Actively Recruiting
Study of Pembrolizumab, Carboplatin, Paclitaxel, and Radiation for the Treatment of Early-Stage Anal Cancer
Led by Dustin Deming · Updated on 2026-03-23
23
Participants Needed
4
Research Sites
236 weeks
Total Duration
On this page
Sponsors
D
Dustin Deming
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Study of Pembrolizumab, Carboplatin, Paclitaxel, and Radiation for the Treatment of Early-Stage Anal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent and HIPAA authorization
- At least 18 years old at consent
- ECOG Performance Status of 0 or 1 within 30 days before registration
- Diagnosed with stage I (T1N0), IIA (T2N0), IIB (T1/2N1), or IIIA (T3 N0/1) invasive squamous cell carcinoma of the anus, or stage IIIB/C (T4 N0/1) less than 5 cm in diameter
- Ineligible for standard 5-fluorouracil and mitomycin-C treatment with radiation
- No prior treatment for anal cancer
- Disease measurable by RECIST v1.1 within 30 days before registration
- Available tissue for correlative analysis or willing to have biopsy
- Adequate organ function based on blood tests within 30 days before registration
- Negative pregnancy test within 14 days before registration for sexually active females of childbearing potential
- Willingness to abstain from heterosexual activity or use effective contraception if sexually active and of childbearing potential
- If HIV-positive, must have well-controlled infection with stable antiretroviral therapy, sufficient CD4+ T-cell count, virologic suppression, no recent AIDS-defining infections, and agree to continue therapy
- If chronic hepatitis B or C infection, must have undetectable viral load or be cured
- Ability to understand and follow study procedures for entire study duration
You will not qualify if you...
- Uncontrolled illnesses including active infection, heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting study compliance
- Active malignancy requiring treatment within past 2 years except certain skin cancers and low-risk prostate cancer
- Pregnant, breastfeeding, or planning to conceive/father children during study and 120 days after last dose
- Severe hypersensitivity to pembrolizumab or its components
- Active autoimmune disease requiring immunosuppression in past 2 years
- Diagnosed immunodeficiency or recent immunosuppressive therapy
- Live vaccine within 30 days before registration
- History or current pneumonitis or interstitial lung disease requiring steroids
- Received investigational drug/device for anal cancer within 30 days
- Prior allogeneic bone marrow/stem cell or organ transplant
- Not recovered from major surgery or ongoing surgical complications
- Conditions or therapies that could interfere with study or participation
- Psychiatric or substance abuse disorders interfering with study compliance
- Prior anti-PD1 immune checkpoint blockade
- Taking contraindicated medications that cannot be stopped or changed before study start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
2
University of Maryland
Baltimore, Maryland, United States, 21201
Actively Recruiting
3
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
4
University of Wisconsin
Madison, Wisconsin, United States, 53705
Actively Recruiting
Research Team
D
Dustin Deming, MD
CONTACT
A
Amber Ryba
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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