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Monoclonal Antibodies
Combination Immunotherapy for Colorectal Cancer (NEST-1 Trial)
Phase 2
Waitlist Available
Led By Pashtoon Kasi, M.D.
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years of age or older
Stage 1-3 adenocarcinoma of the colon with plans to have a surgical resection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 0, day 14, day 45, day 60
Awards & highlights
NEST-1 Trial Summary
This trial is testing a new combination therapy for colorectal cancer patients before surgery. The two drugs given target the immune system and the study will observe any side effects and the efficacy of the treatment.
Who is the study for?
This trial is for adults with early-stage (1-3) colorectal cancer who are planning to have surgery. They must use effective contraception if they can become or get someone pregnant. It's not for those with metastatic cancer, previous immune checkpoint inhibitor treatments, active infections needing treatment, other ongoing clinical trials participation, pregnancy or breastfeeding, on immunosuppressants, or serious heart conditions.Check my eligibility
What is being tested?
The study tests a combination of two investigational drugs: balstilimab and botensilimab—both targeting the immune system—to see their effects on colorectal cancer before surgical tumor removal. Participants will receive these drugs intravenously over an 8-week period prior to surgery.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system such as inflammation in various organs, infusion-related reactions from the IV administration process itself, fatigue, possible digestive issues due to gut inflammation and increased risk of infections.
NEST-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have stage 1-3 colon cancer and plan to have surgery.
NEST-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, day 0, day 14, day 45, day 60
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 0, day 14, day 45, day 60
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Adverse Events
Number of Serious Adverse Events
Number of complications leading to delays of 12 weeks or more in surgery after initiation of treatment
+1 moreSecondary outcome measures
Changes in Minimal Residual Disease assessed using ctDNA pre- and post-surgical resection
NEST-1 Trial Design
1Treatment groups
Experimental Treatment
Group I: Botensilimab and balstilimab (bot/bal)Experimental Treatment2 Interventions
Botensilimab and balstilimab are both monoclonal antibodies that are administered intravenously. A single dose of botensilimab (75 mg IV), and two doses of balstilimab (240 mg IV), will be administered on the same day. A second dose of balstilimab (240 mg IV) will be administered 14 days later (-2 +5 days). Surgical resection will occur 1-6 weeks following the second dose of balstilimab.
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Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,052 Previous Clinical Trials
1,329,860 Total Patients Enrolled
Agenus Inc.Industry Sponsor
49 Previous Clinical Trials
4,954 Total Patients Enrolled
Pashtoon Kasi, M.D.Principal InvestigatorWeill Medical College of Cornell University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with drugs targeting CTLA-4, PD-1, or PD-L1.My cancer has spread to other parts of my body.I am currently in another study and taking a study drug.I am taking medication that weakens my immune system.I do not have recent serious heart problems or uncontrolled heart rhythm issues.I am currently being treated for an infection.I am 18 years old or older.You have had serious allergic reactions to immunotherapies in the past.I have stage 1-3 colon cancer and plan to have surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Botensilimab and balstilimab (bot/bal)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Food and Drug Administration sanctioned Botensilimab and balstilimab for general use?
"Our team at Power assigned a safety rating of 2 to the combination of Botensilimab and balstilimab (bot/bal), as Phase 2 trials provide evidence regarding safety but not efficacy."
Answered by AI
Are there still openings to join this research endeavor?
"Based on the clinicaltrials.gov page, this trial is no longer recruiting candidates and was last updated on October 4th 2022. However, there are 859 other trials currently seeking volunteers to participate in their research efforts."
Answered by AI
Who else is applying?
What site did they apply to?
Weill Cornell Medicine/NewYork-Presbyterian Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I believe that a clinical trial should be considered as the tumors in my lungs are growing despite every week chemo.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
Is there a Hope Village/Hope Lodge near the Clinical Trials?
PatientReceived 1 prior treatment
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