Nivolumab+Ipilimumab+RT in MSS mCRC

Conditions

• Metastatic Microsatellite Stable Colorectal Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Nivolumab — DRUG
  Administered into vein by intravenous infusion every 2 weeks over 6 week study cycle.
• Ipilimumab — DRUG
  Administered into vein by intravenous infusion day 1 of each 6 week study cycle.
• Radiation Therapy — RADIATION
  3 radiation treatments, every other weekday or 2 days during week 1 of cycle 1 only of study.

Study Details

This research is being done to study the effects of the combination of ipilimumab, nivolumab, and radiation therapy in people with metastatic microsatellite stable colorectal cancer. This research study involves the following drugs and interventions: * Ipilimumab * Nivolumab * Radiation Therapy

Key Dates

Start date

Oct 5, 2020

Status verified

Sep 2022

Primary completion

Dec 31, 2023

Completion

Jun 30, 2024

Study Design

Enrollment

32 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Nivolumab+Ipilimumab+Radiation Therapy (RT)
  Study cycles are 6 weeks long, participants will receive: Cycle 1: Nivolumab every 2 weeks during cycle, Ipilimumab 1x on Day 1 of cycle, and Radiation Therapy every other weekday or 2 days for a total of 3 treatments during week 1 of Cycle 1 only. Cycles 2-4: Nivolumab every 2 weeks during each cycle, Ipilimumab 1x on Day 1 of each cycle Cycles 5-Disease Progression: Nivolumab every 2 weeks during each cycle

Primary Outcome Measure

Overall response rate for unirradiated lesions (ORR) [ Time Frame: From the start of the treatment until disease progression/recurrence, up to 5 years ]

Locations (3)

Find similar trials in Boston, MA