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NCT03251924 | SNCTP000003219

Eine Forschungsstudie zu Immuntherapie-Kombinationen bei Patienten mit soliden Krebsarten, die fortgeschritten sind

Data source: BASEC (Imported from 16.08.2019), WHO (Imported from 04.08.2019)
Changed: 21.07.2019
Disease category: Kopf- und Nackenkrebs, Lungenkrebs, Dickdarm- und Mastdarmkrebs, Blasenkrebs, Prostatakrebs

Brief description of trial (Source of data: BASEC)

Der Zweck dieser Studie ist es, die Behandlung mit BMS-986226 alleine oder in Kombination mit Nivolumab oder Ipilimumab zu untersuchen

Health conditions investigated (Source of data: BASEC)

Solide Tumore im fortgeschrittenen Stadium

Health conditions (Source of data: WHO)

Cancer;Tumors;Neoplasm

Rare disease (Source of data: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Source of data: BASEC)

• Experimenteller Arm BMS-986226: BMS-986226
• Experimenteller Arm BMS-986226 und NIvolumab: BMS-986226 in Kombination mit Nivolumab
• Experimenteller Arm BMS-986226 und Ipilimumab: BMS-986226 in Kombination mit Ipilimumab

Interventions (Source of data: WHO)

Drug: BMS-986226;Biological: Nivolumab

Criteria for participation in trial (Source of data: BASEC)

• Solide Tumore im fortgeschrittenen Stadium
• Histologisch oder zytologisch bestätigte maligne Krebserkrankung, die fortgeschritten ist (metastasiert und / oder nicht resezierbar), mit messbarer Erkrankung nach RECIST v1.1
• Mindestens eine für die Biopsie zugängliche Läsion zusätzlich zur Target-Läsion
• Teilnehmer müssen mindestens eine Standardtherapie erhalten haben und im Anschluss einen Krankheitsprogress erleidet oder intolerant gegenüber der Therapie sein
• Leistungsstatus von 0 bis 2 (ECOG, Eastern Cooperative Oncology Group Performance Status)

Exclusion criteria (Source of data: BASEC)

• Teilnehmer mit aktiven Metastasen des Zentralen Nervensystems (ZNS-Metastasen), unbehandelten ZNS-Metastasen, oder mit dem ZNS als einziger Stelle der aktiven Erkrankung sind ausgeschlossen (kontrollierte Gehirnmetastasen sind für den Einschluss erlaubt)
• Teilnehmer mit Meningeosis carcinomatosa
• Frühere Malignome, die in den letzten 2 Jahren aktiv waren, mit Ausnahme von lokal heilbaren Krebsarten, die geheilt wurden, wie Basal- oder Plattenepithel-Hautkrebs, oberflächlicher Blasenkrebs, oder Carcinoma in situ der Prostata, Cervix oder Brust
• Aktive, bekannte, oder vermutete Autoimmunerkrankung
• Unkontrollierte oder bedeutende kardiovaskuläre Erkrankung

Inclusion/Exclusion Criteria (Source of data: WHO)


For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com

Inclusion Criteria:

- Advanced solid tumors

- Histological or cytological confirmation of a malignancy that is advanced (metastatic
and/or unresectable) with measureable disease as defined by Response Evaluation
Criteria In Solid Tumors (RECIST) v1.1

- At least 1 lesion accessible for biopsy in addition to the target lesion

- Participants must have received, and then progressed or been intolerant to, at least 1
standard treatment regimen

- Eastern Cooperative Oncology Group (ECOG) performance status =2

Exclusion Criteria:

- Participants with active central nervous system (CNS) metastases, untreated CNS
metastases, or with the CNS as the only site of disease are excluded (controlled brain
metastases will be allowed to enroll)

- Participants with carcinomatous meningitis

- Prior malignancy active within the previous 2 years except for locally curable cancers
that have been apparently cured, such as basal or squamous cell skin cancer,
superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast

- Active, known, or suspected autoimmune disease

- Uncontrolled or significant cardiovascular disease

Other protocol defined inclusion/exclusion criteria could apply

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT03251924

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT03251924

Further information on trial

Date trial registered

15.08.2017

Incorporation of the first participant

31.08.2017

Recruitment status

Recruiting

Academic title (Source of data: WHO)

A Phase 1/2 Dose Escalation and Combination Cohort Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Efficacy of BMS-986226 Alone or in Combination With Nivolumab or Ipilimumab in Patients With Advanced Solid Tumors

Type of trial (Source of data: WHO)

Interventional

Design of the trial (Source of data: WHO)

Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).

Phase (Source of data: WHO)

Phase 1/Phase 2

Primary end point (Source of data: WHO)

Incidence of adverse events (AE);Incidence of serious adverse events (SAE);Incidence of AE due to discontinuation;Incidence of AE resulting in death;Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria

Secundary end point (Source of data: WHO)

Objective response rate (ORR) measure by Clopper-Pearson method;Median Duration of Response (mDOR) measured by Kaplan-Meier method;Progression Free Survival (PFS) measured by Kaplan-Meier method;Maximum observed plasma concentration (Cmax);Time of maximum observed plasma concentration (Tmax);Area under the concentration-time curve from time 0 to the time of the last [AUC (0-T)];Area under the concentration-time curve in 1 dosing interval [AUC(TAU)];Incidence of anti-drug antibodies to BMS-986226 assessed by immunoassay

Contact information (Source of data: WHO)

Please refer to primary and secondary sponsors

Trial sites

Trial sites in Switzerland (Source of data: BASEC)

Chur, Lausanne, Zürich

Countries (Source of data: WHO)

Canada, Spain, Switzerland, United States

Contact for further information on the trial

Details of contact in Switzerland (Source of data: BASEC)

PD Dr. Richard Cathomas
+41812566646
richard.cathomas@ksgr.ch

Contact for general information (Source of data: WHO)

Bristol-Myers Squibb
Bristol-Myers Squibb

Contact for scientific information (Source of data: WHO)

Bristol-Myers Squibb
Bristol-Myers Squibb

Principal Sponsor/Investigator

Principal sponsor (Source of data: WHO)

Bristol-Myers Squibb

Further trial identification numbers

BASEC ID (Source of data: BASEC)

2018-02136

Secondary ID (Source of data: WHO)

2017-000238-73