[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"microsatellite-stable-rectal-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:microsatellite-stable-rectal-carcinoma":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100649516","phase-2-rectify-1-neoadjuvant-botensilimab--balstilimab-in-msspmmr-early-rectal-cancer-100649516",false,"NCT07735624","RECTIFY-1: Neoadjuvant Botensilimab + Balstilimab in MSS\u002FpMMR Early Rectal Cancer","A Phase 2 Study of the Safety and Efficacy of Neoadjuvant Botensilimab in Combination With Balstilimab in the Treatment of Microsatellite Stable \u002F Mismatch Repair Proficient Early Rectal Cancer (RECTIFY-1)","RECTIFY-1","Inclusion Criteria:\n\n* 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).\n* The tumor must confirmed to be MSS\u002FMMRp by local testing.\n* The tumor must be evaluable by endoscopy.\n* Voluntarily agree to participate by giving signed, dated, and written informed consent prior to any study-specific procedures.\n* Age ≥ 18 years of age. Because no dosing or adverse event data are currently available on the use of botensilimab with balstilimab in participants \\\u003C 18 years of age, children are excluded from this study.\n* Measurable rectal primary on baseline imaging by MRI. The tumor must be definitively at least T1.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate organ function defined as the following laboratory values within 7 days of Cycle 1 Day 1 (C1D1):\n\n  * Neutrophils ≥ 1500\u002FμL (Must be stable and off any growth factor within 4 weeks of first study treatment administration).\n  * Platelets ≥ 50× 103\u002FμL.\n  * Hemoglobin ≥ 8.0 g\u002FdL (transfusion to achieve this level is not permitted within 2 weeks of first study treatment administration).\n  * Creatinine clearance ≥ 30 mL\u002Fmin as measured or calculated per local institutional standards.\n  * Aspartate aminotransferase\u002Falanine aminotransferase ≤ 1.5 × upper limit of normal (ULN).\n  * Total bilirubin ≤ 1.5 × ULN (except patients with Gilbert syndrome who must have a total bilirubin level of ≤ 3.0 × ULN).\n* All participants must undergo multidisciplinary evaluation by a qualified colorectal surgeon, medical oncologist, and radiation oncologist to discuss treatment options for rectal cancer.\n\n  * Per the treating surgeon, the patient must be a candidate for both TES and\u002For TME for rectal cancer.\n  * Per the treating medical oncologist, the patient must be a candidate for standard chemotherapy for rectal cancer.\n  * Per the treating radiation oncologist, the patient must be a candidate for standard radiation\u002Fchemoradiotherapy for rectal cancer.\n* 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 contraceptive measures (See Section 3.4) starting with the Screening Visit through 90 days after the last dose of study treatment. See section 3.4 for more detailed information on contraception requirements.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Tumor is MSI-H\u002FMMRd per any local testing.\n* Known TMB \\>20mut\u002FMb or indication for immune checkpoint inhibitor therapy including hypermutated cancers.\n* Received prior anti-CTLA-4 or anti-PD-1\u002FPD-L1 therapy and\u002For other experimental immunologic agents.\n* Partial or complete bowel obstruction within the last 3 months, signs\u002Fsymptoms of bowel obstruction, or known radiologic evidence of impending obstruction.\n* Uncontrolled irritable bowel syndrome with predominant diarrhea (IBS-D) and\u002For other uncontrolled, chronic diarrhea syndromes.\n* Presence of rectal cancer metastases.\n* Stigmata of hepatic decompensation including a history of variceal bleeding, a history of ascites related to hepatic cirrhosis, or severe portal hypertension.\n* Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥ III), or serious uncontrolled cardiac arrhythmia requiring medication.\n* 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 eligible if treatment was completed at least 2 years before the first dose of study treatment and the patient has no evidence of disease. Patients with history of prior early-stage basal\u002Fsquamous cell skin cancer, low-risk prostate cancer eligible for active surveillance, or noninvasive or in situ cancers who have undergone definitive treatment at any time are also eligible.\n* Treatment with one of the following classes of drugs within the delineated time window prior to C1D1:\n\n  * Cytotoxic, targeted therapy or other investigational therapy within 3 weeks.\n  * Investigational monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or similar therapy, within 4 weeks, or 5 half-lives, whichever is shorter.\n  * Small molecule\u002Ftyrosine kinase inhibitors within 2 weeks or less than 5 circulating half- lives of investigational drug.