A Phase II Trial of MOnaliZumab in Combination With durvAlumab (MEDI4736) for tReatmenT of Small Cell Lung Cancer (MOZART)
Hirva Mamdani
Summary
This study has 2 cohorts: MOZART-ES cohort (for extensive-stage SCLC) and MOZART-LS cohort (for limited-stage SCLC). MOZART-ES cohort: Study treatment will consist of a platinum drug (carboplatin or cisplatin per investigator's choice) plus etoposide plus durvalumab plus monalizumab every 3 weeks for 4 cycles. After 4 cycles, subjects will continue maintenance treatment with durvalumab plus monalizumab every 4 weeks until disease progression, unacceptable toxicity, decision to stop study treatment, or withdrawal of consent. Patients who have received one prior cycle of treatment before enrolling on the study will receive a total of 4 cycles with monalizumab, durvalumab, and chemotherapy. There will be a safety lead-in phase, including 6 to 12 patients, to confirm the safety of the proposed dose of monalizumab to use in combination with chemotherapy and durvalumab. MOZART-LS cohort: Study treatment will consist of durvalumab and monalizumab following standard of care chemo-radiation consisting of a platinum drug (carboplatin or cisplatin per investigator's choice) plus etoposide for 3-4 cycles and standard dose radiation. Radiation therapy should have started before completion of cycle 2 of chemotherapy. NOTE: Subjects who have non-progressive disease and meet the eligibility criteria can start study treatment up to 56 days from completion of chemo-radiation. Durvalumab and monalizumab will be administered every 4 weeks for up to 2 years (26 cycles), disease progression, unacceptable toxicity, decision to stop study treatment, or withdrawal consent, whichever occurs first.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
General Inclusion Criteria: 1. Written informed consent and HIPAA authorization for release of personal health information prior to registration. Note: HIPAA authorization may be included in the informed consent or obtained separately. 2. Age ≥ 18 years at the time of consent. 3. Demonstrate adequate organ function. All screening labs to be obtained within 28 days prior to registration. * Absolute Neutrophil Count (ANC) \> 1500mm\^3 * Hemoglobin ≥ 9 g/dL * Platelet Count (PLT) ≥ 100,000 per mm3 * Calculated creatinine clearance ≥ 40 mL/min * Bilirubin ≤ 1.5 × upper limit of no…
Interventions
- DrugDurvalumab
1500mg IV on Day 1 of every Cycle
- DrugMonalizumab
1500mg IV on Day 1 of every Cycle
- DrugCarboplatin or Cisplatin
On Day 1 of Cycles 1-4 by IV: Carboplatin: AUC 5-6 OR Cisplatin: 75-80mg/m\^2
- DrugEtoposide
80-100mg/m\^2 IV on Days 1-3 of Cycles 1-4
Locations (4)
- Indiana University Melvin and Bren Simon Comprehensive Cancer CenterIndianapolis, Indiana
- University of Iowa Hospitals and ClinicsIowa City, Iowa
- Karmanos Cancer Center (Wayne State University)Detroit, Michigan
- University of Virginia Health SystemCharlottesville, Virginia