External Beam Radiation Therapy and Brachytherapy With Chemotherapy and Immunotherapy for the Treatment of Stage IVB Cervical Cancer

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJonsson Comprehensive Cancer Center

About 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 does not accept healthy volunteers

Qualifiers

Participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of Stage IVB cervical cancer will be enrolled in this study

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

Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to ≤ grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤ grade 2 neuropathy are eligible

The participant provides written informed consent for the trial

Disqualifiers

Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137)

Has received prior hysterectomy. (Prior lymphadenectomy permitted)

Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks to /allocation

Has received prior radiotherapy for cervical cancer

Trial design

Design model

Single group

Treatments tested in this trial

  • Bevacizumab

    Biological/Vaccine

    Given IV

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Brachytherapy

    Radiation

    Undergo brachytherapy

  • Cisplatin

    Drug

    Given IV

  • External Beam Radiation Therapy

    Radiation

    Undergo EBRT

  • Paclitaxel

    Drug

    Given IV

  • Pembrolizumab

    Biological/Vaccine

    Given IV

  • Questionnaire Administration

    Other intervention

    Ancillary study

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: Treatment (EBRT, brachytherapy, chemotherapy, immunotherapy)Experimental treatment 8 interventions

Trial outcomes

Primary outcomes

1

Progression free survival (PFS)

Will be described using Kaplan-Meier plots and median estimates.

Time frame
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
2

Incidence of adverse events

Time frame
Up to 30 days after completion of study treatments

Secondary outcomes

1

PFS

Will be described using Kaplan-Meier plots and median estimates.

Time frame
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
2

Overall survival

Will be described using Kaplan-Meier plots and median estimates.

Time frame
Up to 3 years
3

Duration of response

Time frame
Up to 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jonsson Comprehensive Cancer Center

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator