Metastatic Distal Bile Duct AdenocarcinomaPhase 2NCT04941287
Testing A New Combination of Anti-cancer Immune Therapies, Atezolizumab and CDX-1127 (Varlilumab) With or Without the Addition of a Third Anti-cancer Drug, Cobimetinib, for Advanced-Stage Biliary Tract Cancer
A Phase 2 study testing Atezolizumab, Biopsy and Biospecimen Collection in people with Metastatic Distal Bile Duct Adenocarcinoma and Metastatic Gallbladder Carcinoma, run by National Cancer Institute (NCI) at 29 sites in United States.
Trial summary
This phase II trial investigates the effect of combining two immune therapies, atezolizumab and CDX-1127 (varlilumab), with or without cobimetinib, in treating patients with biliary tract cancer that cannot be removed by surgery (unresectable). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Distal Bile Duct Adenocarcinoma, Metastatic Gallbladder Carcinoma, Metastatic Intrahepatic Cholangiocarcinoma
- What is being tested?
- Atezolizumab, Biopsy and Biospecimen Collection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 29 sitesUnited States
- Study dates
- 15 Dec 2021to 29 Apr 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed biliary tract cancer, having received at least 1 prior line of systemic therapy, and received no more than 2 prior lines of therapy in the metastatic setting (disease recurrence =< 6 months from the last dose of perioperative therapy/day of surgery [whichever is more recent] in resected patients will be considered the first line of therapy)
- Includes intrahepatic cholangiocarcinoma (IHC), extrahepatic cholangiocarcinoma (EHC), and gallbladder carcinoma (GBC), but not Ampulla of Vater cancers
- Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
- Age >= 18 years. Because no dosing or adverse event data are currently available on the use of atezolizumab, cobimetinib, and CDX-1127 (varlilumab) in patients < 18 years of age, children are excluded from this study
- Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 80%)
- Absolute neutrophil count >= 1,500/mcL
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- Hemoglobin >= 9.0 g/dl
- Platelets >= 100,000/mcL
- Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (Patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 3 x institutional ULN
- Serum creatinine =< 1.5 x institutional ULN OR
- Creatinine clearance > 30 mL/min/1.73 m^2 (calculated by Cockcroft-Gault method) for patients with creatinine levels above institutional normal
- Albumin >= 3.0 g/dL
- Prothrombin time (PT)/activated partial thromboplastin time (aPTT) =< 1.5 x ULN (This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular-weight heparin or warfarin, should be on a stable dose)
- Creatine kinase (CK)/creatine phosphokinase (CPK) < 5 x ULN
- Oxygen saturation >= 92% on room air
- Left ventricular ejection fraction > 50%
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- Patients must be willing to undergo 2 sets of core needle biopsies. If possible, biopsied sites should be different than those used for measurable disease/RECIST measurements, but this is not mandatory
- Patients must have an estimated life expectancy of greater than 3 months
- Patients must be able to swallow pills
- Patients should not have evidence of retinal pathology on ophthalmologic examination; or neurosensory retinal detachment, retinal vein occlusion (RVO), or neovascular macular degeneration
- The effects of atezolizumab, cobimetinib, and CDX-1127 (varlilumab) on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and 5 months after the last dose of atezolizumab. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 5 months (150 days) after completion of atezolizumab, cobimetinib, and CDX-1127 (varlilumab) administration
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Patients with prior allogeneic bone marrow transplantation within the past 5 years or prior solid organ transplantation at any point
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (other than alopecia or neuropathy) due to agents administered more than 4 weeks earlier. However, the following therapies are allowed:
- Hormone-replacement therapy or oral contraceptives
- Herbal therapy > 1 week prior to randomization (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to randomization)
- Palliative radiotherapy for bone metastases > 2 weeks prior to randomization
- Prior treatment with anti-CTLA-4, anti-PD-1, or anti-PD-L1or other immune checkpoint inhibitor therapeutic antibodies or pathway-targeting agents with the following exceptions:
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- Patients who have only received previous durvalumab (anti-PD-L1) as part of first line in combination with gemcitabine and cisplatin (TOPAZ-1 regimen [NCT03875235]) are eligible.
- Patients who have only received previous pembrolizumab (anti-PD-1) as part of first line in combination with gemcitabine and cisplatin (KEYNOTE-966 regimen [NCT04003636]) are eligible.
