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CASCADE 2002: PROTECT Study, "PRObiotics to TrEat Anal preCancer Trial

ConditionsHSIL, High Grade Squamous Intraepithelial LesionHPV-Related Squamous Cell CarcinomaAnal HSIL
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21+
SponsorUniversity of California, San Francisco

About this trial

This study is focused on treatment of anal high-grade squamous intraepithelial lesions (HSIL) in persons with HIV (PWH), with the ultimate goal of applying the approach toward prevention of anal cancer in this population

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed informed consent

Participant in ULACNet-101 or participant screened specifically for ULACNet-102.

Biopsy-proven anal HSIL (men or women) shown as part of participation in the ULACNet-101 study or at a screening visit for ULACNet-102.

At least one focus of anal HSIL must be large enough to be monitored for response, i.e.,not completely removed after the screening biopsy.

Disqualifiers

History of any anogenital cancer.

Presence of untreated cervical HSIL or cervical cancer.

Anal HSIL on clinical examination or biopsy that clinicians are concerned for cancer.

Receipt of chemotherapy, radiotherapy or immunosuppressive medication in three months preceding enrollment in ULACNet-101 or at the screening visit for ULACNet-102.

Trial design

Design model

Parallel

Treatments tested in this trial

  • EXE-346 Probiotic

    Drug

    Given as a single-dose, powder packet to mix with water

  • Placebo

    Drug

    Given as a single-dose, powder packet to mix with water

  • Usual Care High Resolution Anoscopy (HRA)

    Procedure/Surgery

    Non-investigational HRA will be performed

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Blinded: EXE-346 probioticExperimental treatment 2 interventions
Group B: Blinded: PlaceboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Proportion of participants with no disease present

No anal disease defined as complete regression of lesions as determined by examination of biopsies obtained at HRA

Time frame
Up to 36 weeks
2

Proportion of participants reporting treatment-emergent adverse events

The frequency of participants reporting adverse events by group will be classified according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0

Time frame
Up to 36 weeks

Secondary outcomes

1

Proportion of participants with demonstrated disease regression

Regression of HSIL associated with any hrHPV type to LSIL or lower, as determined by examination of biopsies obtained at HRA

Time frame
Up to 36 weeks
2

Proportion of participants with HPV-negative status

The proportion of participants with HPV-negative on anal swab for type(s) found at baseline will be reported.

Time frame
1 day

Other outcomes

Sponsors and contacts

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

University of California, San Francisco

Lead sponsor

Exegi Pharma, LLC

Collaborator

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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