Can a Dual-Action antibody boost chemo against bile duct cancer?
NCT ID NCT07765433
First seen Aug 14, 2026 · Last updated Aug 14, 2026
Summary
This trial is testing whether adding ivonescimab to standard chemotherapy (gemcitabine and cisplatin) works better than the usual chemo-immunotherapy combination for people with advanced biliary tract cancer. Ivonescimab is a special antibody that targets two proteins: one that helps the immune system attack cancer and one that helps tumors grow blood vessels. The study will compare how long patients live and how long the cancer stays under control between the two treatment groups.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ivonescimab combined with gemcitabine and cisplatin
- What this could lead to
- If successful, this could offer a new first-line treatment option that may extend survival for people with advanced biliary tract cancer.
- What could go wrong
- This is an early-to-mid-stage trial, so results may not confirm benefit. Adding a new drug could also increase side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 336 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2027
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patient must be ≥ 18 years of age * Patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 * Patient must have histologically or cytologically confirmed adenocarcinoma of the biliary tract including cholangiocarcinoma (intrahepatic or extrahepatic) or gallbladder carcinoma * Patient must not have a diagnosis of ampullary cancer * Patient must have documented metastatic or locally advanced unresectable disease on CT or MR imaging * Patient must have measurable disease as documented on CT or MRI imaging done within 28 days prior to randomization * Patient must not have received prior systemic therapy for current metastatic or locally advanced biliary tract cancer * NOTE: Patients who have previously received adjuvant/neoadjuvant chemotherapy and/or radiotherapy for curative intent non-metastatic disease are eligible if they developed recurrent disease \> 6 months after completion of adjuvant therapy/radiotherapy * Patient must not be on any systemic immunosuppressant therapy other than inhaled steroids, intranasal steroids, topical steroids or systemic steroids up to 10mg prednisone equivalent * Patient must not have received a live attenuated vaccine within 30 days prior to randomization. Patients must also not receive a live attenuated vaccine while on protocol treatment or up to 30 days after the last dose of protocol treatment * Patient must have no contraindication to VEGF inhibitor therapy * Patient must not have significant vascular disease (i.e., aortic aneurysm surgical repair or peripheral arterial thrombosis) within 6 months prior to randomization * Patient must not have inadequately controlled arterial hypertension (systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \[BP\] \> 100 mmHg). Anti-hypertensive therapy to achieve these parameters is allowed * Patient must not have experienced a clinically significant bleeding event within 6 months prior to randomization * Patient must not have experienced gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, or intraabdominal abscess * Patient must not have had surgery within 30 days prior to randomization * Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used * All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy * A patient of childbearing potential is defined as anyone, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) * Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study. Patients of childbearing potential must continue contraceptive measures for 6 months after the last dose of protocol treatment, with the exception of cisplatin requiring 14 months for female patients and 11 months for male patients * Patient must not nurse infants for 4 months after the last dose of pembrolizumab, 3 months after the last dose of durvalumab or ivonescimab and for four weeks after the last dose of cisplatin * Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible * Hemoglobin ≥ 9.0 g/dL (must be obtained ≤ 7 days prior to randomization) * Absolute neutrophil count (ANC) ≥ 1,500/mm\^3 (must be obtained ≤ 7 days prior to randomization) * Platelet count ≥ 100,000/mm\^3 (must be obtained ≤ 7 days prior to randomization) * Bilirubin ≤ 2.5 x institutional upper limit of normal (ULN) (must be obtained ≤ 7 days prior to randomization). Patients with Gilbert's syndrome must have a direct bilirubin \< 1.5 mg/dL * Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase \[SGPT\]) ≤ 2.5 × institutional ULN (must be obtained ≤ 7 days prior to randomization). For patients with liver metastases, AST and ALT ≤ 5 x ULN * Creatinine clearance (CrCI) \> 50ml/min or calculated CrCI \> 50ml/min as determined by Cockcroft-Gault (using actual body weight) Cockcroft-Gault Formula (must be obtained ≤ 7 days prior to randomization) * Urine dipstick for proteinuria \< 2+ or 24 hour urine protein \< 1.0 g (within 7 days prior to initiation of study treatment) * Prothrombin time (PT) or international normalized ratio (INR) and partial thromboplastin time (PTT) ≤ 1.5 X ULN (must be obtained ≤ 7 days prior to randomization). This applies only to patients who are not on therapeutic anti-coagulation. Patients receiving therapeutic anti-coagulation are eligible if on stable dose * Patient must not have National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade \> 2 peripheral neuropathy at the time of randomization * Patient must not have a history of allogeneic organ transplantation * Patient must not have prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease such as colitis or Crohn's disease), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome (i.e.: granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.). The following are exceptions to this criterion: * Patients with vitiligo or alopecia * Patients with hypothyroidism (i.e.: following Hashimoto syndrome) stable on hormone replacement * Any chronic skin condition that does not require systemic therapy * Patients without an active disease in the last 5 years * Patients with celiac disease controlled by diet alone * Patients with insulin dependent diabetes * Patient must not have uncontrolled intercurrent illness that would limit compliance with study requirement, substantially increase the risk of incurring AEs, or compromise the ability of the patient to give written informed consent * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to randomization 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 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 * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2 or better
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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