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durvalumab plus tremelimumab (n=163) vs. Standard of Care (SoC) (n=162)
randomized controlled trial
durvalumab and tremelimumab
durvalumab (20 mg/kg every 4 weeks) until disease progression plus 1mg/kg of tremelimumab every 4 weeks for up to 4 doses
platinum-based doublet chemotherapy
4 to 6 cycles of platinum-based doublet chemotherapy of the investigator’s choice 4 to 6 cycles of platinum-based doublet chemotherapy of the investigator’s choice : pemetrexed plus carboplatin and gemcitabine plus carboplatin (no % for this sub-population)
3 arms: durvalumab with or without tremelimumab vs platinum-based doublet chemotherapy
mNSCLC - L1 - PDL1 positive
only patient with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type were included
open-label
203 cancer treatment centers in 17 countries
P3/ two sided and two interim analysis. A hierarchical multiple testing procedure with a gatekeeping strategy was used to control family-wise type I error at a twosided 5% significance level.
The phase 3 MYSTIC study did not meet its primary end points of improved OS with durvalumab vs chemotherapy or improved OS or PFS with durvalumab plus tremelimumab vs chemotherapy in patients with ≥25% of tumor cells expressing PD-L1.
nivolumab plus ipilimumab (n=396) vs. pemetrexed plus platin (n=397)
randomized controlled trial
nivolumab plus ipilimumab
nivolumab (3 mg per kilogram of body weight every 2 weeks) plus ipilimumab (1 mg per kilogram every 6 weeks)
platinium chemotherapy
platinum doublet chemotherapy based on tumor histologic type every 3 weeks for up to four cycles : pemetrexed (500 mg per square meter of body-surface area) plus cisplatin (75 mg per square meter) or carboplatin (area under the concentration-time curve [AUC], 5 or 6), every3 weeks for up to four cycles
3 arms: Nivolumab, or Nivolumab Plus Ipilimumab. Crossover between treatment groups within the trial was not permitted.
mNSCLC - L1 - PDL1 positive
Patients with known EGFR mutations or ALK translocations sensitive to targeted therapy, an autoimmune disease, or untreated central nervous system metastases were excluded
open label
NA
P3/ two sided and one interim analysis. Repartition between coprimary end point and hierarchy with secondary endpoint. WARNING safety from ITT population
Progression-free survival was significantly longer with first-line nivolumab plus ipilimumab than with chemotherapy among patients with NSCLC and a high tumor mutational burden, irrespective of PD-L1 expression level
pembrolizumab plus ipilimumab (n=284) vs. pembrolizumab plus placebo (n=284)
randomized controlled trial
pembrolizumab plus ipilimumab
pembrolizumab at a dose of 200 mg on day 1 of each 3-week cycle for up to 35 cycles plus IV ipilimumab at a dose of 1 mg/kg on day 1 of each 6-week cycle for up to 18 cycles,
placebo plus pembrolizumab
saline placebo administered intravenously every 6 weeks for up to 18 doses pembrolizumab at a dose of 200 mg on day 1 of each 3-week cycle for up to 35 cycles in combination with placeb at the same dose and schedule.
mNSCLC - L1 - PDL1 positive
double blind
171 sites in 24 countries
P3/ one sided and OS and PFS interim analysis. Repartition between coprimay endpoint and reallocation with ORR, but the study stops for futility
The phase 3 KEYNOTE-598 study of pembrolizumab (Keytruda) plus ipilimumab (Yervoy) in a population of patients with metastatic non–small cell lung cancer (NSCLC) has been discontinued for futility
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