A Study of BMS-936558 With SBRT After Induction Chemotherapy in Cholangiocarcinoma

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Brief Title

A Study of BMS-936558 With SBRT After Induction Chemotherapy in Cholangiocarcinoma

Official Title

A Pilot Study of BMS-936558 With Stereotactic Ablative Radiation Therapy After Induction Chemotherapy in Cholangiocarcinoma

Brief Summary

      This is an Open-label, single-arm, multicenter Phase II pilot study to assess the efficacy
      and safety of BMS-936558 with stereotactic ablative radiation therapy after induction
      chemotherapy in cholangiocarcinoma.
    

Detailed Description

      The current standard regimen for advanced biliary tract cancers as per NCCN guidelines
      (version 2.2019) is gemcitabine plus cisplatin. However, since no single chemotherapy agent
      or combination regimen has consistently led to durable tumor regression, prevention of
      recurrent obstruction following palliative intervention, and extension of survival beyond 8
      to 15 months, there is a pressing need for new treatment approaches in patients with dismal
      prognosis. Recent discoveries in tumor immunology, paralleled by technological advances in
      radiation therapy, have provided promising role for combining ablative radiotherapy with
      targeted immune modulators (El Chediak et al., 2017).

      objectives: Primary: To evaluate the progression-free survival (PFS) at 8 months and the
      disease control rate (DCR) in patients with non-resectable locally-advanced or metastatic or
      recurrent intrahepatic or extrahepatic cholangiocarcinoma (CCA) following BMS-936558
      /stereotactic ablative radiation therapy (SBRT) treatment.

      Secondary:

      1) To evaluate the overall survival (OS) rate in patients with advanced intrahepatic or
      extrahepatic CCA following BMS-936558/SBRT treatment. .

      3) To evaluate tumor response rates at the primary and secondary sites using the response
      evaluation criteria in solid tumors (RECIST1.1) criteria.

      4) To evaluate the duration of response at non-irradiated tumor sites in patients with Stage
      IV disease.

      5) To evaluate the following biomarkers: CD3+, CD4+, and CD8+ T cell infiltration, and
      changes in PD-L1 expression at baseline and following first cycle of BMS-936558 and SBRT.

      6) To assess the safety and tolerability of BMS-936558/SBRT according to the National Cancer
      Institute Common Terminology Criteria for Adverse Events (NCI-CTCAEv5).

      7) To assess the quality of life of the patients through completed FACT-Hep questionnaires.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

To evaluate the progression-free survival (PFS) at 8 months and the disease control rate (DCR) in patients with non-resectable locally-advanced or metastatic or recurrent intrahepatic or extrahepatic CCA following BMS-936558/SBRT treatment

Secondary Outcome

 To evaluate the overall survival (OS) rate in patients with advanced intrahepatic or extrahepatic CCA following BMS-936558/SBRT treatment.

Condition

Cholangiocarcinoma

Intervention

BMS-936558

Study Arms / Comparison Groups

 locally advanced, metastatic or recurrent cholangiocarcinoma
Description:  D1: Compound: BMS-936558 treatment d8: radiotherapy D 20: CT guided Biopsy D 28: BMS-936558 treatment monthly: BMS-936558 treatment CT CAP: after 4doses

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

1

Start Date

April 15, 2021

Completion Date

January 17, 2022

Primary Completion Date

January 17, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Inclusion criteria:

               1. Signed and dated informed consent form.

               2. Patients aged ≥18 years.

               3. Pathologically (histologically or cytologically) and radiologically confirmed
                  diagnosis of non-resectable locally advanced or metastatic or recurrent
                  intrahepatic or extrahepatic CCA within 90 days of registration.

               4. Patients who have stable disease or partial response following 4 cycles of
                  cisplatin/gemcitabine.

               5. ECOG performance score <3

                  o An estimated life expectancy of more than 3 months.

               6. Have adequate hematologic and biochemical function by meeting the following:

                    -  Total bilirubin acceptable level ≤ 1.5 × the institutional upper limit of
                       normal (ULN) range;

                    -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)
                       acceptable levels up to 5 x ULN range;

                    -  Serum urea and serum creatinine acceptable levels up to 1.5 x ULN range;

                    -  Calculated glomerular filtration rate ≥ 45 mL/min according to the Chronic
                       Kidney Disease Epidemiology Collaboration equation (or local institutional
                       standard method).

