGFR-immunoliposomes loaded with doxorubicin in patients with advanced triple negative EGFR positive breast cancer - A multicenter single arm phase II trial. 49 10 30-Jun-2019 martina.schneider@sakk.ch Page 1 of 7
Gastrointestinal Breast SAKK 25/14 SAKK 96/12 PRODIGE 32 PROSPECT SAKK 41/13 SAKK 41/14 Eribulin as 1st line treatment in elderly patients (>= 70 years) with advanced breast cancer: a multicenter phase II trial. Prevention of Symptomatic Skeletal Events with Denosumab Administered every 4 Weeks versus every 12 Weeks A Non- Inferiority Phase III Trial. Systematic surgery vs. monitoring and salvage surgery in operable oesophageal cancer in complete clinical response after chemotherapy. Strategic multicenter randomized phase II-III trial. A phase II/III trial of neoadjuvant folfox, with selective use of combined modality chemoradiation vs. preoperative combined modality chemoradiation for locally advanced rectal cancer patients undergoing low anterior resection with total mesorectal excision. Adjuvant aspirin treatment in PIK3CA mutated colon cancer patients. A randomized, double-blinded, placebocontrolled, phase III trial. Physical activity program in patients with metastatic colorectal cancer who receive palliative first-line chemotherapy. A multicenter open label randomized controlled phase III trial. 77 39 15-Aug-2018 1380 469 (258 in 16-Jan-2019 Breast) 224 0 31-Dec-2024 1060 15 (in CH) 31-Dec-2018 185 18 30-Dec-2018 karin.rothgiesser@sakk.ch daniele.oberti@sakk.ch 524 27 30-Sep-2021 daniela.baertschi@sakk.ch andrea.fuhrer@sakk.ch corinne.schaer@sakk.ch marie-aline.gerard@sakk.ch mario.baresic@sakk.ch catherine.berset@sakk.ch SAKK 41/16 SAKK 41/16 (RECAP trial): Neoadjuvant treatment with Regorafenib and Capecitabine combined with radiotherapy in locally advanced rectal cancer. A Phase Ib trial. 37 1 15-Apr-2019 daniela.baertschi@sakk.ch Page 2 of 7
Gynaecological INOVATYON Phase III international, randomized study of trabectedin plus Pegylated Liposomal Doxorubicin (PLD) versus Carboplatin plus PLD in patients with ovarian cancer progressing within 6-12 months of last platinum. 588 37 30-Jun-2017 moritz.jacobshagen@sakk.ch CML-V Treatment optimization of newly diagnosed Ph/BCR-ABL positive patients with chronic myeloid leukemia (CML) in chronic phase with nilotinib vs. nilotinib plus interferon alpha induction and nilotinib or interferon alpha maintenance therapy. 720 44 (in CH) 30-Jun-2017 moritz.jacobshagen@sakk.ch EBMT HCT vs CT Compare conventional chemotherapy to low dose total body irradiation-based conditioning and hematopoietic cell transplantation as consolidation therapy. 231 16 (in CH) 01-Aug-2017 moritz.jacobshagen@sakk.ch Leukemias GRAALL 2014 Treatment of adult acute lymphoblastic leukemia (ALL), evaluating the addition of a second late intensification course in B- lineage PH-negative ALL, the addition of Nelarabine in high-risk T-lineage ALL, and the reduction of chemotherapy intensity in Ph+ ALL. 50 13 (in CH) 15-Jan-2020 vincent.tchang@sakk.ch HOVON 132 Randomized study with a run-in doseselection phase to assess the added value of lenalidomide in combination with standard remission-induction chemotherapy and postremission treatment in patients aged 18-65 years with previously untreated acute myeloid leukemia (AML) or high risk myelodysplasia (MDS) (IPSS-R risk score > 4.5). 927 173 (in CH) 30-Aug-2017 celine.rueegsegger@sakk.ch Page 3 of 7
Leukemias HOVON 135 A randomized phase II multicenter study to assess the tolerability and efficacy of the addition of ibrutinib to 10-day decitabine in UNFIT (i.e. HCT-CI 3) AML and high risk myelodysplasia (MDS) (IPSS-R > 4.5) patients aged >= 66 years. A study in the frame of the masterprotocol of parallel randomized phase II studies in UNFIT-older AML/high-risk MDS patients. 140 20 (in CH) 31-Mar-2019 celine.rueegsegger@sakk.ch EORTC PEARLS A randomized, phase 3 trial with anti-pd-1 monoclonal antibody pembrolizumab (MK- 3475) versus placebo for patients with early stage NSCLC after resection and completion of standard adjuvant therapy (PEARLS). 1380 28 (in CH) 30-Jun-2023 PEARLS@etop-eu.org ETOP SPLENDOUR A randomised, open-label phase III trial evaluating the addition of denosumab to standard first-line anticancer treatment in advanced NSCLC. 