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

ConditionAnal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDustin Deming

About this trial

A single arm phase II study of pembrolizumab, carboplatin, paclitaxel, and radiation for the treatment of early-stage anal cancer. There are 2 treatments phases and then surveillance. The first treatment phase is the chemoradiation phase (Cycle 1-6, weekly cycles) which is followed by the maintenance phase (Cycle 7-14, 6 week cycles).

Eligibility criteria

Qualifiers

Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.

Age ≥ 18 years at the time of consent.

ECOG Performance Status of 0-1 within 30 days prior to registration.

Histologically proven stage I (T1N0), IIA (T2N0), IIB (T1/2N1), or IIIA (T3 N0/1) invasive squamous cell carcinoma of the anus by AJCC version 9. Stage IIIB/C (T4 N0/1) cancers will also be eligible if less than 5cm in diameter.

Disqualifiers

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring systemic therapy, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements.

Has known additional malignancy that is progressing or has required active treatment within the past 2 years and is not deemed by the investigator to be at low risk for recurrence.

Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study drug(s). NOTE: breast milk cannot be stored for future use while the mother is being treated on study.

Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.

Trial design

Treatments tested in this trial

  • Pembrolizumab
  • Paclitaxel
  • Carboplatin
  • Radiation
  • Pembrolizumab

Treatment groups

23 Participants
are divided into 1 treatment group

Locations

4
Indiana University Melvin and Bren Simon Comprehensive Cancer Center46202, IndianapolisIndiana, United States
University of Maryland21201, BaltimoreMaryland, United States
Rutgers Cancer Institute of New Jersey08903, New BrunswickNew Jersey, United States
University of Wisconsin53705, MadisonWisconsin, United States

Sponsors and collaborators

Dustin Deming

Lead sponsor

Hoosier Cancer Research Network

Sponsor institution

Merck Sharp & Dohme LLC

Collaborator

University of Wisconsin, Madison

Collaborator