Study of Nivolumab-Ipilimumab and cfDNA in Lung Cancer

• Status: Not yet recruiting
• Trial end date: 2025-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research study is to look at how effective two drugs, nivolumab and ipilimumab, are for people with non-small lung cancer that has metastasized (has spread to other parts of the body) and to see what effects these drugs have on these tumors.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Collaborator: Bristol-Myers Squibb
• Treatments: Ipilimumab; Nivolumab

Criteria

Inclusion Criteria:

• Age ≥ 18 years at the time of screening or age of consent.

• Written informed consent obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Weight ≥ 35 kg.

• Must have a life expectancy of at least 12 weeks.

• Recurrent or newly diagnosed metastatic non-small cell lung cancer

• Tumor PDL1 status <50%.

• Non-Squamous and squamous histologies are eligible

• Histologies with targetable mutations are not eligible, regardless of prior treatment with tyrosine kinase inhibitors

• No prior radiation, surgery or chemotherapy is allowed for the current diagnosis of non-small cell lung cancer

• Adequate organ and marrow function

Exclusion Criteria:

• Receipt of any conventional or investigational anticancer therapy within 21 days or palliative radiotherapy within 14 days prior to the scheduled first dose of study treatment.

• Prior receipt of any immune-mediated therapy.

• Incomplete surgical resection

• Concurrent enrolment in another therapeutic clinical study. Enrolment in observational studies will be allowed.

• Any toxicity (excluding alopecia) from prior standard therapy that has not been completely resolved to baseline at the time of consent.

• Participants with prior history of myocardial infarction, transient ischemic attack, congestive heart failure ≥ Class 3 based on New York Heart Association Functional Classification or stroke within the past 3 months prior to the scheduled first dose of study treatment.

• Active or prior documented autoimmune disorders within the past 3 years prior to the scheduled first dose of study treatment with exceptions.

• Participants with confirmed human immunodeficiency virus (even if viral load is undetectable), chronic or active hepatitis B or C, or active hepatitis A.

• History of primary immunodeficiency, solid organ transplantation, or active tuberculosis (by clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice).

• Other invasive malignancy within 2 years. Non-invasive malignancies (i.e., cervical carcinoma in situ, in situ prostate cancer, non-melanomatous carcinoma of the skin, ductal carcinoma in situ of the breast that has been surgically cured) are excluded from this definition.

• Known allergy or hypersensitivity to investigational product formulations.

• History of more than one event of infusion related reactions requiring permanent discontinuation of intravenous drug treatment.

• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection requiring antibiotic therapy, uncontrolled hypertension, bleeding diatheses, or psychiatric illness/social situations that would limit compliance with study requirements, substantially increase risk of incurring adverse events, or compromise the ability of the subject to give written informed consent.

• Current or prior use of immunosuppressive medication within 14 days prior to the scheduled first dose of study treatment with exceptions.

• Receipt of live, attenuated vaccine within 30 days prior to the scheduled first dose of study treatment - Major surgery within 28 days prior to scheduled first dose of study treatment or still recovering from prior surgery.

• Females who are pregnant, lactating, or intend to become pregnant during their participation in the study.

• Participants who are involuntarily incarcerated or are unable to willingly provide consent or are unable to comply with the protocol procedures.

• Any condition that, in the opinion of the investigator, would interfere with safe administration or evaluation of the investigational products or interpretation of subject safety or study results.