Content - Board News

News from the SAKK board

  • Accepted trials May 2018

    HOVON 156, Prof. Dr. med. Thomas Pabst

    A Phase 3, Multicenter, open-label, Randomized Study of gilteritinib versus Midostaurin in Combination with Induction and Consolidation Therapy followed by one-year maintenance in Patients with Newly Diagnosed Acute Myeloid Leukemia (AML) or myelodysplastic syndromes with excess blasts-2 (MDS-EB2) with FLT3 Mutations Eligible for Intensive Chemotherapy.

    The primary endpoint of this multicenter, open-label, randomized, phase III trial is EFS with an accrual of 768 patients (384 per arm) over 2.5-3 years. The accrual in Switzerland is 18-35 patients/year (9 sites). Data of this trial may be used to apply for marketing authorization.

     

    SAKK 33/18: I-Care (MDS)

    Impact of Guidelines Adherence on Efficacy and Safety of Health CARE Provided to MDS Patients in Switzerland.

    The primary endpoints of this multicenter, observational, prospective MDS cohort based on Swiss MDS Registry are QoL, rates of hospitalization, infections, bleeding, thromboembolism, and cardio-vascular events (grade >=3). The total accrual is estimated at 400 to 600 patients in Switzerland.

     

    SAKK 21/18, PD Dr. med. Thomas Ruhstaller, Dr. med. Khalil Zaman, Dr. med. Michael Schwitter

    Ribociclib-endocrine therapy combination versus chemotherapy as 1st line treatment in patients with visceral metastatic breast cancer.

    The treatment of this randomized, open label, phase III trial is Ribociclib and endocrine therapy in arm A and monochemotherapy in arm B for 12-18 weeks, then maintenance Mono-ET. The primary endpoint is QoL-adjusted early disease control (composite primary endpoint). The target accrual is 280 patients/2 years, accrual estimate in Switzerland is 55 patients/year (participation of foreign countries under evaluation).

     

    ENGOT: AtTEND, Dr. med. Manuela Rabaglio-Poretti

    Phase III randomized placebo controlled trial of atezolizumab in combination with paclitaxel and carboplatin in women with advanced/recurrent endometrial cancer.

    The treatment of this randomized, comparative, multicenter, phase III trial is to assess the efficacy of atezolizumab in combination with platinum-taxol chemotherapy in patients with advanced stage III or IV, or recurrent endometrial cancer. The primary endpoint is OS and PFS with a total accrual of 550 patients. Participating sites are Italy, Germany (few sites), Spain, Poland, Switzerland, Austria, The Netherlands, United Kingdom, Australia, New Zealand, and Japan. Trial activation and FPI are planned for Q2-Q3/2018 in Europe.

     

    Foundation One Project, PD Dr. med et Dr. phil. Sacha Rothschild

    Correlation of genomic tumor profile and benefit from immune checkpoint inhibition in stage IIIA(N2) NSCLC.

    Subproject with 50 samples SAKK 16/00 & SAKK 16/14 [stage IIIA(N2) NSCLC]. The objective is to correlate genomic profile of stage IIIA(N2) NSCLC prior to therapy to clinical outcome, benefit of immune checkpoint inhibition, and tumor immunome.

     

    DANTE, Dr. med. Alexander Siebenhüner

    A randomized, open-label Phase II efficacy and safety study of Atezolizumab in combination with FLOT versus FLOT alone in patients with gastric cancer and adenocarcinoma of the oesophago-gastric junction. 

    The treatment of this randomized, open-label Phase II trial is atezolizumab in combination with FLOT versus FLOT alone with PFS/DFS as primary endpoint. The accrual is estimated at 295 patients over 2 years (FPI May 2018), with a contribution in Switzerland of 40 patients over 1.5 years.

     

    SAKK 09/15 -> SAKK 09/18, Lymphadenectomy, PD Dr. med. Cyrill Rentsch

    Extended pelvic lymph node dissection vs. no pelvic lymph node dissection at radical prostatectomy for intermediate and high-risk prostate cancer: A randomized multicenter international trial.

