Study of Pembrolizumab, Carboplatin, Paclitaxel, and Radiation for the Treatment of Early-Stage A… (NCT06493019) | Clinical Trial Compass
RecruitingPhase 2
Study of Pembrolizumab, Carboplatin, Paclitaxel, and Radiation for the Treatment of Early-Stage Anal Cancer
United States23 participantsStarted 2024-09-30
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Patient deemed ineligible for standard of care treatment with 5-fluorouracil (5FU) and mitomycin-C (MMC) concurrently with radiation per treating investigator.
. Patient is treatment naïve for anal cancer diagnosis.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical complete response rate (cCR) following weekly carboplatin and paclitaxel in combination with pembrolizumab and radiation for the treatment of early-stage anal cancer.
. Evaluable disease according to RECIST v1.1 within 30 days prior to registration.
. Archival or newly obtained tissue available for planned correlative analysis. If tissue is not available, subjects may choose to have a standard of care biopsy to meet eligibility.
Exclusion criteria
. 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.
. Patients with an active autoimmune disease requiring immunosuppression in the past 2 years.
. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy equivalent to \> 10mg prednisone per day or any other form of immunosuppressive therapy within 7 days prior to registration. NOTE: Topical corticosteroid or inhaled corticosteroids are allowed.
. Has received a live vaccine or live-attenuated vaccine within 30 days prior to registration. Administration of killed vaccines is allowed. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, BCG, and typhoid oral vaccine. Intranasal influenza vaccines (e.g., Flu-Mist ®) are live attenuated vaccines and are not allowed. NOTE: No live vaccines may be administered while participating in the trial.
. Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.