Breast Protocol Title SAKK 25/14 Eribulin as 1st line treatment in elderly patients ( ≥70 years) with advanced breast cancer : a multicenter phase II trial Drugs Diagnosis Study Design Female Age ≥ 70 Locally advanced or metastatic HER2 neg , endocrine positive or negative Adenocarcinoma of the breast. Measureable or evaluable disease At least 6 months since adjuvant chemotherapy No prior chemotherapy for metastatic disease. Eribulin mesilate 1.1mg /m d1, d8 every 3 weeks until PD Eribulin Metastatic Breast cancer in elderly patients HER2 neg Letrozole + GDC-0032/ Placebo ER pos , Her2 neg Postmenopausal status breast cancer Primary tumor ≥2cm ( CT1-3) by MRI postmenopausal ER Pos / Her2 neg status ARM A No Tachosil Female patients eligible for primary ALND or sentinel lymph node procedure with frozen section and either newly diagnosed or recurrent breast cancer in the conserved breast, chest wall or axilla P.I PD Dr Roger von Moos CRC G Roberts IBCSG GO2888 A Phase II randomized ,double blind study of neoadjuvant letrozole plus GDC-0032 versus Letrozole plus placebo in Postmenopausal women with ER –Positive / Her2 –neg early stage breast cancer Eligibility 2 Letrozole + GDC-0032/ Placebo PI PD Dr. Roger von Moos CRC Gillian Roberts SAKK 23-13 Imapct of a surgical sealing patch on lymphatic drainage after axillary lymphnode dissection for breast cancer. A multicneter randomized phase III trial PI PD Dr. Roger von Moos CRC Gillian Roberts / M Sieber Studien Onkologie 09.Februar 2016 ARM B Tachosil Female patients eligible for primary ARM A No Tachosil ALND or sentinel lymph node procedure with frozen section and ARM B Tachosil either newly diagnosed or recurrent breast cancer in the conserved breast, chest wall or axilla Seite 1 von 17 Lung SAKK 16/08 Cetuximab Preoperative chemotherapy and Cisplatin radiotherapy concomitant to Cetuximab in Docetaxel non-small cell lung cancer (NSCLC) patients with IIIB disease. NSCLC Geschlossen für Accrual PI: Richard Cathomas, CRM: Gabriela Manetsch SAKK 15/12 Early prophylactic cranial irradiation with hippocampal avoidance in patients with limited disease small-cell lung cancer Cisplatin or Limited disease Carboplatin, SCLC Etopside as a standart therapy PI: PD. Dr.Daniel R. Zwahlen; Nurse: G. Manetsch, P. Zurbuchen ETOP Splendour A randomised, open-label phase III trial evaluating the addition of denosumab to standard first-line anticancer treatment in advanced NSCLC Novartis CEGF816X2201C Phase II multicentre open label of EGF816 combination with Nivolumab in patients with mutated EGFR NSCLC and INC280 in combination with Nivolumab with cMET positive NSCLC Group 1 geschlossen Chemotherapie and Arm A Best supportive care Arm B Denosumab Nivolumab und EGF816 and Nivolumab with INC280 Stage IV with or without bone metastasis STAGE IV NSLCL Age 18-75 histol. or cytol. confirmed NSCLC stage IIIB, T4N0–3M0 or T1-T4N3M0, ECOG 0-1, adequate organ function. Exclusion: pre-treatment with any CTx previous RT, unstable cardiac disease or other serious medical conditions 3 cycles of Cetuximab, Cisplatin and Docetaxel 3 weeks of RT (Monday –Friday) surgery Age 18-75 Karnofsky Index ≥ 60% Fluency in either German, French or Italian Newly diagnosed cytologically or histologically confirmed diagnosis of SCLC within 6 weeks before registration Standard treatment with chemotherapy and thoracic radiotherapy in combination with early prophylactic cranial irradiation (hippocampal avoidance) under assessed neurocognitive function. -Histologically or cytologically confirmed advanced stage IV nonsmall cell lung carcinoma -Age ≥ 18 years -ECOG performance status 0-2 -Measurable or evaluable disease - Availability of tumour tissue for translational