Phase Ib/II Single-arm Study of mFOLFOX6, Bevacizumab and Atezolizumab in Advanced Biliary Tract Cancer

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Brief Title

Phase Ib/II Single-arm Study of mFOLFOX6, Bevacizumab and Atezolizumab in Advanced Biliary Tract Cancer

Official Title

A Phase Ib/II Single-arm Study Evaluating the Safety and Efficacy of Combined Immunotherapy With mFOLFOX6, Bevacizumab and Atezolizumab in Advanced-stage Biliary Tract Cancer

Brief Summary

      The main objective of the study is to establish if patients with advanced bile duct cancer,
      who have already received a line of treatment for their disease, will receive any associated
      benefits from the combination of mFOLFOX6, bevacizumab and atezolizumab as a second-line
      therapy All patients who meet the criteria to participate in the study shall receive the
      following drugs intravenously every 14 days: mFOLFOX6 combined with Atezolizumab 840 mg and
      Bevacizumab 10 mg/kg.

      These drugs will be administered until one of the following situations arises: disease
      progress, intolerable side effects, pregnancy or if the patient or the doctor decide to stop
      the treatment.

      Atezolizumab is an antibody that operates on an important receptor of the immune system
      (PD1/PD-L1 axis). Atezolizumab (Tecentriq®) has already been approved in a number of
      countries to treat a range of tumours, although it has not yet been approved for bile duct
      tumours.

      Bevacizumab is an antibody that is joined to the vascular endothelial growth factor (VEGF).
      Bevacizumab was approved for the first time in the USA in 2004 and is now approved in over
      100 countries around the world for a variety of conditions. However, it has not yet been
      approved for treating bile duct cancers.

      mFOLFOX6 is a chemotherapy regime used to treat many kinds of gastrointestinal tumours,
      including bile duct cancer, since it is a treatment approved for this type of tumour.

      The combination of mFOLFOX6 with atezolizumab and bevacizumab (trial drugs), may bring more
      information about an anti-tumour immune response that could improve the results of mFOLFOX6,
      which backs up the research on this treatment combination with cancer patients.
    


Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Overall response rate (ORR)

Secondary Outcome

 Disease control rate (DCR)

Condition

Biliary Tract Cancer

Intervention

mFOLFOX6, Atezolizumab and Bevacizumab

Study Arms / Comparison Groups

 mFOLFOX6 combined with Atezolizumab and Bevacizumab
Description:  Patients will receive mFOLFOX6 combined with Atezolizumab 840 mg and Bevacizumab 10 mg/kg in 14-day cycles.
Treatment will be continued until disease progression, unacceptable toxicity or voluntary withdrawal.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

35

Start Date

October 2021

Completion Date

June 2024

Primary Completion Date

June 2024

Eligibility Criteria

        Inclusion Criteria:

          1. Signed informed consent form

          2. Age ≥ 18 years by the time of inclusion in the study

          3. Ability to comply with the study protocol, in the investigator's judgment

          4. Histologically confirmed advanced BTC

          5. Patient must have received at least one prior line of systemic therapy in
             advanced-stage BTC

          6. Adjuvant or neoadjuvant chemotherapy is allowed, provided it is completed at least 6
             months before start of study treatment

          7. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1

          8. Life expectancy > 12 weeks

          9. Measurable disease, according to RECIST v1.1. Lesions intended to be biopsied should
             not be defined as target lesions

         10. Tumor must be accessible for biopsies and patient willing to provide tissue from a
             newly obtained biopsy of a tumor lesion

         11. Adequate hematologic and end-organ function, defined by the following laboratory test
             results, obtained within 14 days prior to initiation of study treatment.

         12. For women of childbearing potential: Negative serum pregnancy test within 21 days
             prior to Cycle 1 Day 1 (C1D1). Agreement to remain abstinent (refrain from
             heterosexual intercourse) or use of contraceptive methods that result in a failure
             rate of ≤ 1% per year during the treatment period and for at least 180 days after the
             last study treatment

         13. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use
             contraceptive measures and agreement to refrain from donating sperm.

