Combined Immunotherapy and Radiosurgery for Metastatic Colorectal Cancer

Sponsor
Sheba Medical Center
Study ID
NCT03507699
Phase
PHASE1
Status
Completed

Conditions

  • Colorectal Neoplasms Malignant
  • Liver Metastases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Liver radiation therapy — RADIATION
    21 Gy in three fractions to one liver metastasis
  • Nivolumab Injection [Opdivo] — DRUG
    administered IV at a dose of 3mg/kg every 2 weeks
  • Ipilimumab Injection [Yervoy] — DRUG
    administered IV at a dose of 1mg/kg every 6 weeks
  • CMP-001 — DRUG
    A TLR9 agonist, will be administered both into the liver metastasis (three times), and also injected subcutaneously at a dose of 5-10 mg every two weeks.

Study Details

A single institution study to evaluate the safety and tolerability of the combination treatment of nivolumab, ipilimumab, CMP-001 and radiosurgery in patients with metastatic colorectal cancer with liver metastases.

Key Dates

Start date
Dec 15, 2018
Status verified
Apr 2023
Primary completion
Aug 18, 2021
Completion
May 25, 2022

Study Design

Enrollment
19 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Immunotherapy alone
    Nivolumab will be administered at a dose of 3mg/kg every 2 weeks. Ipilimumab will be administered at a dose of 1mg/kg every 6 weeks. CMP-001 will be administered both into the liver metastasis (once), and also injected subcutaneously (four times, over six weeks) at a dose of 5-10 mg.
  • Experimental: Combined radiotherapy and immunotherapy
    Liver radiation therapy: three treatments to one liver metastasis, administered on alternate days. Nivolumab will be administered at a dose of 3mg/kg every 2 weeks. Ipilimumab will be administered at a dose of 1mg/kg every 6 weeks. CMP-001 will be administered both into the liver metastasis (once), and also injected subcutaneously (four times, over six weeks) at a dose of 5-10 mg.

Primary Outcome Measure

Number of participants with serious dose-limiting treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: The dose-limiting toxicity period lasts from day 1 until day 42 inclusive ]

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