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Clinical Trial Updates

OHC Research Clinical Trial Updates

OHC, Blogs, For Physicians, 0 comments
December 22, 2015


OHC is offering two new clinical trials. To view our entire research clinical trial menu, please click here.

1) Lynch Syndrome Trial

This is an investigational trial that runs analyses on patients’ blood, saliva, and tumor tissue to determine if they have “Lynch Syndrome.” If it is determined that they do have Lynch Syndrome, The Ohio State University will help them receive genetic testing to determine if any close relatives also have this condition.

Inclusion Criteria: In order to participate, patients must have been diagnosed with invasive colorectal adenocarcinoma (ANY STAGE) between Jan. 1, 2013 and Dec. 31, 2016. The Biopsy or Resection may be from any hospital in Ohio.

2) Immunotherapy Trial for HER2+ and Metastatic Breast Cancer (MBC)

The BRE 261 trial is now open to enrollment at OHC. This trial is evaluating atezolizumab (anti PD-L1 antibody) with either trastuzumab/pertuzumab or with T-DM1. The trial will initially enroll 12 HER2+ MBC patients before it moves on to the neoadjuvant phase.

Cohort A: Trastuzumab+pertuzumab+atezolizumab
Cohort B: T-DM1+atezolizumab

Once the safety of the combinations is confirmed, stage 2 of the trial will commence in patients eligible for neoadjuvant therapy.

Key eligibility for the MBC patients:

  • HER2+ disease, metastatic or unresectable, locally advanced or recurrent breast cancer
  • Central confirmation of HER2 + status in tumor prior to enrollment No limit on prior lines of therapy for MBC; 1st line pts are also eligible
  • Treated SUPRATENTORIAL brain mets acceptable
  • Tumor tissue from metastatic lesion must be submitted, if clinically feasible
  • Additional biopsies required pre-infusion on C2D1, C2D21, and at radiographic progression
  • Must be cores, so non-lung lesions (liver, skin, nodes, breast, etc.)


Should you have any questions or concerns about either study, please contact:

Brittany Hagen, BS, RN, OCN
Clinical Research Manager
phone: 513-751-2273 ext. 12902
email: bhagen@ohcare.com


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