ivolumab and Trametinib in combination to treat colorectal cancer

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 405

Inclusion Criteria

•Age = 18, signed written informed consent
•Histological or cytological confirmed diagnosis of previously treated mCRC with adenocarcinoma histology and in Stage IV per AJCC
•Confirmed microsatellite status: only participants with pMMR/MSS mCRC are eligible
•Verified KRAS, NRAS (extended RAS) and BRAF mutation status: BRAF V600 mutant are not eligible
•Measurable disease per RECIST 1.1
•Provide Tumor Tissue sample at screening.
•ECOG Performance Status of 0-1

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 107

Exclusion Criteria

1) Target Disease Exceptions
a) Participants with BRAF V600 mutant colorectal cancer are NOT eligible for this study in Part 1, 1A, and 1B only.
2) Medical History and Concurrent Diseases
a) Any serious or uncontrolled medical disorder.
b) Prior malignancy active within the previous 3 years
c) Participants with an active, known or suspected autoimmune disease.
d) Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration.
e) Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
f) All toxicities attributed to prior anti-cancer therapy
g) Toxicities from the prior anti-cancer treatment have not been resolved to Grade 1
h) Current use of a prohibited medication.
i) Prior treatment with any MEK inhibitor
j) History of interstitial lung disease or pneumonitis.
k) Inability to take oral medication
l) Psychological, familial, or sociological condition potentially hampering compliance with the study protocol.
m) Additional criteria for Part 2 only:
i) Prior treatment with regorafenib or TAS-102
ii) Severe hepatic impairment (Child-Pugh C)
iii) Any evidence of active bleeding
iv) Prior or current gastrointestinal perforation or fistula
v) Arterial or venous thrombotic or embolic events within 6 months before the start of study medication
vi) Non-healing wound, non-healing ulcer, or non-healing bone fracture
vii) Active infection
3) Physical and Laboratory Test Findings
4) Allergies/Adverse Drug Reaction
5) Other Exclusion Criteria

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials