At a glance
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A Phase IB Study of Pembrolizumab in Combination With Pemetrexed and Oxaliplatin in Patients With Chemo-Refractory Metastatic Colorectal Cancer
In Brief
A Phase 1 clinical trial evaluating Pembrolizumab, Pemetrexed, and 4 other interventions for Metastatic Colorectal Cancer. Targeting 33 participants across 15 sites.
Detailed Summary
This is a Phase Ib study to evaluate the safety and preliminary anti-tumor activity of pembrolizumab in combination with pemetrexed with or without oxaliplatin in patients with chemo-refractory microsatellite stable (MSS) metastatic colorectal cancer (mCRC) without any further standard treatment options.
Study Details
Timeline
Interventions
Pembrolizumab 200 mg IV on Day 1 of each 21 day cycle until maximum of 35 cycles.
Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle until maximum of 35 cycles.
Oxaliplatin-Dose level1: 85 mg/m2 IV on Day 1 of each 21 day cycle until a maximum of 35 cycles or until discontinued due to patient election, toxicity, disease progression. Dose level 2: 120 mg/m2 IV on Day 1 of each 21 day cycle until a maximum of 35 cycles or until discontinued due to patient election, toxicity, disease progression. The MTD dose of oxaliplatin in the study combination of Cohort 2 will be the recommended Phase II dose (RP2D) for the cohort expansion.
Dexamethasone-4 mg by mouth twice daily on: the day before, the day of, and the day after each dose of pemetrexed.
Folic Acid-400 micrograms by mouth daily starting 5 days prior to first dose of pemetrexed and continue daily to include 21 days after the last dose of pemetrexed.
1000 micrograms administered intramuscularly 7 days prior to the first dose of pemetrexed, every 9 weeks, and should continue until 3 weeks after the last dose of pemetrexed.