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Trial record 38 of 211 for:    Oral Cancer | Recruiting Studies | NIH

Nivolumab and Ipilimumab in Treating Patients With Metastatic/Recurrent ACC of All Sites and Non-ACC Salivary Gland Cancer

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ClinicalTrials.gov Identifier: NCT03146650
Recruitment Status : Recruiting
First Posted : May 10, 2017
Last Update Posted : August 14, 2018
Sponsor:
Collaborators:
Bristol-Myers Squibb
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Northwestern University

Brief Summary:
This phase II trial studies the efficacy (the effect on the tumor) and the safety (the effect on the body) of the study drugs when given as a combination in participants with this type of cancer. Another purpose of the study is to see which tumor markers (proteins in the blood that the body produces in response to the cancer) lead to better results in participants treated with the study drugs. Nivolumab and ipilimumab are antibodies, which are human proteins that recognize and attach to a part of the tumor and/or body's immune cells. They work in slightly different ways to activate the immune system and help the body's immune system to work against tumor cells. Nivolumab and ipilimumab are investigational because they are not approved by the FDA to be used for the type of cancer being studied.

Condition or disease Intervention/treatment Phase
Major Salivary Gland Carcinoma Minor Salivary Gland Carcinoma Recurrent Salivary Gland Carcinoma Stage IV Major Salivary Gland Carcinoma Stage IVA Major Salivary Gland Carcinoma Stage IVB Major Salivary Gland Carcinoma Stage IVC Major Salivary Gland Carcinoma Biological: Ipilimumab Other: Laboratory Biomarker Analysis Biological: Nivolumab Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 63 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Nivolumab and Ipilimumab for Treatment of Metastatic/Recurrent Adenoid Cystic Carcinoma of All Anatomic Sites of Origin and Non-adenoid Cystic Carcinoma Malignant Tumors of the Salivary Gland
Actual Study Start Date : May 19, 2017
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : June 2022


Arm Intervention/treatment
Experimental: Treatment (nivolumab, ipilimumab)
Patients receive nivolumab IV over 30 minutes on days 1, 15, 29, 43, 57, and 71 of course 1 and on days 1 and 15 of course 2, over 60 minutes on days 29 and 57 of course 2 and on days 1, 29, and 57 of subsequent courses. Patients also receive ipilimumab over 90 minutes on days 1 and 43. Courses repeat every 84 days in the absence of disease progression or unexpected toxicity.
Biological: Ipilimumab
Given IV
Other Names:
  • Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody
  • BMS-734016
  • MDX-010
  • MDX-CTLA4
  • Yervoy

Other: Laboratory Biomarker Analysis
Correlative studies

Biological: Nivolumab
Given IV
Other Names:
  • BMS-936558
  • MDX-1106
  • NIVO
  • ONO-4538
  • Opdivo




Primary Outcome Measures :
  1. Median PFS (median Progression-Free Survival) [ Time Frame: Up to 2 years ]
    Median PFS will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria.

  2. PFS at 6 months [ Time Frame: At 6 months ]
    PFS will be assessed at 6 months using RECIST 1.1 criteria.

  3. PFS at 12 months [ Time Frame: At 12 months ]
    PFS will be assessed at 12 months using RECIST 1.1 criteria.


Secondary Outcome Measures :
  1. Response Rate (RR) [ Time Frame: Up to 2 years ]
    RR will be evaluated by RECIST 1.1 in patients with recurrent or metastatic ACC.

  2. Disease Control Rate (DCR) [ Time Frame: At 6 months ]
    DCR will be defined as the sum of Complete Response (CR), Partial Response (PR), and Stable Disease (SD) and will be assessed by RECIST 1.1 in patients with recurrent or metastatic ACC.

  3. Disease Control Rate (DCR) [ Time Frame: At 12 months ]
    DCR will be defined as the sum of Complete Response (CR), Partial Response (PR), and Stable Disease (SD) and will be assessed by RECIST 1.1 in patients with recurrent or metastatic ACC.

