Brief description of trial (Data source: BASEC)
Das Hauptziel dieser Studie ist es, die Sicherheit, Verträglichkeit, dosis-limitierende Toxizitäten (dose-limiting toxicities – DLTs) zu untersuchen und maximial tolerierte Dosis (maximum tolerated dose - MTD)/maximal verabreichte Dosis (maximum administered dose - MAD)/alternative Dosis von BMS-986156 als Monotherapie oder in Kombination mit Nivolumab verabreicht in Patienten mit fortgeschrittenen soliden Tumoren.
Health conditions investigated(Data source: BASEC)
Fortgeschrittene solide Tumore
Health conditions
(Data source: WHO)
Solid Tumors
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Experimentelles Medikament: anti-GITR Antikörper (BMS-986156) 10, 30, 100, 240 oder 800 mg (Je nach Dosis-Zuordnung) intravenös (als Infusion) in 8-wöchigen Zyklen alle 2 Wochen verabreicht, für bis zu 3 Zyklen.
Experimentelles Medikament: Nivolumab (anti-PD-1 Antikörper BMS-936558) 240 mg intravenös (als Infusion) in 8-wöchigen Zyklen alle 2 Wochen verabreicht, für bis zu 3 Zyklen.
Interventions
(Data source: WHO)
Drug: BMS-986156;Drug: Nivolumab
Criteria for participation in trial
(Data source: BASEC)
Für Dosis Eskalation:
Patienten mit jeglichen vorbehandelten fortgeschrittenen (metastatisch oder refraktär) soliden Tumoren.
Für Kohorten Expansion:
Patienten müssen einen vorbehandelten soliden Tumor aufweisen, um geeignet zu sein.
- Leistungsstatus nach der Eastern Cooperative Oncology Group (ECOG) von 0 oder 1.
- Bereitschaft und Eignung vor und während der Behandlung frische Tumor Biopsien zur Verfügung zu stellen.
- Gebärfähige Frauen müssen während der Studienbehandlung und bis 23 Wochen nach Beendigung der Behandlung und zeugungsfähige Männer während der Studienbehandlung und bis 31 Wochen nach der Beendigung der Behandlung eine akzeptable Methode zur Empfängnisverhütung anwenden.
Exclusion criteria
(Data source: BASEC)
- Bekannte Metastasen im zentralen Nervensystem oder wenn das zentrale Nervensystem der einzige Ausgangspunkt der Erkrankung ist.
- Andere begleitende Malignitäten (einige Ausnahmen sind im Prüfplan näher beschrieben)
- Bekannte aktive Autoimmunerkrankung (oder Verdacht auf eine solche Erkrankung)
- Unkontrollierte oder signifikante kardiovaskuläre Erkrankungen
- Krankengeschichte einer chronischen Hepatitis
- Krankengeschichte einer aktiven Hepatitis (B oder C)
- Beeinträchtigte Leber- oder Knochenmarksfunktion
- Große Operation weniger als einen Monat vor Studienstart
Inclusion/Exclusion Criteria
(Data source: WHO)
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com
Inclusion Criteria:
- For Dose Escalation:
- Subjects with any previously treated advanced (metastatic or refractory) solid
tumor
- For Cohort Expansion:
- Subjects must have a previously treated advanced solid tumor to be eligible
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Willing and able to provide pre-treatment and on-treatment fresh tumor biopsy
- Women of child-bearing potential and men must use an acceptable method of
contraception during treatment and for 23 weeks after treatment for women and 31 weeks
for men
Exclusion Criteria:
- Known central nervous system metastases or central nervous system as the only source
of disease
- Other concomitant malignancies (with some exceptions per protocol)
- Active, known or suspected autoimmune disease
- Uncontrolled or significant cardiovascular disease
- History of active or chronic hepatitis (e.g. Hep B or C)
- Impaired liver or bone marrow function
- Major surgery less than 1 month before start of the study
-
Further information on trial
Date trial registered
Oct 21, 2015
Incorporation of the first participant
Oct 9, 2015
Recruitment status
Active, not recruiting
Academic title
(Data source: WHO)
A Phase 1/2a Dose Escalation and Cohort Expansion Study for Safety, Tolerability, and Efficacy of BMS-986156 Administered Alone and in Combination With Nivolumab (BMS-936558, Anti PD-1 Monoclonal Antibody) in Advanced Solid Tumors
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)
Incidence of Clinical Laboratory Abnormalities;Incidence of Death;Incidence of Adverse Events leading to discontinuation;Incidence of Serious Adverse Events;Incidence of Adverse Events
Secundary end point
(Data source: WHO)
Best Overall Response(ORR);Anti-drug antibody response to BMS-986156 and Nivolumab;Anti-drug antibody (ADA) response to BMS-986156;Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T) of BMS-986156;Area under the concentration-time curve in one dosing interval (AUC [TAU]) of BMS-986156;Time of maximum observed concentration (Tmax) of BMS-986156;Maximum observed concentration (Cmax) of BMS-986156;Duration of response;Progression free survival rate (PFSR);Objective response rate (ORR)
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
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
St. Gallen, Zurich
Countries
(Data source: WHO)
Australia, Belgium, Canada, France, Germany, Italy, Netherlands, Spain, Switzerland, United States
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
PD Dr. Markus Jörger
+41 76 559 10 70
markus.joerger@kssg.ch
Contact for general information
(Data source: WHO)
Bristol Myers Squibb
Bristol-Myers Squibb
Contact for scientific information
(Data source: WHO)
Bristol Myers Squibb
Bristol-Myers Squibb
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Ethikkommission Ostschweiz (EKOS)
Date of authorisation by the ethics committee
07.07.2016
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2016-00601
Secondary ID (Data source: WHO)
2015-002505-11
CA009-002
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