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Clinical Trial 19625

Cancer Type: Thoracic
Interventions:BMS-936558 (Nivolumab); Carotuximab; Nivolumab; TRC105 (Carotuximab)

Study Type: Treatment
Phase of Study: Phase I

  • Jhanelle Gray

Call 813-745-6100
or 1-800-679-0775

Study Title

A Phase 1b Dose-Escalation Study Of TRC105 In Combination With Nivolumab In Patients With Metastatic Non-Small Cell Lung Cancer


The purpose of this research study is to determine the effectiveness and safety of Carotuximab (TRC105) when given in combination with nivolumab (also known as Opdivo®).


Primary: To evaluate safety and tolerability and determine a recommended Phase 2 dose for carotuximab when added to standard dose nivolumab in patients with metastatic NSCLC. Secondary: To assess preliminary evidence of antitumor activity when carotuximab is added to nivolumab, by assessing response rate and progression-free survival. To characterize the pharmacokinetic profile of carotuximab when given with nivolumab. To evaluate the formation of carotuximab anti-product antibodies (APA).

Inclusion Criteria

  • Histologically confirmed metastatic non-small cell lung cancer (NSCLC) with disease recurrence or progression during or after prior platinum-containing doublet chemotherapy regimen
  • Formalin fixed, paraffin-embedded (FFPE) tumor tissue block or unstained slides of tumor sample (archival) - Biopsy should be excisional, incisional, or core. Needle aspiration is insufficient.
  • Programmed death ligand 1 (PD-L1) expression on ≥ 1% of tumor cells by validated immunohistochemistry assay
  • Measurable disease by irRECIST
  • Age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
  • Resolution of all acute adverse events resulting from prior cancer therapies to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤ 1 or baseline (except alopecia or neuropathy)
  • Adequate organ function
  • Willingness and ability to consent for self to participate in study
  • Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
  • Additional criteria may apply

  • Exclusion Criteria

  • Autoimmune disease
  • Condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to study treatment
  • History or active interstitial lung disease
  • Immunosuppression, of any kind
  • Prior therapy with T-cell therapy, including an immune checkpoint inhibitor
  • Prior treatment with carotuximab (TRC105) Current treatment on another therapeutic clinical trial
  • Receipt of systemic anticancer therapy, including investigational agents, within 28 days prior to study treatment (Note: If anticancer therapy was given within 28 days prior to starting study treatment, patients are not excluded if ≥ 5 times the elimination half-life of the drug has elapsed.)
  • Major surgical procedure or significant traumatic injury within 4 weeks prior to study treatment, and must have fully recovered from any such procedure; and no date of surgery (if applicable) or anticipated need for a major surgical procedure planned within the next 6 months
  • Prior chest radiotherapy less than or equal to 3 months
  • Hypertension
  • Ascites or pericardial effusion that required intervention within 3 months prior to study treatment
  • History of brain involvement with cancer, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease
  • Angina, myocardial infarction (MI), symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack TIA), arterial embolism, pulmonary embolism, percutaneous transluminal coronary angioplasty (PTCA), or coronary artery bypass grafting (CABG) within 6 months prior to study treatment
  • Deep venous thrombosis within 6 months prior to study treatment, unless patient is anti-coagulated without use of warfarin for ≥2 weeks prior to study treatment; in this case, low molecular weight heparin is preferred
  • Active bleeding or pathologic condition that carries a high risk of bleeding (e.g., hereditary hemorrhagic telangiectasia)
  • Thrombolytic use (except to maintain IV catheters) within 10 days prior study treatment
  • Known active viral or nonviral hepatitis or cirrhosis
  • Active infection requiring systemic treatment
  • History of hemorrhage or hemoptysis (> ½ teaspoon bright red blood) within 3 months prior to study treatment
  • History of peptic ulcer within the past 3 months prior to study treatment, unless treated for the condition and complete resolution has been documented by esophagogastroduodenoscopy (EGD) within 28 days prior to study treatment
  • History of gastrointestinal perforation or fistula in the 6 months prior to study treatment, or while previously on antiangiogenic therapy, unless underlying risk has been resolved (e.g., through surgical resection or repair)
  • Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness.
  • Pregnancy or breastfeeding, not willing to follow contraception guidelines.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results
  • Additional criteria details may apply