  4. Overall Survival (OS) [ Time Frame: Up to 2 years ]
    Overall survival (OS) is defined as time in months from the date of first study treatment to the date of death and will be evaluated using RECIST 1.1 criteria.

  5. PFS (RECIST 1.1 criteria) [ Time Frame: Up to 2 years ]
    PFS defined as time in months from the date of first study treatment to the date of disease progression or death from any cause, whichever comes first.

  6. Overall Response Rate (ORR) [ Time Frame: Up to 2 years ]
    ORR will be assessed by immune-related response (irRECIST) criteria in patients with recurrent or metastatic ACC.

  7. DCR (irRECIST) [ Time Frame: At 6 months ]
    DCR will be defined as the sum of Complete Response (CR), Partial Response (PR), and Stable Disease (SD) and will be assessed by irRECIST in patients with recurrent or metastatic ACC.

  8. DCR (irRECIST) [ Time Frame: At 12 months ]
    DCR will be defined as the sum of Complete Response (CR), Partial Response (PR), and Stable Disease (SD) and will be assessed by irRECIST in patients with recurrent or metastatic ACC.

  9. PFS (irRECIST criteria) [ Time Frame: Up to 2 years ]
    PFS will be evaluated using irRECIST criteria.

  10. OS (irRECIST) [ Time Frame: Up to 2 years ]
    OS is defined as time in months from the date of first study treatment to the date of death and will be evaluated using irRECIST criteria.

  11. Incidence of Adverse Events [ Time Frame: 30 days after study treatment ]
    Assess the safety and tolerability of the combination of nivolumab and ipilimumab by evaluating the number, frequency, and severity of adverse events using CTCAE version 4.03.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed metastatic/recurrent adenoid cystic carcinoma (ACC) or non-adenoid cystic carcinomas (non-ACC) of major or minor salivary glands
  • Patients must have evidence of disease progression and cannot be a candidate for surgical treatment

    • NOTE: Disease progression is defined as one of the following occurring within the 6 months prior to study entry:

      • At least a 20% increase in radiologically or clinically measurable lesions
      • Appearance of any new lesions or
      • Symptomatic and/or deterioration in clinical status
  • Patients must have received at least one prior line of systemic therapy

    • NOTE: There is no limit to the number of prior therapies for stage IV disease
    • NOTE: Patients should not be a candidate for surgical treatment
  • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension in accordance with RECIST criteria v1.1
  • Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) status of 0-2

    • NOTE: ECOG performance status 3 will be allowed only if thought to be directly secondary to adenoid cystic carcinoma disease by treating physician
  • Patients must have adequate organ and bone marrow function within 14 days prior to registration, as defined by: leukocytes >= 2,000/mcL
  • Patients must have adequate organ and bone marrow function within 14 days prior to registration, as defined by: absolute neutrophil count >= 1,500/mcL, regardless of transfusion or growth factor support
  • Patients must have adequate organ and bone marrow function within 14 days prior to registration, as defined by: platelets >= 100,000/mcl, regardless of transfusion or growth factor support
  • Patients must have adequate organ and bone marrow function within 14 days prior to registration, as defined by: total bilirubin total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (except patients with Gilbert syndrome or liver metastasis, who can have total bilirubin < 3.0 x ULN)
  • Patients must have adequate organ and bone marrow function within 14 days prior to registration, as defined by: aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X institutional upper limit of normal (ULN) (or =< 5 times ULN in case of liver metastasis)
  • Patients must have adequate organ and bone marrow function within 14 days prior to registration, as defined by: serum creatinine of < 3.0 X ULN (upper limit of normal) or creatinine clearance > 30 mL/minute (using Cockcroft/Gault formula)
  • Patients with history of central nervous system (CNS) metastases are eligible if CNS disease has been stable for at least 6 weeks prior to study registration in the opinion of the investigator and does not require corticosteroids (of any dose) for symptomatic management

    • NOTE: Only patients with a known history or indication of CNS disease are required to have CNS imaging prior to study entry
  • Females of childbearing potential (FOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours of registration

