Study on Botensilimab and Balstilimab for Colorectal Cancer

Sponsor: Nicholas DeVito, MD

Sponsor score: 0

ClinicalTrials ID:NCT06268015

Provider View

This clinical trial is testing a new treatment using the drugs botensilimab and balstilimab for patients with colorectal cancer that has spread or cannot be removed by surgery. The study aims to see if this combination can help control the cancer and improve patient outcomes.

Patient Parameters

Program Overview

This study is exploring a new treatment approach for patients with colorectal cancer that has spread or cannot be surgically removed. Participants will receive two drugs, botensilimab and balstilimab, in cycles every six weeks. If the cancer progresses, additional chemotherapy drugs, mFOLFOX6 and either bevacizumab or panitumumab, will be added. The study will monitor the safety and effectiveness of this treatment combination, with regular check-ups and scans to track progress. Participants will be followed for up to two years to assess their survival and overall health.

Description

This clinical trial is designed to test a new treatment for colorectal cancer that has spread or cannot be removed by surgery. The study involves using two drugs, botensilimab and balstilimab, to see if they can help control the cancer. Participants will receive these drugs in cycles every six weeks. If the cancer shows signs of progressing, additional chemotherapy drugs, mFOLFOX6 and either bevacizumab or panitumumab, will be added to the treatment plan.

The study will take place at the Duke Cancer Institute and aims to enroll up to 20 participants to ensure at least 15 can be fully evaluated. Participants will undergo various tests and scans to monitor their health and the cancer's response to the treatment. The study will continue until the cancer progresses, the treatment causes unacceptable side effects, or the participant chooses to withdraw.

Participants will have regular check-ups every two weeks during the treatment period, and their progress will be assessed every 12 weeks with scans. After completing the treatment, participants will have a follow-up visit 30 days later and will be monitored for survival every 12 weeks for up to two years.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older.
  • Diagnosed with metastatic or unresectable colorectal cancer without liver, bone, or brain metastases.
  • Cancer must be microsatellite stable.
  • Willing to provide a fresh biopsy of the tumor.
  • Good overall health with an ECOG performance status of 0 or 1.
  • No prior systemic therapy for colon cancer, except in certain cases with approval.
  • Measurable disease according to specific criteria.
  • Women must not be pregnant or breastfeeding and must use effective contraception if of childbearing potential.
  • Men must use effective contraception unless infertile.
  • Expected to live more than 3 months.
  • Provide written informed consent.
  • Adequate organ function based on specific lab tests.

Exclusion Criteria

  • Previous treatment with an immune checkpoint inhibitor.
  • Pregnant or breastfeeding women.
  • Not willing to use effective birth control.
  • Known liver, bone, or brain metastases.
  • Other cancers diagnosed within the last 2 years, except certain types.
  • History of significant autoimmune diseases requiring treatment.
  • History of chronic or autoimmune pancreatitis.
  • Active lung inflammation or pneumonitis.
  • Use of prohibited medications or treatments.
  • Recent live vaccines or active infections.
  • Severe or uncontrolled medical conditions.
  • Recent major surgery or serious injuries.
  • History of organ or stem cell transplants.
  • Bowel obstruction or refractory ascites.
  • Positive tuberculosis test.

Locations

FACILITYZIPCITYSTATE
Duke University27710DurhamNorth Carolina

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