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New treatment option for Biliary Cancer
Official title A Study of CDX-1140, a CD40 Agonist, in Combination With Capecitabine and Oxaliplatin (CAPOX) and Keytruda in Subjects With Biliary Tract Carcinoma (BTC)
ClinicalTrials.gov ID: NCT05849480
What this study is testing
What is oxaliplatin?
oxaliplatin is an investigational medicine, given as a twice-daily infusion into a vein, being studied as a potential treatment for biliary 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: Biliary tract carcinoma (BTC) is cancer of the slender tubes that carry fluids in the liver. People with advanced BTC have few treatment options, and their survival rates are very low.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
- 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 to 120
You may be able to join if
- 1. Participants must have histopathological confirmation of BTC or histopathological confirmation of carcinoma in the setting of clinical and...
- The maximum tumor size of any individual tumor or metastasis must be \<= 8 cm.
- Participants should have progressed on standard of care first line systemic treatment or refused standard treatment.
- Participants must have a disease that is not amenable to potentially curative resection or liver transplantation.
- Participants must have evaluable or measurable disease per RECIST 1.1
You likely can't join if
- Participants who have had standard-of-care anti-cancer therapy or therapy with investigational agents (e.g., chemotherapy, endocrine therapy...
- Prior therapy with anti- CD40.
- Receiving of live vaccines within 30 days prior to the treatment initiation. Examples of live vaccines include, but are not limited to, the...
- Major surgery within 4 weeks prior to treatment initiation.
- Active central nervous system metastases and/or carcinomatous meningitis.
- HIV-infected participants.
See the full eligibility criteria
- 1. Participants must have histopathological confirmation of BTC or histopathological confirmation of carcinoma in the setting of clinical and radiological characteristics which, together with the pathology, are highly...
- The maximum tumor size of any individual tumor or metastasis must be \<= 8 cm.
- Participants should have progressed on standard of care first line systemic treatment or refused standard treatment.
- Participants must have a disease that is not amenable to potentially curative resection or liver transplantation.
- Participants must have evaluable or measurable disease per RECIST 1.1
- ECOG performance status of 0 to 1
- Participants must have adequate organ and marrow function as defined below: Absolute neutrophil count (ANC) \>= 1,000/mcL Platelets \>= 100,000/mcL Total bilirubin \ = 45 mL/min/1.73 m2 for participant with creatinine...
- Age \>=18 years.
- Participants must have recovered from any acute toxicity related to prior therapy, including surgery. Toxicity should be \<= grade 1. Note: participants with thyroid dysfunction caused by prior therapy including the...
- Individuals of child-bearing potential (IOCBP) and individuals able to father a child must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) at the study entry, for the...
- Nursing participants must be willing to discontinue nursing from study treatment initiation through 4 months after study treatment discontinuation.
- HBV-infected participants must be on antivirals and have HBV DNA \<100 IU/mL. HCV-infected participants can be enrolled if HCV RNA level is undetectable.
- Participants must be able to understand and willing to sign a written informed consent document.
- Participants who have had standard-of-care anti-cancer therapy or therapy with investigational agents (e.g., chemotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal...
- Prior therapy with anti- CD40.
- Receiving of live vaccines within 30 days prior to the treatment initiation. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies...
- Major surgery within 4 weeks prior to treatment initiation.
- Active central nervous system metastases and/or carcinomatous meningitis.
- HIV-infected participants.
- History of (non-infectious) pneumonitis or current pneumonitis.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to study drugs or other agents used in study, such as nivolumab, dacetuzumab, APX005M, ADC-1013.
- Prior invasive malignancies within the past 3 years prior to treatment initiation (with the exception of non-melanoma skin cancers, non-invasive bladder cancer, or localized prostate cancer for whom systemic therapy is...
- Any medical condition that requires chronic systemic steroid therapy, or any other form of immunosuppressive medication (inhaled and topical steroids are permitted).
- History of chronic autoimmune disease (e.g., Addison's disease, multiple sclerosis, Graves' disease, Hashimoto's thyroiditis, rheumatoid arthritis, hypophysitis, systemic lupus erythematosus, Wegener's granulomatosis...
- Fridericia's corrected QT interval (QTcF) \>= 480 msec or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome.
- Participants who were not able to tolerate prior immune checkpoint inhibitor therapy.
- Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnancy.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, 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 study runs about 2 years 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.