Recruiting PHASE1, PHASE2 Advanced Cholangiocarcinoma

New treatment option for Advanced Cholangiocarcinoma

Official title Phase I/II Trial of Pemigatinib in Combination With Atezolizumab and Bevacizumab for Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion

ClinicalTrials.gov ID: NCT06439485

What this study is testing

What is Pemigatinib?

Pemigatinib is an investigational medicine, being studied as a potential treatment for advanced cholangiocarcinoma.

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: To learn if pemigatinib in combination with atezolizumab and bevacizumab can help to control cholangiocarcinoma.

Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

Ability to understand and willingness to sign informed consent.
Age ≥18 years.
Has histologically confirmed metastatic or advanced unresectable cholangiocarcinoma.
Has disease that is measurable per the RECIST v1.1.
Has at least one measurable target lesion.

You likely can't join if

Received prior chemotherapy, biologic therapy, immunotherapy, or investigational agent within 3 weeks prior to initiation of study medications.
Had previous treatment with selective FGFR inhibitors including erdafitinib, infigratinib, or futibatinib.
Had prior therapy with any VEGFR-targeting agent targeting including bevacizumab, ramucirumab, pazopanib, lenvatinib, and other anti-angiogenesis...
Has a history and/or has current evidence of extensive tissue calcification including, but not limited to, the soft tissue, kidneys, intestine...
Has corneal or retinal disorder/keratopathy with current evidence of corneal or retinal disorder/keratopathy including, but not limited to, bullous/...
Are currently receiving or are planning to receive during participation in this study, treatment with any potent CYP3A4 inhibitors or inducers or...

See the full eligibility criteria

Who can join

Ability to understand and willingness to sign informed consent.
Age ≥18 years.
Has histologically confirmed metastatic or advanced unresectable cholangiocarcinoma.
Has disease that is measurable per the RECIST v1.1.
Has at least one measurable target lesion.
Has FGFR2 fusion or rearrangement in tumor tissue, as determined by CLIA-validated genomic testing of a tumor tissue specimen (DNA-based or RNA-based).
Is refractory to, has demonstrated intolerance to, had received, or has refused access to, the 1st line systemic therapy including gemcitabine-based therapy with or without immunotherapy including durvalumab or...
Has available a formalin-fixed, paraffin-embedded primary tumor sample.
Is able to take oral medication and to comply with protocol procedures and scheduled visits..
Has Eastern Cooperative Oncology Group performance status of 0 or 1
Has adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment:
Absolute neutrophil count (ANC) ≥ 1.5 × 109/L (1000/µL) without granulocyte colony-stimulating factor support
Platelet count ≥ 100 × 109/L (100,000/µL) without transfusion
Hemoglobin ≥ 90 g/L (9 g/dL), participants may be transfused to meet this criterion.
Aspartate amino transferate (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5 × upper limit of normal (ULN), with the following exceptions:
Participants with documented liver metastases: AST and ALT ≤ 5 × ULN
Participants with documented liver or bone metastases: ALP ≤ 5 × ULN
Serum bilirubin ≤ 1.5 × ULN with the following exception:
Participants with known Gilbert disease: serum bilirubin ≤ 3 × ULN
Serum creatinine ≤ 1.5 × ULN
Serum albumin ≥ 25 g/L (2.5 g/dL)
For participants not receiving therapeutic anticoagulation: international normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN. For patients on anticoagulation, those on therapeutic...
Has a negative human immunodeficiency virus (HIV) test at screening with the following exception: participants with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have...
Has a negative hepatitis B surface antigen (HBsAg) test at screening (unless participant has chronic HBV on anti-viral therapy)
Has a negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening (unless patient has chronic HBV on anti-viral...
The HBV DNA test will be performed only for participant who have a negative HBsAg test and a positive total HBcAb test.
Participants with chronic HBV on antiviral therapy or HCV participants who have completed curative anti-viral therapy can be included.
Contraception requirements for marketed Roche IMPs or NIMPs should be based on recommendations in the Summary of Product Characteristics or, if there is no Summary of Product Characteristics, national prescribing...
For women of childbearing potential: agrees to remain abstinent (refrain from heterosexual intercourse) or to use contraceptive methods, and agrees to refrain from donating eggs, as defined below:
Women must remain abstinent or use contraceptive methods with a failure rate of \< 1% per year during the treatment period and for 6 months after the final dose of atezolizumab/pemigatinib/bevacizumab. Women must...
A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not...
Examples of contraceptive methods with a failure rate of \< 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and...
The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation...
For men: agrees to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agrees to refrain from donating sperm, as defined below:
With a female partner of childbearing potential or pregnant female partner, men must remain abstinent or use a condom during the treatment period and for 6 months after the final dose of atezolizumab/pemigatinib/...
The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation...

