Study of Pembrolizumab, Carboplatin, Paclitaxel, and Radiation for the Treatment of Early-Stage Anal Cancer

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Dustin Deming
Study ID
NCT06493019
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    Chemoradiation Pembrolizumab 200mg IV
  • Paclitaxel — DRUG
    Paclitaxel 50 mg/m\^2 IV
  • Carboplatin — DRUG
    Carboplatin AUC 2 IV
  • Radiation — RADIATION
    Delivered as per institutional standards
  • Pembrolizumab — DRUG
    Maintenance Pembrolizumab 400mg IV

Study Details

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).

Key Dates

Start date
Sep 30, 2024
Status verified
Mar 2026
Primary completion
Apr 15, 2027
Completion
Apr 14, 2029

Study Design

Enrollment
23 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab plus carbopltin and paclitaxel
    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.

Primary Outcome Measure

Clinical complete response rate (cCR) following weekly carboplatin and paclitaxel in combination with pembrolizumab and radiation for the treatment of early-stage anal cancer. [ Time Frame: 6 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Indiana University Melvin and Bren Simon Comprehensive Cancer CenterIndianapolisIndiana46202
Alexia Belmontes
[email protected]
317-278-6505
Anita Turk, MD (PRINCIPAL_INVESTIGATOR)
University of MarylandBaltimoreMaryland21201
Margaret Carder
[email protected]
Yixing Jiang, MD, PhD (PRINCIPAL_INVESTIGATOR)
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903
Christian Perez
[email protected]
Salma Jabbour, MD (PRINCIPAL_INVESTIGATOR)
University of WisconsinMadisonWisconsin53705
Erin Clements
[email protected]
Dustin Deming, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Indianapolis, IN

By research site
Indiana University Melvin and Bren Simon Comprehensive Cancer Center· Indianapolis, INUniversity of Maryland· Baltimore, MDRutgers Cancer Institute of New Jersey· New Brunswick, NJUniversity of Wisconsin· Madison, WI

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