Is NCT07595874 recruiting in Newnan, GA?

Yes, NCT07595874 is currently recruiting participants at its Newnan, GA location. This advanced colon adenocarcinoma clinical trial is actively enrolling qualified participants.

How do I join the advanced colon adenocarcinoma clinical trial in Newnan?

To join this clinical trial in Newnan, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Newnan clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Advanced Colon Adenocarcinoma Clinical Trial in Newnan, GA

About This Advanced Colon Adenocarcinoma Study in Newnan

This phase II trial tests how well giving botensilimab and balstilimab prior or to surgery (neoadjuvent) works for the treatment of colorectal cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and that can be removed by surgery (resectable) colorectal cancer. Immunotherapy with monoclonal antibodies, such as botensilimab and balstilimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving botensilimab and balstilimab before surgery may make the tumor smaller. Giving neoadjuvant botensilimab and balstilimab may be effective for the treatment of advanced resectable colorectal cancer.

Sponsor: City of Hope Medical Center

Who Can Participate

Inclusion Criteria

Documented informed consent of the participant and Legally Authorized Representative (when applicable)

Assent, when appropriate, will be obtained and documented for adults lacking capacity per institutional guidelines

Agreement to allow the use of tissue from past and future surgery and standard of care biopsies

Age: ≥ 18 years

Eastern Cooperative Oncology Group (ECOG) ≤ 2

Histologically confirmed or cytologically confirmed colorectal adenocarcinoma. Patients with high grade dysplasia on histology plus unequivocal endoscopic or radiological evidence of invasive cancer are eligible. Patients diagnosed with rectal cancer who will be treated like colon cancer with curative-intent surgery first and no radiation are also eligible, including:

Upper rectum or rectosigmoid considered as non-rectal and not undergoing neoadjuvant treatment

The tumor component should not extend to less 12 cm from the anal verge.

Any patient with rectal cancer for whom radiotherapy is not advised is included in this protocol (i.e., excluding rectal adenocarcinomas warranting treatment with chemoradiation)

Microsatellite stability by mismatch repair by immunohistochemistry, polymerase chain reaction and/or other Clinical Laboratory Improvement Amendments (CLIA) certified next generation sequencing. Only patients with mismatch repair proficient or microsatellite stable (pMMR/MSS) tumors are allowed to enroll in the study

Candidate for and planning a curative resection. Must have surgeon identified

T4, N+ (American Joint Committee on Cancer \[AJCC\] TNM staging criteria), or both by central radiographic assessment.

Note: Patients with T3N0 stage IIA are excluded. Stage IIB, IIC, IIIA, IIIB, and IIIC are included. Patients with stage IV disease are excluded

Absolute neutrophil count (ANC) ≥ 1,500/mm\^3

Platelets ≥ 75,000/mm\^3

NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment

Hemoglobin ≥ 8 g/dL

NOTE: Red blood cell transfusions are permitted. Patients should not have active clinically significant bleeding requiring regular transfusions. Iron infusions are also allowed

Total bilirubin ≤ 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease, in which case the liver function tests must meet the other eligibility in the protocol)

Aspartate aminotransferase (AST) ≤ 3.0 x ULN

Alanine aminotransferase (ALT) ≤ 3.0 x ULN

Creatinine clearance of ≥ 40 mL/min per the Cockcroft-Gault formula

Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required

Agreement by females and males of childbearing potential\

to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 9 months for women, and at least 6 months for men, after the last dose of oxaliplatin therapy. If patients discontinue oxaliplatin more than 9 months (females) or 6 months (males) before discontinuation of balstilimab and/or botensilimab, females and males of childbearing potential must use an effective method of birth control or abstain from sexual activity for the course of the study through at least 120 days after the last dose of balstilimab and/or botensilimab.

Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only).

The following are acceptable birth control methods for this study: Surgical sterilization (tubal ligation or hysterectomy for women, or vasectomy for men), double-barrier methods (i.e. condoms, diaphragm, cervical cap, or sponge, used together with spermicidal gel or foam), intrauterine device (IUD) (i.e. Progestin, Copper), or hormonal contraceptives (birth control patches, implants, pills, rings, or injections)

Exclusion Criteria

Any treatment for colorectal cancer prior to enrollment that includes (but not limited to) chemotherapy, surgery, radiation, immunotherapy and/or biological therapy.

Note: Surgical intervention e.g. a diverting ostomy to relieve an obstruction from colorectal cancer, those patients will be allowed to enter the study as long as no distant metastatic disease

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

Prior allogeneic organ transplantation

Herbal medications that require a prescription or are anti-cancer

Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Please note: patients with more than 1 colorectal cancer tumor at diagnosis (as long as no stage IV disease) are allowed to participate. Pathologic response to each of the tumors will be examined

Active acute colonic obstruction. Patients whose obstruction is relieved by a successful defunctioning stoma are allowed once recovered to a fitness level consistent with the other eligibility criteria

Clinically significant uncontrolled illness

Females only: Pregnant or breastfeeding

Prior allergic reaction or hypersensitivity to any of the study drug components

Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years before starting treatment, i.e., with use of disease-modifying agents or immunosuppressive drugs (excluding hypothyroidism, vitiligo, and psoriasis that is controlled with topical management)

History or current evidence of any condition, co-morbidity, therapy, 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

Uncontrolled infection with human Immunodeficiency virus (HIV). Patients on stable highly active antiretroviral therapy (HAART) are eligible. Serological testing for HIV at screening is not required

Uncontrolled infection with hepatitis B virus. Patients who are receiving or who have received anti-HBV therapy are eligible. Serological testing for HBV at screening is not required

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. Serological testing for HCV at screening is not required

Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures

Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Newnan?

Yes, this clinical trial (NCT07595874) has an active research site in Newnan, GA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Advanced Colon Adenocarcinoma Treatment Options in Newnan, GA

If you're searching for advanced colon adenocarcinoma treatment options in Newnan, GA, this clinical trial (NCT07595874) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Newnan research site is actively enrolling participants for this clinical trial. You'll receive care from experienced advanced colon adenocarcinoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all advanced colon adenocarcinoma clinical trials near you to find additional studies recruiting in your area.

Advanced Colon Adenocarcinoma Clinical Trial in Newnan, GA

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