ADVANCED TUMORS: PHASE 1 (ESCALATION): PD-1 naive or experienced; TIM3+NIVOLUMAB: CA031002

A Phase 1/2 first-in-human study of BMS-986258 alone and in combination with nivolumab in advanced malignant tumors

Title
Bristol-Myers Squibb CA031002 (TIM-3)
Study Title

A Phase 1/2 first-in-human study of BMS-986258 alone and in combination with nivolumab in advanced malignant tumors

Site Link
Malignancy
Renal cell (kidney), CRC (colon, rectal, colorectal), lung cancer (NSCLC), Head and Neck (SCCHN), Triple Negative Breast (TNBC)
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
2nd line or greater
Investigational Agent
BMS 986258
Drug Class
TIM-3 antibody
PI
Dan Vaena, MD
Sponsor
Bristol Myers Squibb
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • ECOG PS 0-1
  • No active CNS disease (controlled brain mets are allowed)
  • Must have one of the five malignancies below
    • Clear-cell RCC
    • Triple-negative Breast Cancer
    • Squamous cell carcinoma of the head and neck
    • Colorectal cancer
    • Non-small cell lung cancer
  • No other malignancies within 2 years
  • No active, known, or suspected autoimmune disease (except asthma, vitiligo, T1DM, hypothyroidism, Graves disease, or psoriasis not requiring treatment)
  • No severe autoimmune reactions to immunotherapy
  • No need for active steroid therapy
  • No significant cardiac disease
  • No chronic hepatitis
  • No active interstitial lung disease
  • RCC specific eligibility criteria
    • Previously received one or two anti-VEGFR therapies
    • No more than 3 total prior systemic tx in metastatic setting
    • Must have evidence of progression on or after last treatment received and within 6 months of starting study
  • CRC specific eligibilty criteria
    • Must have received and progressed on at least 1 standard therapy for metastatic disease
    • Must have known MSI status
  • NSCLC specific eligibility criteria
    • Must have progressed on or been refractory to platinum doublet
    • Must have known EGFR, ALK, ROS1 status.
      • Those with EGFR or ALK alterations must have previously received TKI therapy
  • SCCHN specific eligibility criteria
    • Not amenable ot local therapy with curative intent
    • Must have progressed on or been intolerant of platinum containing regimen
  • TNBC specific eligibility criteria
    • Must have received and progressed on or been intolerant to at least 1 standard chemotherapy with anthracycline and taxane
Objective

Primary- MTD; Secondary- ORR, mDOR, PFSR, PK parameters, immunogenicity

Assessment Frequency
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Assessment Frequency 2
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Assessment Frequency Link
Path
Lung- non-small cell; Breast- Triple Negative; RCC- clear cell; CRC- any; SCCHN- any
Dosing Frequency
Control Agents
Study Protocol
Randomized
No
X