February 18, 2021 Gynecology

Clinical Trial Information

Protocol: NRG – GY018

SCHEMA NRG GY018

Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.

Eligibility:

  1. Measurable Stage III, measurable Stage IVA, Stage IVB (with or without measurable disease) or recurrent (with or without measurable disease) endometrial cancer.
  2. Histologic confirmation of the original primary tumor is required (submission of pathology report(s) is required). Patients with the following histologic types are eligible:
    1. Endometroid adenocarcinoma, serous adenocarcinoma, dedifferentiated/undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified.
  3. Patients may have received:
    1. No prior chemotherapy for treatment of endometrial cancer or
    2. Prior adjuvant chemotherapy (e.g. paclitaxel/carboplatin alone or as a component of concurrent chemotherapy and radiation therapy with or without cisplatin) provided adjuvant chemotherapy was completed more than 12 months prior to step 2 registration.
  4. Patients may have received prior radiation therapy for treatment for endometrial cancer. Prior radiation therapy may have included pelvic radiation therapy, extended field pelvic/para aortic radiation therapy, intravaginal brachytherapy, and/or palliative radiation therapy. All radiation therapy must be completed at least 4 weeks prior to step 2 registration.
  5. Patients may have received prior hormonal therapy for treatment of endometrial cancer. All hormonal therapy  must be discontinued at least three weeks prior to step 2 registration.
  6. Must be at least 18 years of age.
  7. ECOG performance status 0-2..
  8. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

Ineligibility

  1. Patients with prior treatment with anti-PD-1, anti-PD-L1 or anti-CTLA-4 therapeutic antibody or other similar agents.
  2. Patients who have a history of a severe hypersensitivity reaction to monoclonal antibody or pembrolizumab (MK-3475) and/or its excipients.
  3. Patients who are currently participating and receiving cancer directed study therapy or have participated in a study of an investigational agent and received cancer directed study therapy within 4 weeks prior to step 2 registration.


February 18, 2021 Gynecology

Clinical Trial Information

Protocol: NRG – GY019

SCHEMA NRG GY019

Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.

Eligibility:

  1. Patients must have newly diagnosed, Stage II-IV low-grade serous ovarian cancer (submission of pathology report(s) required). Ovarian cancer = ovarian, fallopian tube and primary peritoneal cancers. p53 immunohistochemistry (IHC) is required and must show nonaberrant pattern (nonaberrant p53 expression is consistent with normal/wildtype TP53). If aberrant p53 expression found on p53 IHC, the patient is not eligible (aberrant p53 expression is consistent with mutant TP53 and supports diagnosis of high grade serous ovarian cancer).
  2. Appropriate stage for study entry based on the following diagnostic workup:
    1. History/physical examination within 14 days prior to registration.
    2. Contrast enhanced imaging of the chest, abdomen and pelvis within 28 days prior to registration.
  3. 18 years of age.
  4. Patients must have undergone an attempt at maximal upfront cytoreductive surgery, with either optimal (less than 1 cm diameter residual disease/nodule) status allowed.
  5. Patients must have undergone a bilateral salpingo-oophorectomy.
  6. ECOG performance status 0-2 within 14 days prior to registration.
  7. Patients must be within less than 8 weeks of primary cytoreductive surgery at time of randomzation.
  8. Patients must be able to take oral medications.

Ineligibility:

  1. Patients with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  2. Patients must not have received neoadjuvant chemotherapy or radiotherapy for the treatment of this disease.
  3. Patients must not have received previous hormonal therapy for the treatment of this disease.

 


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