Nivolumab/Ipilimumab and Chemotherapy Combination in Advanced NSCLC Patients With HIV, HBV, HCV and Long Covid Syndrome
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversita di Verona
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
Eastern Cooperative Oncology Group (ECOG) score ≥2;
Untreated symptomatic brain metastases or leptomeningeal metastases;
Another active concomitant malignancy;
Active, known or suspected, autoimmune disease;
Trial design
Design model
Parallel
Treatments tested in this trial
Nivolumab and Ipilimumab
DrugNivolumab will be administered with ipilimumab, plus 2 cycles of histology-based platinum doublet chemotherapy: * Squamous histology: carboplatin AUC 6 + paclitaxel 200 mg/m2 * Non-squamous histology: carboplatin AUC 5 or 6 + pemetrexed 500 mg/m2 or cisplatin 75 mg/m2 + pemetrexed 500 mg/m Dosing: nivolumab 360 mg every 3 weeks + ipilimumab 1 mg/kg every 6 weeks (up to maximum 2 years) + histology-based, platinum doublet chemotherapy (every 3 weeks for two cycles).
Treatment groups
105 Participants
are divided into 3 treatment groupsGroup A: Cohort A: HBV and HCV patientsExperimental treatment 1 intervention
Group B: Cohort B: HIV patientsExperimental treatment 1 intervention
Group C: Cohort C: Long COVID syndromeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety, defined as onset of grade 3 or 4 (G3/4) treatment-related adverse events (TRAEs), assessed by the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 5.
The primary objectives of the study are safety, defined as onset of grade 3 or 4 (G3/4) treatment-related adverse events (TRAEs), assessed by the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 5.
Time frame
3 years2
Objective Response Rate (ORR) measured as for RECIST 1.1 criteria
Activity in terms of objective response rate (ORR) of nivolumab plus ipilimumab in combination with platinum-based chemotherapy (2 cycles) in first-line advanced NSCLC patients with chronic viral infections.
Time frame
3 yearsSecondary outcomes
1
Overall survival (OS)
Overall survival (OS) is defined as the time between the date of the randomization date and the date of death due to any cause. OS will be censored on the last date a participant was known to be alive.
Time frame
3 years2
Progression-free survival (PFS)
Progression free survival (PFS), according to response evaluation criteria in solid tumors (RECIST) 1.1 as assessed by local investigators, is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD is defined as a ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD.
Time frame
3 years3
Duration of response (DOR)
Duration of response (DOR) is defined as the time from date of first documentation of confirmed response (CR or PR) to date of first documentation of progression or symptomatic deterioration, or death due to any cause among patients who achieve, assessed at 6 and 12 months.
Time frame
3 yearsOther outcomes
1
Exploratory objectives
The exploratory analyses include the evaluation of absolute CD4+, CD4/CD8, HIV viral load changes only in cohort B. In cohort A, HBV variables: HBsAg, HBeAg, HBsAb, HBcAb tot e IgM, HBeAb, HBV-DNA, ALT, AST, PLTs, PT, bilirubin; HCV variables: HCV-RNA, HCV genotype, ALT, AST, albumin, PLTs, PT, bilirubin. In Cohort C, the exploratory analyses in Long Covid patients include protein C reactive (PCR), D-Dimer levels, lymphocyte subpopulations (CD4+, CD8+, CD4/CD8, CD57+), interleukin 1, 6 and 8 and IFNy. Another exploratory objective is represented by the objective response rate (ORR) in patients who don't demonstrate TRAEs grade 3 or 4 of nivolumab plus ipilimumab in combination with platinum-based chemotherapy. Translational researches are also planned, involving circulating and tissue biomarkers to assess the immunological and inflammatory tumor microenvironment. In particular, the plasma samples will be collected at different timepoints
Time frame
4 yearsSponsors and contacts
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Source ClinicalTrials.gov
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