research -Life expectancy of at least 3 months. -No EGFR or ALK mutation Arm A: 4 – 6 cycles of doublet chemotherapy + best supportive care. Arm B: 4 – 6 cycles of doublet chemotherapy + denosumab 120 mg, s.c. every 3-4 weeks. - Premoleculare Screening -Age ≥ 18 years - -ECOG performance status 02 - Measurable disiease - Tumorbiopsie at EGFR mutated patients Group 1 : Patient with EGF816 and Nivolumab Group 2 INC280 and Nivolumab SAE: 5d/24h SAE: 7d/24h PI Michael Mark, CRC Gabriela Studien Onkologie 09.Februar 2016 Seite 2 von 17 LungART Radiotherapy Phase III study comparing post-operative Surgery conformal radiotherapy to no post-operative radiotherapy in patients with completely resected non-small lung cancer and mediastinal N2 Involvement NSCLC compeletely resected + N2 Nodal involvement In: -Age ≥ 18 years - Histological evidence of non-small cell lung cancer -Complete resection by lobectomy, bilobectomy or pneumonectomie -Mediastinal lymph node exploration Excl: -Documented metastases Major pleural or pericardial -Synchronous contra-lateral lung cancer -Previous chest radiotherapy -Clinical progression during postoperativ chemotherapy - Arm with post-operative radiotherapy - Arm without post-operative radiotherapy EMR 100070-004 A Phase III open-label,multicenter trial of avelumab versus docetaxel in subjects with non-small cell lung cancer that has progressed after a platinum – containing doublet Docetaxel 2 75mg/m IV every 3 weeks versus Avelumab 10mg/kg IV every 2 weeks NSCLC Progression during or after a minimum of 1 course of a platinum –based combination therapy or Patients must have progresses within 6 months of completion of a platinum based adjuvant , neo adjuvant or definite chemotherapy or concomitant chemoradiation regimen for locally advanced disease Docetaxel 75mg/m2 IV every 3 weeks versus Avelumab 10mg/kg IV every 2 weeks Double blind Gefitinib / Placebo AZD 92921 / placebo NSCLC PI Dr Michael Mark CRC Gillian Roberts Paraffin block ( Histology) Astra Zeneca Flaura D5160C00007 A Phase III Double Blind , Randomized Study to Assess the Efficacy and Safety of AZD9291 versus a Standard of Care Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor as First – Line Treatment in Patients with Epidermal Growth Factor Receptor Mutation Positive, Locally Advanced or Metastatic Non Small Cell Lung Cancer PI Dr Richard Cathomas CRC Peter Zubuchen / Gillian Roberts Inc Pathologically confirmed adenocarcinoma of the lung (Stage IIIB / IV ) Gefitinib / Placebo AZD 92921 / placebo EGFR mutiert für Ex19del oder L858R bestätigt in Zentral Labor Treatment naive for locally advanced or metastatic NSCLC EXCPrior treatment with any systemic anti cancer therapy for locally advanced / metastatic NSCLC Geschlossen für Recrutierung Studien Onkologie 09.Februar 2016 Seite 3 von 17 SAKK 16/14 Anti-PD-L1 antibody MEDI4736 in addition to neoadjuvant chemotherapy in patients with stage IIIA(N2) NSCLC Bei EK PI: Michael Mark CRC: Gabriela Manetsch Studien Onkologie 09.Februar 2016 Seite 4 von 17 Gastrointestinal N1048 Rectum Prospect Ph II/III trial of Neoadjuvant FOLFOX with selective Use of Combined Modality Chemoradioth.versus Preop. combined Modality Chemoradioth for loc. Advancen rectal cancer Undergoing low anterior Resect. with total Mesorectal Excision PI: PD Dr. R. von Moos CRC: Franziska Hellmann AVA – CTP Standardarm: Chemo- Radio ( 5FUCMT+ 28 day 1.8 Gy) then Surgery, followed with FOLFOX Exp.Arm :FOLFOX + Surgery or Chemo- Radio ( 5FUCMT+ 28 Tg 1.8 Gy) followed with FOLFOX or 5FUCMT depending on surgery result In: - age ≥ 18 years Advanced -ECOG: 0-2 rectal - Stage: T2N1,T3N0,T3N1 adenocarcin - Patient for sphincter-sparing surg.resection prior