Brief description of trial (Data source: BASEC)
Mittels dieser klinischen Studie soll geprüft werden, ob eine Behandlung mit MCS110 und PDR001 sicher ist und Ihr Immunsystem aktivieren und auf diese Weise Ihre Krebserkrankung kontrollieren kann. Dies ist das erste Mal, dass die Kombination von MCS110 und PDR001 am Menschen untersucht wird.
Health conditions investigated(Data source: BASEC)
Patienten, die an dreifach negativem Brustkrebs, Bauchspeicheldrüsenkrebs, Endometriumkarzinom oder Melanom leiden und die trotz Standardtherapie eine Progression aufweisen oder für die es keine Standardtherapie gibt, können an dieser Studie teilnehmen.
Health conditions
(Data source: WHO)
Triple Negative Breast Cancer;Pancreatic Carcinoma;Melanoma;Endometrial Carcinoma
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Die Studienmedikamente MCS110 und PDR001 werden alle drei Wochen in Form von intravenösen Infusionen verabreicht. Tumorbiopsien werden zu Studienbeginn und nach dem ersten und dem dritten Behandlungszyklus entnommen. Diese werden auf Biomarker getestet, um die Wirkung der Studienmedikamente auf die Krebserkrankung zu beurteilen.
Interventions
(Data source: WHO)
Drug: MCS110;Drug: PDR001
Criteria for participation in trial
(Data source: BASEC)
- Alter ab 18 Jahren
- Patienten, die an dreifach negativem Brustkrebs, Bauchspeicheldrüsenkrebs, Endometriumkarzinom oder Melanom leiden und die trotz Standardtherapie eine Progression aufweisen oder für die es keine Standardtherapie gibt
- Patienten, die einwilligen, dass bei Studienbeginn und während der Studie eine Tumorbiopsie entnommen wird und bei denen eine Tumorbiopsie medizinisch machbar ist.
Exclusion criteria
(Data source: BASEC)
- Personen, die keine ausreichende Verhütung praktizieren, sowie schwangere Frauen dürfen nicht an dieser Studie teilnehmen
Inclusion/Exclusion Criteria
(Data source: WHO)
Inclusion Criteria:
- Signed informed consent prior to any procedures
- Patients with advanced melanoma, endometrial carcinoma, pancreatic or TNBC, with
measurable or non-measurable disease who have progressed despite standard therapy or
are intolerant of standard therapy, or for whom no standard therapy exists.
Exclusion Criteria:
- Patient having out of range laboratory values defined as:
- Creatinine clearance < 40 mL/min
- Total bilirubin > 1.5 x ULN
- Absolute neutrophil count < 1.0 x 109/L
- Hemoglobin (Hgb) < 9 g/dL
- Impaired cardiac function or clinically significant cardiac disease
- Active autoimmune disease
- Malignant disease, other than that being treated in this study.
- Presence of = CTCAE Grade 2 toxicity due to prior cancer therapy.
- Pregnant or lactating women
Other protocol-defined inclusion/exclusion may apply.
-
Further information on trial
Date trial registered
Jun 17, 2016
Incorporation of the first participant
Jun 29, 2016
Recruitment status
Completed
Academic title
(Data source: WHO)
A Phase Ib/II, Open Label, Multicenter Study of MCS110 in Combination With PDR001 in Patients With Advanced Malignancies
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase
(Data source: WHO)
Phase 1/Phase 2
Primary end point
(Data source: WHO)
(phase 1) Number of patients with adverse events, as a measure of safety;(phase 2) : Overall Response rate (ORR)
Secundary end point
(Data source: WHO)
Phase 1: Overall Response Rate (ORR);Phase 1: progression free survival (PFS);Phase 2 Overall response rate per Response Criteria;Phase 1 : clinical benefit rate (CBR);Phase 1 : duration of response (DOR);Phase 1 : disease control rate (DCR);Phase 2 : Progression Free Survival (PFS);Pharmacokinetics of MCS110 and PDR001 in combination;Phase 2 Duration Of Response (DOR);Phase 2 : Disease Control Rate (DCR);Phase 2 : Clinical Benefit Rate (CBR);Immunogenicity PDR001;Immunogenicity MCS110
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
Undecided
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Chur, Geneva, Zurich
Countries
(Data source: WHO)
Belgium, Finland, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of, Spain, Switzerland, United States
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Patrick Grabher
+41 79 330 70 18
patrick.grabher@novartis.com
Contact for general information
(Data source: WHO)
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Contact for scientific information
(Data source: WHO)
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Kantonale
Ethikkommission Zürich
Date of authorisation by the ethics committee
24.05.2017
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2016-01872
Secondary ID (Data source: WHO)
2016-000210-29
CMCS110Z2102
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