    The primary endpoint of this international, multicenter, randomized phase III trial is biochemical recurrence-free survival. The total accrual is estimated at 857 patients over 3.4 years (250 patients/year in Switzerland and France).

     

    SAKK 66/1, Dr. med. Anastasios Stathis

    A phase Ib trial of copanlisib in combination with Venetoclax in patients with relapsed or refractory lymphoma.

    Investigator Initiated Trial, Phase I, multicenter trial combining Venetoclax and a fix dose of copanlisib using the standard 3+3 design. 2 expansion cohorts: Marginal Zone Lymphoma (MZL) and Follicular Lymphoma (FL).
    Part A: Dose Escalation (3+3 Scheme)
    Part B: Dose Expansion
    The primary endpoint is dose limiting toxicities. The total accrual is max. 18 patients in the dose escalation phase and with 12 patients each cohort MZL and FL. The accrual in Switzerland is 39 patients over 2.5 years.

    HOVON 150, Prof. Dr. med. Markus Manz

    Phase 3 multicenter, double-blind, randomized, placebo-controlled study of ivosidenib or enasidenib in combination with induction therapy and consolidation therapy followed by maintenance therapy in patients with newly diagnosed AML or MDS-EB2 with an IDH1 and/or IDH2 mutation eligible for intensive chemotherapy.

    The primary endpoint is EFS. 968 patients are planned for accrual, 484 with an IDH1 mutation and 484 with an IDH2 mutation. The accrual in Switzerland is estimated at 50 patients over 3.5 years (5%). Data of this trial may be used to apply for marketing authorization.

  • Accepted trials January 2018

    SAKK 01/18, Coordinating Investigator: Dr. med. Alexandros Papachristofilou

    Reduced intensity radiochemotherapy for Stage IIA/B Seminoma.

    The primary endpoint of this single-arm, multicenter, phase II trial is PFS 3 years. The accrual is 135 patients, 54 patients in stage IIA, 81 patients in IIB at nine sites in Switzerland and 8 sites in Germany.

     

    SAKK 34/17, Coordinating Investigator: Dr. med. Davide Rossi

    Prospective, open-label, multicentered, phase-II trial of ibrutinib induction followed by ibrutinib plus venetoclax consolidation in patients with relapsed/refractory chronic lymphocytic leukemia.

    The primary endpoint of this open-label, multicenter, phase-II trial is MRD negative CR/CRi defined by the IWCLL 2008 criteria, at the end of the consolidation phase. The accrual estimate is 22-45/year and should be concluded in one year.

     

    IELSG-45 (FIORELLA), Coordinating Investigator: Dr. med. Benjamin Kasenda

    A randomized phase III trial on fitness- and comorbidity-tailored treatment in elderly patients with newly diagnosed primary CNS lymphoma.

    The primary endpoint of this multicenter open label phase II trial is PFS at 2 years. The total accrual for part A is 134 patients and for part B 74 patients. The accrual in Switzerlandis estimated at 5-13 patients per year at seven sites. The patient enrollment period is three years. Switzerland, Italy and Germany are participating.

  • New SAKK board members

    At their semi-annual meeting on November 22, 2017, the General Assembly elected Prof. Dr. med. Olivier Michielin and Prof. Dr. med. Emanuele Zucca as new members of the SAKK Board.

  • Accepted trials October 2017

    SAKK 39/17, Coordinating Investigator: PD Dr. med. Markus Jörger

    Ixazomib in combination with Nelfinavir, and Dexamethasone for treatment of patients with relapsed Multiple Myeloma.

    The PE of this multicenter, international phase I/II trial with a 3+3 design is dose limiting toxicities. 240 patients are estimated to be accrued in CH (50 patients.), I, F, N, DK, S, NL and CZ. The accrual should be managed in 2 years.