to oma init. of neoadjuv. therapy according to the primary surgeon. Ex: Stage T4 -Need for abdomioperineal at baseline -RO resection not possible - sympt. bowel obstruction - Chemotherapy within 5 years -pelviv radiation - other invasive malignancy ≤ 5 years Standardarm: Chemo- Radio (5FUCMT+ 28 day 1.8 Gy) then Surgery, followed with FOLFOX Exp.Arm :FOLFOX when response ≥ 20% followeb by Surgery When response ≤ 20% or Progression followed by ChemoRadio ( 5FUCMT+ 28 day1.8 Gy) followed with FOLFOX or 5FUCMT depending on surgery result SAE: 5d/24h mCRC with liver Perfusions metastasis Computertomo with first line grafia bevacizuma (CTP) b Visualization of antiangiogenic effects In: - age ≥ 18 years -ECOG: 0-2 -Histologically confirmed colorectal cancer with hepatic metastas according Recist 1:1 (nodule ≥ 20 mm in longest diameter) - eligible first- line Bevacizumab-containing, fluoropyrimidne –based Chemoth. Ex:- History of untreated Hyperthyreosis -Serum Creat. >1.5 ULN or cclear >60 ml/min -alcohol or drug abuse One staging CT and followed 4 CTP 1. ≤ 72 h before Bevacizumab adm. 2. Within 20to 28 h after end of first Bevacizumab adm 3. ≤ 72 h before second Bevacizumab adm. 4. After tumorprogression according Recist 1:1 or if it is stopped before Progr. a CT is performed in addition to CTP SAE: 7d/24h SAKK 41/13 Aspirin Adjuvant aspirin treatment in PIK3CA mutated colon cancer patients. A randomized, doubleblinded, placebo-controlled, phase III trial Standard chemo In: Stage II (pT3/T4 N0 cM0) or stage III (pTx pN+ cM0) colon cancer. -Availability of cancer tissue central -PIK3CA mutation in exons 9 or 20 - RO resection within 10 weeks maximum before registration. Arm A: Aspirin 100 mg daily for 3 Years and Standard chemo if indicated PI: PD Dr. R. von Moos Bevacizumab CRC: Franziska Hellmann Genehmigt bei Ethik. Swissmedic noch neue Medibadge beantragt. Studien Onkologie 09.Februar 2016 PIK3CA mutated CRC adenocarcin oma ARM B: Placebo daily for 3 Years and Standard chemo if indicated Seite 5 von 17 PI: PD Dr. R. von Moos Ex: Rectal cancer (defined as distance from anal verge to proximal/oral tumor edge ≤15 cm) -Presence of any bleeding disorder -uncontrolled cardiovascular disease (NYHA III or IV) In: Be HER2/neu negative and PD-L1 positive - measurable disease as defined by RECIST 1.1 - Have provided tumor tissue sample deemed adequate for PD-L1 biomarker analysis CRC: Franziska Hellmann MK 3-3475-062 Magenstudie A randomized, active-controlled, partially blinded, biomarker select, Phase III clinical trial of Pembolizumab as monotherapy and in combination with Cisplatin+5 FU versus Placebo+Cisplatin +5FU as first line treatment in subjects with advanced gastric or gastroesophagela junction adenocarcinoma PI: PD Dr. R. von Moos CRC: Franziska Hellmann X- Biotech 2012- PT023 A Phase III Double--‐blinded, Placebo Controlled Study of Xilonix™ or Improving Survival in mCRC Pembrolizuma b Cisplatin+ 5Fu (Capezitabin) MABp1 (Xilonix™) Best suportive care Advanced Gastric or Gastroesop hagel Junction Adenocarcin Ex: squamous cell or undifferentiated gastric cancer. oma - previous therapy for locally advanced or metastatic gastric/GEJ cancer. Subjects may have received prior neoadjuvant or adjuvant therapy as long as it was completed at least 6 months prior to randomization mCRC or unresectabl after Standardtherapy Arm 1: Pembrolizumab 200 mg Monotherapy Q3W Arm 2: Pembrolizumab 200 mg fixed dose Q3W + Cisplatin 80 mg/m2 Q3W + 5-FU* 800 mg/m2/day continuous IV infus. Days 1-5 (120 hours) Arm 3: Placebo Q3W +Cisplatin 80 mg/m2 Q3W + 5-FU* 800 mg/m2/day continuous IV infus. Days 1-5 (120 hours) In: mCRC or unresectable and which is refractory to Subjects randomized