Clinical Study

A Randomized Phase III Study Of Immune Checkpoint Inhibition With Chemotherapy In Treatment-Naïve Metastatic Anal Cancer Patients

Posted Date: Oct 26, 2021

  • Investigator: Davendra Sohal
  • Specialties: Cancer, Oncology
  • Type of Study: Drug

This phase 3 trial will compare the addition of nivolumab to chemotherapy (carboplatin and paclitaxel) versus usual treatment (chemotherapy alone) for the treatment of anal cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab together with carboplatin and paclitaxel may help doctors find out if the treatment is better or the same as the usual approach. Efficacy will be determined by progression free survival. In arm A, Patients will receive carboplatin IV on day 1, and paclitaxel IV on days 1, 8, and 15. Treatment will repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable. toxicity. In Arm B, Patients will receive carboplatin on day 1, paclitaxel IV on days 1, 8 and 15, and nivolumab IV over 30 minutes on days 1 and 15 of cycle 1, and then on day 1 only of subsequent cycles. Treatment will repeat every 28 days for up to 6 cycles for carboplatin and paclitaxel, and up to 2 years for nivolumab in the absence of disease progression or unacceptable toxicity.


Patient Must Have Inoperable, Recurrent, Or Metastatic Disease (Tumor Resectability Should Be Assessed By A Local Surgeon Or A Multidisciplinary Team) Not Amenable To Curative Therapy. Patient Must Have Histological Or Cytological Confirmation Of Anal Squamous Cell Carcinoma (Includes Basaloid And Cloacogenic Lesions) From The Primary Tumor Or A Newly Diagnosed Recurrent/Metastatic Lesion. Patient Must Have Eastern Cooperative Oncology Group (Ecog) Performance Status =< 0-1. Patients Must Have Measurable Disease According To Response Evaluation Criteria In Solid Tumors (Recist) Criteria Version 1.1 And Based On Radiologic Assessment Performed < 4 Weeks Prior To Randomization. Patient Receiving Palliative (Limited-Field) Radiation Therapy Is Allowed, As Long As The Lesion Treated For Palliation Is Not A Target Lesion. Leukocytes >= 3,000/Mcl . Absolute Neutrophil Count >= 1,500/Mcl. Platelets >= 100,000/Mcl . Hemoglobin (Hb) >= 9 G/Dl For Males And >= 9 G/Dl For Females. Total Bilirubin =< 1.5 X Institutional Upper Limit Of Normal (Uln). Aspartate Transaminase (Ast)(Serum Glutamic-Oxaloacetic Transaminase [Sgot]) /Alanine Transferase (Alt)(Serum Glutamate Pyruvate Transaminase [Sgpt]) =< 5 X Institutional Uln. Creatinine =< 1.5 X Institutional Uln Or Creatinine Clearance (Crcl) >= 50 Ml/Min. Human Immunodeficiency Virus (Hiv)-Infected Patients On Effective Anti-Retroviral Therapy (Art) With Undetectable Viral Load Are Eligible. 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. Patients With Known History Or Current Symptoms Of Cardiac Disease, Should Have A Clinical Risk Assessment Of Cardiac Function Using The New York Heart Association Functional Classification. Patients Must Agree To Not Receive Live Vaccines While On This Study. Patient Must Not Have Had Previous Use Of Systemic Chemotherapy Or Other Investigational Drugs For The Treatment Of Inoperable Recurrent Or Metastatic Anal Cancer. Patient Must Not Have Current Or Recent (Within 30 Days Prior To Randomization) Treatment With Another Investigational Drug Or Participation In Another Investigational Study. Patient Must Not Have Had Prior Immunotherapy. Patient Must Not Have A History Of Known Hypersensitivity Reaction To Any Platinum Or Taxane-Based Chemotherapy Or Monoclonal Antibody. Patient Must Not Have Active Autoimmune Disease Or History Of Autoimmune Disease That Might Recur. Patient Must Not Have A Condition Requiring Systemic Treatment With Either Corticosteroids (> 10 Mg Daily Prednisone Equivalents) Or Other Immunosuppressive Medications Within 14 Days Of Randomization. Patient Must Not Have Had Major Surgery Performed =< 28 Days Prior To Randomization. Patient Must Not Have A History Of Interstitial Lung Disease (E.G., Pneumonitis Or Pulmonary Fibrosis) Or Evidence Of Interstitial Lung Disease On Baseline Chest Computed Tomography (Ct) Scan. Patient Must Not Have A Serious Active Infection Requiring Iv Antibiotics At Time Of Randomization. Patient Must Not Have Other Primary Malignancy Within The Last 3 Years, Except For Adequately Treated Carcinoma In Situ Of The Cervix Or Squamous Carcinoma Of The Skin, Or Adequately Controlled Limited Basal Cell Skin Cancer, Or Any Other Cancer From Which The Patient Has Been Disease-Free For At Least 3 Years. Patient Must Not Have Known Peripheral Neuropathy > Grade 1 At The Time Of Randomization.


Phase 3, Metastatic, Anal Cancer

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