    SAKK 23/16 TAXIS, Coordinating Investigator: Prof. Dr. med. Walter Weber

    TAXIS: Tailored Axillary Surgery in Breast Cancer with High Volume or Treatment Resistant Nodal Disease.

    This multimodal phase III trial is planned for accrual of 1,500 patients within 5.4 years, duration until primary analyses at 11 years. This should be feasible. The estimated accrual is currently 480 patients per year from 6 countries or 47 sites, of which 215 patients are from 18 centers in Switzerland.


    SAKK 80/17 CMP001-MEL, Coordinating Investigator: Prof. Dr. med. Olivier Michielin

    A phase I, immunotherapy study of intratumoral CMP-001 in combination with Nivolumab + Ipilimumab for cutaneous metastatic melanoma.

    This phase I multicenter, open-label, single-arm study is divided into Prime Phase and Boost Phase. The Boost phase will last as long as the patients get a clinical benefit from it. The PE is dose limiting toxicities (DLT) of the combination with i.v. administration of the checkpoint inhibitory antibodies CPM001, ipilimumab and nivolumab. Objective response rate (ORR), frequency and severity of adverse events are some of the secondary endpoints. 24 patients are to be accrued.


    PazoQoL GISG 11, Coordinating Investigator: Dr. med. Silvia Hofer

    Quality of life assessment with an innovative electronic tool for patients on 2° or 3 °line therapy for advanced soft tissue sarcoma (STS). Randomization between Pazopanib (registered for this indication) and chemotherapy according to physicians choice (GISG Trial 11).

    The PE is QoL after 9 weeks, follow-up is 2 years. OS gain median: 5 months (31.2 vs 26). The goals for the WG Sarcoma to participate in this trial are to get involved with the German Interdisciplinary Sarcoma Group and the validation of an efficient tool (DGHO award) to capture QoL of sarcoma patients without additional workload for medical personnel.

  • Accepted trials September 2017

    SAKK 66/17, Coordinating Investigator: PD Dr. med. Markus Jörger

    Open-label Phase 1B/2A Study of interstitial laser and 1% N-dihydro-galacto-chitosan (GC) injection (inCVAX) in adult patients with laser-accessible, advanced solid tumors.


    EORTC HALT, Coordinating Investigator: Prof. Dr. med. Matthias Guckenberger

    Targeted therapy beyond progression with or without dose-intensified radiotherapy in oligo-progressive disease (OPD) in oncogene Addicted Lung Tumours (HALT). An international, randomized, multi-center, phase II/III study.


    EMCL-Registry, Coordinating Investigator: Dr. med. Benjamin Kasenda

    The Registry of the European Mantle Cell Lymphoma study group.


    SAKK 39/16, Coordinating Investigator: Dr. med. Thilo Zander

    Open label Phase II, single–arm trial of alternate day dosing of pomalidomide in refractory multiple myeloma.


    SAKK 75/08, Coordinating Investigator: PD Dr. med. Thomas Rustaller

    Comprehensive mutational analysis of esophageal carcinomas for prediction of response to neoadjuvant treatment with radiochemotherapy with or without cetuximab.


    CMP001-BC, Coordinating Investigator: Dr. med. Khalil Zaman, PD Dr. med. Ulf Petrausch

    CMP-001, a toll-like receptor 9 agonist, combined with nivolumab in women with advanced stage triple negative or HER2-positive breast cancer. A randomized phase II trial.


    ETOP ALERT, Coordinating Investigator: Dr. med. Christian Britschgi

    Alectinib for the treatment of pretreated RET-rearranged advanced NSCLC.

  • New President Project Group Breast Cancer

    Andreas Müller, MD from the Cantonal Hospital Winterthur was appointed new president of the Project Group Breast Cancer.

  • Accepted trials May 2017

    SAKK 95/17, WISE, coordinating investigator: PD Dr. Friedemann Honecker

    The preventive effect of a 24 week home-based walking program on symptom burden among breast cancer survivors receiving aromatase inhibitor therapy.

