← Back to Search

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
Absence of current malignancies at other sites, except for adequately treated basal or squamous cell carcinoma of the skin. Cancer survivors who have undergone potentially curative therapy for a prior malignancy who have no evidence of that disease for 5 years and who are deemed at low risk for recurrence are eligible for the study
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12 and 18 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I have no other cancers except for treated skin cancer, or I've been cancer-free from another type for 5 years.
Select...
I have been recently diagnosed with advanced cervical cancer.
Select...
I can take care of myself and perform daily activities.
Select...
I have been diagnosed with squamous cell cervical cancer.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of grade >= 3 acute toxicity
Secondary outcome measures
Rate of >= 90% gross tumor volume reduction
Rate of complete metabolic response
Rate of grade >= 3 chronic toxicity
+3 more

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
~1940
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,427 Total Patients Enrolled
2 Trials studying Cervical Carcinoma
219 Patients Enrolled for Cervical Carcinoma
National Cancer Institute (NCI)NIH
13,608 Previous Clinical Trials
40,915,506 Total Patients Enrolled
20 Trials studying Cervical Carcinoma
29,779 Patients Enrolled for Cervical Carcinoma
Ann H KloppPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04580771 — Phase 2
Cervical Carcinoma Research Study Groups: Treatment (radiation therapy, cisplatin, PDS0101)
Cervical Carcinoma Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT04580771 — Phase 2
Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04580771 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any empty enrolment slots left in this experiment?

"Yes, an online search confirms that this study is recruiting patients. The posting date was October 14th 2020, and the clinical trial has been updated as recently as March 31st 2022. They are searching for a total of 35 patients from 1 medical site."

Answered by AI

What condition does the Liposomal HPV-16 E6/E7 Multipeptide Vaccine PDS0101 help patients with?

"The liposomal HPV-16 E6/E7 Multipeptide Vaccine PDS0101 is most frequently used to treat neoplasm metastasis. In addition, this medication can be given to patients with refractory advanced ovarian cancer or who have an advance directive in place."

Answered by AI

How many people have signed up to take part in this research project?

"Yes, the trial is recruiting patients. According to clinicaltrials.gov, the study was posted on October 14th 2020 and was last edited on March 31st 2022. The research team needs to recruit 35 individuals from 1 site."

Answered by AI

Is PDS0101 FDA-regulated in any way?

"This Phase 2 trial has not yet collected data supporting efficacy, but there is evidence that the Liposomal HPV-16 E6/E7 Multipeptide Vaccine PDS0101 is safe."

Answered by AI

Are there any other similar clinical trials to the Liposomal HPV-16 E6/E7 Multipeptide Vaccine PDS0101?

"Currently, there are 773 active studies examining the Liposomal HPV-16 E6/E7 Multipeptide Vaccine PDS0101. The majority of these trials (300) are in Phase 3. Additionally, most of the clinical trials for this vaccine are being conducted in Shanghai, China. However, there are a total of 44169 locations running trials for the Liposomal HPV-16 E6/E7 Multipeptide Vaccine PDS0101."

Answered by AI
~5 spots leftby Mar 2025