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New treatment option for Metastatic Colorectal Cancer
Official title Phase I/II Study of the Combination Immunotherapy Regimen: SX-682, TriAdeno Vaccine, Retifanlimab and IL-15 Agonist N-803 (STAR15) for Metastatic Colorectal Cancer (mCRC)
ClinicalTrials.gov ID: NCT06149481
What this study is testing
What is Retifanlimab?
Retifanlimab is an investigational medicine, given as a monthly infusion into a vein, being studied as a potential treatment for metastatic colorectal cancer.
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
- Background: Each year, more than 32,000 people in the United States are diagnosed with colorectal cancer that has returned or progressed after treatment and spread to other organs. This is called metastatic colorectal cancer (mCRC).
- Phase 2: a mid-size study of how well it works
- Time commitment: about 3 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120
You may be able to join if
- Participants with histologically confirmed colorectal cancer and evidence of metastatic disease.
- Participants must have received, been ineligible to receive, or refused to receive two lines of standard systemic therapy i.e., a fluoropyrimidine...
- Participants who had progressive disease within 6 months before study treatment following standard adjuvant therapy are eligible if they have not...
- Age \>= 18 years.
- Measurable disease per RECIST 1.1.
You likely can't join if
- Participants with prior investigational drug, chemotherapy, immunotherapy, or any prior therapeutic radiotherapy within 14 days prior to study...
- Participants with palliative radiotherapy performed within 7 days prior to study treatment initiation.
- Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (\> 10 mg/day of...
- intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections in participants with asthma
- using topical, ocular, intra-articular, or intranasal corticosteroids (with minimal systemic absorption
- brief courses of corticosteroids for prophylaxis (e.g., contrast dye allergy).
See the full eligibility criteria
- Participants with histologically confirmed colorectal cancer and evidence of metastatic disease.
- Participants must have received, been ineligible to receive, or refused to receive two lines of standard systemic therapy i.e., a fluoropyrimidine with oxaliplatin or irinotecan with bevacizumab, regorafenib...
- Participants who had progressive disease within 6 months before study treatment following standard adjuvant therapy are eligible if they have not received systemic therapy for metastatic disease. Participants with a...
- Age \>= 18 years.
- Measurable disease per RECIST 1.1.
- ECOG performance status \<= 2.
- Adequate organ and marrow as a function defined below:
- absolute neutrophil count (ANC) \>= 1,500 cells/mm\^3
- platelet count \>= 100,000 cells/mm\^3
- hemoglobin (Hgb) \>= 9 g/dL
- total bilirubin level \< 1.5 x upper limit of normal (ULN)
- alanine aminotransferase (ALT) \<= 2.5 x ULN OR \<= 5 x ULN for participants with liver metastases
- aspartate aminotransferase (AST) level \<= 2.5 x ULN OR \<= 5 x ULN for participants with liver metastases
- creatinine clearance (CrCl) calculated by Cockroft-Gault formula \>= 50 mL/min
- Resolution of toxic effect(s) of prior anti-cancer therapy (except alopecia and neuropathy) to Grade \<=1 or to \<=2 if effective medical management of those toxicities is in place such that they are controlled per...
- Participants with treated brain metastases are eligible if clinically appropriate follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.
- Participants positive for human immunodeficiency virus (HIV) are eligible if they are compliant with appropriate anti-retroviral therapy for at least 6 months, have HIV viral load \ 350 cells/microliter at screening.
- Participants positive for Hepatitis C virus (HCV) are eligible if they have completed definitive anti-viral therapy and have an undetectable viral load.
- Individuals of child-bearing potential (IOCBP) and individuals who can father children must agree to use an effective method of contraception (barrier, hormonal, intrauterine device [IUD], surgical sterilization) at...
- Breastfeeding participants must be willing to discontinue breastfeeding from study treatment initiation through 6 months after study treatment discontinuation.
- Participants must have lesion(s) accessible for biopsy (other than used for measurement of disease) and be willing to undergo mandatory study biopsies in the phase 1 portion of the study. Lesions to be biopsied will be...
- Participants with prior investigational drug, chemotherapy, immunotherapy, or any prior therapeutic radiotherapy within 14 days prior to study treatment initiation.
- Participants with palliative radiotherapy performed within 7 days prior to study treatment initiation.
- Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (\> 10 mg/day of prednisone or equivalent) with the exception of:
- intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections in participants with asthma
- using topical, ocular, intra-articular, or intranasal corticosteroids (with minimal systemic absorption
- brief courses of corticosteroids for prophylaxis (e.g., contrast dye allergy).
- Evidence of interstitial lung disease, history of interstitial lung disease, or active, noninfectious pneumonitis. Participants with chronic post-radiation pulmonary changes/scarring that is asymptomatic are eligible.
- Active infections requiring systemic antibiotics or antifungal or antiviral treatment within 8 days prior to treatment initiation. Participants who have had appropriate antibiotics initiated but are still completing the...
- History of organ transplant, including allogeneic stem cell transplantation.
- Participants who experienced immune-related toxicity during prior checkpoint inhibitor therapy for which permanent discontinuation of therapy was recommended (per product label or consensus guidelines) or any...
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drugs.
- Receipt of a live vaccine within 28 days prior to treatment initiation. Note: Examples of live vaccines include but are not limited to measles, mumps, rubella, varicella-zoster (chickenpox), yellow fever, rabies, BCG...
- History of infection with Hepatitis B virus (HBV) unless on suppressive therapy. Individuals with serologic evidence of a resolved prior HBV infection (i.e., HBsAgnegative and anti-HBc positive) are eligible.
- Pregnancy confirmed with Beta-human chorionic gonadotropin (Beta-HCG) serum or urine pregnancy test performed in IOCBP at screening.
- Uncontrolled intercurrent illness that would limit compliance with study requirements.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 study runs about 3 weeks 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 to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. 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.