Bristol-Myers Squibb CA009002

A Phase 1/2a dose escalation and cohort expansion study for safety, tolerability, and efficacy of BMS-986156 administered alone and in combination with nivolumab in advanced solid tumors

NCT02598960

Non-small cell lung cancer (NSCLC), cervical cancer, bladder cancer (urothelial cancer, transitional cell carcinoma), head and neck (SCCHN, larynx, oropharynx, hypopharynx, oral cavity), ovarian cancer, hepatocellular carcinoma (HCC)

Stage 4

Metastatic/Palliative

2nd line or later

BMS-986156 and nivolumab

GITR agonist, anti-PD-1 antibody

Greg Vidal, MD

Bristol-Myers Squibb

Phase 1

Closed to Accrual

NCT02598960

• Measurable disease

• NSCLC

  • If EGFR mut or ALK positive must have received targeted therapy

  • Must have progressed on both platinum doublet and PD-1 therapy

• Cervical Cancer

  • Persistent, recurrent, or metastatic disease

  • Squamous, adenosquamous or adenocarcinoma histology

  • At least one prior platinum based regimen

  • Confirmation of HPV status

• Bladder cancer

  • Transitional cell carcinoma involving bladder, urethra, ureter, or renal pelvis

  • Minor histologic variants are acceptable

  • Must have progression or recurrence with platinum-containing regimen (in metastatic setting or within 12 months of peri-operative setting)

• SCCHN

  • Must have documented HPV status and subtype

  • Prior treatment with platinum containing regimen with progression or recurrence within 6 months of last dose

  • Cannot be amenable to local therapy with curative intent

• Ovarian

  • Can include epithelial ovarian, primary [peritoneal, or fallopian tube cancer

  • Must have received at least 1 standard systemic therapy for metastatic disease

• HCC

  • Progressive disease to at least one line of therapy or refuse treatment with sorafenib

  • Child-Pugh score of 6 or less. No encephalopathy and Tbili must be <1.5x ULN

  • HBV and HCV must be tested. HBV viral load <100 IU/mL and must be on anti-viral therapy

  • No clinical ascites or variceal bleeding

• No more than 5 prior lines of treatment

• Acceptable lab parameters

• No active CNS metastatases (treated brain mets may be allowed)

• No prior malignancy within 2 years (except for in-situ or non-melanoma skin)

• No autoimmune disease, interstitial lung disease, or requiring immunosuppressive meds

Primary- Safety; Secondary- ORR, PFS, DoR, PK

_

_

Histologic or cytologic confirmation of advanced malignancy. Tissue is required.

N/A

No