    The PE of this multicenter, randomized, interventional trial is Incidence of arthralgia/myalgia/ stiffness (BPI worst pain score). The intervention is that women walk outdoors at least 3’000 steps 5 days a week, measured by a pedometer. The secondary endpoints are QoL, incidence hot flushes, fatigue, physical activity, weight (BMI), treatment discontinuation

     

    PEACE 4, coordinating investigator: Prof. Dr. Silke Gillessen

    A Phase III trial of aceticsalycic acid and Pravastatin in patients with castrate-resistant prostate cancer.

    The primary endpoint of this trial is overall survival. The accrual is estimated at 1’152 patients over 4 years. 40 a year could be included in Switzerland.

  • New president Project Group Lung Cancer

    PD Dr. Martin Früh from the Kantonsspital St. Gallen is confirmed by the Board as new president of the Project Group Lung Cancer.

  • Accepted trials January 2017

    SAKK 65/16 Innomedica trial, coordinating investigator: PD Dr. Markus Joerger

    Evaluation of safety and efficacy of targeted liposomal doxorubicin (TLD-1, Talidox) in patients with advanced solid tumors).

    FIH, 3+3 dose escalation design up to the occurrence of the first DLT, followed by a modified continual reassessment method (CRM) for dose escalation with dose limiting toxicity as PE.

    The accrual is 30 patients. The first patient is expected for July 2017; the last patient is expected to be treated in November 2018.

    SAKK 09/10 Subproject, coordinating investigator: Dr. Alan Dal Pra

    Validation of a Genomic Prostate Cancer Classifier in Men Undergoing Salvage Radiotherapy under the European SAKK 09/10, a Randomized Phase III Trial Assessing Radiotherapy Dose-Escalation after Radical Prostatectomy.

    The primary objective of this retrospective study is to validate the genomic prostate cancer classifier (Decipher®) for the prediction of freedom from biochemical progression. The secondary objective is to validate the Decipher genomic classifier for secondary endpoints such as early biochemical failure, progression-free survival and distant metastasis.

    Accrual is 350 patients in Switzerland, Germany and Belgium. The PE is expected to be reached in 2018. 327 patients are consented for translational research.

     

    SAKK 07/17, coordinating investigator: PD Dr. Frank Stenner

    Nivolumab in combination with Ipilimumab boost in patients above 60 years of age with metastatic renal cell carcinoma: A multicenter single-arm phase lI trial.

    The PE of this multicenter single-arm phase lI trial is best overall response rate (ORR) during treatment.

    Accrual is 35 patients over 1.5 to 2 years.

  • Regulation for the Network Cancer Predisposition Testing and Counseling

    A new regulation for the CPTC Network Genetic testing has been set up.

    If one wants to prescribe genetic testing as a non-medical geneticist, one has to be member of the network CPTC. Therefore, membership has to be defined:

    • Guests
    • Regular member
    • Regular member offering genetic counselling and ordering testing (as defined in SR. 832.112.31 Krankenpflege-Leistungsverordnung / Ordonnance sur les prestations de l'assurance des soins of 29 September 1995, Art. 12 d para.1 lit.f) are:
      •  specialists FMH (or equivalent) for Medical Genetics
      • CPTC Network member who 1/ can prove professional collaboration with a Specialist FMH for Medical Genetics; 2/ attended an SAKK approved course or equivalent; 3/ participate at least to 2 SAKK CPTC Network meetings within 2 years

    The Board members approve the procedure.

  • Young Investigator Initiative

    The Board members approve the Young Investigator Initiative that consists of offers for following essential areas of expertise for successful clinical researchers:

    • Presentation skills and mentoring
    • Knowledge on trials
    • Writing skills
    • Trial conduct
    • Education and networking at events
    • Competitive ideas/research grants

    The main idea of the initiative is for young investigators to elaborate their own protocol and to get involved with clinical research and SAKK.