drugset / Trial / NCT04014530
Pembrolizumab With Ataluren in Patients With Metastatic pMMR and dMMR Colorectal Carcinoma or Metastatic dMMR Endometrial Carcinoma: the ATAPEMBRO Study
Phase 1/2
Recruiting
47 enrolled
Academic Medical Center - University of Amsterdam
Merck Sharp & Dohme LLC · collabPTC Therapeutics · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
Single Center, open label, Phase I-II trial designed to test the safety and efficacy of the combination of Ataluren and Pembrolizumab for the treatment of metastatic mismatch repair deficient and proficient colorectal adenocarcinoma and metastatic mismatch repair deficient endometrial carcinoma.
Timeline
- Start
- 2019-08-01
- Primary completion
- 2023-06-01
- Completion
- 2023-08-01
Publications
- Background Le DT, Uram JN, Wang H, Bartlett BR, Kemberling H, Eyring AD, Skora AD, Luber BS, Azad NS, Laheru D, Biedrzycki B, Donehower RC, Zaheer A, Fisher GA, Crocenzi TS, Lee JJ, Duffy SM, Goldberg RM, de la Chapelle A, Koshiji M, Bhaijee F, Huebner T, Hruban RH, Wood LD, Cuka N, Pardoll DM, Papadopoulos N, Kinzler KW, Zhou S, Cornish TC, Taube JM, Anders RA, Eshleman JR, Vogelstein B, Diaz LA Jr. PD-1 Blockade in Tumors with Mismatch-Repair Deficiency. N Engl J Med. 2015 Jun 25;372(26):2509-20. doi: 10.1056/NEJMoa1500596. Epub 2015 May 30.
- Figaroa OJA, Spaanderman IT, Goedegebuure RSA, Cirkel GM, Jeurissen FJF, Creemers GJ, Bins AD, Tuynman J, Buffart TE. Treatment with checkpoint inhibitors for unresectable non-metastatic mismatch repair deficient intestinal cancer; a case series. BJC Rep. 2025 Sep 22;3(1):67. doi: 10.1038/s44276-025-00171-0.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ataluren | Small molecule | 5 mg/kg | — |
| Subject | Ataluren | Small molecule | 10 mg/kg | — |
| Subject | Ataluren | Small molecule | 20 mg/kg | — |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |