Early Rectal Cancer study: Botensilimab vs Balstilimab
Official title RECTIFY-1: Neoadjuvant Botensilimab + Balstilimab in MSS/pMMR Early Rectal Cancer
ClinicalTrials.gov ID: NCT07735624
What this study is testing
What is Botensilimab?
Botensilimab is an investigational IV medicine being studied as a potential neoadjuvant treatment for early rectal cancer. Botensilimab is designed to block the PD‑1 pathway, helping the immune system recognize and attack cancer cells.
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
- This study is testing whether two new drugs can shrink the tumor. It looks at how well this works before surgery.
- Who it's for
- You may be able to join if you have early rectal cancer. Your cancer must be a specific type that does not fix its own DNA errors.
- What's involved
- You would get one IV shot of the first drug. Then you would get IV shots of the second drug every two weeks.
- Time commitment
- The treatment lasts up to six months. You will need visits for checks and scans.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 6 months
- Which group you join is decided by chance.
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
- Histologically confirmed diagnosis of early-rectal cancer clinically staged T1-T2 N0 M0 by MRI (American Joint Committee on Cancer (AJCC) staging 8th...
- The tumor must confirmed to be MSS/MMRp by local testing.
- The tumor must be evaluable by endoscopy.
- Voluntarily agree to participate by giving signed, dated, and written informed consent prior to any study-specific procedures.
- Age ≥ 18 years of age. Because no dosing or adverse event data are currently available on the use of botensilimab with balstilimab in participants \<...
You likely can't join if
- Tumor is MSI-H/MMRd per any local testing.
- Known TMB \>20mut/Mb or indication for immune checkpoint inhibitor therapy including hypermutated cancers.
- Received prior anti-CTLA-4 or anti-PD-1/PD-L1 therapy and/or other experimental immunologic agents.
- Partial or complete bowel obstruction within the last 3 months, signs/symptoms of bowel obstruction, or known radiologic evidence of impending...
- Uncontrolled irritable bowel syndrome with predominant diarrhea (IBS-D) and/or other uncontrolled, chronic diarrhea syndromes.
- Presence of rectal cancer metastases.
See the full eligibility criteria
Who can join
- Histologically confirmed diagnosis of early-rectal cancer clinically staged T1-T2 N0 M0 by MRI (American Joint Committee on Cancer (AJCC) staging 8th edition, 2017).
- The tumor must confirmed to be MSS/MMRp by local testing.
- The tumor must be evaluable by endoscopy.
- Voluntarily agree to participate by giving signed, dated, and written informed consent prior to any study-specific procedures.
- Age ≥ 18 years of age. Because no dosing or adverse event data are currently available on the use of botensilimab with balstilimab in participants \< 18 years of age, children are excluded from this study.
- Measurable rectal primary on baseline imaging by MRI. The tumor must be definitively at least T1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Neutrophils ≥ 1500/μL (Must be stable and off any growth factor within 4 weeks of first study treatment administration).
- Platelets ≥ 50× 103/μL.
- Hemoglobin ≥ 8.0 g/dL (transfusion to achieve this level is not permitted within 2 weeks of first study treatment administration).
- Creatinine clearance ≥ 30 mL/min as measured or calculated per local institutional standards.
- Aspartate aminotransferase/alanine aminotransferase ≤ 1.5 × upper limit of normal (ULN).
- Total bilirubin ≤ 1.5 × ULN (except patients with Gilbert syndrome who must have a total bilirubin level of ≤ 3.0 × ULN).
- All participants must undergo multidisciplinary evaluation by a qualified colorectal surgeon, medical oncologist, and radiation oncologist to discuss treatment options for rectal cancer.
- Per the treating surgeon, the patient must be a candidate for both TES and/or TME for rectal cancer.
- Per the treating medical oncologist, the patient must be a candidate for standard chemotherapy for rectal cancer.
- Per the treating radiation oncologist, the patient must be a candidate for standard radiation/chemoradiotherapy for rectal cancer.
- The effects of botensilimab with balstilimab on the developing human fetus are unknown. For this reason, women of child-bearing potential (WOCBP) and men enrolled in this study must agree to use highly effective...
- Ability to understand and the willingness to sign a written informed consent document.
What rules you out
- Tumor is MSI-H/MMRd per any local testing.
- Known TMB \>20mut/Mb or indication for immune checkpoint inhibitor therapy including hypermutated cancers.
- Received prior anti-CTLA-4 or anti-PD-1/PD-L1 therapy and/or other experimental immunologic agents.
- Partial or complete bowel obstruction within the last 3 months, signs/symptoms of bowel obstruction, or known radiologic evidence of impending obstruction.
- Uncontrolled irritable bowel syndrome with predominant diarrhea (IBS-D) and/or other uncontrolled, chronic diarrhea syndromes.
- Presence of rectal cancer metastases.
- Stigmata of hepatic decompensation including a history of variceal bleeding, a history of ascites related to hepatic cirrhosis, or severe portal hypertension.
- Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart...
- Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment, i.e., patients with a history of prior malignancy are...
- Cytotoxic, targeted therapy or other investigational therapy within 3 weeks.
- Investigational monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or similar therapy, within 4 weeks, or 5 half-lives, whichever is shorter.
- Small molecule/tyrosine kinase inhibitors within 2 weeks or less than 5 circulating half- lives of investigational drug.
- Prior therapy for rectal cancer.
- Prior pelvic radiation therapy.
- Prior treatment for rectal cancer.
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
- Any evidence of current interstitial lung disease (ILD) or pneumonitis, or prior history of ILD or non-infectious pneumonitis requiring glucocorticoids.
- History of allogeneic organ transplant.
- Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
- Patients with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) within 14 days or another immunosuppressive medication within 30 days of the first dose of study...
- 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).
- History or current evidence of any condition, co-morbidity, therapy, any active infections, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full...
- Uncontrolled infection with HIV and/or active infection with opportunistic pathogens. Patients stable on antiretroviral therapy with undetectable viral load and normal CD4 counts for at least 6 months prior to study...
- Known to be positive for HBV surface antigen, or any other positive test for HBV indicating acute or chronic/latent infection. HBV testing is required for study entry.
- Known active HCV as determined by positive serology and confirmed by polymerase chain reaction (PCR).
- History of untreated TB and/or positive quantiferon/Tspot test without previous tuberculosis prophylaxis, or untreated active infection with Mycobacterium tuberculosis. Testing must be negative for study entry.
- Active or known prior infection with nontuberculous mycobacteria.
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, 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, but confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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?
This study is enrolling now at Boston, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.