        Exclusion Criteria:

          1. Malignancies other than BTC within 3 years prior to C1D1 with the exception of those
             with a negligible risk of metastasis or death (e.g., expected 5-year overall survival
             > 90%) treated with expected curative outcome (such as adequately treated carcinoma in
             situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer
             treated surgically, ductal carcinoma in situ treated surgically)

          2. Patients with known microsatellite instability high (MSI-H) status. Patients with
             unknown MSI status are eligible and the MSI status will be analyzed retrospectively.
             Patients who are then determined to be MSI-H will be allowed to continue the study
             treatment, but will be replaced by microsatellite-stable (MSS) or MSI-low tumors.

          3. Untreated central nervous system (CNS) metastases. Treatment of brain metastases,
             either by surgical or radiation techniques must have been completed at least 4 weeks
             prior to initiation of study treatment.

          4. Radiation therapy within 21 days prior to C1D1 and/or persistence of radiation-related
             adverse effects

          5. Prior allogeneic bone marrow transplantation or solid organ transplant for another
             malignancy in the past

          6. Spinal cord compression not definitively treated with surgery and/or radiation

          7. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent
             drainage procedures

          8. Uncontrolled tumor pain. Patients who require narcotic pain medication during
             screening should be on a stable dose regimen prior to C1D1. 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 considered for loco-regional therapy if appropriate prior to
             enrollment.

          9. Treatment with any investigational agent or approved therapy within 28 days or two
             investigational agent half-lives (whichever is longer) prior to C1D1

         10. Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including
             anti-PD-1 and anti-PD-L1, or VEGF/VEGFR inhibitors

         11. Known dihydropyrimidine dehydrogenase deficiency or thymidylate synthase gene
             polymorphism predisposing the patient for 5-fluorouracil (5-FU) toxicity

         12. History of severe allergic, anaphylactic, or other hypersensitivity reactions to
             chimeric or humanized antibodies or fusion proteins

         13. Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster
             ovary cells or any components of atezolizumab or bevacizumab formulations

         14. Current or recent (within 10 days of study enrollment) use of acetylsalicylic acid (>
             325 mg/day), clopidogrel (> 75 mg/day) or thrombolytic agents for therapeutic purposes

         15. History of clinically significant cardiac or pulmonary dysfunction including the
             following:

               -  Inadequately controlled hypertension (that is defined as systolic blood pressure
                  > 140 mmHg and/or diastolic blood pressure > 90 mmHg that is treated or
                  untreated)

               -  Prior history of hypertensive crisis or hypertensive encephalopathy

               -  Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or
                  recent arterial thrombosis) within 6 months of C1D1

               -  History of stroke or transient ischemic attack within 6 months prior to C1D1

               -  Significant cardiovascular disease [such as New York Heart Association (NYHA)
                  cardiac disease (Class II or greater), myocardial infarction, or cerebrovascular
                  accident] within 3 months prior to C1D1, severe cardiac arrhythmia requiring
                  medication or severe conduction abnormalities, unstable arrhythmias, acute
                  coronary syndromes (including unstable angina), or history of coronary
                  angioplasty/ stenting/bypass grafting within past 6 months.

               -  Patients with known left ventricular ejection fraction (LVEF) < 40% will be
                  excluded

               -  Patients with known coronary artery disease, congestive heart failure not meeting
                  the above criteria, or LVEF < 50% must be on a stable medical regimen that is
                  optimized in the opinion of the treating physician, in consultation with a
                  cardiologist if appropriate

         16. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis
             obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active
             pneumonitis on screening chest computed tomography (CT) scan

         17. Major surgical procedure within 4 weeks prior to C1D1 or anticipation of need for a
             major surgical procedure during the course of the study

         18. Evidence of tumor invading or abutting major blood vessels

         19. Serious non-healing wound, active ulcer or untreated bone fracture

         20. History of abdominal fistula or gastrointestinal perforation within 6 months prior to
             C1D1

         21. History of hemoptysis (≥ ½ teaspoon of bright red blood per episode), or any other
             serious hemorrhage, or at risk of bleeding (gastrointestinal history of bleeds,
             gastrointestinal ulcers, etc.)

