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Association details:
Evidence:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
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Title:

Nivolumab Plus FOLFOXIRI/Bevacizumab in First Line Chemotherapy of Advanced Colorectal Cancer RASm/BRAFm Patients

Excerpt:
...Histologically confirmed diagnosis of colorectal cancer RAS/BRAF mutated....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Phase II Study on NIVolumab in combination with FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan)/Bevacizumab in first line chemotherapy of Advanced COloRectal cancer patients with mutated RAS or BRAF genes. Studio di fase II con Nivolumab in combinazione con FOLFOXIRI (fluorouracile, acido folinico, oxaliplatino e irinotecano)/Bevacizumab come trattamento di I linea in pazienti con tumore colorettale avanzato con mutazione dei geni RAS o BRAF.

Excerpt:
...• Age = 18 years on day of signing informed consent.• Histologically confirmed metastatic CRC RAS/BRAF mutated.• Suitable for first line chemotherapy.• Life expectancy > 3 months.• At least one site of measurable disease per RECIST criteria.• Performance status of 0-1 on the ECOG Performance Scale.• Adequate organ function, all screening labs should be performed within 28 days of treatment initiation.• Availability of 1 tumor block at baseline. ...
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Phase II study of nivolumab in combination with FOLFOXIRI/bevacizumab as first-line treatment in patients with advanced colorectal cancer RAS/BRAF mutated (mut): NIVACOR trial (GOIRC-03-2018).

Published date:
05/26/2022
Excerpt:
In subgroups analysis of MSS pts the ORR was 78.9% with a mDOR of 7.59 (95% CI 6.21 -11.43) months, DCR of 96.2%, and mPFS of 9.8 (95%CI 8.18-15.24) months….The primary endpoint ORR was met. These results show the preliminary efficacy and safety of NIV in combination with FOLOXIRI/BEV as first-line therapy in pts with mCRC RAS/BRAF mut.
Secondary therapy:
FOLFOXIRI
DOI:
10.1200/JCO.2022.40.16_suppl.3509
Trial ID: