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SNCTP000002038 | NCT01968109 | BASEC2016-00429

Studie zur Bewertung der Sicherheit von Anti-LAG-3 allein oder in Kombination mit Nivolumab bei der Behandlung von soliden Tumoren.

Data source: BASEC (Imported from 28.09.2020), WHO (Imported from 27.09.2020)
Changed: 30.08.2020
Disease category: Other Cancer

Brief description of trial (Data source: BASEC)

Studie zur Beurteilung der Sicherheit und Verträglichkeit, Bestimmung von Nebenwirkungen, welche die Dosierung begrenzen, und Ermittlung der maximal verträglichen Dosis von BMS-986016 allein und in Kombination mit Nivolumab bei Patienten mit bestimmten fortgeschrittenen (mit Metastasen und/oder inoperabel) soliden Tumoren und um vorläufige Hinweise auf den klinischen Nutzen dieser Kombination zu liefern.

Health conditions investigated (Data source: BASEC)

Dosiseskalation:
Patienten mit anderen nicht mit immunonkologischen Wirkstoffen vorbehandelten Tumoren, einschließlich Kopf- und Nacken-, Magen-, Hepatozellulären-, Zervix-, Ovarial-, Blasen- und Kolorektalkarzinomen;
Patienten mit Melanom und NSCLC in Erstlinie;
Patienten mit Nierenzellkarzinom nicht mit IO;
Patienten mit NSCLC, bei denen während oder nach einer Therapie mit Anti-PD-1- oder Anti-PD-L1 eine Progression auftritt;
Patienten mit Melanom, bei denen während oder nach der Therapie mit Anti-CTLA-4- und/oder Anti-PD-1-/Anti-PDL-1-Antikörpern eine Progression auftritt;

Dosisexpansion:
Alles oben genannte mir Ausnahme von Zervix-, Ovarial-, und Kolorektalkarzinomen

Health conditions (Data source: WHO)

Neoplasms by Site

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: BASEC)

Nivolumab, Anti-LAG-3

Interventions (Data source: WHO)

Biological: Relatlimab;Biological: Nivolumab;Biological: BMS-986213

Criteria for participation in trial (Data source: BASEC)

Progress oder Unverträglichkeit bei mindestens einer Behandlung mit der Standardtherapie
Behandlung mit einer beliebigen Anzahl an Vortherapien
Leistungsstatus nach ECOG von 0 oder 1
Mindestens eine Läsion mit messbarer Krankheit zum Studienstart
Verfügbarkeit von bereits existierenden Tumorbiopsieproben (oder Einverständnis für eine Tumorbiopsie vor der Behandlung, falls noch keine vorhanden ist)

Exclusion criteria (Data source: BASEC)

Primäre ZNS Tumore oder solide Tumore mit ZNS Metastasen als einziger Punkt mit Krankheitsaktivität
Autoimmunerkrankung
Enzephalitis, Meningitis, oder unkontrollierte Krampfanfälle im Jahr vor Unterzeichnung der Einverständniserklärung
Unkontrollierte ZNS Metastasen

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 cervical, ovarian, bladder and colorectal cancer
(CRC), head and neck, gastric and hepatocellular cancer naive to immuno-oncology
agents; 1st line melanoma and 1st line/2nd line NSCLC; Renal Cell Carcinoma naive to
IO; NSCLC progressing while on or after therapy with anti-PD1/anti-PDL-1 and melanoma
subjects progressed while-on or after treatment with anti-PD1 or anti-PDL1 with or
without anti-CTLA-4.

- For Dose Expansion: all of the above in escalation except for cervical, ovarian, and
CRC

- Progressed, or been intolerant to, at least one standard treatment regimen, except for
participants in 1st line cohorts.

