A Randomized Phase III Trial of Platinum Chemotherapy plus Paclitaxel with Bevacizumab and Atezolizumab versus Platinum Chemotherapy plus Paclitaxel and Bevacizumab in Metastatic (stage IVB), Persistent, or Recurrent Carcinoma of the Cervix. (GOG-3030)

Purpose

To determine whether the addition of atezolizumab to chemotherapy and bevacizumab improves overall survival compared to chemotherapy plus bevacizumab in patients with metastatic persistent or recurrent carcinoma of the cervix

Criteria

1.       Histologically- or cytologically-confirmed diagnosis of metastatic (stage IVB), persistent or recurrent cervical cancer (histologies other than squamous, adenocarcinoma, or adenosquamous will be excluded) not amenable for curative treatment with surgery and/or radiation therapy.

2.       No prior systemic anti-cancer therapy for metastatic, persistent, or recurrent disease.

3.       Negative test result for Hepatitis

4.       Must be postmenopausal

You cannot

1.       Have disease involving the bladder or rectum

2.       Have evidence of abdominal free air

3.       Patients previously treated with chemotherapy except when used concurrently with radiation therapy. Patients who have received either concurrent paclitaxel with radiation therapy or carboplatin/paclitaxel as neoadjuvant or adjuvant therapy are ineligible for the study.

4.       Have known brain metastases or spinal cord compression. It is mandatory to perform a scan of the brain in cases of suspected brain metastases (CT or MRI) or spinal cord compression (MRI).

5.       Have an active GI bleed, Crohn’s disease, inflammatory bowel disease.

6.       Have clinically significant heart disease.

Details

1.       All patients will be treated with seven or more cycles Bevacizumab, Cisplatin or Carboplatin/Paclitaxel treatment per standard of care and physician judgement.

2.       Lab collection with every cycle.



Interested in more information on clinical research? Contact WK Health System Clinical Research Department 318-212-8130 or ckay@wkhs.com

Closed to enrollment

Interested in more information? Contact Us:

Destin Black, M.D., Principal Investigator
Gynecologic Oncology Associates
(318) 212-8727

IRB: WIRB
IRB Number:
Trial Type: NA
Sponsor: GOG