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Alkylating agents

Vaccine + Chemoradiation for Cervical Cancer

Phase 2

Waitlist Available

Led By Ann H Klopp

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Newly diagnosed locally advanced squamous cell carcinoma of cervix (Federation of Gynecology and Obstetrics [FIGO] 2018 stage IB3-IVA with primary tumor >= 5 cm and/or positive pelvic or periaortic nodal disease assessed by imaging)

World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Must not have

Previous chemotherapy for the cervix tumor

Receipt of immunotherapy (e.g., interferons [IFNs], check-point inhibitors, tumor necrosis factor, interleukins, etc.) or biological response modifiers (granulocyte-macrophage colony-stimulating factor [GM-CSF], granulocyte colony-stimulating factor, macrophage colony-stimulating factor) within 4 weeks before the first study vaccination

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 12 and 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying a vaccine given with chemotherapy and radiation to treat patients with cervical cancer.

Who is the study for?

This trial is for individuals with newly diagnosed stage IB3-IVA cervical cancer, specifically squamous cell carcinoma. Participants must have a tumor size of at least 5 cm or positive nodal disease and should not have other current malignancies except certain skin cancers. They need to be in good physical condition (ECOG 0-2) and have normal organ function tests. People with HIV, hepatitis B or C, serious infections, recent immunotherapy or steroid use, known allergies to the vaccine components, previous pelvic radiation or chemotherapy for cervical cancer are excluded.

What is being tested?

The IMMUNOCERV trial is testing the combination of a new HPV-related vaccine called PDS0101 with standard chemoradiation therapy using cisplatin against advanced cervical cancer. The vaccine aims to boost the immune system's response against HPV-infected tumor cells by including specific protein pieces from the virus.

What are the potential side effects?

Potential side effects may include typical reactions related to vaccines such as soreness at injection site, fever and fatigue; chemotherapy-associated nausea, vomiting and hair loss; radiation therapy might cause skin irritation and fatigue. More severe but less common could be immune-related responses due to the vaccine.

Eligibility Criteria

Inclusion Criteria

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

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I have been recently diagnosed with advanced cervical cancer.

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I can take care of myself and perform daily activities.

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I have been diagnosed with squamous cell cervical cancer.

Exclusion Criteria

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

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I have had chemotherapy for cervical cancer.

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I haven't received immunotherapy or biological response modifiers in the last 4 weeks.

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I had major surgery less than 4 weeks ago and haven't fully recovered.

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I have a history of significant autoimmune disease or inflammatory bowel disease.

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I haven't taken high doses of steroids or immunosuppressants in the last week.

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I have had a hysterectomy or will have one as part of my cervical cancer treatment.

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I have had radiation therapy in the pelvic area before.

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I have a condition that affects my immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 12 and 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 12 and 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 and 18 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Rate of grade >= 3 acute toxicity

Secondary study objectives

Rate of >= 90% gross tumor volume reduction

Rate of complete metabolic response

Rate of grade >= 3 chronic toxicity

+3 more

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 (radiation therapy, cisplatin, PDS0101)Experimental Treatment3 Interventions

Patients undergo radiation therapy over 1 hour 5 days per week (Monday-Friday) for 5-7 weeks and receive cisplatin IV over 4 hours QW during the 5 weeks of radiation therapy in the absence of disease progression and unacceptable toxicity. Patients also receive PDS0101 SC on days -10, 7, 28, 49, and 170 in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

2013

Completed Phase 3

~3120

Radiation Therapy

2017

Completed Phase 3

~7250