- ECOG performance status between 0 and 2

- At least 1 lesion with measurable disease at baseline

- Availability of an existing tumor biopsy sample (and consent to allow pre-treatment
tumor biopsy)

Exclusion Criteria:

- Primary central nervous system (CNS) tumors or solid tumors with CNS metastases as the
only site of active disease

- Autoimmune disease

- Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed
consent

- Uncontrolled CNS metastases

Other protocol defined inclusion/exclusion criteria could apply

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT01968109

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT01968109

Further information on trial

Date trial registered

25.09.2013

Incorporation of the first participant

14.10.2013

Recruitment status

Recruiting

Academic title (Data source: WHO)

A Phase I/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination With Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors

Type of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

Allocation: 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)

Proportion of participants with Adverse Events (AEs);Proportion of participants with Serious Adverse Events (SAEs);Proportion of Deaths;Proportion of participants with laboratory abnormalities in blood;Proportion of participants with laboratory abnormalities in blood serum;Proportion of participants with laboratory abnormalities in urine;Objective response rate (ORR);Disease control rate (DCR);Duration of response (DOR);Number of AEs in the Broad Scope MedDRA Anaphylactic Reaction SMQ;Proportion of participants with AEs leading to discontinuation of treatment

Secundary end point (Data source: WHO)

Number of AEs in the Narrow Scope MedDRA Anaphylactic Reaction SMQ;Overall survival (OS);Progression-free survival (PFS) rates;Duration of response (DOR);DCR;ORR;Best overall response (BOR);QTc interval from centrally read electrocardiograms (ECGs);Immunogenicity measured by anti-drug antibody (ADA) for BMS-986016 (all participants) and nivolumab;Degree of fluctuation (DF) or fluctuation index ([Cmax - Ctau]/Css,avg]) of BMS-986016 administered both alone and in combination with nivolumab;Ctau accumulation index; ratio of Ctau at steady state to Ctau after the first dose (AI_Ctau) of BMS-986016 administered both alone and in combination with nivolumab;Cmax accumulation index; ratio of Cmax at steady state to Cmax after the first dose (AI_Cmax) of BMS-986016 administered both alone and in combination with nivolumab;Accumulation index; ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose (AI_AUC) of BMS-986016 administered both alone and in combination with nivolumab;Effective elimination half-life that explains the degree of Cmax accumulation observed (T-HALFeff Cmax) of BMS-986016 administered both alone and in combination with nivolumab;Effective elimination half-life that explains the degree of area under the concentration-time curve (AUC) accumulation observed (T-HALFeff AUC) of BMS-986016 administered both alone and in combination with nivolumab;Volume of distribution at steady state (Vss) of BMS-986016 administered both alone and in combination with nivolumab;Total body clearance (CLT) of BMS-986016 administered both alone and in combination with nivolumab;Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-986016 administered both alone and in combination with nivolumab;Concentration at the end of a dosing interval (Ctau) [Eg: concentration at 336 hours] of BMS-986016 administered both alone and in combination with nivolumab;Trough observed serum concentration (Ctrough) of BMS-986016 administered both alone and in combination with nivolumab;Time of maximum observed serum concentration (Tmax) of BMS-986016 administered both alone and in combination with nivolumab;Maximum observed serum concentration (Cmax) of BMS-986016 administered both alone and in combination with nivolumab

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, Austria, Canada, Denmark, Finland, France, Germany, Italy, Japan, Netherlands, Norway, Spain, Switzerland, United Kingdom, United States

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

Prof. Dr. Reinhard Dummer
+41442552507
Reinhard.Dummer@usz.chv

Contact for general information (Data source: WHO)

Bristol-Myers Squibb;Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:
Bristol-Myers Squibb
Clinical.Trials@bms.com

Contact for scientific information (Data source: WHO)

Bristol-Myers Squibb;Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:
Bristol-Myers Squibb
Clinical.Trials@bms.com

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

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

11.10.2016

Further trial identification numbers

Trial identification number of the ethics committee (BASEC-ID) (Data source: BASEC)

2016-00429

Secondary ID (Data source: WHO)

2014-002605-38
CA224-020