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New treatment option for HPV-Related Carcinoma
Official title Dynamic ctDNA Assessment in Cervical and Anal Canal Tumors: Optimizing Follow-up and Clinical Outcomes
ClinicalTrials.gov ID: NCT06640283
What this study is testing
What is Pembrolizumab?
Pembrolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hpv-related carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- After definitive radiotherapy (RT) treatment (with or without chemotherapy), cervical and anal canal neoplasms frequently exhibit disease persistence or recurrence. Due to the local inflammatory process post-treatment, response assessment by imaging (current gold standard) is limited, often necessitating multiple follow-ups and repeated invasive biopsies.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histological diagnosis of anal canal or cervical cancer.
- Documented presence of HPV.
- Locally confined or locally advanced disease, defined as:
- Anal canal carcinoma stage I to III, according to American Joint Committee on Cancer (AJCC) 8th edition;
- Cervical carcinoma stage I B2 to IV A, according to AJCC 8th edition.
You likely can't join if
- Patients with unequivocal distant metastasis at diagnosis.
- For participants with positive ctDNA after treatment, those candidates for participation in Phase II will be excluded if there is unequivocal...
- Need for recurrent blood transfusions, such as weekly frequency.
- Another uncontrolled disease representing a life risk, as determined by medical judgment.
- Personal history of another active invasive malignant neoplasm in the last 5 years, except for non-melanoma skin carcinomas and in situ carcinomas.
- Pregnant individuals.
See the full eligibility criteria
- Histological diagnosis of anal canal or cervical cancer.
- Documented presence of HPV.
- Locally confined or locally advanced disease, defined as:
- Anal canal carcinoma stage I to III, according to American Joint Committee on Cancer (AJCC) 8th edition;
- Cervical carcinoma stage I B2 to IV A, according to AJCC 8th edition.
- Indication for definitive treatment with radiotherapy, with or without concomitant chemotherapy.
- Eastern Cooperative Oncology Group (ECOG)-Performance Status (PS) 0 - 1.
- Age ≥ 18 years.
- Signing of the Informed Consent Form (ICF).
- HIV-positive patients may be included if Cluster of Differentiation 4(CD4) count is greater than or equal to 200.
- Patients may participate in other concurrent studies, as long as they do not involve interventions related to the treatment of the underlying cancer.
- Patients with unequivocal distant metastasis at diagnosis.
- For participants with positive ctDNA after treatment, those candidates for participation in Phase II will be excluded if there is unequivocal radiological progression in the first imaging exam after the completion of...
- Need for recurrent blood transfusions, such as weekly frequency.
- Another uncontrolled disease representing a life risk, as determined by medical judgment.
- Personal history of another active invasive malignant neoplasm in the last 5 years, except for non-melanoma skin carcinomas and in situ carcinomas.
- Pregnant individuals.
- Active opportunistic infection or disease.
- History of autoimmune diseases.
The study team makes the final eligibility decision.
Where it's taking place
- São Paulo, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.