- Prior treatment with MEK or ERK inhibitors
- Treatment with any other investigational agent within 4 weeks prior to randomization
- Treatment with systemic immunostimulatory agents (including, but not limited to, interferon [IFN]-alpha or interleukin [IL]-2) within 6 weeks prior to randomization
- Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone (> 10 mg), cyclophosphamide, tacrolimus, sirolimus, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to randomization
- Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled
- The use of physiologic doses of systemic corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed
- The use of topical and inhaled corticosteroids are allowed due to low systemic absorption
- Patients taking bisphosphonate therapy for symptomatic hypercalcemia. Use of bisphosphonate therapy for other reasons (e.g., bone metastasis or osteoporosis) is allowed
- Presence of therapeutically actionable mutation with approved targeted therapy (e.g. FGFR fusion patients are eligible for study therapy in the 3rd line setting). Patient must have received somatic mutation testing (tissue or liquid) prior to enrollment
- Clinically significant ascites (palpable on exam, paracentesis in last 3 months, and/or symptomatic)
- Patients with known primary central nervous system (CNS) malignancy or symptomatic CNS metastases are excluded, with the following exceptions:
- Patients with asymptomatic treated CNS metastases may be enrolled, provided all the criteria listed above are met as well as the following:
- Radiographic demonstration of improvement upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study
- No stereotactic radiation or whole-brain radiation within 28 days prior to randomization
- Screening CNS radiographic study >= 4 weeks from completion of radiotherapy and >= 2 weeks from discontinuation of corticosteroids
- Follow-up brain imaging 3 months after central nervous system (CNS)-directed therapy shows no evidence of progression
- History of malignant bowel obstruction
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to Chinese hamster ovary cell products, chimeric, humanized, or other recombinant human antibodies or fusion proteins
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to atezolizumab, cobimetinib, or CDX-1127 (varlilumab)
- Patients receiving any medications or substances that are considered moderate to strong inhibitors or inducers of CYP3A and are not able to switch to an alternative that minimizes interaction potential will ineligible. Coadministration of cobimetinib with a strong CYP3A4 inhibitor can increase cobimetinib systemic exposure significantly (e.g. itraconazole increased serum systemic cobimetinib exposure by 6.7 fold). On the other end, coadministration of cobimetinib with a strong CYP3A inducer may decrease cobimetinib systemic exposure by more than 80% thus reducing its efficacy. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated list such as http://medicine.iupui.edu/clinpharm/ddis/; medical reference texts such as the Physicians' Desk Reference may also provide this information. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
- Patients on mild inhibitors or inducers of CYP3A are allowed
- Patients with a known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease.
- Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible.
- Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)
- Patients who have received immunosuppressive treatment for systemic autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, multiple sclerosis, vasculitis, or glomerulonephritis within the last 2 years.
- Patients with a history autoimmune endocrine disorders on stable doses of physiologic hormone replacement may be eligible.
- Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible.
- Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:
- Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations
- Rash must cover less than 10% of body surface area (BSA)
- Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)
- No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)
- Patients with history Guillain-Barre syndrome or myasthenia gravis at any point will not be eligible
- History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
- Patients with active tuberculosis (TB) are excluded
- Severe infections within 4 weeks prior to randomization, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
- Signs or symptoms of infection within 2 weeks prior to randomization
- Received oral or intravenous (IV) antibiotics within 2 weeks prior to randomization
- Patients receiving prophylactic/suppressive antibiotics will not be eligible
- Major surgical procedure within 28 days prior to randomization or anticipation of need for a major surgical procedure during the course of the study
- Administration of a live, attenuated vaccine within 4 weeks before randomization or anticipation that such a live, attenuated vaccine will be required during the study and up to 5 months after the last dose of atezolizumab.
- Influenza vaccination should be given during influenza season only (approximately October to March). Patients must not receive live, attenuated influenza vaccine within 4 weeks prior to Randomization or at any time during the study.
