GY009

GY009 Pegylated Liposomal Doxorubicin Hydrochloride with Atezolizumab and/or Bevacizumab in Treating Patients with Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

ClinicalTrials.gov NCT #02839707

This study is being carried out under the sponsorship of NRG Oncology, an organization dedicated to clinical research in the field of gynecologic cancer. NRG Oncology is funded by the Federal Government through the National Cancer Institute (NCI)

Brief Summary:

Randomized phase II/III trial study with pegylated liposomal doxorubicin hydrochloride (PLD) and/or atezolizumab and/or bevacizumab to determine which combination will work better in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back.

Chemotherapy, such as pegylated liposomal doxorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. 
Immunotherapy with monoclonal antibodies, such as atezolizumab and bevacizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.


Treatment Arms:

This research study has two study groups.  You will be "randomized" into one of two study groups in the study. Randomization means that you are put into a group by chance. A computer program will place you in one of the study groups.  Neither you nor your doctor can choose the group you will be in.  You will have an equal chance of being placed in any group.

Arm II (PLD, bevacizumab, atezolizumab) 
Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1, bevacizumab IV over 30-90 minutes on days 1 and 15, and atezolizumab IV over 30-60 minutes on days 1 and 15.

Arm III (PLD, bevacizumab) 
Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 and bevacizumab IV over 30-90 minutes on days 1 and 15.


Follow-Up:

For up to two years after treatment is finished. 


Partial Eligibility Criteria:

  • Must have the psychological ability and general health that permits completion of the study requirements and required follow up
  • High grade ovarian cancer, including high grade serous; clear cell; endometrioid, grade 3; and others (adenocarcinoma, nitric oxide synthase [NOS]; mixed epithelial carcinoma; undifferentiated carcinoma); NOTE: low grade serous, mucinous and carcinosarcoma histologies are excluded; ovarian cancer = ovarian, fallopian tube or primary peritoneal cancer; required data element: submission of pathology report
  • Recurrent, platinum resistant ovarian cancer (defined as progression within < 6 months from completion of platinum based therapy; the date should be calculated from the last administered dose of platinum therapy)
  • Have been treated with 1-2 prior regimens (including primary therapy) and have not received 
    • Anti-programmed cell death (PD)-1, anti- programmed cell death ligand (PD-L)1 or anti-cytotoxic T-lymphocyte-associated protein (CTLA)-4 therapeutic antibody or other similar agents
    • Bevacizumab (or any other anti-vascular therapy, e.g., cediranib) for platinum resistant recurrence; (Note: prior bevacizumab in initial therapy and/or platinum sensitive recurrent setting is allowed)
    • Prior treatment with PLD (pegylated liposomal doxorubicin hydrochloride)
  • Prior radiotherapy to the abdomen or pelvis

Final eligibility assessment is done by the health care professionals associated with the trial.

 

For additional information, please contact the Research Nurses:

  • Nona Blauvelt, RN, MSN, AOCN; 610-738-2522
  • Susan Metzger, RN, MSN; 610-738-2515

GY019

GY019 A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients with Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum

ClinicalTrials.gov NCT #04095364

This trial is part of the National Clinical Trials Network (NCTN) program, which is sponsored by the National Cancer Institute (NCI).

Purpose:

The purpose of this study is to compare the treatment of chemotherapy drugs carboplatin/paclitaxel and letrozole hormonal therapy to letrozole alone. The use of the hormonal therapy drug, letrozole without chemotherapy may shrink or stabilize cancer in the same way that chemotherapy also does, but without the added side effects of chemotherapy. Letrozole is a drug called an aromatase inhibitor, which indirectly stops the body from producing estrogen.

Treatment Arms:

Arm I Standard Care
Carboplatin +paclitaxel for 6 cycles-followed by Letrozole (hormone therapy) daily until disease growsts receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1, bevacizumab IV over 30-90 minutes on days 1 and 15, and atezolizumab IV over 30-60 minutes on days 1 and 15.

Arm II Experimental
Letrozole (hormone therapy) daily until disease grows.

Follow-Up:

Study assessments every 3 months for 2 years, then every 6 months for three years, then annually for 10 years. 

Partial Eligibility Criteria:

  • Patients must have newly diagnosed, Stage II-IV low-grade serous ovarian cancer.
  • Patients must be able to take per oral (P.O.) medications.
  • No previous chemotherapy, radiotherapy or hormonal therapy for their disease.

For additional information, please contact the Research Nurses:

  • Nona Blauvelt, RN, MSN, AOCN; 610-738-2522
  • Susan Metzger, RN, MSN; 610-738-2515

GY020

GY020 A Phase III Randomized Trial of Radiation +/-  Pembrolizumab (MK-3475) for Newly Diagnosed Early Stage High Intermediate Risk Mismatch Repair Deficient (dMMR) Endometrioid Endometrial Cancer

ClinicalTrials.gov NCT #NCT04214067

This trial is part of the National Clinical Trials Network (NCTN) program, which is sponsored by the National Cancer Institute (NCI).

Purpose:

Can we lower the chance of your endometrial cancer coming back by adding an immunotherapy drug to the usual treatment with radiation?

The purpose of this study is to compare the usual treatment (radiation) to using the usual treatment plus pembrolizumab (immunotherapy).  The addition of pembrolizumab to the usual treatment could reduce the risk of your cancer coming back..

Treatment Arms:

Arm I Standard Care
Vaginal brachytherapy or pelvic Radiation.

Arm II Experimental
Vaginal brachytherapy or Pelvic Radiation plus pembrolizumab (MK-3475).

Follow-Up:

Follow-up for 5 years. 

Partial Eligibility Criteria:

Stage I endometrioid endometrial cancer and a combination of age and risk factors as listed below:

  • Myometrial invasion ≥ 50% - 
  • Lymphovascular space invasion –
  • Grade 2 or 3

-OR-

Stage II endometrial cancer

Patients must have received no prior therapy for endometrial cancer, including hormonal therapy, chemotherapy, targeted therapy, immunotherapy or radiation therapy.


For additional information, please contact the Research Nurses:

  • Nona Blauvelt, RN, MSN, AOCN; 610-738-2522
  • Susan Metzger, RN, MSN; 610-738-2515
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