Guadecitabine and Nivolumab in Treating Refractory Metastatic Colorectal Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT03576963
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

  • Colorectal Adenocarcinoma
  • CpG Island Methylator Phenotype
  • Metastatic Microsatellite Stable Colorectal Carcinoma
  • Refractory Colorectal Carcinoma
  • Stage IV Colorectal Cancer AJCC v8
  • Stage IVA Colorectal Cancer AJCC v8
  • Stage IVB Colorectal Cancer AJCC v8
  • Stage IVC Colorectal Cancer AJCC v8

Eligibility Criteria

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

Interventions

  • Guadecitabine — DRUG
    Given SC
  • Nivolumab — BIOLOGICAL
    Given IV

Study Details

This phase Ib/II trial studies the side effects and best dose of guadecitabine when given together with nivolumab and to see how well they work in treating participants with colorectal cancer that does not respond to treatment and has spread to other places in the body. Drugs used in chemotherapy, such as guadecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving guadecitabine and nivolumab may work better in treating participants with colorectal cancer.

Key Dates

Start date
Jan 30, 2020
Status verified
Apr 2021
Primary completion
Jan 30, 2022
Completion
Jan 30, 2023

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (guadecitabine, nivolumab)
    This study consists of an initial dose escalation followed by an expansion cohort. Dose escalation of guadecitabine starts from 30 mg/m\^2 given SC on days 1-5 every 28 days in combination with fixed dose of nivolumab at 240 mg given IV on days 8 and 22 every 28 days. Dose escalation will continue until the maximum tolerated dose is reached or all planned doses are administered.

Primary Outcome Measure

Maximum tolerated dose (MTD) of guadecitabine when given in combination with nivolumab [ Time Frame: Up to 28 days ]

Locations (2)

FacilityCityStateZIPSite coordinators
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
Hoag Memorial Hospital PresbyterianNewport BeachCalifornia92658-

Find similar trials in Los Angeles, CA

By research site
USC / Norris Comprehensive Cancer Center· Los Angeles, CAHoag Memorial Hospital Presbyterian· Newport Beach, CA

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