Nivolumab/Ipilimumab and Chemotherapy Combination in Advanced NSCLC Patients With HIV, HBV, HCV and Long Covid Syndrome

Trial details

Who runs it

Universita di Verona

Trial code

NCT05597800

Record updated

28 October 2022

Original description

Study type: Phase 2 - Interventional Trial Number of patients to be enrolled: 105 Participating countries: Italy Study drugs: nivolumab and ipilimumab Cohort A: HBV and HCV patients Cohort B: HIV patients Cohort C: Long COVID syndrome The stratification factors are HBV/HCV positive (cohort A), HIV positive (cohort B), patients with Long Covid syndrome (Cohort C), histology (squamous vs non-squamous histology), and gender (male vs female).Read full original descriptionShow less

A Phase 2, Multicenter, Open Label, Clinical Trial Evaluating Safety and Activity of Nivolumab/Ipilimumab and Chemotherapy Combination in Advanced NSCLC Patients With HIV, HBV, HCV and Post-acute Sequelae of SARS-CoV2 Infection (PASC).

Study type: Phase 2 - Interventional Trial Number of patients to be enrolled: 105 Participating countries: Italy Study drugs: nivolumab and ipilimumab Cohort A: HBV and HCV patients Cohort B: HIV patients Cohort C: Long COVID syndrome The stratification factors are HBV/HCV positive (cohort A), HIV positive (cohort B), patients with Long Covid syndrome (Cohort C), histology (squamous vs non-squamous histology), and gender (male vs female).

Inclusion: Participants must have histologically confirmed diagnosis of metastatic or unresectable NSCLC; No sensitizing EGFR, ALK, ROS1, BRAF and NTRK alterations; Eastern Cooperative Oncology Group (ECOG) score 0-1 (physically able to carry out light housework or office work through to being fully active as they were before cancer); No prior systemic anticancer therapy; Tissue or Programmed death-ligand 1 (PD-L1) results available; HIV-1 or HIV-2 chronic infection, defined as i) a positive HIV 1-2 western blot or other FDA/CE approved HIV confirmatory test (regardless the results of the HIV 1-2 screening test used [2nd, 3rd, 4th generation tests, rapid tests or laboratory tests (i.e., ELISA, EIA, CLIA, etc.)], ii) the referring physician's written record that HIV infection was documented, with supporting information on the participant's relevant medical history and/or current antiretroviral treatment for HIV infection; Only subjects with chronic or resolved HBV infections might be eligible. Chronic HBV infections is defined as: the persistence of HBsAg positivity for more than 6 months (regardless HBeAg result, HBV-DNA level and the presence of liver necroinflammation). Resolved HBV infection is defined by: the absence of liver inflammation (clinically and laboratory), HBsAg negativity and HBsAb (anti-HBs antibodies) and HBcAb (anti-HBc IgG) positive result; Only subjects with resolved HCV infections might be eligible. Subjects with a newly diagnosed chronic HCV infection (defined as: positive HCV antibodies + detectable HCV-RNA) should be treated for HCV infection before enrollment. Acute HCV infection [defined as a positive HCV-RNA and i) a negative serological HCV assay (HCV-Ab) or ii) a positive serological HCV assay (HCV-Ab) with a negative test 6 months earlier] cannot be enrolled in the study; Patients with past HCV infection, with no evidence of chronic infection (i.e., anti-HCV antibody positivity, HCV-RNA negativity) should be excluded; Patients with confirmed Long Covid syndrome or PASC defined, as suggest by World Health Organization (WHO), as "condition occurs in individuals with a history of probable or confirmed SARS CoV-2 infection, usually 3 months from the onset of COVID-19 with symptoms and that last for at least 2 months and cannot be explained by an alternative diagnosis". This condition must be present at enrollment; Participants must have a nasopharyngeal swab positive for Sars-Cov2 within 12 months before enrolment; Participants must be either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to first treatment; Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam; scans must have been performed within 4 weeks prior to registration; Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug; Ability to understand and to sign a written informed consent document.

Exclusion: Another active concomitant malignancy; Active, known or suspected, autoimmune disease; Active HBV or HCV infection, presence of any infectious disease requiring specific treatment; Active Sars-Cov2 infection; Eastern Cooperative Oncology Group (ECOG) score ≥2; Untreated symptomatic brain metastases or leptomeningeal metastases.

ClinicalTrials.gov NCT05597800