to MABp1 or standard therapy. To be considered refractory, a placebo will receive 7.5 mg/kg subject must have experienced progression (or Q2W intolerance) after treatment with standard approved regimens including, oxaliplatin, irinotecan flouropyrimidine, bevacizumab, and cetuximab or panitumumab if KRAS wildtype Swissmedic aproval fehlt noch PI: Sara Bastian CRC: Franziska Hellmann SAKK 41/14 Active -2 Physical activity program in patients with mCRC who receive palliative first- line chemotherapy. A multicenter open label randomized com^ntrolled phase lll trial PI: PD Dr. R. von Moos Structured PA and Pedometer mCRC first line Standard Chemo CRC: Franziska Hellmann Studien Onkologie 09.Februar 2016 Seite 6 von 17 Urogenital SAKK 01/10 Carboplatin chemotherapy and invelved node radiotherapy in stage IIA/B seminoma 1dose (21 days) of carboplatin AUC 7 30 Gy or 36 Gy radiotherapy histologically confirmed seminoma treated with inguinal orchidectom y classical seminoma treated with orchidectomy inguinal Tumor stage pT1-4 cN1-2 M0 Exclusion: mixed histology seminoma, any prior abdominal radiotherapy hormonal therapy Abiraterone Radiotherapy metastatic prostate carcinoma high risk newly diagnosed patients or with histologic confirmed prostate adenocarcinoma previously treated and relapsed, intention to treat with long term hormone therapy, adequate organ function. Exclusion: prior systemic therapy for advanced prostate carcinoma metast. brain disease, clin. significant cardiovascular disease, gastrointestinal bleeding After progression of abiraterone treatment 1Cycle Carboplatin Stage IIA 30 Gy radiotherapy Stage IIB 36 Gy radiotherapy PI: Richard Cathomas CRM Gabriela Manetsch STAMPEDE Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy Amendment PI: Räto Strebel CRM: Gabriela Manetsch Metab-Pro Metastatic prostate cancer Metformin Abiraterone prednisone Metformin, Abiraterone and prendison Castration resistant prostate cancer Weekly Carboplatin AUC 3 until PD or unacceptable toxicity Castration resistant prostate cancer Newly diagnosed M1 Arm A: Hormone therapy Arm G: Hormone therapy + Abiraterone Arm H: Hormone therapy + Radiotherapy to prostate All other patients Arm A: Hormone therapy Arm G: Hormone therapy + Abiraterone Daily Abiraterone, Prednisone and Metformin PI: Richard Cathomas, CRM: Gabriela Manetsch Pro-Plat Studie Single arm open label phase II pilot study of carboplatin in patients with metastatic castration-resistant prostate cancer and PTEN LOSS PI Richard Cathomas CRM Gabriela Manetsch Studien Onkologie 09.Februar 2016 PTEN Loss in archival tumor Weekly carboplatin AUC 3 . One cycle 28 days send to St. Gallen Fresh tumorbiopsie at baseline and optional during Progression after at least one the first cycle taxane based chemotherapy and at least one therapy with a newer hormonal agent Exclusion:prior treatment with any platinum Seite 7 von 17 CAINTA Randomised phase II CAbazitaxel dose Individualisation and neutropenia prevention Trial Cabezitaxel every three weeks PI Richard Cathomas CRM Gabriela Manetsch GO29294 Phase III open-label multicenter randomized study to investigate the efficacy and safety of MPDL3280A (Anti-PD-L1 Antibody) compared with chemotherapy in patients with locally advanced or metastatic urothelial Bladder cancer after failure with platinum-containing chemotherapy MPDL3280A randomisiert versus Chemotherapi e (Vinflunine, Docetaxel, Paclitaxel) Castration resistant prostate cancer progressed during or after completion of docetaxel therapy Stadium IV bladder cancer Inclusion:indication for 3 weekly cabazitaxel therapy, may have abiraterone and TAK700 or enzelutamid Exlcusion:previous cabazitaxel ARM A: Cabazitaxel every