Nivolumab + Ipilimumab + Radiation for Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen ByTheodore S Hong, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This research is being done to study the effects of the combination of ipilimumab, nivolumab, and radiation therapy in people with microsatellite stable pancreatic cancer. The names of the study interventions involved in this study are: * Ipilimumab * Nivolumab * Radiation Therapy

Eligibility Criteria

This trial is for adults over 18 with metastatic MSS pancreatic cancer who have had at least one prior chemotherapy treatment. They must be in good health otherwise, with proper organ and marrow function, and a life expectancy of more than 3 months. Participants need to have tumors suitable for radiation therapy and measurable disease outside the radiation field.

Inclusion Criteria

My cancer has worsened after at least one chemotherapy treatment.

My organ and bone marrow functions are normal as per recent tests.

I can do most of my daily activities without help.

+6 more

Exclusion Criteria

I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 5 months for woman and 7 months for men, after the last dose of trial treatment

You have had a serious allergic reaction to any type of monoclonal antibody in the past.

+15 more

Participant Groups

The study tests a combination of two immunotherapy drugs, Nivolumab and Ipilimumab, along with Radiation Therapy on patients with microsatellite stable (MSS) pancreatic cancer to see how effective this trio is against the disease.

1Treatment groups

Experimental Treatment

Group I: Nivolumab + Ipilimumab + RadiationExperimental Treatment3 Interventions

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits, (Study cycles are 6 weeks.) * Nivolumab via iv, at predetermined dose every 2 weeks for duration of study. * Ipilimumab via iv at a predetermined dose on day 1 of 4 study cycles. * Radiation treatments will be administered every other weekday or 2 days during week 1 of cycle 1.

Ipilimumab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Yervoy for: