Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
mFOLFOX6 · 1 trial · 1 indication
PFS was defined as the time from randomization to the first documented disease progression (PD) per RECIST 1.1 based on blinded central imaging vendor review or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. Hazards ratio (HR) and associated 95% confidence intervals (CIs) from a Cox proportional hazard model with Efron's method of tie handling and with a single treatment covariate was presented for the first course study treatment per protocol.
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of analysis were censored at the date of last known contact. HR and associated 95% CIs from a Cox proportional hazard model with Efron's method of tie handling and with a single treatment covariate was presented for the first course study treatment per protocol.
| Arm | Type | Description |
|---|---|---|
| Pembrolizumab | EXPERIMENTAL | Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 treatments (approximately 2 years). Participants that have stopped the initial course of pembrolizumab and have stable disease but progress after discontinuation can initiate a second course of pembrolizumab for up to 17 cycles (approximately 1 year additional). |
| Standard of Care (SOC) | ACTIVE_COMPARATOR | Participants receive 1 of 6 possible standard chemotherapy regimens: mFOLFOX6, or mFOLFOX6+bevacizumab 5 mg/kg IV on Day 1 of each 2-week cycle, or mFOLFOX6+cetuximab 400 mg/m\^2 IV over 2 hours then 250 mg/m\^2 over 1 hour weekly in each 2-week cycle, or FOLFIRI, or FOLFIRI+bevacizumab 5 mg/kg IV on Day 1 of each 2-week cycle, or FOLFIRI+cetuximab 400 mg/m\^2 IV over 2 hours then 250 mg/m\^2 over 1 hour weekly in each 2-week cycle. Participants with documented disease progression following chemotherapy can crossover to receive pembrolizumab for up to 35 cycles (approximately 2 years). Participants that have stopped pembrolizumab and have stable disease but progress after discontinuation can initiate a second course of pembrolizumab for up to 17 cycles (approximately 1 year additional). |
| Name | Type | Description |
|---|---|---|
| mFOLFOX6 | DRUG | Regimen consists of oxaliplatin 85 mg/m\^2 IV on Day 1, leucovorin 400 mg/m\^2 or levoleucovorin 200 mg/m\^2 IV on Day 1, 5-fluorouracil (5-FU) 400 mg/m\^2 IV bolus on Day 1 and then 1200 mg/m\^2/day IV over 2 days for total dose of 2400 mg/m\^2 in each 2-week cycle |
| FOLFIRI | DRUG | Regimen consists of irinotecan 180 mg/m\^2 IV on Day 1, leucovorin 400 mg/m\^2 or levoleucovorin 200 mg/m\^2 IV on Day 1, 5-FU 400 mg/m\^2 IV bolus on Day 1 and then 1200 mg/m\^2/day IV over 2 days for total dose of 2400 mg/m\^2 in each 2-week cycle |
| Pembrolizumab | BIOLOGICAL | IV infusion |
| Bevacizumab | BIOLOGICAL | IV infusion |
| Cetuximab | BIOLOGICAL | IV infusion |
Inclusion Criteria: * Locally confirmed dMMR or MSI-H stage IV colorectal carcinoma * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 10 days prior to study start * Life expectancy of at least 3 months * Measurable disease * Female participants of childbearing potentia...
mFOLFOX6 is a chemotherapy regimen used in the treatment of colorectal carcinoma. It is being studied as a standard therapy comparator in clinical trials for patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) stage IV colorectal carcinoma. The regimen is part of an active-controlled trial design.
mFOLFOX6 is associated with Merck & Company, Inc. (NYSE: MRK). The company is developing the drug for oncology indications, specifically colorectal carcinoma. Merck is conducting clinical trials involving mFOLFOX6 as a comparator therapy.
mFOLFOX6 is in Phase 3 clinical development for colorectal carcinoma. It is being evaluated in a completed Phase 3 trial that enrolled 307 participants. The drug is investigational and has not been approved by regulatory authorities based on the available information.
mFOLFOX6 is involved in clinical trial NCT02563002, titled 'Study of Pembrolizumab (MK-3475) vs Standard Therapy in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (MK-3475-177/KEYNOTE-177)'. This Phase 3 trial has been completed and enrolled 307 participants.
In the context of the KEYNOTE-177 trial, mFOLFOX6 is used as the standard therapy comparator. The trial compares pembrolizumab (MK-3475) against standard therapy, which includes mFOLFOX6, in patients with MSI-H or dMMR stage IV colorectal carcinoma. The trial is active-controlled, meaning mFOLFOX6 serves as the active control arm.