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Advanced NSCLCPhase 1/2NSCLCNCT04043195

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

A Phase 1/2 study testing Nivolumab, Oxaliplatin and Ipilimumab in people with Advanced NSCLC, run by Hatim Husain at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced NSCLC
What is being tested?
Nivolumab, Oxaliplatin and Ipilimumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
14 Aug 2019to Dec 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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.
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  • Prior allogeneic bone marrow transplantation or solid organ transplantation.
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

Other trials in United States

About this study

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

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).

Read the detailed 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.

Conditions
Advanced NSCLC
Keywords
NSCLC, Ipilimumab, Nivolumab, Oxaliplatin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NivolumabDrug

    Also called Opdivo

    240 mg every 2 weeks. Nivolumab will continue for up to 2 years.

  • OxaliplatinDrug

    Also called Eloxatin

    65 mg/m2 every 2 weeks. Oxaliplatin will continue for up to 12 cycles.

  • IpilimumabDrug

    Also called Yervoy

    1 mg/kg every 6 weeks. Ipilimumab will continue for up to 4 cycles

Study groups in NCT04043195
Study groupRoleWhat they receive
Nivolumab + Oxaliplatin + IpilimumabExperimentalCohort 1
Receives: Drug: Nivolumab; Drug: Oxaliplatin; Drug: Ipilimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR)

    To estimate ORR by RECIST 1.1

    Measured: 4 months

Secondary outcomes (2)

  1. Overall survival (OS)

    Overall survival (OS)

    Measured: 1 and 2 year

  2. Progression-free survival (PFS)

    Progression-free survival (PFS)

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2019
  2. Study start14 Aug 2019
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04043195
Sponsor's protocol ID
181485
Acronym
NSCLC
Status last verified
May 2025
First submitted
25 Jul 2019
Last updated
28 May 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Nivolumab, Oxaliplatin and Ipilimumab in people with Advanced NSCLC, run by Hatim Husain at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04043195.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.

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