A Phase II Study of Pembrolizumab, Carboplatin, Paclitaxel, and Radiation for the Treatment of Early-Stage Anal Cancer
Dustin Deming
Summary
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. 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. 2. Age ≥ 18 years at the time of consent. 3. ECOG Performance Status of 0-1 within 30 days prior to registration. 4. 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. 5. Patient deemed ineligible for standard of ca…
Interventions
- DrugPembrolizumab
Chemoradiation Pembrolizumab 200mg IV
- DrugPaclitaxel
Paclitaxel 50 mg/m\^2 IV
- DrugCarboplatin
Carboplatin AUC 2 IV
- RadiationRadiation
Delivered as per institutional standards
- DrugPembrolizumab
Maintenance Pembrolizumab 400mg IV
Locations (4)
- Indiana University Melvin and Bren Simon Comprehensive Cancer CenterIndianapolis, Indiana
- University of MarylandBaltimore, Maryland
- Rutgers Cancer Institute of New JerseyNew Brunswick, New Jersey
- University of WisconsinMadison, Wisconsin