Breast

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
Diagnosis
Eligibility
Study Design
2
Metastatic Breast cancer in elderly
patients
HER2 neg
- 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
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
Female patients eligible for primary ALND or sentinel ARM A No Tachosil
lymph node procedure with frozen section and either newly
diagnosed or recurrent breast cancer in the conserved ARM B Tachosil
breast, chest wall or axilla
Wieder offen ab 02.12.2016
Eribulin mesilate 1.1mg/m
d1, d8 every 3 weeks until PD
PI: PD Dr. Roger Von Moos
CRC: Gillian Roberts
SAKK 23-13
Impact of a surgical sealing patch on
lymphatic drainage after axillary lymphnode
dissection for breast cancer. A multicentre
randomized phase III trial
Closed for Accrual 13.12.2016
PI: PD Dr. Roger Von Moos
CRC: Gillian Roberts / Marianne Sieber
Version 16/12 Studien Onkologie
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Breast
Protocol Title
SAKK 21/12
A stratified multicenter Phase II trial of
transdermal CR1447 (4 –OH testosterone ) in
endocrine negative – androgen receptor
positive metastatic or locally advanced
breast cancer
Diagnosis
Eligibility
Study Design
Locally advanced or metastatic,
histologically confirmed breast
adenocarcinoma requiring therapy
and not suitable for local treatment
Stratum A endocrine responsive HER2 neg BC
ER pos (≥1%) PRpos (≥1%) HER2 neg
ER pos (≥1%), PRneg, HER2 neg or
ERneg, PRpos(≥1%), HER2 neg
Stratum B triple neg (ERneg Prneg Her2 neg and
ARpos BC
CR1447 400mg per day applied
to the haunches and thighs
Metastatic triple neg Breast cancer
-
Women or men ≥18 years
Incurable locally advance or metastatic TNBC
No prior chemotherapy or targeted systemic therapy
Radiation therapy for metastatic disease is
permitted
- Prior chemotherapy (including taxanes) in the
neoadjuvant or adjuvant setting is allowable if
treatment was completed ≥ 12 months prior to
randomisation
- Measurable disease
- ECOG 0 or 1
Atezolizumab (840mg q2w) +
2
Nab paclitaxel 100mg/m qw)
PI: PD Dr. Roger Von Moos
CRC: Gillian Roberts
ROCHE WO29522
A phase III mulitcenter randomised placebo
controlled study of atezolizumab ( Anti-PDL1Antibody) in combination with nab
paclitaxel compared with placebo with nab
paclitaxel with previously untreated
metastatic triple neg breast cancer
PI: PD Dr. Roger Von Moos
CRC: Gillian Roberts
IBCSG 14-01 AURORA
Aiming to Understand the Molecular
Aberrations in Metastatic Breast Cancer
PI: Dr. Michael Schwitter
CRC: Gillian Roberts
Version 16/12 Studien Onkologie
Metastatic breast cancer
Versus Placebo + Nab paclitaxel
(100mg/m2qw)
Inclusion:
- Women or men with metastatic or locally relapsed
breast cancer manageable with systemic therapy.
- Patient agrees to provide newly collected metastatic
lesion tissue sample and blood samples
Exclusion:
- Received more than 1 line of systemic therapy (any
type) in the metastatic setting
- Bone only metastatic disease
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IBCSG PALLAS
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
Premenopausal or Postmenopausal
women or men with Stage II (Stage
II A limited to a maximum of 1000
patients) or Stage III early invasive
breast cancer.
Multicentric and or multifocal and or
invasive early invasive cancer ER+
and or PR+ and HER2 neg.
