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Platinum-containing compounds

Combination Therapy for Advanced Cervical Cancer

Phase 1 & 2

Waitlist Available

Led By Dana M Chase

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with stage IVB adenocarcinoma, adenosquamous carcinoma, or squamous-cell carcinoma of the cervix not yet treated with systemic chemotherapy or radiation therapy

Patients must have PD-L1 status, CPS score of over 1

Must not have

Received prior therapy with anti-PD-1, anti-PD-L1, or anti PD L2 agent

Received prior systemic anti-cancer therapy within 4 weeks

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of cycle 1 of chemotherapy (per protocol) to tumor progression or recurrence at any site, commencement of non-protocol anticancer therapy or death from any cause, whichever occurs first, up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial combines different treatments like radiation therapy, chemotherapy, and immunotherapy to test their safety and effectiveness in treating patients with advanced cervical cancer. The treatments include external beam radiation therapy (EBRT) and

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects may include fatigue from radiation; kidney issues or hearing loss from cisplatin; nerve damage or allergic reactions from paclitaxel; high blood pressure or bleeding from bevacizumab; immune-related reactions like inflammation of organs from pembrolizumab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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

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

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I am currently being treated for an infection.

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I have had Hepatitis B or currently have Hepatitis C.

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

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I have had radiation therapy for cervical cancer.

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

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I have or had lung inflammation that needed steroids.

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

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I have had a hysterectomy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of cycle 1 of chemotherapy (per protocol) to tumor progression or recurrence at any site, commencement of non-protocol anticancer therapy or death from any cause, whichever occurs first, up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of cycle 1 of chemotherapy (per protocol) to tumor progression or recurrence at any site, commencement of non-protocol anticancer therapy or death from any cause, whichever occurs first, up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of cycle 1 of chemotherapy (per protocol) to tumor progression or recurrence at any site, commencement of non-protocol anticancer therapy or death from any cause, whichever occurs first, up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression free survival (PFS)

Secondary study objectives

Overall survival

PFS

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5450

Brachytherapy

2007

Completed Phase 3

~2140