← Back to Search

Chemotherapy

Pembrolizumab + Chemotherapy + Radiation for Anal Cancer

Phase 2
Recruiting
Led By Dustin Deming, MD
Research Sponsored by Dustin Deming
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Summary

This trial is testing a new treatment for early-stage anal cancer using a combination of pembrolizumab, carboplatin, paclitaxel, and radiation. Patients will undergo two treatment

Who is the study for?
This trial is for individuals with early-stage anal cancer. Participants should be suitable for chemotherapy and radiation, but specific inclusion and exclusion criteria details are not provided.
What is being tested?
The study tests a combination of pembrolizumab (an immunotherapy drug), carboplatin, paclitaxel (chemotherapy drugs), and radiation therapy in two phases: chemoradiation followed by maintenance, to treat early-stage anal cancer.
What are the potential side effects?
Potential side effects may include immune-related reactions from pembrolizumab, nerve damage or allergic reactions from paclitaxel, kidney or hearing issues from carboplatin, and skin irritation or fatigue from radiation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinical complete response rate (cCR) following weekly carboplatin and paclitaxel in combination with pembrolizumab and radiation for the treatment of early-stage anal cancer.
Secondary study objectives
Assess the overall response rate of weekly carboplatin and paclitaxel in combination with pembrolizumab and radiation for the treatment of anal cancer.
Assess tumor downstaging
Disease-free survival of patients undergoing this treatment strategy.
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pembrolizumab plus carbopltin and paclitaxelExperimental Treatment4 Interventions
All patients in the chemoradiation phase will receive a combination of pembrolizumab, carboplatin, and paclitaxel. For the first 6 cycles (a cycle is a week) carboplatin and paclitaxel will be administered by IV every week. Pembrolizumab will be administered by IV on cycles 1 and 4. The next phase is the maintenance phase. This will occur from cycle 7-14 with each cycle being 6 weeks. Pembrolizumab will be administered every cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation
2003
Completed Phase 2
~780
Carboplatin
2014
Completed Phase 3
~6120
Pembrolizumab
2017
Completed Phase 2
~2070
Paclitaxel
2011
Completed Phase 4
~5810

Find a Location

Who is running the clinical trial?

Dustin DemingLead Sponsor
Merck Sharp & Dohme LLCIndustry Sponsor
3,950 Previous Clinical Trials
5,174,960 Total Patients Enrolled
University of Wisconsin, MadisonOTHER
1,210 Previous Clinical Trials
3,157,716 Total Patients Enrolled
~15 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top