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Brachytherapy + Nivolumab for Rectal Cancer

(IMPERIA Trial)

Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Dr. Te Vuong
Must not be taking: Immunosuppressants, Investigational agents
Disqualifiers: Metastasis, Autoimmune disease, Infection, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a small Phase II study testing whether targeted internal radiation treatment (HDREBT) followed by two doses of the immunotherapy drug Nivolumab is safe, practical, and potentially effective before patients undergo surgery (TME) to remove rectal cancer.

Are You a Good Fit for This Trial?

This trial is for adults (18+) with rectal adenocarcinoma located 5–15 cm from the anal verge, at stage cT2 or cT3, without distant spread. The cancer must be removable by surgery and have certain features on MRI. Participants need to have a specific tumor marker status (pMMR/MSI-L) and be planned for radiation before surgery.

Inclusion Criteria

I have had pelvic radiation before but can still have TME surgery.
I am able to care for myself and perform daily activities.
I have rectal adenocarcinoma located 5 to 15 cm from the anal verge.
See 9 more

Exclusion Criteria

I have previously received treatment for rectal cancer.
I have a bowel obstruction seen on MRI or found during a medical exam.
Psychiatric, social, or severe uncontrolled medical conditions compromising compliance or safety
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Brachytherapy

Participants receive targeted internal radiation treatment (HDREBT) delivered in 4 fractions over Days 1-4

1 week
4 visits (in-person)

Immunotherapy

Participants receive up to 2 doses of nivolumab (3 mg/kg IV every 2 weeks starting at 7-14 days post HDREBT)

4 weeks
2 visits (in-person)

Surgery

Surgical resection of tumor (total mesorectal excision) occurs 6-8 weeks post HDREBT

1 week
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • HDRBET
  • Nivolumab
  • Total Mesorectal Excision (TME)

Trial Overview

The study tests if giving targeted internal radiation (HDR brachytherapy), then two doses of immunotherapy drug Nivolumab, before standard rectal cancer surgery (TME) is safe and practical. It’s a small Phase II trial.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Brachytherapy (HDREBT) followed by nivolumab and total mesorectal excisionExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dr. Te Vuong

Lead Sponsor

Trials
3
Recruited
3+

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