1000 96 (in CH) 30-Mar-2018 SPLENDOUR@etop-eu.org Lung Lung ART EORTC LungArt: Phase III study comparing postoperative conformal radiotherapy to no postoperative radiotherapy in patients with completely resected non-small cell lung cancer and mediastinal N2 Involvement. 700 6 (in CH) 31-Dec-2018 lungart@gustaveroussy.fr; geraldine.martineau@gustaveroussy.fr SAKK 15/12 SAKK 16/14 Early prophylactic cranial irradiation with hippocampal avoidance in patients with limited disease small-cell lung cancer. A multicenter phase II trial. Anti-PD-L1 antibody MEDI4736 in addition to neoadjuvant chemotherapy in patients with stage IIIA(N2) non-small cell lung cancer (NSCLC). A multicenter single-arm phase II trial. 42 34 31-Mar-2018 68 22 30-Mar-2019 andrea.fuhrer@sakk.ch corinne.rusterholz@sakk.ch Page 4 of 7
Lung SAKK 19/16 Binimetinib, pemetrexed and cisplatin, followed by maintenance with binimetinib and pemetrexed, in patients with advanced nonsmall cell lung cancer with KRAS mutations. A multicenter phase IB trial. 18 0 30-Mar-2019 corinne.rusterholz@sakk.ch andrea.fuhrer@sakk.ch HD 21 HD21 for advanced stages: Treatment optimization trial in the first-line treatment of advanced stage Hodgkin lymphoma; comparison of 6 cycles of escalated BEACOPP with 6 cycles of BrECADD. 1500 1 (in CH) 30-Jun-2020 nina.stojcheva@sakk.ch Lymphomas IELSG-37 SAKK 35/14 SAKK 35/15 SAKK 36/13 A randomized, open-label, multicentre, twoarm phase III comparative study assessing the role of involved mediastinal radiotherapy after Rituximab containing chemotherapy regimens to patients with newly diagnosed Primary Mediastinal Large B-Cell Lymphoma (PMLBCL). Rituximab with or without ibrutinib for untreated patients with advanced follicular lymphoma in need of therapy. A randomized, double-blinded, SAKK and NLG collaborative Phase II trial. A phase I trial of obinutuzumab in combination with venetoclax in previously untreated follicular lymphoma patients. Combination of ibrutinib and Bortezomib followed by ibrutinib maintenance to treat patients with relapsed and refractory mantle cell lymphoma. A multicenter Phase I/II trial. 540 13 (in CH) 31-Jan-2018 simona.berardi@sakk.ch 190 38 30-Sep-2018 chiara.secondini@sakk.ch 25 2 30-Sep-2018 katrin.eckhardt@sakk.ch 58 13 31-Dec-2018 anna.tomaszewska@sakk.ch Page 5 of 7
Lymphomas T-Cell Project Das T-Cell project ist eine Registrierstudie mit Referenzpathologie um Daten zu seltenen malignen Erkrankungen der T-Zell Linie zu gewinnen. Nachträgliche Erfassung im PATRAS am 06.09.2013, Freigabe ca. 2008/2009. 43 31-Dec-2017 simona.berardi@sakk.ch New Drugs SAKK 67/15 An open-label Phase 1/2a study of BAL101553 administered as intravenous 48- hour infusions in adult patients with advanced solid tumors. 103 12 31-Dec-2017 silvia.stuedeli@sakk.ch SAKK 01/10 Carboplatin Chemotherapy and Involved Node Radiotherapy in Stage IIA/B Seminoma. 115 86 15-Jun-2017 corinne.schaer@sakk.ch SAKK 06/14 A phase I/II open label clinical trial assessing safety and efficacy of intravesical instillation of VPM1002BC in patients with recurrent non-muscle invasive bladder cancer after standard BCG therapy. 39 12 31-Dec-2017 milica.enoiu@sakk.ch Urogenital SAKK 08/14 SAKK 08/16 Investigation of Metformin in patients with castration resistant Prostate Cancer in combination with Enzalutamide vs. Enzalutamide alone (IMPROVE TRIAL) A randomized, open label, phase II trial. ODM-201 maintenance therapy in patients with metastatic castration resistant prostate cancer (mcrpc) previously treated with one novel hormonal agent first line and nonprogressive disease after second line treatment with a taxane: A multicenter randomized double-blind placebo-controlled phase II trial. 168 36 30-Sep-2018 martina.schneider@sakk.ch 88 1 30-Jun-2018 andrea.fuhrer@sakk.ch SAKK 63/12 Prospective cohort study with collection of clinical data and serum of patients with prostate disease. 1930 624 15-Oct-2019 chiara.secondini@sakk.ch Page 6 of 7
Urogenital SAKK 96/12 STAMPEDE Prevention of Symptomatic Skeletal Events with Denosumab Administered every 4 Weeks versus every 12 Weeks A Non- Inferiority Phase III Trial. Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy A multi-arm multi-stage randomised controlled trial. 1380 469 (211 in Uro) 16-Jan-2019 andrea.fuhrer@sakk.ch corinne.schaer@sakk.ch 70 (in CH) corinne.schaer@sakk.ch = change in responsibility or new trial compared to last newsletter Page 7 of 7