OncoMatch/Clinical Trials/NCT06493019
Study of Pembrolizumab, Carboplatin, Paclitaxel, and Radiation for the Treatment of Early-Stage Anal Cancer
Is NCT06493019 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments including Pembrolizumab and Paclitaxel for anal cancer.
Treatment: Pembrolizumab · Paclitaxel · Carboplatin — 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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Chemotherapy
Disease stage
Required: Stage I (T1N0), IIA (T2N0), IIB (T1/2N1), IIIA (T3 N0/1), IIIB/C (T4 N0/1) <5CM (other)
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.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-PD-1 therapy
Has had prior anti-PD1 immune checkpoint blockade.
Lab requirements
Blood counts
WBC ≥ 1500 /mm^3; ANC ≥ 1500/mm^3; Hgb ≥ 9 g/dL; Platelets ≥ 100,000 /mm^3
Kidney function
Creatinine ≤ 1.5 × 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
Liver function
Total bilirubin ≤ 1.5 × ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN; AST ≤ 2.5 × ULN; ALT ≤ 2.5 × ULN
Demonstrate adequate organ function as defined below. All screening labs to be obtained within 30 days prior to registration.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center · Indianapolis, Indiana
- University of Maryland · Baltimore, Maryland
- Rutgers Cancer Institute of New Jersey · New Brunswick, New Jersey
- University of Wisconsin · Madison, Wisconsin
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06493019 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
What disease stage is eligible?
Stage I (T1N0) or IIA (T2N0) or IIB (T1/2N1) or IIIA (T3 N0/1) or IIIB/C (T4 N0/1) <5CM is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify