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

NCT04043195 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: 181485
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Advanced NSCLC

Keywords

NSCLC; Ipilimumab; Nivolumab; Oxaliplatin

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  To estimate ORR by RECIST 1.1

  4 months

Secondary Outcomes (2)

• Overall survival (OS)

  1 and 2 year

• Progression-free survival (PFS)

  1 year

Study Arms (1)

Nivolumab + Oxaliplatin + Ipilimumab

EXPERIMENTAL

Cohort 1

Drug: Nivolumab; Drug: Oxaliplatin; Drug: Ipilimumab

Interventions

Nivolumab DRUG

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

Also known as: Opdivo

Nivolumab + Oxaliplatin + Ipilimumab

Oxaliplatin DRUG

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

Also known as: Eloxatin

Nivolumab + Oxaliplatin + Ipilimumab

Ipilimumab DRUG

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

Also known as: Yervoy

Nivolumab + Oxaliplatin + Ipilimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Hatim Husain: lead

Study Sites (1)

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

MeSH Terms

Interventions

Nivolumab; Oxaliplatin; Ipilimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals

Study Officials

• Hatim Husain

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: August 2, 2019
• Study Start: August 14, 2019
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 28, 2025

Record last verified: 2025-05

Locations

US (1)