Brief description of trial (Data source: BASEC)
Der Zweck dieser Studie ist es, die Sicherheit und Anti-Tumor-Aktivität von Relatlimab-Kombinationstherapie bei soliden Krebsarten zu untersuchen, die fortgeschritten sind oder sich ausgebreitet haben.
Health conditions investigated(Data source: BASEC)
Krebserkrankungen im fortgeschrittenen Stadium
Health conditions
(Data source: WHO)
Advanced Cancer
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Parallele Zuweisung zu einem von zwei Behandlungsarmen.
Prüfmedikation Arm A: Relatlimab + Nivolumab + BMS-986205
Prüfmedikation Arm B: Relatlimab + Nivolumab + Ipilimumab
Interventions
(Data source: WHO)
Biological: Relatlimab;Biological: Nivolumab;Drug: BMS-986205;Biological: Ipilimumab
Criteria for participation in trial
(Data source: BASEC)
- Histologisch oder zytologisch bestätigte unheilbare solide maligne Krebserkrankung, die fortgeschritten ist (metastasiert und / oder nicht resezierbar), mit messbarer Erkrankung nach RECIST v1.1
- Verfügbares Tumorgewebe für Biomarker-Bestimmungen
- Leistungsstatus von 0 oder 1 (ECOG, Eastern Cooperative Oncology Group Performance Status)
Exclusion criteria
(Data source: BASEC)
- Teilnehmer mit bekannten oder vermuteten nicht kontrollierten Metastasen des Zentralen Nervensystems (ZNS-Metastasen) oder mit dem ZNS als einziger Stelle der aktiven Erkrankung
- Teilnehmer mit einer Vorgeschichte von interstitieller Lungenerkrankung (ILD) / Pneumonitis
- Frühere Malignome, die in den letzten 3 Jahren aktiv waren, mit Ausnahme von lokal heilbaren Krebsarten, die geheilt wurden, wie Basal- oder Plattenepithel-Hautkrebs
Inclusion/Exclusion Criteria
(Data source: WHO)
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:
- Histologic or cytologic confirmation of select incurable solid malignancies that are
advanced (metastatic and/or unresectable), with measurable disease per RECIST v1.1
- Available tumor tissue for biomarker analysis
- Eastern Cooperative Oncology Group Performance Status (ECOG) status of 0 or 1
Exclusion Criteria:
- Known or suspected central nervous system (CNS) metastases or with the CNS as the only
site of active disease
- History of interstitial lung disease / pneumonitis
- Prior malignancy active within the previous 2 years except for locally curable cancers
that have been cured, such as basal or squamous cell skin cancer
- Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed
consent
Other protocol-defined inclusion/exclusion criteria apply
-
Further information on trial
Recruitment status
Active, not recruiting
Academic title
(Data source: WHO)
A Phase 1/2 Study of Relatlimab (Anti-LAG-3 Monoclonal Antibody) Administered in Combination With Both Nivolumab (Anti-PD-1 Monoclonal Antibody) and BMS-986205 (IDO1 Inhibitor) or in Combination With Both Nivolumab and Ipilimumab (Anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant 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)
Number of clinical laboratory test abnormalities;Number of Adverse Events (AEs);Number of Serious Adverse Events (SAEs);Number of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria;Number of AEs leading to discontinuation;Number of AEs leading to death;Objective Response Rate (ORR);Disease Control Rate (DCR);Median Duration of Response (mDOR)
Secundary end point
(Data source: WHO)
Progression-Free Survival (PFS)
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)
Lausanne, Zurich
Countries
(Data source: WHO)
Australia, France, Italy, Spain, Switzerland, United Kingdom, United States
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Prof. Dr. med. Reinhard Dummer
0041 44 255 25 07
Reinhard.dummer@usz.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)
Kantonale
Ethikkommission Zürich
Date of authorisation by the ethics committee
14.11.2018
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2018-01313
Secondary ID (Data source: WHO)
2018-000058-22
CA224-048
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