               7. Negative serum or urine pregnancy test at screening for women of childbearing
                  potential who are sexually active.

               8. Highly effective contraception for both males and females of child-bearing
                  potential who are sexually active throughout the study and for at least 5 months
                  and 7 months after the last BMS-936558 treatment administration, respectively.

               9. Candidate for percutaneous biopsy as per tumor location evidenced by CT scan and
                  interventional radiologist.

        Exclusion Criteria:

          1. Patients who have progression following 4 cycles of cisplatin/gemcitabine evidenced by
             CT scan as per RECIST 1.1.

          2. Active brain metastases or leptomeningeal metastases.

          3. Prior organ transplantation or allogenic stem-cell transplantation.

          4. Known prior severe hypersensitivity to IMP or any component in its formulations,
             including known severe hypersensitivity reactions to monoclonal antibodies (NCI-CTCAE
             v4.03 Grade ≥ 3).

          5. Active infection requiring systemic therapy within 28 days before the first dose of
             study treatment (e.g., urinary tract infection).

          6. Known history of testing positive for the human immunodeficiency virus or known
             acquired immunodeficiency syndrome.

          7. Evidence of liver cirrhosis.

          8. Current use of immunosuppressive medication, except for the following:

               -  Intranasal, inhaled, topical steroids, or local steroid injection (e.g.,
                  intra-articular injection);

               -  Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or
                  equivalent;

               -  Steroids as premedication for hypersensitivity reactions (e.g., CT scan
                  premedication).

          9. Active autoimmune diseases that might deteriorate upon receiving an immune-stimulatory
             agent.

         10. Conditions such as vitiligo, psoriasis, diabetes type I, or hypo- or hyper-thyroid
             diseases not requiring immunosuppressive treatment are eligible.

         11. Commonly excluded conditions include: Addison's disease, thyroiditis/Hashimoto's
             thyroiditis, systemic lupus erythematosus, Sjogren's syndrome, scleroderma, myasthenia
             gravis, Goodpasture's syndrome, and Grave's disease

         12. Hepatic insufficiency manifesting as clinical jaundice, hepatic encephalopathy, and/or
             variceal bleed within 60 days prior to study entry.

         13. Transmural myocardial infarction within 6 months of enrollment; provided that
             anti-platelets cannot be stopped to perform percutaneous biopsy.

         14. Congestive heart failure (≥ New York Heart Association Classification Class II)
             requiring hospitalization within the last 6 months provided that anti-platelets cannot
             be stopped to perform percutaneous biopsy.

         15. Serious cardiac arrhythmia requiring medical treatment provided that anti-platelets
             cannot be stopped to perform percutaneous biopsy.

         16. Recent cerebral vascular accident/stroke within 6 months of enrollment provided that
             anti-platelets cannot be stopped to perform percutaneous biopsy.

         17. End-stage renal disease requiring dialysis.

         18. Other severe acute or chronic medical conditions including immune colitis,
             inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis, or psychiatric
             conditions including recent (within the past year) or active suicidal ideation or
             behavior.

         19. Vaccination within 4 weeks of the first dose of BMS-936558 and while on trial is
             prohibited except for administration of inactivated vaccines.

         20. Treatment with an investigational agent within 28 days before the first dose of study
             treatment.

         21. Prior treatment with any drug or antibody (anti-PD-1, anti-PD-L1, anti-PD-L2,
             anti-CD137, or anti-CTLA-4 antibody) targeting T cell co-stimulation or checkpoint
             pathways.

         22. Patients suspected by the physician that he/she will not be compliant to the protocol
             conduct.

         23. Pregnant women are excluded from this study; breastfeeding should be discontinued.

         24. Patients participating in another clinical trial.

         25. Patients not willing to sign the consent form.

         26. Any psychiatric condition that would prohibit the understanding or rendering of
             informed consent.

         27. Legal incapacity or limited legal capacity patients receiving other oncology specific
             medication not authorized in the protocol.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ali Shamseddine, MD, , 

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations


NCT ID

NCT04648319

Organization ID

BIO-2019-0447

Secondary IDs

CA209-7DJ

Responsible Party

Sponsor

Study Sponsor

American University of Beirut Medical Center

Collaborators

 Bristol-Myers Squibb

Study Sponsor

Ali Shamseddine, MD, Principal Investigator, American University of Beirut Medical Center


Verification Date

November 2020