three weeks 25mg /m2 ARM B: Cycle 1 25mg/m2 Cycle > 2 PK-guided dose every three weeks Inclusion: FFP tumor for PD-L1 expression, Stage IV, life expectancy >12 weeks MPDL3280A 1200mg every 3 weeks or Chemotherapie every 3 weeks Excluion: CNS untreated, uncontrolled hypercalcemia Rekrutierung geschlossen PI Richard Cathomas CRM Gabriela Manetsch SAKK 63/12 Prospective cohort study with collection of clinical data and serum of patients with prostate disease Blood sample at patient for biopsy Eligible for biopsy Inclusion: depending on allocated group Exlcusion: Other concurrent active malignancy Psychiatric disorder PI: Räto Strebel CRM: Peter Zurbuchen Gabriela Manetsch Cohort study with a prospective collection and biobanking of sera from 5 patient groups with specific indications for PSA-testing, and with longitudinal follow-up. SAKK 08/14 Investigation of Metformin in patients with castration resistand prostate cancer in combination with Enzelutamid vs. Enzelutamid alone (IMPROVE TRIAL) Wird eingereicht Anfang 2016 PI: Richard Cathomas CRC: Gabriela Manetsch ABI-RE Studie Studien Onkologie 09.Februar 2016 Abiraterone Response to Inclusion:confirmed biochemical Biomarker sampling, Seite 8 von 17 An open label Biomarker Driven Phase II Clinical Trial of Abiraterone Acetate (AA) ReChallenge in patients with metastatic castration-resistant prostate cancer and prior response to AA abiraterone response to prior abiraterone , any other therapy Exclusion: TAK 700 , know brain metastasis Abiraterone täglich 1000mg, Tagebuch PI: Richard Cathomas CRC: Gabriela Manetsch Studien Onkologie 09.Februar 2016 Seite 9 von 17 Haematologie HD 17 Therapieoptimierungsstudie in der Primärtherapie des intermediären Hodgkin Lymphoms: Therapiestratifizierung mittels FDG-PET 2 Cyclen Beacopp esc. Hodgkin Lymphom 2 Cyclen ABVD Age 18 - 60 Stage IA-B, IIA-B with risk faktors Exclusion: Composite Lymphoma , COPD with insufficiency, symptomatic cardiac disease, long-time therapy with steroids, prior RT Randomisation: PET-4 (+/-) + 30 Gy IF-RT PET-4 (+) + 30 Gy IN-RT or Follow- up SAE: 5d/24h PI: Ulrich Mey CRC: Franziska Hellmann SAKK 35/14 Rituximab Rituximab with or without ibrutinib for Ibrutinib untreated patients with advanced follicular /Placebo lymphoma in need of therapy. A randomized, double-blinded, SAKK and NLG collaborative Phase II trial. Follikuläres Lymphom Age 18-85 Confirmed FL CD20+; grade 13a, stage III+IV in need of systemic therapy. Exclusion: tumor bulk requiring fast response, previous systemic therapy, concomitant disease requiring anticoagulation with warfarin or equivalent Ibrutinib /placebo 560mg/d for 24 months starting 14 days before rituximab Rituximab 375mg/m2 weekly (4 weeks)and afterwards in 8-weekly intervals for 12 further infusions – if restaging after 12 weeks shows less than MR or restaging after 24 /52 weeks less than PR → off study. mantle cell lymphoma Overexpression of cyclin D1 protein or evidence of t(11;14)(q13;q32), refractory or relapsed in need of therapy, measurable disease. Exclusion: Prior therapy with ibrutinib or Bortezomib, anticoagulation with warfarin or equivalent Phase I: Ibrutinib daily (dose dipending on DLT) and Bortezomib 1,3mg/m2 d1, 4,8, 11 q3wk Phase II: Ibrutinib daily (dose established in part I) and Bortezomib 1,3mg/m2 d1, 4,8, 11 For max. 6 cycles CLL (untreated or relapsed / refractory Age ≥ 18 CLL according to NCI/IWCLL Exclusion: more than 3 previous treatment lines, positive hepatitis B , HIV Obinutuzumab (C1 D1+2, 8, 15) and C 2-6 on D1, alone or in combination with Bendamustine, Chlorabucil or FC PI: Ulrich Mey CRM: Gisela Mayer SAKK 36/13 Ibrutinib Combination of ibrutinib and bortezomib bortezomib followed by