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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Pembrolizumab

2017

Completed Phase 3

~3130

Carboplatin

2014

Completed Phase 3

~6120