A Phase II Trial of Durvalumab (MEDI4736) and Tremelimumab in Combination With Chemotherapy in HIV-infected Patients With Non-small Cell Lung Cancer
Georgetown University
Summary
This is a phase II trial of durvalumab and tremelimumab in combination of platinum-based chemotherapy. Patients with stage IV Non-Small-Cell-Lung Cancer (NSCLC) with human immunodeficiency virus (HIV) infection will be eligible. Patients will receive standard platinum-based chemotherapy plus durvalumab for 4 cycles (every 3 weeks), followed by durvalumab (with or without pemetrexed for non-squamous NSCLC) maintenance therapy. It is hypothesized that Durvalumab and tremelimumab in combination with standard chemotherapy is safe and effective for the treatment of stage IV NSCLC in patients with HIV infection.
Description
This is an open-label, non-randomized phase II trial of durvalumab and tremelimumab in combination with platinum-based doublet chemotherapy. Patients with stage IV NSCLC with HIV infection will be eligible. Patients will receive standard chemotherapy plus durvalumab (1500 mg) and tremelimumab (75 mg) every three weeks for 4 cycles, followed by maintenance treatment with durvalumab (1500 mg Q4W; with or without pemetrexed for non-squamous NSCLC per the discretion of the investigator). A dose of tremelimumab 75 mg will be given at week 16. Patient will be enrolled into the trial using an optima…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients with stage IV NSCLC who had undergone no previous systemic therapy for stage IV disease. 2. Patients with HIV must be on an effective combination anti-retroviral therapy (cART) regimen for ≥ 4 weeks. Also, patients need to meet the following criteria. * Documented HIV viral load \< 400 copies/mL * No AIDS-defining opportunistic infections within the last 12 months * No concurrent incurable AIDS-defining malignancy 3. Age \> 18 years at time of study entry. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 5. Body weight \>30kg 6.…
Interventions
- DrugDurvalumab
durvalumab 1500 mg, intravenous, every 3 weeks for 4 cycles, followed by 1500 mg, intravenous, every 4 weeks (maintenance treatment)
- DrugTremelimumab
tremelimumab 75 mg, intravenous, every 3 weeks for 4 cycles. A dose of tremelimumab 75 mg will be given at week 16.
Locations (4)
- Georgetown Lombardi Comprehensive Cancer CenterWashington D.C., District of Columbia
- Medstar Washington Hospital CenterWashington D.C., District of Columbia
- Marlene and Stewart Greenebaum Comprehensive Cancer CenterBaltimore, Maryland
- Harry and Jeannette Weinberg Cancer Institute at Franklin SquareBaltimore, Maryland