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Combined Immunotherapy and Radiosurgery for Metastatic Colorectal Cancer

NCT03507699 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2023-04-18

No results posted yet for this study

Summary

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.

Conditions

  • Colorectal Neoplasms Malignant
  • Liver Metastases

Interventions

RADIATION

Liver radiation therapy

21 Gy in three fractions to one liver metastasis

DRUG

Nivolumab Injection [Opdivo]

administered IV at a dose of 3mg/kg every 2 weeks

DRUG

Ipilimumab Injection [Yervoy]

administered IV at a dose of 1mg/kg every 6 weeks

DRUG

CMP-001

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.

Sponsors & Collaborators

  • Checkmate Pharmaceuticals

    collaborator INDUSTRY

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Sheba Medical Center

    lead OTHER_GOV

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-15
Primary Completion
2021-08-18
Completion
2022-05-25
FDA Drug
Yes

Countries

  • Israel

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03507699 on ClinicalTrials.gov