ibrutinib maintenance to treat patients with relapsed and refractory mantle cell lymphoma; a multicentre Phase I/II trial. PI: Ulrich Mey 2 x BEACOPP esc. + 2 x ABVD CRM: Gisela Mayer Roche MO28543 GREEN: SAE 24/7 A multicenter, open-label, single-arm, phase IIIB, international study evaluating the safety of obinutuzumab alone or in combination with chemotherapy in patients with previously untreated or relapsed/refractory chronic lymphocytic leukemia. Studien Onkologie 09.Februar 2016 Obinutuzumab Bendamustin Chlorambucil FC Seite 10 von 17 PI: Ulrich Mey CRM: Gisela Mayer Roche BO25323 (CLL14) A prospective, open-label, multicentre randomized phase III trial to compare the efficacy and safety of a combined regimen of obinutuzumab and GDC-0199 (ABT-199) versus obinutuzumab and chlorambucil in previously untreated patients with CLL and coexisting medical conditions. Untreated CLL requiring treatment, CIRS >6 or CrCl < 70 ml/min. Exclusion: transformation of CLL, organ impairment score of 4 by CIRS, active infection Arm A: Ga101 (6 cycles) + ABT 199 (12 cycles) Lenalidomid progressive dexamethason multiple e myeloma Measurable disease for MM, progression after at least two months of lenalidomid therapy Exclusion: CNS involved, previous G4 AE due to lenalidomid treatment Lenalidomid D1-21 Dexamethasone D1, 8, 15, 22 Nelfinavir D1-21 until PD or toxicity Nelfinavir Non Lenalidomide responsive Dexamethason myeloma e PD after or during Lenalidomidcontaining therapy, mesurable disease for MM Exclusion: CNS involved, previous G4 AE due to lenalidomid treatment Lenalidomid D1-21 Dexamethasone D1, 8, 15, 22 Nelfinavir D1-21 until PD or toxicity GA101 ABT 199 Chlorambucil CLL (untreated) Arm B: Ga101 (6 cycles) + Chlorambucil (12 cycles) PI: Karin Holoch CRC: Gisela Mayer SAKK 39/10 Nelfinavir and lenalidomide/dexamethasone in patients with progressive multiple myeloma that have failed lenalidomidecontaining therapy. A single arm phase I/II trial PI: Ulrich Mey CRC: Gisela Mayer SAKK 39/13 FORTUNE, SAE 24/5 Nelfinavir as bortezomib-sensitizing drug in patients with proteasome inhibitornonresponsive myeloma. A multicenter phase II trial. PI: Ulrich Mey CRC: Gisela Mayer Phase 1 Pharma Mar SAE 24/7 Lurbinectedin Advanced Phase I Multicenter, Open-label, Clinical and Cisplatin solid tumors Pharmacokinetic Study of Lurabinectedin (PM01183) in Combination with Cisplatin in Studien Onkologie 09.Februar 2016 ECOG ≤1, ≤ 2 ctx-lines, measurable disease. Exclusion: symptomatic brain metastasis, > 1 neuropathy or hearing Dose escalation of PM01183 in combination with cisplatin 60mg/m2 Prophylaxis: group of patients Seite 11 von 17 Patients with Advanced Solid tumors PI: Roger von Moos, impairment with aprepitant + standard antiemetica versus group of patients only standard antiemetics (aprepitant prohibited!) CRC: Gisela Mayer SAKK 21/12 A phase I and stratified , multicentre Phase II trial of transdermal CR 1447 ( 4-OH testosterone) in endocrine responsive – HER2 negative and triple negative – androgen receptor positive metastatic or locally advanced breast cancer Closed for accrual CR 1447 ( 4OH testosterone) endocrine responsive – HER2 negative and triple negative – androgen receptor positive metastatic or locally advanced breast cancer Phase I ER pos (≥1%)and or PR pos (≥1%)or PRneg , in all cases Her2 neg BC Phase II ER pos (≥1%)and or PR pos (≥1%)or PRneg , in all cases Her2 neg BC( Stratum A) Or triple neg and AR pos (≥1%)BC (stratum B) Phase 1 CR1447 dose escalation in cohorts of 3-6 endocrine responsive Her2 neg BC Phase II Stratum A Patinets with endocrine responsive HER2 neg BC RD of CR1447 Stratum B patients with triple neg and determined ARpos BC RD of CR144 