Combination Therapy for Advanced Cervical Cancer

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen ByDana M Chase

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Jonsson Comprehensive Cancer Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This phase I/II trial tests the safety and effectiveness of receiving external beam radiation therapy (EBRT) and brachytherapy along with chemotherapy, consisting of cisplatin and paclitaxel, and immunotherapy, consisting of bevacizumab and pembrolizumab, for the treatment of patients with stage IVB cervical cancer. EBRT is type of radiation therapy that uses a machine to aim high-energy rays at the cancer from outside of the body. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. A monoclonal antibody, such as pembrolizumab, is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Giving EBRT and brachytherapy along with chemotherapy and immunotherapy may be a safe and effective way to treat patients with stage IVB cervical cancer.

Eligibility Criteria

This trial is for patients with advanced stage IVB cervical cancer. Participants should be eligible to receive radiation, chemotherapy with cisplatin and paclitaxel, and immunotherapy drugs like bevacizumab and pembrolizumab. Specific eligibility criteria are not provided but typically include factors such as age, overall health status, and previous treatments.

Inclusion Criteria

I have advanced cervical cancer and haven't started any chemotherapy or radiation.

My cancer has a PD-L1 score higher than 1.

I am 18 or older with a confirmed diagnosis of advanced cervical cancer.

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.

I haven't had cancer treatment in the last 4 weeks.

I have an immune system disorder or I'm on long-term steroids.

I have another cancer that has been treated or progressed in the last 3 years.

I am currently being treated for an infection.

I have had Hepatitis B or currently have Hepatitis C.

I am HIV-positive with a history of Kaposi's sarcoma or Multicentric Castleman's Disease.

I have had radiation therapy for cervical cancer.

I have cancer cells in the fluid around my brain and spinal cord.

I have or had lung inflammation that needed steroids.

I have received an organ or tissue transplant from another person.

I have had a hysterectomy.

Participant Groups

The study tests the combination of external beam radiation therapy (EBRT) & brachytherapy with chemotherapy (cisplatin & paclitaxel) plus immunotherapy drugs (bevacizumab & pembrolizumab). It aims to assess if this treatment can safely improve outcomes in stage IVB cervical cancer patients.

1Treatment groups

Experimental Treatment

Group I: Treatment (EBRT, brachytherapy, chemotherapy, immunotherapy)Experimental Treatment8 Interventions

PART 1: Patients receive cisplatin IV, paclitaxel IV, pembrolizumab IV over 30 minutes, and bevacizumab IV on day 1 of each cycle. Cycles repeat every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients receive no treatment for 3 weeks. PART 2: Patients undergo EBRT for 25 treatments delivered over 5 weeks, and brachytherapy over 3-5 treatments. Patients also receive pembrolizumab IV over 30 minutes and bevacizumab IV on day 1 of each cycle. Cycles for immunotherapy repeat every 21 days for a total of 2 years in the absence of disease progression or unacceptable toxicity. Participants who complete study intervention after 2 years of pembrolizumab are eligible for up to 1 year of additional pembrolizumab (second course) upon experiencing disease progression. Patients undergo CT, PET/CT, and/or MRI throughout the study. Patients also undergo blood sample collection throughout the study.

Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Platinol for: