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Klinische Studien

CA209-848

AcronymISRCTNEudraCTNCT (clinicaltrials.gov)DRKS
Checkmate 8482016-002898-35NCT03668119

A Randomized, Open-Label, Phase 2 Study of Nivolumab in Combination with Ipilimumab or Nivolumab Monotherapy in Participants with Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)

Status: Active (Recruitment Closed)

Purpose / Objectives

Primary Outcome

Primary Outcome Measures : Objective Response Rate (ORR)

Secondary Outcomes

Secondary Outcome Measures :

  1. Duration of response (DOR)
  2. ORR assessed by investigator
  3. TTR
  4. Clinical benefit rate (CBR)
  5. Overall survival (OS)
  6. PFS
  7. Incidence of Adverse Events
  8. Incidence of Serious Adverse Events
  9. Incidence of laboratory abnormalities
  10. Incidence of anti-drug antibody (ADA)

Diagnosis

Patient attributes

Age

18-99

Inclusion criteria

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

Inclusion Criteria:

  • Refractory, metastatic, or unresectable TMB-H solid tumors who must have received at least one prior line of therapy including standard of care, if available
  • Available tumor tissue and blood for TMB testing
  • Participants must have measurable disease for response assessment

Exclusion criteria

  • Participants with melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC) or hematological malignancy as primary site of disease
  • Participants who received prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
  • Treatment with any chemotherapy, radiation therapy, biologics for cancer, or investigational therapy within 28 days of first administration of study treatment

Trial design

  • Phase II
  • Multicenter
  • Prospective
  • Randomized
  • Two-arm
  • Open Label

Intervention

Nivolumab versus Nivolumab/Ipilimumab

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

Study Sites

Medizinische Klinik & Poliklinik III (Bonn)

Study office

Status

Active (Recruitment Closed)

Principal Investigator

Univ.-Prof. Dr. med. Peter Brossart

Deputy of Principal Investigator

  • PD Dr. Georg Feldmann

Subinvestigator

  • Dr. Franz-Georg Bauernfeind
  • Dr. med. Johannes Blieninger
  • Dr. Linne Dobrosch

Contact at Site

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