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Clinical Trial 19625

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

Study Type: Treatment
Phase of Study: Phase I
Investigators:

  • Jhanelle Gray

Overview

Study Title

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

Summary

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®).

Objective

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