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Title:
J1794 - A Phase 1b/2 Study of BMS-813160 in Combination with Chemotherapy or Nivolumab in Patients with Advanced Solid Tumors
Protocol Number:
J1794
Phase:
Phase I/II
Physician:
Dung Le
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
To evaluate the safety, tolerability, pharmokinetics, Pharmodynamics and efficacy of new drug in combination with Chemotherapy or Nivolumab as a treatment of patients with metastatic colorectal and pancreatic cancers.
Eligibility:
1.Ablility to swallow pills and capsules 2.Must have advanced and measureable solid tumors. 3. No progressive CNS metastases. 4. Must be adenocarinoma cancer. 5 No uncontrolled or significant cardiovascular diseases. 6. Negative for HIV, Hepatitis B and C. 7. Have not had prior organ allograft or bone marrow transplantation. 8. No previous treatments with CYP9A4, CCR2 and CCR5 inhibators. 9. No surgeries or diseases that cause absorption issues.
Treatment:
This study is using chemotherapy, nivolumab and an immunotherapy in combination to target colorectal and pancreatic cancers. The phase 1b study will be evaluating safety and tolerability of BMS-813160 in combination with chemotherapy or Nivolumab in patients with solid tumors. Once Phase 1b is completed phase 2 will begin evaluating efficacy of BMS-813160 with chemotherapy Nivolumab. BMS -813160 is an immunotherapy that inhibits the CCR2 and CCR5 in cancer. Patients will be randomized to either BMS-813160 with chemotherapy or BMS-813160 with Nivolumab. BMS -813160 is a pill that will be taken daily.
Population:
Adult
Last Update
03/05/2019 05:03 AM