\n* Prior therapy for rectal cancer.\n* Prior pelvic radiation therapy.\n* Prior treatment for rectal cancer.\n* Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.\n* Any evidence of current interstitial lung disease (ILD) or pneumonitis, or prior history of ILD or non-infectious pneumonitis requiring glucocorticoids.\n* History of allogeneic organ transplant.\n* Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.\n* 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 treatment. Inhaled or topical steroids, and adrenal replacement steroid doses (≤ 10 mg daily prednisone equivalent) are permitted in the absence of active autoimmune disease.\n* 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).\n* 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 duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.\n* Uncontrolled infection with HIV and\u002For 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 entry are eligible. Serological testing for HIV at screening is not required.\n* Known to be positive for HBV surface antigen, or any other positive test for HBV indicating acute or chronic\u002Flatent infection. HBV testing is required for study entry.\n* Known active 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 by PCR for at least 6 months prior to study entry.\n* History of untreated TB and\u002For positive quantiferon\u002FTspot test without previous tuberculosis prophylaxis, or untreated active infection with Mycobacterium tuberculosis. Testing must be negative for study entry.\n* Active or known prior infection with nontuberculous mycobacteria.","ALL","18 Years",{"count":20,"type":21},16,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a multi-site, prospective, non-randomized phase 2 study evaluating neoadjuvant botensilimab in combination with balstilimab for patients with microsatellite stable (MSS) \u002F mismatch repair proficient (MMRp) early rectal cancer staged T1-T2 N0 by MRI and considered candidates for surgical resection without standard neoadjuvant therapies. Participants will receive a single IV dose of botensilimab on Day 1 followed by balstilimab IV every 2 weeks for up to 6 months, with tumor response assessments during treatment and follow-up afterward.",[27,28,29],"Early Rectal Cancer","Stage I Rectal Cancer","Microsatellite Stable Rectal Carcinoma",[31,32,29,33],"Early rectal cancer","Non-operative management","stage I rectal cancer","RECRUITING","2026-08-17",{"date":37,"type":38},"2026-08-18","ACTUAL",{"date":40,"type":21},"2026-09",{"date":42,"type":21},"2032-12-31",{"name":44,"class":45},"Dana-Farber Cancer Institute","OTHER",3,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100580909","phase-2-a-study-of-botensilimab-and-balstilimab-for-rectal-adenocarcinoma-100580909","NCT06843434","A Study of Botensilimab and Balstilimab for Rectal Adenocarcinoma","A Phase II Study of Neoadjuvant Botensilimab and Balstilimab Immunotherapy for Mismatch Repair Proficient Rectal Adenocarcinoma","Inclusion Criteria:\n\n* Willing and able to provide written informed consent for trial.\n\n  a. If participant is unable to provide written informed consent, the legally authorized representative (LAR) of the person who is being asked to participate in this research study may give consent on the participant's behalf.\n* Be ≥18 years of age on the date of signing informed consent.\n* ECOG performance status of 0 or 1.\n* Histologically confirmed rectal adenocarcinoma.\n* Adenocarcinoma with distal margin of 15 cm or less from the anal verge on endoscopy, staged with endorectal ultrasound (ERUS) or magnetic resonance imaging (MRI) as cT3\u002FcT4 N0 or cT(any) cN1\u002F2.\n* No evidence of distant metastases\n* Radiologically measurable or clinically evaluable disease per Protocol Section 13.0.\n* Tumor specimen that demonstrates intact mismatch repair enzymes by immunohistochemistry or microsatellite stability as demonstrated by NGS or PCR.\n* Negative pregnancy test done within 14 days prior to beginning treatment, for women of childbearing potential only. Subjects of childbearing potential must be willing to use an adequate method of contraception. Appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives, or double barrier method (diaphragm plus condom). Contraception is required for the course of the study starting with the first dose of study medication through 150 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.\n* Nonchildbearing potential is defined as follows (by other than medical reasons):\n\n  1. ≥45 years of age and has not had menses for \\>1 year\n  2. Patients who have been amenorrhoeic for \\\u003C2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation\n  3. Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure, otherwise the patient must be willing to use 2 adequate barrier methods throughout the study.\n* Demonstrate adequate organ function as defined in the Table 6-1 below within 28 days of Cycle 1 Day 1, and all screening labs should be performed within 28 days of treatment initiation.\n\nHematological Absolute neutrophil count (ANC): ≥1,500 \u002Fmm\\^3 Platelets: ≥100,000 \u002F mcL Hemoglobin: ≥8.0 g\u002FdL\n\nRenal Serum creatinine OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl): ≤1.5 × upper limit of normal (ULN) OR ≥60 mL\u002Fmin for subject with creatinine levels \\> 1.5 × institutional ULN AST (SGOT) and ALT (SGPT): ≤ 2.5 × ULN\n\nCoagulation International normalized ratio (INR) or Prothrombin time (PT) or activated partial thromboplastin time (aPTT): For patients not taking warfarin: INR ≤ 1.5 or PT ≤ 1.5 x ULN; and either PTT or aPTT ≤ 1.5 x ULN. Patients on warfarin may be included on a stable dose with a therapeutic INR \\\u003C3.5\n\nExclusion Criteria:\n\n* Recurrent rectal cancer.\n* Prior pelvic radiation therapy, chemotherapy, or surgery for rectal cancer.\n* Tumor is causing symptomatic bowel obstruction (patients who have a temporary diverting ostomy are eligible).\n* Other invasive malignancy ≤ 2 years prior to registration. Exceptions are non-melanoma skin cancer that has undergone potentially curative therapy and in situ cervical carcinoma.\n* Active infection requiring systemic therapy.\n* Other anticancer or experimental therapy. No other experimental therapies (including chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, matrix metalloprotease inhibitors, thalidomide, anti-VEGF\u002FFlk-1 monoclonal antibody or other experimental drugs) of any kind are permitted while the patient is receiving study treatment.\n* Known history of interstitial lung diseases\u002Fpneumonitis\n* Known history of human immunodeficiency virus (HIV) (HIV 1\u002F2 antibodies)\n* Known active hepatitis B (e.g., HbsAg reactive) or hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected).\n* Live vaccination within 28 days prior to receiving the first dose of immunotherapy. The use of inactivated seasonal influenza vaccines (e.g., Fluzone®) will be permitted on study without restriction.\n* Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine or booster \\\u003C 7 days before C1D1. For vaccines requiring more than 1 dose, the full series should be completed prior to C1D1, when feasible. Booster shot not required but also must be administered \\> 7 days from C1D1 or \\> 7 days from future cycle on study\n* Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke or myocardial infarction within 180 days of enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥ III), or serious uncontrolled cardiac arrhythmia requiring medication.\n\n  a. QTcF (QT interval corrected using Fridericia's formula) of ≥450 ms.\n* Known active tuberculosis.\n* Receiving systemic corticosteroid therapy 1 week prior to the first dose of study drug or receiving any other form of systemic immunosuppressive medication.\n\n  a. Corticosteroid use as a premedication for IV contrast allergies\u002Freactions is allowed. Subjects who are receiving daily corticosteroid replacement therapy are also an exception to this rule. Daily prednisone at doses of ≤ 7.5 mg or equivalent hydrocortisone dose are examples of permitted replacement therapy. Use of inhaled or topical corticosteroids is permitted.\n* Has ongoing or recent (within 5 years) evidence of significant autoimmune disease or any other condition that required treatment with systemic immunosuppressive treatments. The following are not exclusionary: vitiligo, childhood asthma that has resolved, endocrinopathies (such as hypothyroidism or type 1 diabetes) that require only hormone replacement.\n* Prior allogeneic tissue\u002Fsolid organ transplant, except for corneal transplants.",{"count":55,"type":21},40,[24],"The purpose of this study is to find out whether the combination of botensilimab and balstilimab (BOT\u002FBAL) is a safe and effective treatment that causes few or mild side effects for people with mismatch repair proficient (MMRp)\u002Fmicrosatellite stable (MSS) locally advanced rectal adenocarcinoma. The investigators will also find out whether BOT\u002FBAL is an effective treatment when given in combination with standard chemotherapy.",[29,59],"Locally Advanced Rectal Adenocarcinoma",[29,61,62,63,64,65],"mismatch repair proficient locally advanced rectal adenocarcinoma","locally advanced rectal adenocarcinoma","microsatellite stable locally advanced rectal adenocarcinoma","Memorial Sloan Kettering Cancer Center","24-389","2026-06-15",{"date":68,"type":38},"2026-06-16",{"date":70,"type":38},"2025-02-20",{"date":72,"type":21},"2028-02-20",{"name":64,"class":45},7]