Trial of Chemoradiation and Pembrolizumab in Patients With Rectal Cancer
Status:
Withdrawn
Trial end date:
2020-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Osama Rahma, MD
Collaborators:
Hoosier Cancer Research Network Merck Sharp & Dohme Corp.