Patient case: 68-year-old male with colon cancer; genetic feature: MLH1 methylation suppression (microsatellite instability)

Clinical trial: A Study of TRK-950 in Combinations With Anti-Cancer Treatment Regimens in Patients With Advanced Solid Tumors

Summary: The main purpose of this study is to establish the safety and the recommended dose of TRK-950 in combination with FOLFIRI, Gemcitabine / Cisplatin, Gemcitabine / Carboplatin, Ramucirumab / Paclitaxel, PD1 inhibitors (Nivolumab or Pembrolizumab), and Imiquimod Cream for selected advanced solid tumors.

Detailed description: This study is an open-label, Phase 1b study evaluating TRK-950 in combination with 1) FOLFIRI or 2) Gemcitabine / Cisplatin or 3) Gemcitabine / Carboplatin or 4) Ramucirumab/Paclitaxel or 5) PD1 inhibitors (Nivolumab or Pembrolizumab) or 6) Imiquimod Cream for subcutaneous lesions in Patients with Selected Advanced Solid Tumors. The objectives of this study are to determine the safety, tolerability, MTD, recommended Phase 2 dose (RP2D), PK, and preliminary anti-tumor activity of TRK-950 when used in combination with other treatment regimens.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed solid malignancy for which the following treatment regimens are warranted:
  -  A. Colon Cancer:FOLFIRI as standard of care
  -  B. Cholangiocarcinoma, Bladder Cancer: Gemcitabine / Cisplatin as standard of care
  -  C. Ovarian Cancer who have relapsed at least 6 or more months after completion of a previous platinum-based therapy: Gemcitabine / Carboplatin as standard of care
  -  D. Gastric Cancer: Ramucirumab / Paclitaxel as standard of care
  -  E. Solid Tumors: Eligible for PD1 Inhibitor (nivolumab or pembrolizumab) monotherapy as standard of care according to the approved drug label by the relevant regulatory authority
  -  F. Locally advanced or metastatic disease in a cancer with at least one palpable subcutaneous malignant lesion(≤ 2 cm in diameter) for treatment with TRK-950 and Imiquimod cream
  -  Primary or metastatic tumors measurable per RECIST v1.1 on CT scan or by calipers (subcutaneous lesions)
  -  Karnofsky performance of ≥70
  -  Life expectancy of at least 3 months
  -  Age ≥ 18 years
  -  Signed, written IRB-approved informed consent
  Exclusion Criteria:
  -  Laboratory values or medications that are contraindicated in the selected standard of care treatment regimens
  -  New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG
  -  Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy. Prophylactic antibiotics are acceptable.
  -  Pregnant or nursing women
  -  Treatment with radiation therapy within 2 weeks, or treatment with surgery, chemotherapy, immunotherapy, or investigational therapy within four weeks prior to study entry.
  -  Unwillingness or inability to comply with procedures required in this protocol
  -  Known active infection with HIV, hepatitis B, hepatitis C
  -  Serious nonmalignant disease that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
  -  Patients who are currently receiving any other investigational agent
  -  Any contraindicated condition or drug which would make the patient ineligible for the respective treatment regimen that is to be used in combination with TRK-950 (for example, autoimmune disorders for nivolumab or pembrolizumab treatment) as described in the Full Prescribing Information

Relevance to patient case: not relevant