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NOT YET RECRUITING
NCT05597800
PHASE2

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

Sponsor: Universita di Verona

View on ClinicalTrials.gov

Summary

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).

Official title: 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).

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

105

Start Date

2023-02-01

Completion Date

2027-03-30

Last Updated

2022-10-28

Healthy Volunteers

No

Interventions

DRUG

Nivolumab and Ipilimumab

Nivolumab 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).

Locations (1)

Centro Ricerche Cliniche

Verona, Veneto/Verona, Italy