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PhII Nivolumab + Ipilimumab & SCR in MSI-H/Dmmr Local Adv Rectal Adenocarcinoma

May Cho


A Study On:

  • Rectum

Status:

  • Open

Eligibility

Adults

Interested in joining this trial?

Official Title

A Phase II Study of Neoadjuvant Nivolumab Plus Ipilimumab and Short-Course Radiation in MSI-H/dMMR Locally Advanced Rectal Adenocarcinoma

Details

This study is being done to answer the following question:
Can we lower the chance of your rectal cancer growing or spreading by adding nivolumab and ipilimumab to short-course radiation prior to surgery?
We are doing this study because we want to find out if this approach is better or worse than the usual approach for your locally advanced rectal cancer. The usual approach is defined as care most people get for locally advanced rectal cancer.
If you decide to take part in this study, you will get immunotherapy with nivolumab and ipilimumab for two 28 day cycles. You will then be treated with short-course radiotherapy, followed by two additional 28-day cycles of immunotherapy with nivolumab plus ipilimumab, followed by restaging with digital rectal exam (DRE), CT scan and magnetic resonance imaging (MRI) and then total mesorectal excision (TME).
After you finish surgery, you and your doctor will discuss whether chemotherapy would be helpful to try and prevent your cancer from returning. Your doctor will continue to follow your condition closely for at least five years and watch you for side effects and disease recurrence. You will be followed in the clinic with blood tests every 3 months for 2 years and every 6 months for 3 additional years, scans at least annually for 5 years, and colonoscopy one year after surgery and periodically (every 3-5 years) after that. Your condition will be followed for a total of 10 years, or longer if needed.


Eligibility

You can join if...

Eligibility Criteria:

  • Patient must have confirmed rectal cancer.
  • Patient must not have previously received chemotherapy or immunotherapy for rectal cancer.
  • Patient must not have previously received radiotherapy to the pelvis.
  • Patient must not have had major surgery performed within 28 days prior to registration.
  • Patient must not be pregnant or breast-feeding. All patients of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy.

Get in touch with our study team