- Coronavirus disease 2019 (COVID-19) vaccination is not exclusionary but should be administered at least 7 days before study start
- Patients with psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study because one or more study agents have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with atezolizumab, cobimetinib, and CDX-1127 (varlilumab), breastfeeding should be discontinued if the mother is treated with atezolizumab, cobimetinib, and CDX-1127 (varlilumab)
- Patients who are using ethinyl estradiol containing oral contraceptives when administered concomitantly with cobimetinib, are excluded due to increased risk of venous thromboembolism
- Patients with a history of clinically significant cardiac dysfunction, including the following:
- Left ventricular ejection fraction (LVEF) below institutional lower limit of normal (LLN) or below 50%, whichever is lower
- Current unstable angina
- Current symptomatic congestive heart failure (CHF) of New York Heart Association class 2 or higher
- Uncontrolled hypertension >= grade 2 (patients with a history hypertension controlled with anti-hypertensives to =< grade 1 are eligible).
- Uncontrolled arrhythmias
- Myocardial infarction, severe/unstable angina, symptomatic chronic heart failure (CHF), cerebrovascular accident or transient ischemic attack within the previous 6 months
- History of treatment with cardiotoxic agents
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045
UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida, 33180
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
Roswell Park Cancer Institute
Buffalo, New York, 14263
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
Northwestern University
Chicago, Illinois, 60611
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, 33146
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, 33442
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
M D Anderson Cancer Center
Houston, Texas, 77030
Los Angeles General Medical Center
Los Angeles, California, 90033
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, 33176
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, 85054
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, 33324
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: A Randomized Phase 2 Study of Combination Atezolizumab and CDX-1127 (Varlilumab) With or Without Addition of Cobimetinib in Previously Treated Unresectable Biliary Tract Cancers
This phase II trial investigates the effect of combining two immune therapies, atezolizumab and CDX-1127 (varlilumab), with or without cobimetinib, in treating patients with biliary tract cancer that cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Varlilumab is an immune agonist antibody that may further strengthen the immune system's attack on the cancer. Cobimetinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Giving atezolizumab in combination with varlilumab and cobimetinib may work better than atezolizumab and varlilumab alone in treating patients with unresectable biliary tract cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the response rate (ORR) of patients with unresectable, pre-treated biliary cancers treated with the combination of atezolizumab and CDX-1127 (varlilumab) with or without cobimetinib.
II. To assess the progression free survival (PFS) of patients with unresectable, pre-treated biliary cancers treated with the combination of atezolizumab and CDX-1127 (varlilumab) with or without cobimetinib.
SECONDARY OBJECTIVES:
- To assess the safety and tolerability of combination of atezolizumab and CDX-1127 (varlilumab) with or without cobimetinib in patients with unresectable, pre-treated biliary cancers.
II. To assess overall survival (OS) of patients with unresectable, pre-treated biliary cancers treated with the combination of atezolizumab and CDX-1127 (varlilumab) with or without cobimetinib.
III. To determine the effect of combination atezolizumab and CDX-1127 (varlilumab) +/- cobimetinib on T cell subpopulations systemically and intratumorally.
CORRELATIVE OBJECTIVES:
- To explore the effect of atezolizumab and CDX-1127 (varlilumab) +/- cobimetinib on local and systemic immune activation pathways, immune suppressive pathways, and cytokine/chemokine signaling in peripheral blood and within the tumor microenvironment.
II. To assess whether atezolizumab and CDX-1127 (varlilumab) clearance at baseline and over time correlate with clinical outcomes (ORR, PFS and OS) and the presence of cachexia.
III. To assess immunogenicity by monitoring for the presence of anti-drug antibodies (ADA) to both atezolizumab and CDX-1127 (varlilumab).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive cobimetinib orally (PO) once daily (QD) on days 1-21 of each cycle, atezolizumab intravenously (IV) over 30-60 minutes on days 1 and 15 of each cycle, and varlilumab IV over 90 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo a computed tomography (CT) or magnetic resonance imaging (MRI) at baseline, every 8 weeks while on treatment, and at end of treatment or progression. Patients also undergo a tumor biopsy at baseline and on day 21 of cycle 1. Patients also undergo blood sample collection on study.
ARM B: Patients receive atezolizumab IV over 30-60 minutes on days 1 and 15 of each cycle and varlilumab IV over 90 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo a CT or MRI at baseline, every 8 weeks while on treatment, and at end of treatment or progression. Patients also undergo a tumor biopsy at baseline and on day 21 of cycle 1. Patients also undergo blood sample collection on study.
After completion of study treatment, patients are followed up at 30 days and then every 3 months until death, withdrawal of consent, or study closure.