What rules you out

Received prior chemotherapy, biologic therapy, immunotherapy, or investigational agent within 3 weeks prior to initiation of study medications.
Had previous treatment with selective FGFR inhibitors including erdafitinib, infigratinib, or futibatinib.
Had prior therapy with any VEGFR-targeting agent targeting including bevacizumab, ramucirumab, pazopanib, lenvatinib, and other anti-angiogenesis inhibitors.
Has a history and/or has current evidence of extensive tissue calcification including, but not limited to, the soft tissue, kidneys, intestine, myocardium, vascular system, and lung. Exceptions include calcified lymph...
Has corneal or retinal disorder/keratopathy with current evidence of corneal or retinal disorder/keratopathy including, but not limited to, bullous/ band keratopathy, inflammation, or ulceration, keratoconjunctivitis...
Are currently receiving or are planning to receive during participation in this study, treatment with any potent CYP3A4 inhibitors or inducers or moderate CYP3A4 inducers within 14 days or 5 half-lives (whichever is...
Have consumed grapefruit, grapefruit juice, grapefruit hybrids, pomegranates, star fruits, pomelos, Seville oranges or products containing juice of these fruits within 7 days prior to first dose of study drug.
Had a Grade 3-4 gastrointestinal bleed within 3 months prior to enrollment.
Has a history of deep vein thrombosis, pulmonary embolism, or any other thromboembolism, including portal venous thrombosis within 3 months prior to enrollment. Venous port or catheter thrombosis, incidental...
Has current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants (including direct oral anticoagulants); thrombolytic agents for therapeutic (as opposed to...
Had significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, transient ischemic attack or cerebrovascular accident); unstable arrhythmia; or...
Has a history of uncontrolled or poorly-controlled hypertension (\>150 mmHg systolic or \>100 mmHg diastolic).
Has a history of hypertensive crisis or hypertensive encephalopathy.
Had a serious or non-healing wound, ulcer, or bone fracture within 28 days prior to enrollment.
Has undergone major surgery (including open biopsy, surgical resection, wound revision; or any other major surgery involving entry into a body cavity); or significant traumatic injury within 28 days prior to enrollment...
Is receiving chronic antiplatelet therapy, nonsteroidal anti-inflammatory drugs (e.g., ibuprofen, naproxen), dipyridamole, clopidogrel, or similar agents. Once-daily aspirin use (≤325 mg/day) is allowed.
Has had significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to randomization.
Has a history of central nervous system disease or evidence of this disease upon physical or neurological examination.
Has a history of Grade ≥ 2 hemoptysis (defined as ≥ 2.5 mL of bright red blood per episode) within 1 month prior to screening.
Has a history or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding (i.e., in the absence of therapeutic anticoagulation).
Has a history of abdominal fistula, gastrointestinal (GI) perforation, intra-abdominal abscess, or active GI bleeding within 6 months prior to randomization.
Has a history of leptomeningeal disease.
Has uncontrolled tumor-related pain.
Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to enrollment. Participants should have recovered from the effects of...
Asymptomatic metastatic lesions that would likely cause functional deficits or intractable pain with further growth (e.g., epidural metastasis that is not currently associated with spinal cord compression) should be...
Has uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (at a frequency of at least once monthly) o Participants with indwelling catheters (e.g., PleurX®) are allowed...
Has current evidence of endocrine alterations of calcium/phosphate homeostasis, eg, parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis, and other disorders.
Has elevated phosphorus or abnormal serum calcium, or phosphorus, or calcium-phosphorus product ≥ 55 mg2/dL2:
Inorganic phosphorus \> 1.02 × ULN Has active or a history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus...
Participants with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study. Participants with controlled Type 1 diabetes mellitus (as determined by the treating...
Participants with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., participants with psoriatic arthritis are excluded) are eligible for the study provided all of...
Rash must cover \< 10% of body surface area
Disease is well controlled at baseline and requires only low-potency topical corticosteroids No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet-A radiation...
Has a history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis; or has evidence of active pneumonitis upon screening via...
History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
Has active tuberculosis.
Had a major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipates need for a major surgical procedure during the study.
Had a history of malignancy other than cholangiocarcinoma within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \> 90%), such as...
Had a severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.
Received treatment with therapeutic oral- or IV antibiotics within 2 weeks prior to initiation of study treatment.
Participants receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.
Had a prior allogeneic stem cell or solid organ transplantation Has any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an...
Received treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipates need for such a vaccine during treatment or within 5 months after the final dose of treatment...
Received treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic...
Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for...
Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal...
Received treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, or anti-TNF-α agents) within 2 weeks prior to...
Participants who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible...
Participants who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency...
Has a history of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.
Has a known hypersensitivity to Chinese hamster ovary-cell products or to any component of the atezolizumab formulation.
Has a known allergy or hypersensitivity to any component of the pemigatinib, bevacizumab, or atezolizumab formulations.
Is pregnant or breastfeeding or intends to become pregnant during study treatment or within 6 months after the final dose of study treatment.
Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment.
Has a history of hypovitaminosis D requiring supraphysiologic doses (eg, 50,000 UI/weekly) to replenish the deficiency. Vitamin D supplements are allowed.

The study team makes the final eligibility decision.

Where it's taking place

Houston, Texas, 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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.

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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.