Table 2.
Immunotherapy plus target therapy and Tyrosine kinase inhibitors.
| STUDY (#=non cited in the text) |
AGENTS | PHASE | SETTING | %MSS | PRIMARY ENDPOINT | RESULTS* *In the experimental arm when applicable |
|---|---|---|---|---|---|---|
|
NCT03406871
REGONIVO TRIAL (30) |
regorafenib + nivolumab | Ib | Advanced or metastatic, >II line | 96 | Dose limiting toxicity (DLT) | regorafenib 80mg/die |
| NCT03712943 | regorafenib + nivolumab | I/Ib | Advanced or metastatic, >I line | 100 | Maximum tolerated dose (MTD) and DLT | regorafenib 80mg/die |
|
NCT04126733
(31) |
regorafenib + nivolumab | II | Advanced or metastatic, II or III line | 100 | ORR | 7% |
|
NCT03657641
(33) |
regorafenib + pembrolizumab | I/II | Advanced or metastatic, II /IV line | 100 | mPFS | 2.0 months |
|
NCT03475953
REGOMUNE (34) |
regorafenib + avelumab | II | Advanced non resectable/ metastatic, pretreated | 100 | ORR | Ongoing |
|
NCT03797326
LEAP-005 (35) |
lenvatinib + pembrolizumab Colorectal cancer cohort |
II | Metastatic and/or unresectable, pretreated >2 line | 100 | ORR | 22% |
|
NCT04776148
LEAP-017 |
lenvatinib + pembrolizumab | III | Advanced | NA | PFS | Ongoing |
|
NCT03539822
CAMILLA TRIAL (37) |
durvalumab + cabozantinib | I/II | Metastatic, III line and beyond | 100 | ORR | 30% |
|
NCT04017650
SWOG S2107 (39) |
encorafenib + cetuximab + nivolumab | I/II | Metastatic, II line and beyond | 100 | ORR, Safety | 45% |
|
NCT01988896
(42) |
atezolizumab + cobimetinib Colorectal cancer cohort |
I/Ib | Metastatic any line | 74 | ORR | 8% |
|
NCT02788279
IMBlaze370 (34) |
atezolizumab + cobimetinib vs regorafenib | III | Locally advanced or metastatic, III line | 95 | OS | 8.87 months |
| NCT02876224# | cobimetinib + aezolizumab + bevacizumab | Ib | Unresectable metastatic, II line and beyond | NA | Safety | Ongoing |
| NCT03642067# | nivolumab + relatlimab | II | Metastatic, II line and beyond | NA | ORR, PR, CR | Ongoing |
| NCT04110093# | regorafenib + anti PD-1 (nivolumab, canrelizumab, sintilimab, toripalimab) | II | Metastatic, III line and beyond | NA | ORR, PFS | Ongoing |
| NCT05382741# | durvalumab + regorafenib | IIb | Adjuvant (IV stage NED) | NA | DFS | Ongoing |
| NCT05409417# | tislellimab + CAPOX + bevacizumab tislelizumab + mFOLFOX + cetuximab |
II/III | Metastatic (liver metastasis) | NA | conversion rate, safety | Ongoing |
| NCT04963283# | cabozantinib + nivolumab | II | Metastatic or unresectable, II line | NA | DCR | Ongoing |
| NCT03608046# | avelumab + cetuximab + irinotecan | II | Metastatic, II line | NA | ORR | Ongoing |
NA, not available.