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 (May 2026). This Phase 2 trial studies multiple treatments including Pembrolizumab and Paclitaxel for anal cancer.
Treatment: Pembrolizumab · Paclitaxel · Carboplatin · Pembrolizumab — 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
Disease stage
Required: Stage I (T1N0), IIA (T2N0), IIB (T1/2N1), IIIA (T3 N0/1), IIIB/C (T4 N0/1) IF <5CM (AJCC version 9)
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.
Cannot have received: investigational drug/device for anal cancer
Has received any investigational drug or used an investigational device for the treatment of anal cancer within 30 days prior to registration.
Lab requirements
Blood counts
WBC ≥ 1500 /mm^3; ANC ≥ 1500/mm^3; Hemoglobin ≥ 9 g/dL; Platelets ≥ 100,000 g/dL
Kidney function
Creatinine ≤ 1.5 × ULN OR measured/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. * White blood cell (WBC) ≥ 1500 /mm^3 * Absolute Neutrophil Count (ANC) ≥ 1500/mm^3 * Hemoglobin (Hgb)a ≥ 9 g/dL * Platelets (Plt) ≥ 100,000 g/dL * 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
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
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