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CA 224-047 Relatlimab (BMS)

AcronymISRCTNEudraCTClinicaltrials.govDRKS

Status: Active

Purpose / Objectives

Primary Outcome

Phase 2: The Phase 2 Primary objective is to compare the ORR of BMS-986213 to Nivolumab monotherapy in participants with unresectable or metastatic melanoma.

 

Phase 3: The Phase 3 Primary objective is to compare PFS of BMS-986213 to Nivolumab monotherapy in particpants with previously untreated, unresectable or metastatic melanoma.

Secondary Outcomes

The Phase 2 secondary objectives are:

 

To estimate the Treatment effect, measured by ORR, as determined by BICR using RECIST v1.1, in subgroups based on combinations of LAG3-expression (positive or negative) and PDL-1 Status (positive or negative) among participants with unresectable or metastatic Melanom treated with BMS-986213 compared th those treated with nivolumab monotherapy.

 

The Phase 3 secondary objectives are:

 

To compare Overall survival (OS) of BMS-986213 to Nivolumab monotherapy in participants with unresectable or metastatic melanoma.

To compare ORR of BMS-986213 to nivolumab monotherapy in participants with unresectable or metastatic melanoma.

Diagnosis

Patient attributes

Stage

III/IV

Inclusion criteria

Participants must have an ECOG Performance Status of ≤ 1.

Participants must have histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the AJCC staging System (8th Edition)

Participants must bei Treatment naive (ie, no Prior systemic anticancer therapy for unresectable or metastatic melanoma).
Note that the following Prior adjuvant or neoadjuvant melanoma therapies are allowed if all related adverse Events have eithe returned to baseline or stabilized.

Anti-PD-1 or anti-CTLA-4 therapy with at least 6 months between the last dose and date of recurrence

Interferon therapy with the last dose at least 6 weeks Prior to randomization

Participants must have measurable diesease by CT or MRI per RECIST v1.1 criteria.

 

 

Trial design

  • Phase II
  • Phase III
  • Double-blind

Documents (password protected)

Responsibilities in overall trial

Bristol-Myers Squibb GmbH & Co. KGaA

  • Tel. +49 (0) 89 - 12142 -0
  • Fax +49 (0) 89 - 12142 -392

National Coordinating Investigator

Prof Dirk Schadendorf

Study Sites

Klinik & Poliklinik für Dermatologie & Venerologie Köln

Study office

Status

Active

Principal Investigator

Univ.-Prof. Dr. med. Dr. Cornelia Mauch

Deputy of Principal Investigator

  • Dr. Nicole Kreuzberg

Subinvestigator

  • Bodo Bühler
  • Carina Gärtner

Contact at Site