A Multi Arm Study of MK-1308A in MSI-High Metastatic Stage IV Colorectal Cancer

• Research type

  Research Study

• Full title

  A Phase 2, Multicenter, Multi Arm, Study to Evaluate Pembrolizumab (MK-3475) or MK-1308A (Co-formulated quavonlimab (MK-1308)/pembrolizumab) in Participants with Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer: (MK-1308A-008)

• IRAS ID

  1003758

• Contact name

  David Fogelman

• Contact email

  david.fogelman@merck.com

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Eudract number

  2020-005114-18

• Clinicaltrials.gov Identifier

  NCT04895722

• Research summary

  CRC is a serious, life-threatening condition. Globally, the incidence of CRC reported in 2018 was ~1.8M (~10% of all cancers), and the number of worldwide cancer-related deaths due to CRC was ~881,000, thus the second leading cause of cancer death worldwide. There is a high unmet need in patients with dMMR/MSI-H CRC.

  This is a Phase 2 partially randomised, active-controlled, parallel-group, multi-site, open-label study of MK-1308A in participants (male and female) who are at least 18 years of age with with mismatch repair deficient or microsatellite instability-high Stage IV colorectal cancer (CRC) who have measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, and who are either chemotherapy refractory (Cohort A), have received no prior lines of therapy (Cohort B), or whose tumors are PD-1 refractory (Cohort C).
  MK-1308A refers to coformulated quavonlimab/pembrolizumab.

  MK-1308A or pembrolizumab will be administered every 6 weeks intravenously, for approximately 2 years (17 doses). Each participant may participate in the study for approximately 3 years.

  About 240 participants will take part in the trial from approximately 12 countries:
  Cohort A: 120 participants will be randomised in a 1:1 to receive either Pembrolizumab or MK-1308A
  Cohort B/Cohort C: 60 participants will be treated with MK-1308A

  Participants who complete study intervention after receiving 17 administrations of MK-1308A or pembrolizumab, and participants who attain a complete response and stop study intervention may be eligible for up to 9 additional administrations of MK-1308A or pembrolizumab (approximately 1 year) on experiencing disease progression.

  This study is sponsored by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (“MSD”), of Kenilworth, New Jersey, USA.

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  21/EE/0122

• Date of REC Opinion

  2 Jul 2021

• REC opinion

  Further Information Favourable Opinion