Inclusion
Arm A Palbociclib ( 2 years ) +
Premenopausal women or men with Stage II or Stage endocrine ( 5 years)
III early invasive breast cancer
Arm B Endocrine ( 5 years)
Multicentric and or multifocal and or invasive early
invasive cancer ER+ and or PR+ and HER2 neg
Exclusion
Stage I or IV breast cancer
Advanced triple negative EGFR
positive breast cancer,
Inclusion
Histologically proven diagnosis of TNBCin metastatic
or locally advanced non operable stage
EGFR expression in primary tu or metastases of at
least (1+) in immunohistochemistry, assessed by
central pathologist
Exclusion
Previous radiotherapy for the metastatic
disease(palliative radiotherapy of only non target
lesions is allowed
P:I Dr M Schwitter
CRC Gillian Roberts Open 11.11.2016
SAKK 24/14 Anti EGFR immunoliposomes
loaded with doxorubicin in patients with
advanced triple negative EGFR positive
breast cancer
A multicentre single arm phase II trial
Initiation 27.01.2017
Version 16/12 Studien Onkologie
First-line treatment with antiEGFR-IL-dox, given at a dose of
50 mg/m2 intravenous, on day 1
of
each cycle, cycle length is 28
days.
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Lung
Protocol Title
SAKK 15/12
Early prophylactic cranial irradiation with
hippocampal avoidance in patients with
limited disease small-cell lung cancer
Diagnosis
Eligibility
Limited disease SCLC
-
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
Stage IV with or without bone
metastasis
- Histologically or cytologically confirmed advanced
stage IV non-small 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
PI: PD Dr.Daniel R. Zwahlen
CRC: Gabriela Manetsch
ETOP Splendour
A randomised, open-label phase III trial
evaluating the addition of
denosumab to standard first-line anticancer
treatment in advanced
NSCLC
PI: Dr. Michael Mark
CRC: Alexandra Jori / Franziska Hellmann
Version 16/12 Studien Onkologie
Study Design
Standard treatment with
chemotherapy (Cisplatin or
Carboplatin, Etopside)
and thoracic radiotherapy in
combination with early
prophylactic cranial irradiation
(hippocampal avoidance) under
assessed neurocognitive
function.
SAE: 5d/24h
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.
SAE: 7d/24h
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Lung
Protocol Title
Diagnosis
LungART
NSCLC compeletely resected + N2
Phase III study comparing post-operative
Nodal involvement
conformal radiotherapy to no post-operative
radiotherapy in patients with completely
resected non-small lung cancer and
mediastinal N2 Involvement
PI: PD Dr. Daniel Zwahlen
CRC: Gillian Roberts
SAKK 16/14
NSCLC III A(N2) operabel
Anti-PD-L1 antibody MEDI4736 in addition to
neoadjuvant chemotherapy in patients with
stage IIIA(N2) NSCLC
Eligibility
Inclusion:
- Age ≥ 18 years
- Histological evidence of non-small cell lung cancer
- Complete resection by lobectomy, bilobectomy or
pneumonectomie
- Mediastinal lymph node exploration
Exclusion:
- Documented metastases
- Major pleural or pericardial
- Synchronous contra-lateral lung cancer
- Previous chest radiotherapy
- Clinical progression during post-operativ
chemotherapy
Inclusion:
NSCLC IIIA, müssen Cisplatin haben können im ersten
Zyklus, Operabilität, measurable disease
Exclusion:
N3 disease, any previous treatment, known CNS
Metastasen
PI: Dr. Michael Mark
CRC: Gabriela Manetsch
CA209-227
Stage IV or recurrent NSCLC
Open-Label Phase 3 Trial of Nivolumab, or
Nivolumab plus Ipilimumab, or Nivolumab
plus platinum doublet chemotherapy versus
platinum doublet Chemotherapy in Subjects
with Chemotherapy-Naïve Stage IV or
Recurrent NSCLC
PDL Status
Study Design
-
Arm with post-operative
radiotherapy
Arm without post-operative
radiotherapy
3 Zyklen Chemotherapie
(Cisplatin und Taxotere) alle 3
Wochen
2 Zyklen Immuntherapie alle 2
Wochen
Operation
Bei R0 Immuntherapie für 24 Mt
alle 2 Wochen
Bei R1/R2 Radiotherapie und
dann Immuntherapie für 24 Mt
alle 2 Wochen
6 Arme Therapie
Momentan geschlossen
PI: Dr. Michael Mark
CRC: Gabriela Manetsch
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Gastrointestinal
Protocol Title
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
Diagnosis
Advanced rectal adenocarcinoma
-
-
PI: PD Dr. Roger Von Moos
CRC: Franziska Hellmann
SAKK 41/13
Adjuvant aspirin treatment in PIK3CA mutated
colon cancer patients. A randomized, doubleblinded, placebo-controlled, phase III trial
PI: PD Dr. Roger von Moos
CRC: Franziska Hellmann
Version 16/12 Studien Onkologie
Eligibility
PIK3CA mutated
CRC
adenocarcinoma
Inclusion:
Age ≥ 18 years
ECOG: 0-2
Stage: T2N1,T3N0,T3N1
Patient for sphincter-sparing surg.resection prior to init.
