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New treatment option for Colorectal Cancer
Official title A Study of Botensilimab and Balstilimab for Colorectal Cancer With ctDNA+ After Surgery and Chemotherapy
ClinicalTrials.gov ID: NCT07227636
What this study is testing
What is Botensilimab?
Botensilimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for colorectal cancer.
Also referred to as AGEN1181.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The researchers are doing this study to find out whether the combination of botensilimab and balstilimab (BOT/BAL), followed by balstilimab alone, is an effective treatment for people with microsatellite stable (MSS) colorectal cancer or colorectal liver metastases (CRLM) who have measurable residual disease (MRD) after standard treatment with surgery and chemotherapy or total neoadjuvant therapy (TNT).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Subject or legally authorized representative, is willing and able to provide written informed consent.
- Histologically- or cytologically- confirmed colorectal cancer.
- ≥ 18 years of age on day of signing informed consent.
- Consent for use of archival tissue and blood draws for research purposes.
- Performance status of ECOG 0 or 1.
You likely can't join if
- Presence of metastatic or recurrent disease.
- Known DNA polymerase epsilon (POLE) or DNA polymerase delta (POLD) activating mutation.
- R1 (microscopic residual tumor) or R2 resection (macroscopic residual tumor at resection margin).
- Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an...
- Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the...
- Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., dexamethasone containing antiemetic regimen or steroids as...
See the full eligibility criteria
Who can join
- Subject or legally authorized representative, is willing and able to provide written informed consent.
- Histologically- or cytologically- confirmed colorectal cancer.
- ≥ 18 years of age on day of signing informed consent.
- Consent for use of archival tissue and blood draws for research purposes.
- Performance status of ECOG 0 or 1.
- Known non-MSI-H/pMMR by IHC, PCR or NGS testing. MSKCC confirmation of non-MSI-H/pMMR status is not mandatory prior to enrollment and treatment on the study. For patients with outside testing, if sufficient tissue is...
- Consent to undergo MSK IMPACT or NGS, if not previously done
- Disease specific criteria:
- Cohorts 1a and 2a: Undergone a complete surgical resection (R0) for stage III colon or rectal cancer, followed by adjuvant chemotherapy with FOLFOX or CAPEOX. Post-operative chemotherapy not required if received...
- Cohorts 1b and 2b: Undergone a complete surgical resection (R0) for liver metastasis (ablation or stereotactic body radiation therapy [SBRT], but not Y-90, is permitted) and completed standard peri-operative...
- Positive ctDNA following completion of appropriate standard of care therapy.
- Patients must sign informed consent within 6 weeks of positive ctDNA result. The 6 weeks is considered from the date that the ctDNA is resulted, and not the date it is drawn. Adequate organ function, defined as:
- Absolute Neutrophil Count ≥ 1,500/mm3.
- Platelet count ≥ 75,000/mm3.
- Hemoglobin ≥ 9.0 g/dL
- Creatinine clearance (CrCl) ≥60 mL/min.
- AST and ALT ≤ 2.5 × ULN
- Bilirubin ≤ 1.5 × ULN or Direct bilirubin ≤ ULN
- people of childbearing potential (or with partners of childbearing potential) must use effective contraception for the course of the study starting with the screening visit through at least 5 months after the last dose...
What rules you out
- Presence of metastatic or recurrent disease.
- Known DNA polymerase epsilon (POLE) or DNA polymerase delta (POLD) activating mutation.
- R1 (microscopic residual tumor) or R2 resection (macroscopic residual tumor at resection margin).
- Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., dexamethasone containing antiemetic regimen or steroids as CT scan contrast premedication) may be enrolled.
- The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed.
- Hypersensitivity to botensilimab or balstilimab or any of its excipients.
- Chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered...
- History of, or any evidence of active, non-infectious pneumonitis.
- Active infection requiring systemic therapy.
- Current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best...
- Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- 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 90 days after the last dose of trial treatment.
- Prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 agent.
- Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years of the start of study treatment (i.e., with use of disease-modifying agents or immunosuppressive drugs). The...
- people with vitiligo or alopecia
- people with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement or psoriasis not requiring systemic treatment
- Known active TB (Bacillus tuberculosis).
- Uncontrolled infection with human immunodeficiency virus (HIV). Patients on stable highly active antiretroviral therapy with undetectable viral load and normal CD4 counts for at least 6 months prior to study entry are...
- Known to be positive for hepatitis B virus (HBV) surface antigen, or any other positive test for HBV indicating acute or chronic infection. Patients who are receiving or who have received anti-HBV therapy and have...
- Known active hepatitis C virus (HCV) as determined by positive serology and confirmed by polymerase chain reaction (PCR). Patients on or who have received antiretroviral therapy are eligible provided they are virus-free...
- Received a live vaccine within 30 days of planned start of study therapy
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Rockville Centre, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.