Novartis A phase 1b/II multicenter study of the combination of LEE011 and BYL719 with letrozole in adult patinets with advanced ER+ breast cancer LEE011, BYL719, Letrozole Advanced ER + Breast cancer Phase 1b expansion dose No prior systemic treatment in the advanced (metastatic locally advanced ) setting with the exception of treatment with letrozole for a max.duration of one month prior to starting study treatment. At least one measurable lesion Histological confirmed diagnosis, Negative Cytologie before start of treatment, patient have recurrent high-risk NMIBC for progression, Exclusion: Severe incontinence, allergy to PPD test, residual urinary bladder volume after micturition >150ml, uncontrollable urinary tract infection, metastatic disease LEE011 BYL719 + Letrozole Wieder geoffnet am 10.11.2015, nu rein pat pro site SAKK 06/14 A phase I/II open label clinical trial VPM1002BC assessing safety and efficacy of intravesical installation of VPM1002BC in patients with recurrent non-muscle invasive bladde cancer after standard BCG therapy Recurrent non –muscle invasive bladder cancer PI: Dr Strebel CRC Gabriela Manetsch Installation of VPM1002BC (Urologe) Retention of IMP at least 1h Observation at leat 4h Melanome AMGEN 20110266: 24/ 7 A Phase 2, Multicenter, Randomized, Openlabel Trial Assessing the Efficacy and Safety of Talimogene Studien Onkologie 09.Februar 2016 Talimogene laherparepvec (T-vec) Melanoma (stage IIIb IVM1a) Histologically stage IIIB, IIIC or IVM1a, at least on injectable lesion ≥ 10mm, measurable disease, LDH ≤ 1.0 ULN Arm 1: T-vec max. 4.0 ml for 6 doses followed by surgery Arm 2: surgical resection Seite 12 von 17 Laherparepvec Neoadjuvant Treatment Plus Surgery Versus Surgery Alone for Resectable, Stage IIIB to IVM1a Melanoma Exclusion: primary ocular or mucosal melanoma, active hepatitis B or C,prior therapy with tumor vaccine PI: Roger von Moos, CRC: Gisela Mayer AMGEN 20120328: A Phase 3b, Multicenter, Open-label, Single-Arm, Expanded Access Protocol of Talimogene Laherparepvec for the Treatment of Subjects in Europe With Unresectable Stage IIIB to IVM1c Melanoma Talimogene laherparepvec (T-vec) Melanoma (stage IIIb + IVM1c) PI: Roger von Moos, CRC: Gisela Mayer AMGEN 20120139: Survival Studie Noch nicht eingereicht Melanoma (stage IIIb IVM1a) Unresected melanoma stage IIIB to IVM1c, no other satisfactory alternative therapy, at least on injectable lesion ≥ 10mm, LDH ≤ 1.5 ULN Exclusion: greater than 3 visceral metastasis (does not incl. lung or nodal metastasis, bone metastasis, primary ocular or mucosal melanoma, active hepatitis B or C Previous treatment with T-vec First dose T-vec max. 4.0 ml of 6 10 PFU/ml, therafter max. 4.0ml of 8 10 PFU/ml q2wks for at least 6 months or until unacceptable toxicity Questionnaire and physical assessment (telefonic) every 3 months PI: Roger von Moos, CRC: Gisela Mayer Studien Onkologie 09.Februar 2016 Seite 13 von 17 Gynäkologie Studien Onkologie 09.Februar 2016 Seite 14 von 17 SAKK INOVATYON Phase III international,randomized study of Trabectedin (Yondelis) plus PLD Versus Carboplatin plus PLD in Patients with ovarian cancer progressing within 6-12 months of last platinum Trabectedin (Yondelis) ovarian cancer PLD progressing within 6-12 Carboplatin months of last platinum PI: Roger von Moos CRC: Franziska Hellmann, Gillian Roberts Mito 16b – MANGO – OV2b A mulitcenter Phase III randomized study with second line chemotherapy plus or minus bevacizumab in patients with platinum sensitive epithelial ovarian cancer recurrence after a bevacizumab / chemotheraoy first line Standard Therapie PLD- Doxorubicin + Carboplatin Gemcitabine + Carboplatin Paclitaxel + Carboplatin P:I PD Dr. Roger von Moos CRC