    • NOTE: A FOCBP is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

      • Has not undergone a hysterectomy or bilateral oophorectomy
      • Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for > 12 months)
  • FOCBP and men who are sexually active with FOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment and the designated post-treatment period
  • Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study

Exclusion Criteria:

  • Patients must not have had chemotherapy or radiotherapy =< 28 days prior to study registration
  • Patients who have not recovered to =< grade 1 or tolerable grade 2 from adverse events due to agents administered >= 28 days earlier are not eligible
  • Patient must not be a candidate for surgical treatment or radiation
  • Patients may not be receiving any other investigational agents =< 28 days prior to registration
  • Patients who have had prior exposure to immune checkpoint inhibitors are not eligible; please contact principal investigator, 312-926-4248 for specific questions on potential interactions

    • NOTE: Immune checkpoint inhibitors working through OX40 are an exception (for example, MEDI6383, MEDI6469, MEDI0562, oxelumab, and PF-04518600) and are permitted >= 28 days prior to study registration
  • Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including chronic prolonged systemic corticosteroids (defined as corticosteroid use of duration one month or greater), should be excluded; these include but are not limited to patients with a history of:

    • Immune related neurologic disease
    • Multiple sclerosis
    • Autoimmune (demyelinating) neuropathy
    • Guillain-Barre syndrome
    • Myasthenia gravis
    • Systemic autoimmune disease such as SLE
    • Connective tissue diseases
    • Scleroderma
    • Inflammatory bowel disease (IBD)
    • Crohn's
    • Ulcerative colitis
    • Patients with a history of toxic epidermal necrolysis (TEN)
    • Stevens-Johnson syndrome
    • Anti-phospholipid syndrome
    • NOTE: Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
  • Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following, are not eligible:

    • Ongoing or active infection (including minor localized infections) requiring oral or IV treatment
    • Symptomatic class 3 or 4 congestive heart failure, defined as a clinical syndrome resulting from any structural or functional cardiac disorder that impairs the ability of the ventricle to fill with or eject blood
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Psychiatric illness/social situations that would limit compliance with study requirements
    • Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints
  • Patients should not have any condition requiring systemic treatment with corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to first dose of study drug

    • NOTE: Inhaled or topical steroids and adrenal replacement steroids at any dose are permitted in the absence of active autoimmune disease; a brief (less than 3 weeks) course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by a contact allergen) is permitted
  • Female patients who are pregnant or nursing are not eligible
  • No other prior malignancy is allowed except for the following:

    • Adequately treated basal cell or squamous cell skin cancer,
    • In situ cervical cancer,
    • Or any other cancer from which the patient has been disease free for at least three years
  • Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) is not permitted
  • Any known positive test for hepatitis B or hepatitis C virus indicating acute or chronic infection is not permitted
  • Patients who received a live, attenuated vaccine =< 30 days before study registration or are anticipated to require such a live attenuated vaccine are not eligible

    • NOTE: Influenza vaccination should be given during influenza season only (approximately October to March); patients must not receive live, attenuated influenza vaccine (e.g., FluMist) =< 30 days prior to study registration or at any time during the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03146650


Contacts
Contact: Study Coordinator (312)695-1301 cancertrials@northwestern.edu

Locations
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Maria Matsangou, M.D.    312-695-6182      
Principal Investigator: Maria Matsangou, M.D.         
Sponsors and Collaborators
Northwestern University
Bristol-Myers Squibb
National Cancer Institute (NCI)
Investigators
Principal Investigator: Maria Matsangou, M.D. Northwestern University

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT03146650     History of Changes
Other Study ID Numbers: NU 16N03
STU00204579 ( CTRP (Clinical Trial Reporting Program) )
NU 16N03 ( Other Identifier: Northwestern University )
P30CA060553 ( U.S. NIH Grant/Contract )
NCI-2017-00406 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: May 10, 2017    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Salivary Gland Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Carcinoma
Stomatognathic Diseases
Salivary Gland Diseases
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs