Table 5.
Examples of Ab-based immunotherapy in combination with chemotherapy in clinical trials as novel therapeutics in colorectal cancer.
| Study Name | Intervention Model | Estimated Enrollment | Drug | Phase | Date | NTC number | Major findings |
|---|---|---|---|---|---|---|---|
| LEAC-102 for Advanced Colorectal Cancer | Single Group Assignment | 30 | LEAC-102 500mg capsule and FOLFOX+Bevacizumab/Cetuximab | Phase 1 Phase 2 |
2016 | NCT02826837 | No Results Posted |
| Reolysin in Combination With FOLFOX6 and Bevacizumab or FOLFOX6 and Bevacizumab Alone in Metastatic Colorectal Cancer | Parallel Assignment | 109 | 1. FOLFOX + Bevacizumab + Reolysin 2. FOLFOX + Bevacizumab |
Phase 2 | 2012 | NCT01622543 | The addition of Reolysin to FOLFOX6/bevacizumab increases the patient’s overall response rate (204). |
| Efficacy of FOLFOX+Bevacizumab in Combination With Irinotecan in the Treatment of Metastatic Colorectal Cancer (CHARTA) | Parallel Assignment | 250 | 1. Oxaliplatin, 5FU/LV, Bevacizumab 2. 5FU/LV, Oxaliplatin, Bevacizumab, Irinotecan |
Phase 2 | 2011 | NCT01321957 | ↑ Survival of patients (205). |
| Sequential Treatment Strategy for Metastatic Colorectal Cancer (ITACa) | Parallel Assignment | 350 | 1. FOLFIRI or FOLFOX +Bevacizumab 2. FOLFIRI or FOLFOX 3. FOLFIRI or FOLFOX + CETUXIMAB 4. FOLFIRI or FOLFOX + BEVACIZUMAB and CETUXIMAB |
Phase 3 | 2013 | NCT01878422 | Adding bevacizumab to standard first-line chemotherapy did not benefit progression-free survival, overall survival, and response rate (206). |
| 2nd-line Treatment of Metastatic Colorectal Cancer (BEVATOMOX) | Parallel Assignment | 83 | 1. Bevacizumab, oxaliplatin, and 5FU combination 2. Bevacizumab, oxaliplatin, and raltitrexed combination |
Phase 2 | 2012 | NCT01532804 | Terminated No Results Posted |
| Neoadjuvant Treatment With mFOLFOXIRI Plus Cadonilimab (AK104) Versus mFOLFOX6 in Locally Advanced Colorectal Cancer (OPTICAL-2) | Parallel Assignment | 82 | 1. mFOLFOXIRI + Cadonilimab 2. mFOLFOX6 |
Phase 2 | 2022 | NCT05571644 | Not yet recruiting |
| FOLFOXIRI + Bev + Atezo vs FOLFOXIRI + Bev as First-line Treatment of Unresectable Metastatic Colorectal Cancer Patients (AtezoTRIBE) | Parallel Assignment | 201 | Different combination of: Bevacizumab Irinotecan Oxaliplatin L-Leucovorin 5-fluorouracil Atezolizumab |
Phase 2 | 2018 | NCT03721653 | ↑ Progression-free survival in patients (207). |
| A Study of Biomarker-Driven Therapy in Metastatic Colorectal Cancer (mCRC) (MODUL) | Parallel Assignment | 609 | Different combination of: Cetuximab FOLFOX induction regimen Fluoropyrimidine (5-FU/LV or capecitabine) Atezolizumab Vemurafenib Bevacizumab Trastuzumab Pertuzumab Cobimetinib 5-FU/LV |
Phase 2 | 2014 | NCT02291289 | N/A |
| Study of Pembrolizumab Treatment After CYAD-101 With FOLFOX Preconditioning in Metastatic Colorectal Cancer | Sequential Assignment | 24 | Different combination of: CYAD-101 FOLFOX Pembrolizumab |
Phase 1 | 2021 | NCT04991948 | Recruiting |
| Chemotherapy and Immunotherapy as Treatment for MSS Metastatic Colorectal Cancer With High Immune Infiltrate (POCHI) | Single Group Assignment | 55 | Different combination of: Capecitabine Oxaliplatin Bevacizumab Pembrolizumab |
Phase 2 | 2020 | NCT04262687 | Recruiting |
| Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers | Sequential Assignment | 120 | Different combination of: Tucatinib Trastuzumab Oxaliplatin Leucovorin Fluorouracil Capecitabine Pembrolizumab |
Phase 1 Phase 2 |
2020 | NCT04430738 | Recruiting |