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.
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
Interventions
Drug | Synonyms | Arms |
---|
Nivolumab | | Nivolumab + Oxaliplatin |
Oxaliplatin | | Nivolumab + Oxaliplatin |
Ipilimumab | | Nivolumab + 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
Name | Type | Description | Interventions |
---|
Nivolumab + Oxaliplatin | Experimental | Cohort 1 | |
Nivolumab + Oxaliplatin + Ipilimumab | Experimental | Cohort 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: | Recruiting |
Lead Sponsor: | Hatim Husain |
Trial Keywords
- NSCLC
- Ipilimumab
- Nivolumab
- Oxaliplatin
Last Updated
April 5, 2021