of neoadjuv. therapy according to the primary surgeon
Exclusion:
Stage T4
Need for abdomioperineal at baseline
RO resection not possible
sympt. bowel obstruction
Chemotherapy within 5 years
pelviv radiation, other invasive malignancy ≤ 5 yearsr
invasive malignancy ≤ 5 year
Inclusion:
- 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 registr.
Exclusion: 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)
Study Design
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
Chemo- Radio ( 5FUCMT+ 28
day1.8 Gy) followed with
FOLFOX or 5FUCMT
depending on surgery result
SAE: 5d/24h
Arm A: Aspirin 100 mg daily
for 3 Years and Standard
chemo if indicated
ARM B: Placebo daily for 3
Years and Standard chemo if
indicated
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Gastrointestinal
Protocol Title
Diagnosis
MK 3475-062 Magenstudie
A randomized, active-controlled, partially
blinded, biomarker select, Phase III clinical
trial of Pembolizumab as monotherapy and
in combination with Cisplatin+5FU versus
Placebo+Cisplatin+5FU as first line
treatment in subjects with advanced gastric
or gastroesophagela junction
adenocarcinoma
Advanced Gastric or
Gastroesophagel Junction
Adenocarcinoma
X- Biotech 2012- PT023
A Phase III Double--‐blinded, Placebo Controlled
Study of Xilonix™ or Improving Survival in
mCRC
mCRC or unresectabl
after Standard-therapy
Closed for accrual
PI: Dr. 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. Roger von Moos
CRC: Franziska Hellmann
Version 16/12 Studien Onkologie
Eligibility
- Inclusion: 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
- Exclusion: squamous cell or undifferentiated gastric
cancer.
- 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
- Inclusion: mCRC or unresectable and which is
refractory to standard therapy. To be considered
refractory, a
- subject must have experienced progression (or
intolerance) after treatment with standard
- approved regimens including, oxaliplatin, irinotecan
flouropyrimidine, bevacizumab, and cetuximab or
panitumumab if KRAS wildtype
- Exclusion: mechanical obstruction
- Uncontrolled medical disorder or active infection
- Uncontrolled significant cardiovascular disease
- Uncontrollen Hypertension >140mmHg syst. >90 mmHg
diast.
- Inclusion: Age 18-75 (80 If WHO is 0-1)
mCRC
first line
- Adjuvant chemo has been compleated more than 4
for inoperable or metastatic disease
months before inclusion
- measurbale disease Recist 1:1, inf noe measurabel
metast. But CEA > at least > 2 x ULN)
- Exclusion: Cycle ergometer stress test shows signs of
ischemic heart disease or high grade arrhythm.
- NYHA II, recent Myocardinf., unstabile AP, uncontrolled Hypertension, COPD or GOLD > Stadium II
- Inability to ride a cycle ergometer
- Inability to perform 50 Watt on a cycle ergometer
Study Design
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)
Subjects randomized to
MABp1 or placebo will receive
7.5 mg/kg Q2W
Arm A: Standard palliative
chemotherapy and
structueren phyical exercise
intervention ( 12 weeks
cycling training twice a week
and pedometer)
Arm B: Standard palliative Ch
Emotherapy
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Gastrointestinal
Protocol Title
SAKK Prodige 32
Systematic surgery vs. monitoring and salvage
surgery in operable oesophageal cancer in
complete clinical response after chemoradiation
Strategic multicenter randomised phase II-III trial
PI: Dr. Sara Bastian
CRC: Franziska Hellmann
Version 16/12 Studien Onkologie
Diagnosis
Eligibility
Stage cT2 N1-3 M0 or cT3-T4a N0
or N1-3 M0 Squam. cell carcinoma
or adenoca. of thoracic oesophag.
