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Study of Pembrolizumab, Carboplatin, Paclitaxel, and Radiation for Early-Stage Anal Cancer

This study is looking at a new way to treat early-stage anal cancer using a combination of drugs and radiation. It involves the drugs Pembrolizumab, Paclitaxel, and Carboplatin, along with radiation therapy. Researchers want to see if this combination can lead to a complete response (meaning no signs of cancer) after treatment. You may be able to join if you are at least 18 years old and meet certain health criteria. The study plans to enroll 23 participants.

Study design
This is a single-arm Phase II study, meaning all 23 participants will receive the same treatment. It involves two treatment phases followed by observation.
What's involved
The study involves two treatment phases: a chemoradiation phase (6 weekly cycles) followed by a maintenance phase (8 cycles every 6 weeks).
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, clinical complete response, is measured at 6 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06493019

Study of Pembrolizumab, Carboplatin, Paclitaxel, and Radiation for the Treatment of Early-Stage Anal Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
Dustin Deming
~23 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:PembrolizumabPaclitaxelCarboplatinRadiation

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Clinical complete response rate (cCR) following weekly carboplatin and paclitaxel in combination with pembrolizumab and radiation for the treatment of early-stage anal cancer.
Measured over 6 months

Conditions

Anal Cancer

Explore related trials

Anal Carcinoma

Where it's being run

4 sites across 4 states
Indiana1
Maryland1
New Jersey1
Wisconsin1

Study leadership

  • Dustin Deming, MD · PRINCIPAL_INVESTIGATOR · University of Wisconsin, Madison

Who to contact

Dustin Deming, MD
[email protected]
608-262-0439
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

White blood cell (WBC) ≥ 1500 /mm\^3
Absolute Neutrophil Count (ANC) ≥ 1500/mm\^3
Hemoglobin (Hgb)a ≥ 9 g/dL
Platelets (Plt) ≥ 100,000 /mm\^3
Creatinine ≤ 1.5 × upper limit of normal (ULN) OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≥30 mL/min for creatinine levels \>1.5 × institutional ULN
Total bilirubin ≤ 1.5 × ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \>1.5 × ULN
Aspartate aminotransferase (AST) ≤ 2.5 × ULN
Alanine aminotransferase (ALT) ≤ 2.5 × ULN 10. Females of childbearing potential who are sexually active with a male able to father a child must have a negative pregnancy test (serum or urine) within 14 days prior to registration. 11. Females of childbearing potential who are sexually active with a male able to father a child must be willing to abstain from heterosexual activity or use an effective method(s) of contraception. Males able to father a child who are sexually active with female of childbearing potential must be willing to abstain from heterosexual activity or to use an effective method(s) of contraception. 12. If a subject is HIV-infected, participants must have well-controlled HIV on antiretroviral therapy (ART), defined as:

What this trial measures

  • Clinical complete response rate (cCR) following weekly carboplatin and paclitaxel in combination with pembrolizumab and radiation for the treatment of early-stage anal cancer.6 months

    Meets both of the following criteria: 1. There is no documented residual cancer on anoscopy. If residual cancer is suspected, a biopsy must be obtained. 2. No documented residual cancer or new metastatic disease on PET/CT, or if a PET/CT cannot be obtained, CT or MR imaging with contrast can be used. Physiologic PET avidity in the anal canal without evidence of cancer on anoscopy is still consistent with a clinical complete response.