Dynamic ctDNA Assessment in Cervical and Anal Canal Tumors: Optimizing Follow-up and Clinical Outcomes

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

November 1, 2024

Primary Completion Date

December 31, 2026

Study Completion Date

January 31, 2027

Conditions
HPV-Related CarcinomaUterine Cervical CancerAnal Canal CancerHPV-Related Anal Squamous Cell CarcinomaHPV-Related Cervical Carcinoma
Interventions
DIAGNOSTIC_TEST

ctDNA test

ctDNA involves the collection of peripheral blood samples for the analysis of circulating tumor DNA (ctDNA). The samples are processed using next-generation sequencing (NGS) and/or digital polymerase chain reaction (PCR) techniques to detect specific genetic alterations related to the tumor. The objective is to assess the presence and quantity of ctDNA, providing information on tumor burden and treatment response.

DRUG

Pembrolizumab

Participants will receive the institution's standard treatment during Phase I. If ctDNA remains positive between 8 and 12 weeks after the standard treatment, the participant will be invited to proceed to Phase II, which will consist of intravenous immunotherapy for up to 12 months, or until disease progression or unacceptable toxicity occurs. Continuous monitoring with ctDNA testing will be performed during Phase II.

Trial Locations (1)

01246-000

Instituto do Câncer do Estado de São Paulo - ICESP, São Paulo

All Listed Sponsors
collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

lead

Instituto do Cancer do Estado de São Paulo

OTHER

NCT06640283 - Dynamic ctDNA Assessment in Cervical and Anal Canal Tumors: Optimizing Follow-up and Clinical Outcomes | Biotech Hunter | Biotech Hunter