Finding studies
Finding studies
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Lead
Nisha Mohindra, MD
With
OUTLINE: This is a multi-center study. INVESTIGATIONAL TREATMENT: Phase I, Cohort 1 Induction Therapy: * Carboplatin AUC 6 IV, Day 1 * Nab-paclitaxel 100 mg/m\^2 IV, Days 1, 8, 15 * pembrolizumab 2 mg/kg IV, Day 1 * Cycle length: 21 days; number of cycles: 4 Phase I, Cohort 1 Maintenance Therapy: For subjects who have confirmed CR, PR, or SD (non-progression) after 4 cycles of induction therapy, maintenance therapy with pembrolizumab 2\* mg/kg will continue on Day 1 of each 21-day cycle. Treatment will continue until progression of disease, unacceptable toxicity, or for a maximum of 2 years from Cycle 1, Day 1 (C1D1). Subjects who complete 24 months of treatment with pembrolizumab may be eligible for up to one year of additional study treatment if they progress after stopping study treatment provided they continue to meet inclusion criteria requirements. If unacceptable toxicity is seen in Phase I, Cohort 1, 12 additional participants will be enrolled. Phase I, Cohort 2 Induction Therapy (if necessary): * Carboplatin AUC 6 IV, Day 1 * Nab-paclitaxel 100 mg/m\^2 IV, Days 1, 8, 15 * pembrolizumab 2 mg/kg IV, Day 1 (cycle 2-4 only) * Cycle length: 21 days; Number of cycles: 4 Phase I, Cohort 2 Maintenance Therapy: For subjects who have confirmed CR, PR, or SD (non-progression) after 4 cycles of induction therapy, maintenance therapy with pembrolizumab 2\* mg/kg will continue on Day 1 of each 21-day cycle. Treatment will continue until progression of disease, unacceptable toxicity, or for a maximum of 2 years from Cycle 2, Day 1 (C2D1). Subjects who complete 24 months of treatment with pembrolizumab may be eligible for up to one year of additional study treatment if they progress after stopping study treatment provided they continue to meet inclusion criteria requirements. Phase II Induction Therapy: * Carboplatin AUC 6 IV, Day 1 * Nab-paclitaxel 100 mg/m\^2 IV, Days 1, 8, 15 * pembrolizumab 200mg IV, Day 1 of each cycle * Cycle length: 21 days; number of cycles: 4 Phase II Maintenance Therapy: For subjects who have confirmed CR, PR, or SD (non-progression) after 4 cycles of induction therapy, maintenance therapy with pembrolizumab 200 mg will continue on Day 1 of each 21-day cycle. Treatment will continue until progression of disease, unacceptable toxicity, or for a maximum of 2 years from Cycle 1, Day 1 (C1D1). Subjects who complete 24 months of treatment with pembrolizumab may be eligible for up to one year of additional study treatment if they progress after stopping study treatment provided they meet the requirements. \*As additional data from ongoing trials becomes available, the dose of pembrolizumab may be adjusted.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
