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Nivolumab and Ipilimumab in Combination With Immunogenic Chemotherapy for Patients With Advanced NSCLC

NCT04043195

Description:

The purpose of this study is to examine the safety and efficacy of combining Nivolumab and low-dose Oxaliplatin with or without Ipilumumab in patients who have had their advanced NSCLC cancer worsen on or after being treated with certain immunotherapies (drugs that target the immune system). Nivolumab (Opdivo®) is approved by the Food and Drug Administration (FDA) for the treatment of metastatic (the cancer has spread) NSCLC. It is a type of drug called a monoclonal antibody (a type of protein). Monoclonal antibodies bind to other proteins, such as PD-1 (programmed cell death-1), on immune cells, which allows the immune cells to continue working against the tumor. Ipilumumab (Yervoy®) is also a monoclonal antibody, but binds to a protein called CTLA-4 (cytotoxic T-lymphocyte-associated protein 4). Oxaliplatin is a type of immunogenic chemotherapy, which may increase the body's immune response to the cancer. Both are approved for treatment of other types of cancers, but not in patients with NSCLC.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Nivolumab and Ipilimumab in Combination With Immunogenic Chemotherapy for Patients With Advanced NSCLC
  • Official Title: Nivolumab (Anti-PD1 Antibody) and Ipilimumab (Anti-CTLA4 Antibody) in Combination With Immunogenic Chemotherapy for Patients With Advanced Non-Small Cell Lung Cancer

Clinical Trial IDs

  • ORG STUDY ID: 181485
  • NCT ID: NCT04043195

Conditions

  • Advanced NSCLC

Interventions

DrugSynonymsArms
NivolumabNivolumab + Oxaliplatin
OxaliplatinNivolumab + Oxaliplatin
IpilimumabNivolumab + Oxaliplatin + Ipilimumab

Purpose

The purpose of this study is to examine the safety and efficacy of combining Nivolumab and low-dose Oxaliplatin with or without Ipilumumab in patients who have had their advanced NSCLC cancer worsen on or after being treated with certain immunotherapies (drugs that target the immune system). Nivolumab (Opdivo®) is approved by the Food and Drug Administration (FDA) for the treatment of metastatic (the cancer has spread) NSCLC. It is a type of drug called a monoclonal antibody (a type of protein). Monoclonal antibodies bind to other proteins, such as PD-1 (programmed cell death-1), on immune cells, which allows the immune cells to continue working against the tumor. Ipilumumab (Yervoy®) is also a monoclonal antibody, but binds to a protein called CTLA-4 (cytotoxic T-lymphocyte-associated protein 4). Oxaliplatin is a type of immunogenic chemotherapy, which may increase the body's immune response to the cancer. Both are approved for treatment of other types of cancers, but not in patients with NSCLC.

Trial Arms

NameTypeDescriptionInterventions
Nivolumab + OxaliplatinExperimentalCohort 1
  • Nivolumab
  • Oxaliplatin
Nivolumab + Oxaliplatin + IpilimumabExperimentalCohort 2
  • Nivolumab
  • Oxaliplatin
  • Ipilimumab

Eligibility Criteria

        The following list is a summary. Additional criteria apply.

        Inclusion Criteria:

        Patients must meet all of the following criteria to be eligible for study entry.

          -  At least 18 years or older

          -  Histologically or cytologically confirmed, advanced non-squamous or squamous NSCLC

          -  Last line of therapy for advanced non-squamous or squamous NSCLC must be with an
             anti-PD1 or PDL1 antibody with confirmed progression on or after that treatment.
             Patients may have received no more than 3 lines of prior therapy including no more
             than 2 prior lines of therapy containing a PD-(L)-2 antibody. Patients must have
             received prior cisplatin or carboplatin based doublet chemotherapy.

          -  Measurable disease, as defined by RECIST v1.1

          -  Adequate hematologic and end-organ function, defined by the laboratory test results
             within 14 days prior to randomization:

          -  For female patients of childbearing potential and male patients with partners of
             childbearing potential, agreement to use a highly effective form(s) of contraception
             during study treatment that results in a low failure rate of <1% per year when used
             consistently and correctly. Female patients should continue contraception use for 5
             months after the last dose of nivolumab and ipilimumab and for 6 months after the last
             dose of oxaliplatin. Make patients treated with chemotherapy should continue
             contraception use for 7 months after the last dose of chemotherapy. Men should refrain
             from donating sperm during this same period. Such methods include combined (estrogen
             and progestogen containing) hormonal contraception, with another additional barrier
             method always containing a spermicide, intrauterine device (IUD), intrauterine
             hormone-releasing system (IUS), bilateral tubal occlusion or vasectomized partner (on
             the understanding that this is the only one partner during the study duration), and
             sexual abstinence.

               -  Oral contraception should always be combined with an additional contraceptive
                  method because of a potential interaction with the study drug. The same rules are
                  valid for male patients involved in this study if they have a partner of
                  childbearing potential. Male patients must always use a condom.

               -  Women who are not postmenopausal (>12 months of non-therapy-induced amenorrhea)
                  or surgically sterile must have a negative serum pregnancy test result within 14
                  days prior to initiation of study drug.

        Exclusion Criteria:

        General Medical Exclusions

          -  Women who are pregnant, lactating, or intending to become pregnant during the study.

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

          -  History of autoimmune disease

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

          -  Major surgical procedure other than for diagnosis within 28 days prior to
             randomization or anticipation of need for a major surgical procedure during the course
             of the study.

          -  Prior allogeneic bone marrow transplantation or solid organ transplantation.

        Exclusion Criteria Related to Medications

          -  Treatment with any approved anti-cancer therapy within 2 weeks prior to initiation of
             study treatment.

          -  Treatment with any other investigational agent with therapeutic intent within 21 days
             prior to enrollment.

          -  Received therapeutic oral or intravenous (IV) antibiotics within 2 weeks prior to
             enrollment.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective response rate (ORR)
Time Frame:4 months
Safety Issue:
Description:To estimate ORR by RECIST 1.1

Secondary Outcome Measures

Measure:Overall survival (OS)
Time Frame:1 and 2 year
Safety Issue:
Description:
Measure:Progression-free survival (PFS)
Time Frame:1 year
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Hatim Husain

Trial Keywords

  • NSCLC
  • Ipilimumab
  • Nivolumab
  • Oxaliplatin

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