or gastro-oesphjunct. (Siewert type
I or II)
- Inclusion: Age ≥ 18 years < 75 years
- Stage cT2 N1-3 M0 or cT3-T4a N0 or N1-3 M0 Siewert
type I or II
- Patient deemed operable curative-intent and
programmed for first chemoradioth. following
multidisciplinary meeting
- Exclusion: Cancer of the cervical esophagus (15 to 19
cm from the dental arches)
- Weight loss at registration > 15 % without recovery after
nutritional care
- Severe comorbidity threatening short-term life prognosis
Study Design
Arm A:
Systematic surgery
Arm B:
Monitoring and salvage
surgery in case of resectable
locoregional recurrence
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Urogenital
Protocol Title
SAKK 01/10
Carboplatin chemotherapy and involved
node radiotherapy in stage IIA/B seminoma
Diagnosis
Eligibility
Study Design
histologically confirmed seminoma
treated with inguinal orchidectomy
Classical seminoma treated with orchidectomy inguinal
Tumor stage pT1-4 cN1-2 M0
Exclusion: mixed histology seminoma, any prior
abdominal radiotherapy
1Cycle Carboplatin
Stage IIA 30 Gy radiotherapy
Stage IIB 36 Gy 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
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
Castration resistant prostate cancer PTEN Loss in archival tumor send to St. Gallen
Progression after at least one taxane based chemotherapy
and at least one therapy with a newer hormonal agent
Exclusion: prior treatment with any platinum
Weekly carboplatin AUC 3 .
One cycle 28 days
Fresh tumorbiopsie at
baseline and optional during
the first cycle
PI: PD Dr. Richard Cathomas
CRM: Gabriela Manetsch
STAMPEDE
Systemic Therapy in Advancing or
Metastatic Prostate Cancer: Evaluation of
Drug Efficacy
MOMENTAN Geschlossen!!!
PI: PD Dr. Räto Strebel
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: PD Dr. Richard Cathomas
CRM: Gabriela Manetsch
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Urogenital
Protocol Title
CAINTA
Randomised phase II Cabazitaxel dose
Individualisation and neutropenia
prevention Trial
Diagnosis
Eligibility
Castration resistant prostate cancer Inclusion:indication for 3 weekly cabazitaxel therapy, may
progressed during or after
have abiraterone and TAK700 or enzelutamid
Exlcusion: previous cabazitaxel
completion of docetaxel therapy
Study Design
ARM A: Cabazitaxel every
three weeks 25mg /m2
ARM B: Cycle 1 25mg/m2
Cycle > 2 PK-guided dose every
three weeks
PI: PD Dr. Richard Cathomas
CRC: Gabriela Manetsch
SAKK 63/12
Prospective cohort study with collection of
clinical data and serum of patients with
prostate disease
PI: PD DR. Räto Strebel
CRC: Alexandra Jori / Gabriela Manetsch
SAKK 08/14
Investigation of Metformin in patients with
castration resistand prostate cancer in
combination with Enzelutamid vs.
Enzelutamid alone (IMPROVE TRIAL)
Eligible for biopsy
Inclusion:
Depending on allocated group
Exlcusion:
Other concurrent active malignancy
Psychiatric disorder
Castration resistant prostate cancer Inclusion: Progression, agree to participate in the 3
mandatory translational part
Exlcusion:
Novel treatment
Cohort study with a
prospective collection and
biobanking of sera from 5
patient groups with specific
indications for PSA-testing,
and with longitudinal followup.
Arm A:
Enzelutamide and Metformin
Arm B:
Enzelutamide alone
PI: PD Dr. Richard Cathomas
CRC: Gabriela Manetsch
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Urogenital
Protocol Title
Diagnosis
ABI-RE Studie
Response to abiraterone
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
Eligibility
Study Design
Inclusion:
confirmed biochemical response to prior abiraterone , any other
therapy
Exclusion:
TAK 700 , know brain metastasis
Biomarker sampling,
Abiraterone täglich 1000mg,
Tagebuch
Measurable or evaluable
Lesion, known PD-L1 status, no more than two
chemotherapy regime, no more than three regimes
Pembrolizumab 200mg every
three weeks
PI: PD Dr. Richard Cathomas
CRC: Gabriela Manetsch
Merck -3475 199-0 multinational open-label
of pembrolizumab in subjects with
metastatic castration-resistant prostate
cancer previously treated with docetaxelbased chemotherapy
Catration restistant prostate
cancer
Temporarily closed
PI: PD Dr. Richard Cathomas
CRC: Gabriela Manetsch
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Haematologie
Protocol Title
HD 17
Therapieoptimierungsstudie in der
Primärtherapie des intermediären Hodgkin
Lymphoms: Therapiestratifizierung mittels
FDG-PET
Diagnosis
Hodgkin Lymphom
Nur noch wenige Patienten können eingeschlossen
werden. Es müssen Slots reserviert werden.
Eligibility
Study Design
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
2 x BEACOPP esc. + 2 x ABVD
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
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
Measurable disease for MM,
progression after at least two
months of lenalidomid therapy
Exclusion: CNS involved,
previous G4 AE due to
lenalidomid treatment
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.
Randomisation:
PET-4 (+/-) + 30 Gy IF-RT
PET-4 (+) + 30 Gy IN-RT or Follow- up
SAE: 5d/24h
PI: PD Dr. Ulrich Mey
CRC: Franziska Hellmann
SAKK 35/14
Follikuläres Lymphom
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.
PI: PD Dr. Ulrich Mey
CRM: Gisela Mayer
SAKK 36/13
mantle cell lymphoma
Combination of ibrutinib and bortezomib
followed by ibrutinib maintenance to treat
patients with relapsed and refractory mantle
cell lymphoma; a multicentre Phase I/II trial.
PI: PD Dr. Ulrich Mey
CRM: 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
progressive multiple
myeloma
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
Lenalidomid D1-21
Dexamethasone D1, 8, 15, 22
Nelfinavir D1-21
until PD or toxicity
PI: PD Dr. Ulrich Mey
CRM: Gisela Mayer
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Haematologie
Protocol Title
SAKK 39/13 FORTUNE, SAE 24/5
Nelfinavir as bortezomib-sensitizing drug in
patients with proteasome inhibitornonresponsive myeloma. A multicenter
phase II trial.
Diagnosis
Non responsive myeloma
Eligibility
Study Design
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
- Age ≥ 18 , Newly diagnosed
MM, monocl. plasma cells in
bone marrow ≥ 10% and/or
byopsy –proven
Plasmacytoma.
- Monocl. protein in serum
and/or urine
- Measurable disease for MM
Phase 3:
Arm: Denosumab 120 mg s/c + Placebo i/v über
15 Min. Q4w
PI: PD Dr. Ulrich Mey
CRM: Gisela Mayer
SAKK 35/15
A phase I trial of obinutuzumab in combination
with venetoclax in previously untreated follicular
lymphoma patients.
Teilnahme zugesagt
PI: PD Dr. Ulrich Mey
CRM: Gisela Mayer
SAKK CLL13
A phase I trial of obinutuzumab in combination
with venetoclax in previously untreated follicular
lymphoma patients.