- Conditions
- Metastatic Distal Bile Duct Adenocarcinoma, Metastatic Gallbladder Carcinoma, Metastatic Intrahepatic Cholangiocarcinoma, Recurrent Distal Bile Duct Adenocarcinoma, Recurrent Gallbladder Carcinoma, Recurrent Intrahepatic Cholangiocarcinoma
- Being tested
- Atezolizumab, Biopsy, Biospecimen Collection, Cobimetinib, Computed Tomography
- Medical subject headings
- Gallbladder Neoplasms, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtezolizumabBiological
Also called MPDL 3280A, MPDL 328OA, MPDL-3280A, MPDL3280A
Given IV
BiopsyProcedure or surgery
Also called BIOPSY_TYPE, Bx
Undergo tumor biopsy
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
CobimetinibDrug
Also called Cotellic, GDC 0973, GDC-0973, GDC0973
Given PO
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo a CT scan
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
VarlilumabDrug
Also called CDX 1127, CDX-1127, CDX1127, Immunoglobulin G1, Anti-(Human CD Antigen CD27) (Human Monoclonal CDX-1127 Clone 1f5 Heavy Chain), Disulfide with Human Monoclonal CDX-1127 Clone 1f5 Kappa-chain, Dimer
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm A (cobimetinib, atezolizumab, varlilumab) | Experimental | Patients receive cobimetinib PO QD on days 1-21 of each cycle, atezolizumab IV over 30-60 minutes on days 1 and 15 of each cycle, and varlilumab IV over 90 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo a CT or MRI at baseline, every 8 weeks while on treatment, and at end of treatment or progression. Patients also undergo a tumor biopsy at baseline and on day 21 of cycle 1. Patients also undergo blood sample collection on study. Receives: Biological: Atezolizumab; Procedure: Biopsy; Procedure: Biospecimen Collection; Drug: Cobimetinib; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Drug: Varlilumab |
| Arm B (atezolizumab, varlilumab) | Experimental | Patients receive atezolizumab IV over 30-60 minutes on days 1 and 15 of each cycle and varlilumab IV over 90 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo a CT or MRI at baseline, every 8 weeks while on treatment, and at end of treatment or progression. Patients also undergo a tumor biopsy at baseline and on day 21 of cycle 1. Patients also undergo blood sample collection on study. Receives: Biological: Atezolizumab; Procedure: Biopsy; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Drug: Varlilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing a Response
Response is defined as a complete response (CR) (disappearance of all lesions) or partial response (PR) (>= 30% decrease in the sum of target lesions) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria after receiving at least one dose of the assigned study regimen.
Measured: Up to 2 years
Duration of Progression Free Survival (PFS)
Time from the date of enrollment to the date of documented tumor progression (>= 20% increase in the sum of target lesions, measurable increase in a non-target lesion, or appearance of a new lesion) by RECIST v1.1 or death due to any cause, whichever occurs first for participants who received at least one dose of their assigned study regimen.
Measured: Up to 2 years
Secondary outcomes (5)
The Number of Participants Experiencing Grade 3, 4 and 5 Adverse Events
Defined by Common Terminology Criteria for Adverse Events, version 5.0. The highest grade experienced by the participant will be reported.
Measured: Up to 2 years
Duration of Overall Survival (OS)
Time from date of enrollment to time of death or censor date (Participants who withdrew consent were censored to the date of withdrawal and participants still in follow-up were censored to the date of last contact.).
Measured: Up to 2 years
Change in T-cell Populations
The change in density of CD8+ T cells at baseline to after treatment.
Measured: Baseline up to 2 years
The Change in Clearance Rates
Analysis of the activity of drugs in the body over a period of time, including the processes by which drugs are absorbed, distributed in the body, localized in the tissues, and excreted. The change will be assessed from before treatment to after 2 doses of treatment.
Measured: At 6 weeks
The Amount of Anti-drug Antibodies With Treatment
Analysis of an agent's ability to provoke an immune response (humoral and/or cell-mediated) in the subject
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start15 Dec 2021
- Primary completion2 Jan 2024
- Study completion29 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Distal Bile Duct AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Nilofer S Azad, Principal investigator, JHU Sidney Kimmel Comprehensive Cancer Center LAO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04941287
- Sponsor's protocol ID
- NCI-2021-06445
- Other IDs
- NCI-2021-06445, ETCTN10476, 10476, 10476, UM1CA186691
- Status last verified
- May 2025
- First submitted
- 25 Jun 2021
- Last updated
- 23 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.