CA027-002: A Phase 1/2a Study of BMS-986253 in Combination with Nivolumab or Nivolumab plus Ipilimumab in Advanced Cancers
Indication :

Tumeurs solides avancés


Sponsor :

BMS


Phase :

I, II


Ligne :

At least 2


Traitement :

anti-IL8 et Nivolumab


Site :

CHUV


Contact(s) :
Angela Orcurto
Investigateur Principal

CHUV
Service de l' Immuno-Oncologie

Rue du Bugnon 46
Lausanne
1011

0213143854
do.ion.ref@chuv.ch

Primary objective :

To characterize safety, tolerability, and DLTs, and to determine the RP2D of BMS-986253 (IL-8) administered in combination with nivolumab, or in combination with nivolumab and ipilimumab in participants with advanced solid tumors.


Inclusion criteria :
  • Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1
  • At least 1 lesion accessible for biopsy
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1

Exclusion criteria :
  • Participants with CNS metastases as the only site of active disease (Participants with controlled brain metastases; however, will be allowed to enroll)

  • Participants with leptomeningeal metastases will be excluded

  • Participants with active, known or suspected autoimmune disease

  • Participants with conditions requiring systemic treatment with either corticosteroids (> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration

  • Participants with a known history of testing positive for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS)

  • Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy

  • Previous SARS-CoV-2 infection iwthin 10 days for mild infections or 20 days for sever/critical illnes prior to C1D1

  • Previous SARS-CoV-2 vaccine within 14 days of C1D1

  • Other protocol defined inclusion/exclusion criteria could apply