Teilnahme zugesagt
PI: PD Dr. Ulrich Mey
CRM: Gisela Mayer
AMGEN 20090482 SAE: 7d/24h
newly diagnosed multiple
A Randomized, Double-Blind, Multicenter Study
myeloma
of Denosumab Compared With Zoledronic Acid
(Zometa) in the Treatment of Bone Disease in
Subjects with Newly Diagnosed Multiple Myeloma
Einschluss geschlossen
PI: Dr. Sara Bastian
CRC: Franziska Hellmann
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Arm B: Placebo s/s + Zoledronic acid 4 mg i/v
über 15 Min. Q4w
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Phase 1
Protocol Title
Novartis
A phase 1b/II multicenter study of the
combination of LEE011 and BYL719 with
letrozole in adult patients with advanced
ER+ breast cancer
Diagnosis
Eligibility
Study Design
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
At our site the following Arm
is open
Arm 2 Dose expansion,
Cohort
2(300mg
BYL719
evening
dosing
+2.5mgLetrozole)
Histol.confirmed, neg. Cytologie before start of treatment, patient
have recurrent high-risk NMIBC for PD.Exclusion:Severe
incontinence, allergy to PPD test, residual urinary bladder volume
after micturition >150ml, uncontrollable urinary tract infection,
metastatic disease
Installation of VPM1002BC
(Urologe)
Retention of IMP at least 1h
Observation at leat 4h
solid tumors
BRCAm ovarian cancer, BRCAm HER2-neg. breast cancer,
SLCL (relapsed >12 wks after first line platinum based ctx) ATM
neg. gastric cancer, measurable disease. Exclusion: prior PDL1, anti-CTLA4 therapy or PARP-inhibitor, known brain
metastasis
Olaparib 300mg BID run in w1
– 4 therafter MEDI14736 –
Infusion q4wks and Olaparib
continuos
until PD
advanced solid tumor
Histol. confirmed advanced/recurrent solid tumors who failed
standard therapy orno effective therapy is available, measurable
disease patient must have a port a cath
Exclusion: not recovered AE ≤ G1, inability to swallow oral
medication, symptomatic brain metastasis, known HIV, hepatitis
BD treatment with > 2 antihypertensive medication
Dose escalation of:
BAL101553 as a 48-hour
continuos infusion on D1, 8,
15 q4wk
and
oral BAL101553 D15-21 of C2
(instead of D15 Infusion)
Advanced ER + Breast
cancer
Amendment 5 open on 02.12.2016
P.I PD Dr. Roger von Moos
CRC: Gillian Roberts
SAKK 06/14
Recurrent non –muscle
A phase I/II open label clinical trial
invasive bladder cancer
assessing safety and efficacy of intravesical
installation of VPM1002BC in patients with
recurrent non-muscle invasive bladder
cancer after standard BCG therapy
PI: PD DR. Räto Strebel
CRC: Gabriela Manetsch
AstraZeneca
A phase I/II Study of MEDI4736 (Anti PD-L1
Antibody) in Combination with Olaparib
(PARP inhibitor) in Patients with advanced
Solid Tumors
PI: Dr. Sara Bastian
CRC: Gisela Mayer
CDI-CS-003/SAKK 67/15
An open-label Phase 1/2a study of
BAL101553 administered as intravenous 48hour infusion in adult patients with
advanced solid tumors.
PI: PD DR. Roger von Moos
CRC: Gisela Mayer
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Novartis CMCSZ2102
A Phase 1b/II, open label, multicenter study
of MCS110 in combination with PDR001 in
patients with advanced malignancies
Advanced solid tumors
Phase Ib : advanced :
 Melanoma
 Endometrial cancer
 Pancreatic cancer
 Triple negative breast cancer
Phase II
 PD1/PD-L1treatment naïve TNBC
 PD1/PD-L1treatment naïve pancreatic cancer
 PD1/PD-L1treatment naïve endometrial cancer
 PD1/PD-L1treatment resistant melanoma
advanced adenocarcinoma
lower and middle rectum
Inclusion:
- Stage 2 and 3 according AJCC 2012, mrT3/4 N0, mrTx N1-2
cM0
- Age 18-75
- A multi-disciplinary tumor board recommends neoadjuvant
radio-chemotherapy and
- Surgery
Exclusion:
- Any prior treatment for rectal cancer. Major surgery or
significant traumatic injury within 28 days before registration
(colostomy
- accepted).
Concomitant strong CYP3A4 inhibitors
PI: PD DR. Roger von Moos
CRC: Gillian Roberts
Open ca. Jan / feb 2017
SAKK 41/16
A multicenter phase Ib trial
(RECAP).
Neoadjuvant treatment with Regorafenib
andCapecitabine combined with radiotherapy in
locallyadvanced rectal cancer.