         22. INR > 1.5 and aPTT > 1.5 x ULN within 7 days prior to C1D1 (excluding patients on
             prophylactic or therapeutic anticoagulation)

         23. History or evidence of inherited bleeding diathesis or significant coagulopathy at
             risk of bleeding

         24. Proteinuria at screening as demonstrated by urine dipstick ≥ 2+ or 24-hour proteinuria
             > 1.0 g

         25. Treatment with systemic immunosuppressive medication (including, but not limited to,
             corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and
             anti-tumor necrosis factor (TNF)-alpha agents) within 2 weeks prior to initiation of
             study treatment, or anticipation of need for systemic immunosuppressive medication
             during study treatment

         26. Systemic immunostimulatory agents (including, but not limited to interferons and
             interleukin [IL]-2) are prohibited within 4 weeks or five half-lives of the drug
             (whichever is longer) prior to C1D1

         27. Autoimmune conditions: History of autoimmune disease including but not limited to
             myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus,
             rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with
             antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome,
             Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis with
             the following exceptions:

               -  Patients with a history of autoimmune-related hypothyroidism who are on thyroid
                  replacement hormone are eligible for the study

               -  Patients with controlled Type 1 diabetes mellitus

               -  Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with
                  dermatologic manifestations only (e.g., patients with psoriatic arthritis are
                  excluded) are eligible for the study provided all of following conditions are
                  met: Rash must cover less than 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, methotrexate, retinoids, biologic agents, oral
                  calcineurin inhibitors, or high potency or oral corticosteroids within the
                  previous 12 months

         28. Infectious diseases

               -  Severe infection within 4 weeks prior to initiation of C1D1, including, but not
                  limited to, hospitalization for complications of infection, bacteremia, or severe
                  pneumonia

               -  Treatment with therapeutic oral or intravenous antibiotics within 2 weeks prior
                  to initiation of study treatment

               -  Patients with active hepatitis B (chronic or acute; defined as having a positive
                  hepatitis B surface antigen [HBsAg] test at screening)

               -  Patients with past hepatitis B virus (HBV) infection or resolved HBV infection
                  (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of
                  HBsAg) are eligible. HBV DNA test must be performed in these patients prior to
                  C1D1.

               -  Patients with active hepatitis C. Patients positive for hepatitis C virus (HCV)
                  antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV
                  RNA.

               -  Positive HIV test at screening or at any time prior to screening. Patients
                  without a prior positive HIV test result will undergo an HIV test at screening,
                  unless not permitted per local regulations

               -  Known active tuberculosis

               -  Patients must not receive any kind of living, attenuated vaccine (e.g. Fluenz®
                  Tetra) within 4 weeks prior to C1D1 or at any time during the study and for at
                  least 5 months after the last dose of study drug.

         29. Pregnant or lactating or intending to become pregnant during the study or within 5
             months after final dose for atezolizumab or 6 months for bevacizumab. Women who are
             not post-menopausal (≥ 12 continuous months of amenorrhea with no identified cause
             other than menopause) or surgically sterile must have a negative serum pregnancy test
             within 21 days prior to C1D1.

         30. Uncontrolled serious medical or psychiatric illness
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jens Siveke, Prof. Dr., 0049 201 723 77412, [email protected]

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT05052099

Organization ID

MO40094


Responsible Party

Sponsor

Study Sponsor

University Hospital, Essen


Study Sponsor

Jens Siveke, Prof. Dr., Principal Investigator, Universitätsklinikum Essen


Verification Date

October 2021