Gillian Roberts Bevacizumab Novocure EF-22 Novo TTF – 100L System (200kHz output frequency) An open label pilot study of the NOVOTTF100L(O)System (NovoTTF Theapy) concomitant with weekly paclitaxel for recurrent ovarian carcinoma PI:Roger von Moos , CRC: Franziska Hellmann, G.Mayer Studien Onkologie 09.Februar 2016 Paclitaxel recurrent ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma - Epithelial ovarian, epithelial fallopian tube cancer or primary peritoneal cancer - Progression free interval 6-12 mt. from 1. Day of platinum based chemotherapy - May have received up to two platinum –based chemotherapy at least one must have contained Taxane Exclusion:none respond to last platinum –based therapy or last relaps occurred <6 mt or >12 mt from last does platinum Epithelial Ovarcarinom, eileiterkarzinom , Peritoneal ca. A: PLD 30mg/m2 +Carboplatin on Day 1 Q4wo (Kontrollarm) Rezidiv oder progression mindestens 6 Monatenach dem letzten Chemotheraoiezyklus einer Erstlinientherapie bestehend aus carboplatin und Paclitaxel einschliesslich Bevacizumab. Arm 2 Bevacizumab 10mg / kg alle 2 Wochen oder 15mg/kg alle 3 Wochen + 6 Zykeln standard chemotherapie, nache den initialen 6 Behandlungszyklen, Bevacizumab mono bis progression IN: -recurrent ovarian cancer with any number or prior therapies -Prior paclitaxel must have been administered on a 3-weekly schedule and not associated with toxicity requiring discontinuation EX: -Meningeal carcinomatosis or known brain metastases -Chemotherapy within 4 weeks prior to treatment start.-Radiotherapy within 4 weeks Paclitaxel 80 mg/m2. weekly for 8 weeks and then for all subsequent cycles on days 1, 8, 15 of each subsequent 28 day cycle B: PLD 30 mg/ m2 +Trabectedin 1.1 mg/m2 on Day 1 q3wo Up to 6 Cycles or PD SAE: 7d/24h Arm 1 6 Zyklen standard chemotherapie NovoTTF-100L(O) System: Continuous NovoTTF Therapy (200 kHz) treatment for at least 18 hours/day for the first 2 courses (8 weeks) and thereafter for the first 3 weeks of each 4 week course (i.e. 3 weeks on 1 week off) SAE: 5d/24h Seite 15 von 17 Palliative Care SAKK 96/12 Denosumab; Calcium; Prevention of Symptomatic Skeletal events Vitamin D with Denosumab Administered every 4 Weeks versus every 12 Weeks Metastatic Breast or Prostate cancer (castration resistant) stage IV, all subtypes allowed except small cells Age ≥ 18 years; Patients must have ≥ 3 bone metastases; WHO performance status 0-2; calcium levels in the normal range; Histologically or cytological confirmed diagnosis; prostate cancer receive or is receiving antineoplastic treatment; Patients with prostate cancer must have evidence of disease progression on continuous androgen deprivation therapy (CRPC); Liver transaminases within normal range; Bone metastases from castration resistant prostate cancer or from breast cancer. Arm A (standard Arm): Denosumab 120 mg (Xgeva®) sc. q4w Arm B (reduced Arm): 3x Denosumab 120 mg (Xgeva®) sc. q4w followed by Denosumab 120 mg (Xgeva®) sc. q12w Both Arms are supplemented with 500 mg Calcium and 400U Vitamin D PI: Roger von Moos CRC: Peter Zurbuchen SAE: 5d/24h Studien Onkologie 09.Februar 2016 Seite 16 von 17 Beobachtungsstudien QoliTrap Beobachtungsstudie zur Erfassung der Lebensqualität bei Patienten mit metas. kolorektalem Karzinom unter Zaltrap® (Aflibercept)Therapie in Kombination mit FOLFIRI (Zaltrap) Metast. Colorect. Aflibercept in carcinoma Kombination mit FOLFIRI In: geplante Behandlung mit Aflibercept in Kombination mit FOLFIRI Fragebögen betreffend Lebensqualität, jede 2. Woche vor Therapiebeginn für mind. 12 Wochen SAE: 7d/24h CRC: Franziska Hellmann Studien Onkologie 09.Februar 2016 Seite 17 von 17
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