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Trial of Chemoradiation and Pembrolizumab in Patients With Rectal Cancer

NCT02586610 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2017-01-20

No results posted yet for this study

Summary

This is a phase II, prospective open label multi-center study in which subjects with stage II-III rectal cancer will be accrued in order to determine the pathological complete response rate of neoadjuvant pembrolizumab in combination with chemoradiation treatment (CRT). Subjects must have a diagnosis of rectal cancer, stage II (T3-4, N0) or stage III (any T, N1-2). Subjects must have received no prior treatments (chemotherapy, pelvic radiation or surgery) for their rectal cancer.

Eligible subjects will receive standard chemoradiation with pembrolizumab administered every 3 weeks on days 1, 22, and 43 of the neoadjuvant interval. In all subjects, restaging endorectal or pelvic MRI with chest and abdominal CT will be performed at 6-8 weeks after completion of neoadjuvant treatment to determine resectability and to rule out any evidence of metastases. Subjects who have resectable disease will undergo surgery within 2-4 weeks of imaging; 8-12 weeks after completion of chemoradiation. Subjects who are found to have unresectable or metastatic disease post treatment with the combination of CRT+ pembrolizumab should receive standard of care definitive treatment per the discretion of their treating physician.

Conditions

Interventions

DRUG

Pembrolizumab

Pembrolizumab 200 mg IV Days 1, 22 and 43

DRUG

Capecitabine

Capecitabine 825 mg/m2 PO twice a day (daily total 1650 mg/m2) on 5 consecutive days / week M-F given on the radiation days for 28 days

RADIATION

Radiation Therapy

Radiation 50.4 GY in daily fractions of 1.8 Gy over a 6 week interval (excludes weekends)

Sponsors & Collaborators

  • Hoosier Cancer Research Network

    collaborator OTHER

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Osama Rahma, MD

    lead OTHER

Principal Investigators

  • Osama Rahma · Hoosier Cancer Research Network

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2018-06-30
Completion
2020-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02586610 on ClinicalTrials.gov