Ist bei der Ethik zur Einreichung
PI: Iannis Metaxas
CRC Franziska Hellmann
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(caudal end is defined at
max. of 12
cm from anal verge
measured by endoscop
Regorafenib 40-120 mg per
day
Dose level 1–3 d1-14 & d22-35
Dose level -1 d1-5, 8-12 & d2226, 29-33 followed by surgery
Capecitabine 825 mg/m2 bid
d1-38
Radiotherapy 1.8 Gy per day
in 28fractions
Followed by surgery
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Melanome
Protocol Title
AMGEN 20110266: 24/ 7
A Phase 2, Multicenter, Randomized, Openlabel Trial Assessing the
Efficacy and Safety of Talimogene
Laherparepvec Neoadjuvant Treatment Plus
Surgery Versus Surgery Alone for
Resectable, Stage IIIB to IVM1a Melanoma
Diagnosis
Melanoma
(stage IIIb -IVM1a)
Eligibility
Histologically stage IIIB, IIIC or IVM1a, at least on injectable
lesion ≥ 10mm, measurable disease, LDH ≤ 1.0 ULN
Exclusion: primary ocular or mucosal melanoma, active hepatitis
B or C,prior therapy with tumor vaccine
Study Design
Arm 1:
Talimogene laherparepvec
(T-vec) max. 4.0 ml for 6 doses
followed by surgery
Arm 2: surgical resection
PI: PD Dr. Roger von Moos
CRC: Gisela Mayer
AMGEN 20120328
A Phase 3b, Multicenter, Open-label, SingleArm, Expanded Access Protocol of
Talimogene Laherparepvec for the
Treatment of Subjects in Europe With
Unresectable Stage IIIB to IVM1c Melanoma
Melanoma
(stage IIIb + IVM1c)
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
First dose Talimogene
Previous treatment with T-vec
Questionnaire and physical
assessment (telefonic) every 3
months
laherparepvec
(T-vec) max. 4.0 ml of
6
10 PFU/ml, therafter max. 4.0ml
8
of 10 PFU/ml q2wks for at least 6
months or until unacceptable
toxicity
Screening geschlossen
PI: PD Dr. Roger von Moos
CRC: Gisela Mayer
AMGEN 20120139: Survival Studie
Melanoma
(stage IIIb -IVM1a)
PI: PD Dr. Roger von Moos
CRC: Gisela Mayer
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Gynäkologie
Protocol Title
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
PI: PD Dr. 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
Accrual reached
Diagnosis
ovarian cancer progressing within 6-12
months of last platinum
Eligibility
- 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.
Rezidiv oder progression mindestens 6
Monatenach dem letzten
Chemotheraoiezyklus einer
Erstlinientherapie bestehend aus
carboplatin und Paclitaxel
einschliesslich Bevacizumab.
Study Design
A: PLD 30mg/m2 +Carboplatin on Day 1
Q4wo
(Kontrollarm)
B: PLD 30 mg/ m2 +Trabectedin (Yondelis)
1.1 mg/m2 on Day 1 q3wo
Up to 6 Cycles or PD
SAE: 7d/24h
Arm 1 6 Zyklen standard chemotherapie
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
PI: PD Dr. Roger von Moos
CRC: Gisela Mayer
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Palliative Care
Protocol Title
Diagnosis
SAKK 96/12
Metastatic Breast or Prostate cancer
Prevention of Symptomatic Skeletal events (castration resistant) stage IV, all subtypes
with Denosumab Administered every 4 allowed except small cells
Weeks versus every 12 Weeks
Eligibility
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
Study Design
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: PD Dr. Roger von Moos
CRC: Alexandra Jori / Gabriela Manetsch
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SAE: 5d/24h
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Beobachtungsstudien
Protocol Title
QoliTrap
Beobachtungsstudie zur Erfassung der
Lebensqualität bei Patienten mit metas.
kolorektalem Karzinom unter Zaltrap®
(Aflibercept)Therapie in Kombination mit
FOLFIRI
Diagnosis
Metast. Colorect. carcinoma
Eligibility
Inclusion:
Geplante Behandlung mit Aflibercept in Kombination mit
FOLFIRI
Study Design
Fragebögen betreffend
Lebensqualität, jede 2. Woche
vor Therapiebeginn
für mind. 12 Wochen
SAE: 7d/24h
CRC: Franziska Hellmann
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